A Report 201213

2012-13

Annual Report2012-13

Government of IndiaMinistry of Chemicals & Fertilizers

Department of Pharmaceuticals

Annual Report | 2012-13

Contents1. IntroduCtIon

2. An overvIew of PhArmACeutICAls Industry

3. PhArmACeutICAls Industry

4. nAtIonAl PhArmACeutICAls PrICIng AuthorIty

5. PublIC seCtor undertAkIngs

6. nAtIonAl InstItute of PhArmACeutICAl eduCAtIon & reseArCh (nIPer)

7. new InItIAtIves

8. ImPlementAtIon of rAjbhAshA

9. generAl AdmInIstrAtIon

10. PerformAnCe evAluAtIon And mAnAgement system

11. CItIzen CentrIC governAnCe

12. InformAtIon And teChnology

13. Annexure


brief Contents1. IntroduCtIon 7

1.1 mandate of department of Pharmaceuticals 71.2 vision and mission of the department 8

2. An overvIew of PhArmACeutICAls Industry 92.1 financial Performance of the drugs and Pharmaceuticals Industry 112.2 Imports 122.3 exports 122.4 share in national trade 132.5 Pharma export Promotion Council (Pharmexcil) 132.6 International Cooperation/export Promotion of Pharmaceuticals 142.7 Proposed major areas of International Conference 142.8 India Pharma summit - 2012 14

3. PhArmACeutICAls Industry 153.1 Pharmaceuticals Industry 173.2 Creation of IPr facilitation Centers in Phamexcil 173.3 Pharmaceuticals Policy 173.4 foreign direct Investment in Pharmaceutical sector 18

4. nAtIonAl PhArmACeutICAls PrICIng AuthorIty 214.1 nPPA 234.2 drug Price equalization Account (dPeA) 26

5. PublIC seCtor undertAkIngs 295.1 Central Public sector undertakings 315.2 joint sector undertakings 395.3 wholly owned subsidiaries 405.4 status of Annual Accounts 415.5 generic drugs Campaign – the jan Aushadhi Campaign 41

6. nAtIonAl InstItute of PhArmACeutICAl eduCAtIon & reseArCh (nIPer) 43

7. new InItIAtIves 71

8. ImPlementAtIon of rAjbhAshA 75


9. generAl AdmInIstrAtIon 799.1 organisation set up 819.2 record management 839.3 grievance Cell 83

10. PerformAnCe evAluAtIon And mAnAgement system 8510.1 our vision 8710.2 our mission 8710.3 our objective 8710.4 functions 87

11. CItIzen CentrIC governAnCe 8911.1 our vision 9111.2 our mission 9111.3 our Clients 9111.4 our Commitment 9111.5 our services 9111.6 our Activities 9111.7 rtI-2005 9111.8 CPgrAms 92

12. InformAtIon And teChnology 9312.1 local Area network (lAn) 9512.2 It Infrastructure 9512.3 website 9512.4 video Conferencing 9512.5 file tracking system 9512.6 voice mail facility 9612.7 e. governance 96

13. Annexure 97Annexure – I 99Annexure – II 103Annexure – III 105Annexure – Iv 111Annexure – v 113

Chapter 1IntroductIon1.1 Mandate of Department of Pharmaceuticals

1.2 Vision and Mission of the Department


7

ChAPter – 1IntroduCtIon

1.1 Mandate of departMent of pharMaceuticals

The Department of Pharmaceuticals in the Ministry of Chemicals & Fertilizers was created on 01.07.2008 to provide greater focus for the growth of the Pharmaceuticals industry.

Following work has been allocated to the Department of Pharmaceuticals:

1) Drugs and Pharmaceuticals, excluding those specifically allotted to other departments.

2) Promotion and co-ordination of basic, applied and other research in areas related to the Pharmaceuticals sector.

3) Development of infrastructure, manpower and skills for the Pharmaceuticals sector and management of related information.

4) Education and training including high end research and grant of fellowships in India and abroad, exchange of information and technical guidance on all matters relating to pharmaceutical sector.

5) Promotion of public – private – partnership in pharmaceutical related areas.

6) International cooperation in pharmaceutical research, including work related to international conferences in related areas in India and abroad.

7) Inter-sectoral coordination including coordination between organizations and institutes under the Central and State Governments in areas related to the subjects entrusted to the Department.

8) Technical support for dealing with national hazards in pharmaceutical sector.

9) All matters relating to National Pharmaceuticals Pricing Authority including related functions of price control/monitoring.

10) All matters relating to National Institutes for Pharmaceuticals Education and Research (NIPERs).

11) Planning, development and control of; and assistance to, all industries dealt with by the Department.

12) Bengal Chemicals and Pharmaceuticals Limited.

13) Hindustan Antibiotics Limited & its subsidiaries as & JVs.

14) Indian Drugs and Pharmaceuticals Limited & its subsidiaries.

15) Karnataka Antibiotics and Pharmaceuticals Limited.

16) Rajasthan Drugs and Pharmaceuticals Limited.

17) Bengal Immunity Limited.

18) Smith Stanistreet Pharmaceuticals Limited.

A draft proposal to modify the 2nd Schedule to the Government of India (ALLOCATION OF BUSINESS) RULES 1961 was forwarded to the Cabinet Secretariat on 11.01.2013.

The work of the Department has been organized into three Divisions viz. Pharmaceuticals Industry Division, Public Sector Undertakings Division and R&D Division comprising National Institute of Pharmaceutical Education & Research, (NIPER) and Research & Development. The National Pharmaceuticals Pricing Authority (NPPA), an attached office of this Department, is entrusted with fixation and revision of prices of Pharmaceuticals products under Drug Price Control Order, 1995 (DPCO, 1995).

There are five Central Public Sector Undertakings (CPSUs) viz Indian Drugs and Pharmaceuticals Limited (IDPL), Hindustan Antibiotics Limited (HAL), Bengal Chemicals and Pharmaceuticals Limited (BCPL), Bengal Immunity Limited (BIL) and Smith Stanistreet Pharmaceuticals Limited(SSPL). Earlier Karnataka Antibiotics & Pharmaceuticals Limited. (KAPL) was a joint venture between Hindustan Antibiotics Limited (HAL) and State Government of Karnataka and Rajasthan Drugs and Pharmaceuticals Limited (RDPL) was a joint venture of Indian Drugs and Pharmaceuticals Limited (IDPL) and the State Government of Rajasthan. But in order to sustain the growth & development of KAPL & RDPL, Government has approved de-linking of both these companies from HAL & IDPL respectively. The shares of KAPL held by HAL have now been transferred to the President of India w.e.f. 1st October, 2009 and


8

similarly shares of RDPL held by IDPL have been transferred to the President of India w.e.f. 17th August, 2010. The shareholding of respective States in these joint ventures would continue to remain unaffected.

National Institutes of Pharmaceuticals Education & Research (NIPERs) are autonomous institutions under this Department.

Shri M.K. Alagiri is the Minister of Chemicals and Fertilizers and Shri Shrikant Kumar Jena is the Minister of State, Independent Charge in the Ministry of Statistics and Programme implementation and Minister of State in the Ministry of Chemicals and Fertilizers. Shri Dilsher Singh Kalha, is Secretary in the Department of Pharmaceuticals w.e.f 25.01.2012.

1.2 Vision and Mission of the departMent

Vision:

Based on the mandate given to the Department of Pharmaceuticals through the allocated functions a vision has been fixed in concurrence with the Cabinet Secretariat, which is as follows:

“India : The largest global provider of quality medicines at reasonable prices.”

Mission:

• Ensure availability of drugs at reasonable prices as per provisions of the Drug Prices Control Order, 1995

• Develop Human Resources for Pharmaceutical Industry and Drug Research and Development

• Formulate Scheme/ Project for promoting Public-Private Partnership for development of pharmaceuticals Industry

• Formulate Scheme/ Project for promoting Pharma Brand India through International Cooperation

• Formulate Scheme/ Project for promoting environmentally sustainable development of Pharmaceutical Industry

Chapter 2An overvIew of PhArmAceutIcAls Industry2.1 FinancialPerformanceoftheDrugsandPharmaceuticalsIndustry2.2 Imports2.3 ExportofDrugsandPharmaceuticalsIndustry2.4 ShareinNationalTrade2.5 PharmaExportPromotionCouncil(Pharmexcil)2.6 InternationalCooperation/ExportPromotionofPharmaceuticals2.7 ProposedMajorareasofInternationalConference2.8 IndiaPharmaSummit-2012


11

ChAPter – 2An overvIew of PhArmACeutICAls Industry

2.1 financial perforMance of the drugs and pharMaceutical industry

The financial performance of the Drugs and Pharmaceutical industry for the year 2010-11, 2011-12 & 2012-13 (Forecast) and the quarterly performances during the Year 2012-13, all compared as a percentage change over the year ago are given in Table below:-

Drugs and Pharmaceuticals : Growth and Profitability in the Year 2012-13(%age change over year ago)

sl. no. particulars Quarterly annualJune’12 sept.’12 dec.’12 March’13 2010-11 2011-12 2012-13

forecast forecast forecast1 Income 14.0 17.4 15.3 11.4 10.9 16.0 14.52 Net sales 14.7 13.2 15.2 14.3 12.4 16.5 14.43 Total expenses 23.2 9.1 -1.9 12.0 19.2 18.4 9.64 Raw Materials 8.1 11.10 16.6 11.0 14.8 11.3 11.85 Salaries & Wages 15.4 19.6 15.6 13.0 21.1 15.7 15.96 Power & fuel 45.6 50.7 17.6 16.0 20.1 9.4 28.97 Selling & Marketing 41.0 34..1 14.0 12.2 11.9 10.2 23.88 Other expenses 60.4 -4.0 -10.0 14.1 15.9 40.6 9.89 Depreciation 14.3 13.8 10.0 20.0 12.4 15.3 14.510 Interest expenses 48.7 12.6 13.0 -15.0 6.6 46.5 10.911 Tax provision 11.0 37.4 94.3 28.6 73.6 -48.4 39.212 PBDIT -31.6 45.4 60.3 20.7 -1.1 0.8 20.213 PAT -63.5 116.6 - 3.4 -31.6 -9.8 58.914 PBDIT/Net Sales (%) 12.3 19.4 18.6 19.2 19.0 16.7 17.5

Source: Center for Monitoring Indian Economy (CMIE) Report December 2012.

Net sales of the industry grew by a healthy 14.7 percent in the quarter ending June 2012 as compared to the year ago quarter. The depreciation in the value of rupee against the USD, though favorable for the export-oriented drug companies had an adverse impact on the profits of companies. The industry imports around 38 percent of its raw material requirements which exerted pressure on the profit margins. Huge forex losses brought down the profit of the drugs & pharmaceuticals industry in the June 2012 quarter. The industry’s PAT slumped during the quarter.

The drugs & pharmaceuticals industry performed well in the second quarter ending September 2012. Rising sale from the US generic market, strong growth in

domestic market, robust growth in other income and slower growth in expenses boosted the financial performance of the drugs & pharmaceuticals industry. Net sales of the industry grew by a healthy 13.2 percent in the September 2012 quarter as compared to the year ago quarter. Other income increased during the quarter due to forex gains made by some companies. Raw materials expense, the largest cost component of the industry, rose by a slower percent as compared to the growth in sales. In the absence of forex losses, other expenses also fell. Resultantly, the industry’s operating expenses corresponding to goods sold rose by a slower percent. This improved the core operating performance of the industry. A healthy operating performance and a robust growth


12

in other income boosted the financial performance of the drugs & pharmaceuticals industry.

The sales growth of the pharma industry is likely to remain healthy in the second half of the year 2012-13. The Pro Generic policy of developed markets and strong demand scenario in the developing market. Export volumes are likely to remain healthy due to strong demand for generic drugs. On a y-o-y basis, the rupee continues to remain weak. Hence, export realizations are also likely to remain strong.

2.2 iMports

As per the Directorate General of Commercial Intelligence and Statistics (D.G.C.I.S.) Kolkata, value of imports of “Medicinal and Pharmaceuticals Products” for the period 2003-04 to 2011-12 is as under:

(Rs. in crore)

year Value of import of “Medicinal and pharmaceuticals

products”

growth (%)

2003-04 2,956 3.182004-05 3,139 6.192005-06 4,515 43.842006-07 5,866 29.922007-08 6,734 14.792008-09 8,649 28.432009-10 9,959 15.152010-11 11,114 11.602011-12(P) 14385 29.43

(Source: Directorate General of Commercial Intelligence and Statistics (DGCIS), Kolkata)

It may be observed that the imports have shown a growth of 29.43% in the year 2011-12 compared to previous year. The country is almost self-sufficient in production of most of formulations/ pharmaceuticals products. As such imports are being resorted to on quality & economic considerations and not necessarily due to non-availability from domestic sources. Manufacturers of Drugs & Pharmaceuticals are free to produce any drugs approved by the Drug control authorities.

Import of Drugs & Pharmaceuticals is regulated as per the Foreign Trade Policy of Government of India. Import of some drugs and drug intermediates are restricted under current Foreign Trade Policy. These restrictions are basically due to common HS codes assigned to some narcotic substances or similarity to some Ozone Depleting Substances (ODS) with pharmaceutical products.

2.3 EXPORTS

As per DGCIS, Kolkata Exports of “Drugs and Pharmaceuticals and Fine Chemicals” for the period 2003-04 to 2010-11 are below:-

(Rupees in crore)

year Value of exports of “drugs and

pharmaceuticals and fine chemicals”

growth (%)

2003-04 15,213 18.61

2004-05 17,228 13.25

2005-06 21,230 23.23

2006-07 25,666 20.89

2007-08 29,354 14.37

2008-09- 39,821 35.66

2009-10 42,456 6.62

2010-11 48,810 14.97

2011-12(P) 63,347 29.78

Source: DGCIS, Kolkata

It may be observed that the exports have shown a growth of 29.78% in the year 2011-12 compared to previous year.

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

2003-04 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 2010-11 2011-12

2,956 3,1394,515

5,8666,734

8,6499,959

11,114

14385

Rs.

inC

rore

s

Years

VALUE OF IMPORT OF "MEDICINAL &PHARMACEUTICALS PRODUCTS"


13

2.4 share in national trade(Value in Rs. Crore)

items/years 2007-08 2008-09 2009-10 2010-11 2011-12a: total national exports 655864 840755 845534 1142922 1459281(a) Drugs Pharmaceuticals and Fine

chemicals 29354 39821 42456 48810 63347

share in total export % 4.5 4.7 5.0 4.3 4.3B: total national imports 101232 1374436 1363736 1683467 2344772(b) Medicinal and Pharmaceuticals

Products 6734 8649 9959 11114 14385

share in total import % 0.7 0.6 0.7 0.7 0.6(c) Trade Balance (a)-(b) 22620 31172 32497 37696 48962

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

2003-04 2004-05 2005-06 2006-07 2007-08 2008-09- 2009-10 2010-11 2011-12

15,213 17,22821,230

25,66629,354

39,821 42,45648,810

63,347

Rs.

inC

rore

s

Years

Value of Export of "Drugs Pharmaceuticalsand Fine chemicals"

2003-04 2004-05 2005-06 2006-07 2007-08 2008-09- 2009-10 2010-11 2011-12

Exports 19 13 23 21 14 36 7 15 30

Imports 3 6 44 30 15 28 15 12 29

19

13

23 21

14

36

7

15

30

3 6

44

30

15

28

15 12

29

-

5

10

15

20

25

30

35

40

45

50

Indi

ces

Growth of Import "Medicinal and Pharmaceu�cals Products" & "Export Drugs

Pharmaceu�cals and Fine chemicals"

1459281

63347

Total National Exports

Drugs Pharmaceuticals and Fine chemicals

2344772

14385

Total National Imports

Medicinal and Pharmaceuticals Products

The share of Exports of the “Drugs Pharmaceuticals and Fine Chemicals” in the total National Exports declined from 4.50% to 4.30% during the period 2007-08 to 2011-12, However in the absolute terms there is growth in Exports. The share of Imports is declined 0.7% to 0.6% in the corresponding period.

2.5 PHARMA EXPORT PROMOTION COUNCIL (PHARMEXCIL)

The Department had played a pivotal role in the

formation of Pharmexcil consequent to the recommendation from 9th Five Year Plan Working Group Report on Drugs and Pharmaceuticals. In the light of this, the Department constantly interacts with Pharmexcil in their work areas. The role of Pharmexcil is for facilitation of exports of Drugs, Pharmaceuticals, Biotechnology products, Herbal medicines and Diagnostics, to name a few. It is authorised to issue Registration-cum-Membership Certificate (RCMC) which is one of the requirements for the importers


14

and exporters of commodities. In addition to this, Pharmexcil is concerned with giving export thrust to the various products through visits of delegations to various markets abroad, organizing of seminars, workshops and exhibitions. As a major area of work, Pharmexcil also holds Buyers/Sellers meets and compiles detailed data base on pharma exports and problems in exporting pharma products.

2.6 international cooperation/ EXPORT PROMOTION OF pharMaceuticals

An important focus area for the Department of Pharmaceuticals is promotion of Indian Pharmaceutical Products in global market. The Department participated in the following International Cooperation events during 2012-2013:-

1. Participation in US-India Bio-Pharma and Healthcare Summit organized by USA-India chamber of Commerce (USAIC) held on 11th May, 2012 at Massachusetts in USA.

2. Participation in the Fourth Session of the Indo-Ukrainian Inter-Governmental Commission on Trade, Economic, Scientific, Technological, Industrial and Cultural cooperation (IUIGC) held on 31 May-June 1, 2012 at Kyiv, Ukraine.

3. Participation in the meeting of India-EU Sub Commission on Trade held on 30th October, 2012 in New Delhi.

4. Participation in the 18th Session of India-Russia Working Group on Trade and Economic Cooperation (IRWGTEC) held on 11th -12th October, 2012 in New Delhi.

5. Participation in the VI Session of India-Russia Forum on Trade and Investment held on 15th October, 2012 in New Delhi.

6. The Department of Pharmaceuticals has signed a Memorandum of Understanding with Belarus on 14th November, 2012 for Cooperation in the Field of Production and Trade of Pharmaceutical Products.

The Department of Pharmaceuticals also provided financial assistance for the following activities/events for promotion and development of the Pharma sector:

1. For organizing a Workshop on “Promoting/ use of Quality Generic Medicines”.

2. For organizing Bio Asia: Global Bio-business forum in January, 2013.

3. For preparation of 1st draft & 2nd Interim draft of DPR 2020 for developing India as drug discovery &Pharma Innovation Hub 2020.

4. For submitting a DPR on Establishment of an Indian Pharma Innovation Venture Fund for Drug Design, Discovery & Development.

2.7 PROPOSED MAJOR AREAS OF international cooperation

The Department proposes to leverage Inter-Country partnership through MoUs for formulating greater market access to Indian Pharma in key markets like Russia, Ukraine, Kazakhstan etc amongst the CIS, Mexico, Brazil, Venezuela, etc in LAC region, Japan, ASEAN, etc in the East Asia, South Africa, Nigeria, Kenya, etc in Africa and some key Gulf Countries like Saudi Arabia, UAE, etc. It is also targeting focus on European countries like Spain, Greece, Germany, France and Italy for APIs and niche formulations.

2.8 INDIA PHARMA SUMMIT-2012

The Department of Pharmaceuticals in collaboration with Federation of Indian Chamber of Commerce and Industry (FICCI) and WHO India organized “India Pharma Summit 2012”, on 4th December, 2012 in New Delhi.The theme of India Pharma Summit 2012 was “INDIAN PHARMA - ACCESS TO MEDICINES & GLOBAL OUTREACH”. The India Pharma Summit was a one day event to showcase India’s capability in the Pharma Sector before all the stakeholders as well as to provide the networking opportunities to the Indian Pharma Industry for having a meaningful interaction with various stakeholders. It provided a platform that brought all the stakeholders such as policy makers from Government of India, State Governments, Indian Pharma Industry, Regulatory Authorities from focus countries, Academia, Global Pharma Leaders/ Experts on one platform and facilitated a meaningful interaction. It generated a healthy debate as well to come up with the solutions to issues of the problems being faced by Pharma Sector. India Pharma Summit 2012 was the 4thevent in successful series after the Department of Pharmaceuticals was carved out of Department of Chemicals & Petrochemicals in July 2008.

Chapter 3PhArmAceutIcAls Industry

3.1 PharmaceuticalIndustry3.2 CreationofIPrFacilitationCentresinPharmexcil3.3 PharmaceuticalPolicy3.4 ForeignDirectInvestmentinPharmaseuticalSector


17

ChAPter – 3PhArmACeutICAl Industry

3.1 PHARMACEUTICAL INDUSTRY

The annual turnover of the Indian Pharmaceutical Industry is estimated to be about Rs. 119075.61 Crores during the year 2010-11. The share of export of Drugs, Pharmaceuticals and Fine Chemicals is more than Rs. 47363.32 Crores. This segment of Industry has shown tremendous progress in terms of infrastructure development, technology base and wide range of products. The industry has developed excellent GMP (Good Manufacturing Practices) compliant facilities for the production of different dosage forms. The strength of the industry is in developing cost effective technologies in the shortest possible time for drug intermediates and bulk activities without compromising on quality. This is realized through the country’s strengths in organic chemicals’ synthesis and process engineering.

The domestic Pharma Industry has recently achieved some historic milestones through a leadership position and global presence as a world class cost effective generic drugs’ manufacturer of AIDS medicines. Many Indian companies are part of an agreement where major AIDS drugs based on Lamivudine, Stavudine, Zidovudine, Nevirapine are supplied to Mozambique, Rwanda, South Africa and Tanzania which have about 33% of all people living with AIDS in Africa. Many US Schemes are sourcing Anti Retrovirals from Indian companies whose products are already US FDA approved.

The Indian Pharmaceutical companies maintain highest standards in Purity, Stability and International Safety, Health and Environmental (SHE) protection in production and supply of bulk drugs. This speaks of the high quality standards maintained by a large number of Indian Pharma companies as these bulk actives ingredients are used by the buyer companies in manufacture of dosage forms which are again subjected to stringent assessment by various regulatory authorities in the importing countries. More of Indian companies are now seeking regulatory approvals in USA in specialized segments like Anti-

1 Source CMIE(July, 2012)2 Source CMIE(Mar, 2011)

infectives, Cardiovasculars, CNS group. Along with Brazil & PR China, India has carved a niche for itself by being a top generic Pharma player.

Many Indian companies have got various international regulatory approvals for their plants, from agencies like USFDA, MHRA-UK, TGA-Australia, MCC-South Africa etc. Outside USA India is the only country having the highest number of USFDA approved plants for generic drugs’ manufacture outside USA. Major share of Indian Pharma exports is going to developed western countries and it speaks not only about excellent quality of Indian pharmaceuticals but also about the reasonableness of the prices. Some of the leading Indian Pharma companies derive 50% of their turnover from International business.

3.2 CREATION OF IPR FACILITATION CENTRES IN PHARMEXCIL

The Working Group on Drugs and Pharmaceuticals for the 11th Five Year Plan (2007-2012) recommended setting up of 3 IPR Facilitation Centres at 3 offices of Pharmexcil in order to disseminate information on IPRs and related issues to the Pharma Industry in an effective manner. For this purpose, a fund Rs. 5 crores was proposed by the Working Group for the 11th Five Year Plan. The first centre was opened at Hyderabad on 11th July, 2008. Subsequently, centre at Mohali was opened. These centres are offering various services to the members like General Information on Patents, Patent status of pharmaceutical products in India and other countries, Interpretation of search information etc. Keeping in view the importance of this scheme, it has been recommended to Planning Commission to continue and further strengthen this scheme in the 12th Five Year Plan.

3.3 PHARMACEUTICAL POLICY

This Department has been exercising Drug Price Control on the basis of criteria mentioned in ‘Modifications in Drug Policy, 1986’ announced in September, 1994, which is based on production data of 1990.

Further the Department of Pharmaceuticals prepared a draft National Pharmaceutical Pricing Policy, 2011


18

(NPPP-2011) based on the criteria of essentiality and requirements as stipulated by Ministry of Health & Family Welfare. The draft National Pharmaceutical Pricing Policy, 2011(NPPP-2011) was circulated among the concerned Ministries/Stakeholders. The draft Policy was/is also available on the Department’s website www.pharmaceuticals.gov.in for comments by 30.11.2011 of any other interested person. In the draft policy it was proposed to bring the NLEM-2011 & associated medicines under price control.

The Department of Pharmaceuticals has notified the National Pharmaceutical Pricing Policy-2012 (NPPP-2012). The objective is to put in place a regulatory framework for pricing of drugs so as to ensure availability of required medicines – “essential medicines” – at reasonable prices even while providing sufficient opportunity for innovation and competition to support the growth of industry, thereby meeting the goals of employment and shared economic well being for all.

The salient features of this policy are as under:

• All the medicines, as under National List of Essential Medicines (NLEM) -2011, that takes care of the healthcare needs of the majority of the population of the country, will come under Price Control.

• Nearly 614 formulations, spread over 27 therapeutic categories including HIV, diabetes, heart diseases, cancer etc will be under price control.

• The Prices of nearly 63% of medicines under NLEM-2011 will decrease by more than 20%. In some cases this reduction is even up to 80%of the present market price. For example Diclofenac 50mg tablet, priced at Rs. 4.65 per tablet will be capped at Rs. 1.97 per tablet.

• The total domestic pharma market is around Rs. 60,000 Crores and with the implementation of NPPP-2012, nearly Rs 15,000 Crores market will come under price control which is 25% of the domestic market.

3.4 FOREIGN DIRECT INVESTMENT IN pharMaseutical sector

Foreign Direct Investment (FDI) up to 100% has been in operation in Pharmaceutical Sector since 2001. However, during the period of August 2006 to December 2010, acquisitions of some of the major Indian Pharma Companies like Ranbaxy and Piramal, led to a strong apprehension that these takeovers could affect the domestic Pharma Industry especially the Generic Medicines.

The Department of Pharmaceuticals requested the Department of Commerce to conduct a study on the takeovers of Indian companies by the MNCs. The Department of Commerce entrusted the work to Ernst & Young. Department of Commerce informed that the report recommended continuation of the existing FDI policy (100% through automatic route) in pharmaceutical sector.

However, with a view to examine the issued involved in FDI in a broader perspectives, Planning Commission had, with the approval of the Hon’ble Prime Minister, constituted a High Level Committee (HLC) under the Chairpersonship of Shri Arun Maira, Member (Industry), Planning Commission to consider all the relevant aspects. The majority of the members of the Committee were of the view that the acquisitions in Pharmaceutical Sector should be monitored and controlled through Competition Commission of India (CCI).

The Hon’ble Prime Minister chaired a meeting to discuss the FDI policy in drugs and pharmaceutical sector on 10th October, 2011. The meeting deliberated upon the report of Shri Arun Maira, Member (industry) Planning Commission, which followed a CCEA decision to get greater clarity on the issue of FDI policy governing mergers and acquisitions in the pharmaceutical sector, while striking a balance between larger public health concerns and strengthening domestic manufacturing capacities. The following considered decisions were taken in the meeting:

(a) India will continue to allow FDI without any limits (100%) under the automatic route for Greenfield


19

investments in the pharma sector. This will facilitate addition of manufacturing capacities, technology acquisition and development;

(b) In case of brownfield investments in the pharma sector, FDI will be allowed through the FIPB approval route for a period of upto six months. During this period, necessary enabling regulations will be put in place by the CCI for effective oversight on mergers and acquisitions to ensure that there is a balance between public health concerns and attracting FDI in the pharma sector. Thereafter, the requisite oversight will be done by the CCI entirely in accordance with the competition laws of the country.

Subsequently, Department of Industrial Policy & Promotion issued Press Note No. 3 (2011 Series) dated 8.11.2011 amending the existing FDI policy under which 100% FDI was permitted through

automatic route. As per Press Note 3(2011 Series) issued by Department of Industrial Policy and Promotion on 08.11.2011:-

(i) FDI, upto 100%, under the automatic route, would continue to be permitted for greenfield investments in the Pharmaceuticals sector.

(ii) FDI upto 100%, would be permitted for brownfield investment (i.e. investments in existing companies), in the pharmaceuticals sector, under the Government approval route.

On 03.12.2012, a meeting was held under the Chairmanship of Hon’ble Prime Minister and it was decided that FIPB shall continue to scrutinize proposals for FDI in brownfield Pharma till the CCI is equipped with the power to impose conditionalities on Mergers and Acquisitions with Public Health concerns

Chapter 4nAtIonAl PhArmAceutIcAls PrIcIng AuthorIty4.1 NPPA4.2 DrugPriceEqualizationAccount(DPEA)


23

ChAPter – 4nAtIonAl PhArmACeutICAl PrICIng AuthorIty (nPPA)

4.1 nppa

The National Pharmaceutical Pricing Authority (NPPA) was established as an independent body of experts under the Ministry of Chemicals and Fertilizers by Gazette notification dated 29.08.1997. The Authority is entrusted with the task of price fixation / revision of the 74 scheduled bulk drugs and formulation containing any of the scheduled drugs under the Drugs (Prices Control) Order, 1995 as well as monitoring and enforcement of prices. NPPA also provides inputs to the Government for policy formulation and on other specific issues concerning affordable medicines to the consumer.

The functions of the National Pharmaceutical Pricing Authority (NPPA) are:

(1) To implement and enforce the provisions of the Drugs (Price Control) Order (DPCO), 1995 in accordance with the power delegated to it.

(2) To undertake and/or sponsor relevant studies in respect of pricing of drugs/formulations.

(3) To monitor the availability of drugs, identify shortages, if any, and to take remedial steps.

(4) To collect/maintain data on production, exports and imports, market share of individual companies, profitability of companies etc. for bulk drugs and formulations.

(5) To deal with all legal matters arising out of the decisions of the Authority.

(6) To render advice to the Central Government of changes/revisions in the drug policy.

(7) To render assistance to the Central Government in parliamentary matters relating to drug pricing.

The organizational structure of NPPA is given in the chart below:-

The performance of NPPA since its inception (up to 31.01.2013) is as under:

The National Pharmaceutical Pricing Authority (NPPA) since its inception has fixed / revised the prices of scheduled bulk drugs in 532 cases, which includes 342 bulk drugs and 190 derivatives of scheduled bulk drugs.

Of these, the prices of 7 scheduled bulk drugs and 3 derivative and 510 formulations were fixed / revised during the period from 01.04.2012 to 31.01.2013.

The NPPA compiles the annual data on production of selected monitored bulk drugs. The data on production for the years 2009-10, 2010-2011, 2011-2012 and 2012-13 (upto November, 2012) is given in the Annexure - I.

The price of scheduled bulk drugs fixed during the last four years & since inception are given in Annexure - II and summarized below:

BulK drugs prices

particulars 2009-10 2010-11 2011-12 2012-13(upto 31st Jan., 13

sinceinceptionof nppa

No. of Bulk Drugs Where Price Increased 15 10 19 06 158

No. of Bulk Drugs Where Price Decreased 10 07 01 04 347

No. of Bulk Drugs Where price fixed For First Time 02 01 0 0 17

No change In Price 01 03 01 0 10

total 28 21 21 10 532


24

Monitoring of prices

The NPPA monitors and analyses month-wise price movements of non-scheduled formulations based on the reports of IMS Health. The prices of these formulations are fixed / determined by manufacturers themselves depending on various factors like the cost of production, market competition, company’s profitability status etc. NPPA monitors the prices of non-scheduled formulations through various methods like (a) scrutiny of price lists submitted by manufacturers (b) analysis of monthly ‘Stockiest Secondary Audit Reports’ published by IMS Health, and (c) complaints / references received from official and non-official sources. Wherever price increase beyond 10% is noticed, manufacturers of such formulations are asked to clarify the reasons for such price increases.

The manufacturers are impressed upon to bring down the prices voluntarily and to maintain the price

forMulation pacKsparticulars 2009-10 2010-11 2011-12 2012-13

(upto 31st Jan., 13)

since inception of

nppa

Price Increased 184 223 257 81 1870

Price Decreased 450 60 50 104 3513

Price fixed for first time 1155 371 239 253 6315

No change in prices 35 59 61 72 472

total 1824 713 607 510 12170

level. So far 33 companies have reduced prices of 65 non-scheduled formulation packs voluntarily after intervention of NPPA. This is an on-going process. Further, NPPA has fixed the price of 30 non-scheduled formulations under para 10(b) of DPCO, 1995. Thus prices of 95 non-scheduled formulation packs have been reduced through the intervention of NPPA till 31st January, 2013.

creation of enforceMent diVision & its perforMance

A separate Enforcement Division was created in NPPA in June, 2007 to facilitate suo-moto detection of violation of DPCO 1995. Since inception 4032 samples were analysed leading to prima facie detection of 1308 cases of overcharging and 549 cases of selling of scheduled medicines without price approval.


25

recoVery of oVercharged aMount

There are a total no. of 919 cases wherein demand notices have been issued involving total overcharged amount of Rs. 2596.69 crores including interest since inception of NPPA till January, 2013. An amount of Rs. 234.31 crores has been recovered till 31.01.2013 which also includes recovery through Court orders. During the year 2012-13 (upto 31.01.13) Demand Notice have been issued for Rs. 134.44 crore and Rs. 14.49 crore has been recovered. As on 31.01.13, 116 cases involving total demand of Rs. 2448.36 crore are under litigation in various High Courts and also in the Supreme Court, out of which Rs. 180.62 crore has already been deposited by the companies in pursuance of the court order and the balance

performance of enforcement divisionyear no. of samples

collectedprima facie

Violations detectedreferred for

overchargingIdentified for Price fixation

2007-08 1450 840 456 384

2008-09 520 284 172 112

2009-10 464 246 208 38

2010-11 533 225 216 9

2011-12 559 156 152 4

2012-13 (upto Jan. 2013 * 486 106 104 2

* 70 cases are under process

amount is still pending. 50 cases amounting to Rs. 16.63 crore are pending with the Collectors of various States for recovery arrears of Land Revenue. The recovery of the overcharged amount is affected due to various Court orders passed by various High Court and also Supreme Court in cases filed by the Pharmaceuticals Companies challenging the price fixation / notification issued by NPPA / Government. Inclusion of some bulk drugs under price control (scheduled-I of DPCO’95) has also been challenged by the Pharma companies in different courts of India. NPPA / Government is defending such cases through SG, ASG’s and Senior Government Counsels. Whenever necessary NPPA files urgent application in the Courts for vacation of interim orders and also for early hearing / disposal of the case.

The Status of cases of overcharging since inception till 30th January, 2013

si no.

particulars aug, 1997 to March 2006

2006-07 2007-08 2008-09 2009-10 2010-11 2011-12 2012-13(upto Jan., 2013)

cummulative (Aug, 97 to Jan., 2013)

1 No. of Cases 335 67 118 135 89 42* 46 93 919

2. Overcharged amount demanded alongwith interest

700.22 38.01 820.31 435.62 156.22 146.93 164.94 134.44 2596.69

3. Amount Realized 99.16 0.96 4.51 51.41 35.41 17.26 10.69 14.91 234.31


26

si no.

particulars aug, 1997 to March 2006

2006-07 2007-08 2008-09 2009-10 2010-11 2011-12 2012-13(upto Jan., 2013)

cummulative (Aug, 97 to Jan., 2013)

4. Amount Outstanding

601.06 37.05 815.80 384.21 120.81 129.67 154.25 119.53 2362.38

5. Amount still under litigation including cases referred to collector and contested by the companies in the court of law

-- -- -- -- -- -- -- -- 2267.74

6. Cases referred to collector & amount still to be recovered

-- -- -- -- -- -- -- -- 16.63

7. Amount pending relating to the overcharging cases under process

-- -- -- -- -- -- -- -- 78.01

4.2 drug prices equalisation account (dpea)

Drug Prices Equalisation Account (DPEA) has been maintained by Government under the provisions of Drugs (Prices Control) Order, 1979. Under the DPCO, 1979 there were 345 bulk drugs under price control. The Department computed tentative liabilities in respect of 47 bulk drugs only on suo-motu basis covering 172 cases till the Interim stay dated 30.6.1997 was granted by the Hon’ble Bombay High court in the Writ petition No. 2368/1996 filed by the Indian Drugs Manufacturer’s Association (IDMA) and Organisation of pharmaceutical producers of India (OPPI) restraining the Department and its committees etc., from issuing fresh notices to the drug companies calling for information required for determining liabilities. Out of these 172 cases where the liabilities have already been determined tentatively and communicated to the companies, only 72 such cases during the period 1994-97 could be referred to the Drugs Prices Liabilities Review Committee (DPLRC)

constituted on 21.3.1994 under the Chairmanship of a judge of Hon’ble Delhi High Court retired in October, 1994) alongwith two members to review/ determine the liability in such cases. Out of these 72 cases, the Committee after deliberation in each case and giving adequate opportunity of hearing to the drug companies to present their point of view gave reports in 47 cases. In view of the stay granted by the Hon’ble Bombay High Court the Committee had not taken up the other 25 cases and also any fresh case. On the basis of the recommendations of the DPLRC, Department issued demand notices in 45 cases (no liability in one case and one case inked with another case). Most of these companies filed Writ petition in the different High Courts against the demand notices. The total amount of liability on the basis of the recommendations of the DPLRC is to the tune of Rs. 228.47 crore (appx). During the current year till November, 2012 DPEA Cell has recovered about Rs. 137.00 crores of the liabilities. Till November 2012 total amount collected and deposited in DPEA is Rs. 299.65 crores.


27

Since, no new cases could be taken up by DPLRC for determination of the DPEA liability because of the stay granted by the Hon’ble Bombay High Court, there was no work with the DPLRC. Hence a conscious decision wastaken by the Government to keep the DPLRC under suspended animation w.e.f. 31 December, 2005 vide Resolution dated 16th December, 2005. At that time 25 cases were pending with the DPLRC

because of stay, where no quantification could be done. In addition to these 25 cases, there may be a large number of DPEA liability cases in respect of 298 bulk drugs where information from the companies concerned is to be gathered for determination of the DPEA liability. The aforesaid W. P. No. 2368/1996 has since been dismissed by Hon’ble High Court vide its judgement dated 22.12.2011.

Chapter 5PublIc sector undertAkIngs5.1 CentralPublicSectorUndertakings5.2 JointSectorUndertakings5.3 WhollyOwnedSubsidiaries5.4 Status of Annual Accounts5.5 GenericDrugsCampaign–TheJanAushadhiCampaign


31

ChAPter – 5PublIC seCtor undertAkIngs

5.1 central puBlic sector undertaKingsThe total production and sales of five Pharma Central Public Sector Undertakings (CPSUs) under the control of this Department for the last four years are as under:-

(Rs. in crore)

2009-10* 2010-11* 2011-12* 2012-13*(up toNovember 2012)

Production 616.22 545.01 496.08 300.26Sales Turnover 590.87 522.3 501.91 269.57

0

100

200

300

400

500

600

700

* Provisional

i) KarnataKa antiBiotics & pharMaceuticals liMited (Kapl), Bangalore

Karnataka Antibiotics & Pharmaceuticals Limited (KAPL) is a profit making Mini Ratna Central PSU having 59% of the equity shares of GoI and 41% of equity shares of Karnataka State Industrial and Investment Development Corporation (KSIIDC). The paid up share capital of the company as on date is Rs.13.49 crores. The Company was incorporated on 13th March, 1981 and the commercial production started from August, 1984. The manufacturing units and the registered office of the company is located at Bangalore (Karnataka). The main products are Pharmaceuticals formulations like tablets, capsules, injectables, etc. It is a Memorandum of Understanding (MOU) signing company.

Earlier it was a Joint Sector Undertaking of Hindustan Antibiotics Limited (HAL) in collaboration with KSIIDC. But in the interest of continued growth and development of the company, Government has implemented the delinking of KAPL from HAL and transferred the shareholding of HAL in KAPL to Government of India. Government of India had also invested Rs. 7.10 crore in KAPL for upgrading its manufacturing facilities conforming to WHO-GMP standards and setting up a new WHO-GMP compliant Cephalosporin plant. Other joint venture partner, viz. Karnataka State Industrial and Investment Development Corporation (KSIIDC) would bring in additional investment of Rs. 4.90 crore in KAPL. The company has also ISO-9001 and ISO 14001 accreditation.

It has been continuously generating profits for the last 12 years and the performance of the company has further improved.

production & sales(Rs. in crore)

2009-10 2010-11 2011-12 2012-13*(up toNovember 2012)

Production 218.75 240.31 251 165.92Sales Turnover 212.82 210.04 230.89 137.43

0

50

100

150

200

250

300

* Provisional

Product range of the company includes Antibiotics, Anti-diabetic, cardiovasculars, pain management, general medicines and animal health products. Presently the Company is undertaking creation of separate manufacturing facilities for Cephalosporin product at an estimated cost of Rs.22.23 crores. The Project is likely to be completed by end of the financial year 2012-13. When the project is completed, it will be possible for the Company to increase its exports, as new range of products can be added to export.

ii) raJasthan drugs & pharMaceuticals liMited (rdpl), Jaipur

Rajasthan Drugs and Pharmaceuticals Limited (RDPL) is a consistently profit making Central Public KAPL - Small Volume Parenterals Plant


32

Sector Unit in Joint Sector with a total paid-up equity capital of Rs. 4.98 crores where Government of India (GoI) and Rajasthan State Industrial Development & Investment Corporation Limited (RIICO) hold 51% and 49% respectively. It was incorporated in 1978 and commercial production started in 1981. The Company has its manufacturing facilities & registered office at Road no. 12, VKI Industrial Area, Jaipur (Rajasthan).

The company has carved for itself a name in the institutional market in India as a reputed manufacturer of high quality life saving drugs and other specialized medicines, with its marketing activities spread throughout the country.

The company is engaged in manufacture and selling of medicines of high quality at reasonable rates to the Govt. of Rajasthan, Central Government Institutions, viz ESIC, Defence, Railways, other PSUs and also to other State Govt. Institutions, and proud to be a prime partner in the novel and noble endeavour of Government of India in the implementation of Jan Aushadhi Scheme where quality generic (unbranded) medicines are made available to the public at large in the country at affordable prices.

The product range of the Company includes anti-infectives, anti-malarial, NSAIDS, antacids, analgesic, anti-pyretics & anti-inflammatory, anti-emetics, anti-spasmodics, anti-diarrhoeal / anti-amoebic, cough expectorants, cardio-diabetics, anti-allergic, anti-bacterials, anti-fungal, vitamins & mineral, ophthalmic preparations & Oral Rehydration Salt (ORS).

The company is further diversifying its marketing activities into Pharma Prescription Markets (Open Trade Sales), Veterinary Markets, Marketing of Ayurvedic and other Indian system of medicines

This is a formulation unit engaged in production of Tablets, Capsules, Liquid Orals, ORS Powder & Opthalmic medicines in a Schedule ‘M’ compliant facility.

The company, under the quality management, has a existence of a well-equipped laboratory with modern equipments like High Performance/Pressure Liquid Chromatography (HPLC), Fourier Transform Infrared Spectroscopy (FTIR) etc., for ensuring high quality parameters.

In the interest of continued growth and development of the company, Government has delinked RDPL from Indian Drugs & Pharmaceuticals Ltd. (IDPL) (the original promoter representing GOI) and transferred the shareholding of IDPL in RDPL to Government of India in August 2010.

The Company has since then enhanced its manufacturing capacities by installing new machines and at the same time the workers have also acquired skills and expertise for attaining high productivity. The Company has changed its outlook and entered in the

RDPL – Blister Packing Machine

arena of select Public Sector Companies showing consistent profits amidst stiff competition. It is now fairly on the path of growth.


33

in order to enhance its market share and also in its endeavour to improve the profitability of the organization.

production & sales(Rs. In crore)

2009-10 2010-11 2011-12* 2012-13*(up toNovember 2012)


0

10

20

30

40

50

60

70

80

90

*Provisional

proJects undertaKen & future proJects

The Company has almost completed the Phase-I (Schedule ‘M’) of the expansion and modernization plan and has embarked upon Phase-II programme to qualify for WHO (GMP) requirements to become eligible for exploring International Markets as well as for participating in the Internationally Funded Projects of GOI and other Governments.

was incorporated on 30th March, 1954. This was the first Public Sector Company in drugs and Pharmaceuticals. HAL has its plant located at Pimpri. The company produces a wide range of Pharmaceutical formulations including agro-vet products. There are two joint sector units promoted by HAL in collaboration with the respective State Governments. These are Maharashtra Antibiotics & Pharmaceuticals Ltd. (MAPL) at Nagpur, Maharashtra (since closed) and Manipur State Drugs & Pharmaceuticals Ltd. (MSDPL) at Imphal, Manipur (since closed). Karnataka Antibiotics & Pharmaceuticals Limited (KAPL), Bangalore, which was earlier a Joint Sector Undertaking of HAL in collaboration with Karnataka Government, has since been de-linked from HAL after approval of the Government.

RDPL- Liquid Filling And Sealing Machine

Hindustan Antibiotics Limited, Pimpri, Pune-411018 Company's Main Entrance

After establishment, the company made profits for several years. However, as the company started incurring continuous losses since 1993-94, it was referred to the Board for Industrial & Financial Reconstruction (BIFR) in January, 1997. BIFR declared the company formally sick on 31.3.1997 and appointed Industrial Development Bank of India (IDBI), Mumbai as the Operating Agency (OA) for a Techno-Economic Viability Study and Report. Accordingly, a Rehabilitation Scheme was prepared by HAL which was later revised on the directions of the BIFR and the Government.

iii) hindustan antiBiotics liMited (hal), piMpri, pune

Hindustan Antibiotics Ltd. (HAL), Pimpri, Pune


34

Based on the Scheme, the Government approved the Rehabilitation of the company on 9th March 2006 followed by BIFR approval on 5th June 2007. The Rehabilitation Scheme inter alia involved the following:-

(Rs. in crores)sl. no.

particulars amount

1. Cash infusion 137.59*2. Write off/exemptions from

Government of India267.57

3. Sacrifices by Banks, financial institutions and PSUs

103.34

total 508.50(* This includes interest free loan of Rs. 56.96 crores to be repaid by HAL by sale of land within a period of two years.)

The entire cash infusion of Rs. 137.59 crores has been released to the company. Parliament has approved writing off of loan and waiver of interest to the extent of Rs. 259.43 crores. As regards generation of Rs. 56.96 crore as part of Cash Infusion, BIFR issued guidelines for sale of land as per the Rehabilitation Scheme through an Assets Sale Committee. Action is under progress by HAL in this regard.

Further, Government has additionally approved proposals of Rs. 30.17 crore received from HAL for setting up new powder injectable facilities for Cephalosporin and upgradation of existing vialling facilities for Betalactum (Penicilllin) Antibiotics complying to WHO-GMP standards at an estimated

cost of Rs. 20.17 crores and for upgradation of manufacturing facilities of Tablet, Capsule and Liquid Sections complying to WHO-GMP standards at an estimated cost of Rs. 10.00 crore in order to make the company further viable.

HAL has completed the work on Cephalosporin in record time of 9 months. It has commissioned commercial production in February, 2009 and also obtained WHO-Certification for the same. Work relating to upgradation of existing vialling facilities for Betalactum Antibiotics has also been completed and production has been started.

New Cephalosporin Plant Building of Hindustan Antibiotic Ltd., Pimpri,, Pune

HAL-Dry Powder Injectable Packing Line for Cephalosporin Plant

production & sales:

Details of Production & Sales of HAL from 2009-10 onwards are as under:

(Rs. in crore)

2009-10 2010-11 2011-12* 2012-13*(up toNovember 2012)


020406080

100120140

* Provisional

future proJects

sl. no.

project estimated cost (rs. in crore)

1. Upgradation of Large Volume Parenteral with facilities complying to WHO-GMP

45.00


35

iV) Bengal cheMicals & pharMaceuticals liMited (Bcpl), KolKata

BCPL was a chemicals manufacturing company set up in the private sector in 1901 by Dr. Acharya P.C. Roy, the great visionary and scientist. Later on being sick, it was taken over by the Government and nationalized on 15th December, 1980. A new public sector company in the name and style of Bengal Chemicals & Pharmaceuticals Limited (BCPL) was incorporated in March, 1981.

The company has four manufacturing units one each at Maniktala (Kolkata), Panihati at North 24 Parganas (West Bengal), one at Mumbai (Maharashtra) and one at Kanpur (UP). Besides, the company is having nine sales outlets and three C&F agencies spread all over India. The company manufactures and markets a wide range of industrial chemicals, drugs and Pharmaceuticals besides cosmetics and home products. In the home products, the well known products include Cantharidine Hair Oil and Lamp Brand Phenol are quite popular.

Post 1980, company continued its operations. However, due to continued losses, the company was declared sick by the Board for Industrial and Financial Reconstruction (BIFR) on 14th January, 1993. A Revival Package was accordingly prepared & approved by the BIFR on 4th April, 1995. The package was reviewed by BIFR from time to time, based on which a Modified Revised Rehabilitation Scheme was then prepared. BIFR approved this Modified Scheme on 14.1.2004.

Finally, based on the requirements for modernization of plants & machinery and taking into account the earlier Schemes, the Board for Reconstruction of Public Sector Enterprises (BRPSE) at its meeting held on 25.8.2006 recommended a modified revival plan for revival of BCPL.

The recommendations of BRPSE were confirmed by the Cabinet Committee on Economic Affairs (CCEA) which approved the BRPSE Scheme in its meeting held on 21st December 2006. The Revival Scheme which include interalia:

(i) Cash infusion by GOI Rs. 207.19 crores(ii) Write off / Waiver of Rs. 233.41 crores Loans/Interest

Parliament has approved writing off of GOI loans & interest of Rs. 233.41 crore and cash infusion component of Rs. 207.19 crore. The component as approved by the Government has been released. The company has appointed Consultants for undertaking the work of upgradation & modernization of plant & machinery including compliance with Schedule ’M’/WHO- GMP standard.

production & sales:

Details of Production & Sales of BCPL from 2009-10 onwards are as under:

(Rs. in crore)

2009-10* 2010-11* 2011-12* 2012-13*(up toNovember 2012)


0102030405060708090

* Provisional

steps taKen for upgradation & ModerniZation

Upgradation& Modernization Projects including capacity augmentation for Chemical Plants at Panihati (West Bengal) and in Pharmaceutical Plants at Maniktala (Kolkata) and Kanpur have been BCPL- Mumbai Building


36

undertaken. In addition, Greenfield Projects for Cephalosporin and Betalactum range of products are under commissioning at Maniktala. Upgradation of Ointment, Stores Building, Batalactum, Cepahlosporin Blocks, ETP, Roads, drains etc. are also completed at Maniktala. Upgraded Phenol Manufacturing and filling, Composite Production Block, renovated Alum Plant, QC Block, Finished Goods Stores, Administrative Block and other allied services are in operation at Panihati after renovation.

The Upgradation & Modernization of Tablet, ORS Powder, Liquid and Home Product Sections at Kanpur is in progress. Modernization of QA Block, Utilities, Amenities, ETP completed at Kanpur.

V) indian drugs & pharMaceuticals liMited (idpl), gurgaon

Indian Drugs and Pharmaceuticals Ltd (IDPL) was incorporated on 5th April, 1961 for achieving India’s march towards self-sufficiency and self-reliance in the field of drugs and pharmaceuticals, particularly with the primary objective of creating self sufficiency in essential life saving drugs and medicines. IDPL is the largest Central Pharma Public Sector Undertaking in India with plants at Rishikesh (Uttarakhand), Hyderabad (Andhra Pradesh) and Gurgaon (Haryana) and wholly owned subsidiaries, namely, IDPL (Tamil Nadu) Ltd., Chennai (Tamil Nadu) and Bihar Drugs & Organic Chemicals Ltd.(BDOCL) at Muzaffarpur (Bihar). In addition, IDPL has one joint sector undertaking, promoted in collaboration with the Orissa State Government, namely, Orissa Drugs & Chemicals Ltd. (ODCL) Bhubaneswar.

units, product profile & ManpoWer

unit Maniktala panihati Mumbai KanpurProducts Tablets, Capsules, Ointment,

Spirituous preparations, Non-spirituous preparations, Antiseptic preparations, Injectables, Anti snake venom serum (ASVS), Syrup, Hair oil etc.

Alumina ferric, Phenol, Naphthalene balls, Bleaching powder, Floor Cleanser, Liquid soap.

Hair oil Tablet, Non-spirituous preparations, Hair oil

Manpower as on 01.11.2012

269 140 15 23

Total Manpower as on 01.11.2012: 656, Officers: 119 Non-Officers: 537

BCPL- Panihati Administrative Building

future proJects

A project for manufacture of Anti-Rabies and other vaccines at Panihati under Joint Venture/PPP mode have been considered. Front View of IDPL- Tamilnadu Ltd., Chennai Plant


37

IDPL played a major role in the strategic National Health Programmes like Family Welfare Programme & Populations Control (Mala-D & Mala–N) anti-malarial (Chloroquine) and prevention of dehydration (ORS) by providing quality medicines.

IDPL was formally declared sick by the Board for Industrial & Financial Reconstruction (BIFR) on 12th August, 1992. A revival package for the company was formulated and approved by BIFR on 10th February, 1994. However, after taking into account the performance of the company which fell short of the targets, the BIFR on 23.1.1996 treated the sanctioned package as failure, and thereafter in its meeting held on 4.12.2003 BIFR confirmed its prima-facie opinion about winding up of IDPL in terms of Section 20(1) of the Sick Industrial Companies (Special Provisions) Act, 1985.

However, given the possibility of revival of the company, Department of Chemicals & Petrochemicals (Now Department of Pharmaceuticals) filed an appeal against the opinion of BIFR in Appellate Authority for Industrial & Financial Reconstruction (AAIFR) on 10.2.2004.

Consequently, an Expert Committee was appointed in September, 2004, to study the Techno-Financial Feasibility of rehabilitating IDPL. In this connection, a Technical Audit of various plants of IDPL was also assigned to National Institute of Pharmaceutical Education and Research (NIPER). NIPER in its report submitted to the Department on 31.8.2005, recommended revival of all plants of IDPL and its subsidiaries in phases for production of existing and new products. IDBI, the then Monitoring Agency on behalf of BIFR, supported the recommendations for revival of IDPL subject to certain conditions.

Accordingly, in a meeting held under the Chairmanship of the then Minister (C&F&S), it was decided to revive all the five units of IDPL in a phased manner. Hon’ble AAIFR at its hearing on 13.9.2005 set aside the impugned order of BIFR dated 4.12.2003 and

remanded the matter back to BIFR for taking further action for rehabilitation of IDPL.

A Draft Rehabilitation Scheme for revival of Indian Drugs & Pharmaceuticals Limited (IDPL) was considered by the Board for Reconstruction of Public Sector Enterprises (BRPSE) at its meeting held on 9.3.2007 and recommended for approval. The scheme was placed before the Cabinet for approval. Cabinet considered the proposal at its meeting held on 17.5.2007 and referred it to Group of Ministers (GoM) for consideration at the first instance. GoM was constituted on 1.6.2007. The first meeting of the GoM was held on 11.10.2007. Based on the recommendation of GoM and Draft scheme prepared earlier, a Pre-Feasibility Report was prepared by an Expert Agency, Ernst & Young. Now the revival scheme of the company is under the consideration of Central Government.

Despite being a sick company, during the country’s calamity of outbreak of Plague in 1994, IDPL was the only company which played the sheet anchor role in supplying Tetracycline for the entire Nation. Similarly, company had made uninterrupted supply of Chloroquine to combat Malaria epidemic in different parts of the country. In 2005 to combat national emergency (Leptospirosis) arising due to floods in Maharashtra, IDPL had supplied required Doxycycline Caps within no time.

Packing / Inspection Hall, Chennai Plant, IDPL


38

production and sales progress:

Details of Production & Sales figures of IDPL from 2009-10 onwards are as under:

(Rs. in crore)

2009-10 2010-11* 2011-12* 2012-13*(up toNovember 2012)

Production 108.20 55.24 49.75 33.43Sales Turnover 96.59 60 52.47 34.42

0

20

40

60

80

100

120

* Provisional

Vi) Bengal iMMunity liMited (Bil)

BIL was a sick company in the private sector in the name and style of Bengal Immunity Company Limited. The management of the company was taken over by the Central Government with effect from the 18th May, 1978. It was nationalized w.e.f. 1st October, 1984 and a new public sector company in the name and style of Bengal Immunity Limited was incorporated on the 1st October, 1984.

The company has two manufacturing units, one each at Baranagar at Kolkata (West Bengal) and at Dehradun (Uttrakhand).

The Board for Industrial and Financial Reconstruction (BIFR) formally declared the company sick on 9th March, 1993. BIFR heard the case from time to time. In the hearing held on 13th September, 2002, BIFR formed its prima-facie opinion to wind up the company. The opinion was confirmed by BIFR in the hearing held on 25th February, 2003. With the approval of the Cabinet, VSS was introduced in the company. The company has since relieved all employees under VSS as on 30th September, 2003.

The company is closed. The Official Liquidator has already been appointed by the Kolkata High Court. However, on a Writ Petition filed by the BIL Employees Union, the appointment of Liquidator in respect of BIL has been stayed by High Court of Kolkata by its order dated 08.08.2005. High court of Kolkata also directed that AAIFR shall hear and dispose of the application of BIL Employees Unions. AAIFR in its order dated 9.11.2005 directed that possibility of revival through some other alternative Pharmaceuticals company or some firm producing some other goods using the available assets should be considered. Thereafter a Committee was constituted in this Department to look into the issue of revival of BIL looking to the order passed by AAIFR.

The Committee, constituted to explore the possibility of revival of Bengal Immunity Limited (BIL), recommended revival of BIL through public private partnership mode. Bids were then called on revival proposals and in continuation of orders of AAIFR dated 03.03.2008 and 5 short listed companies were IDPL- Quality Control Lab. Chennai Plant

Presently, under different Class of Therapeutic Medicines, around 82 generic/branded drugs covering tablets, capsules, injection, vitamins, ORS pouches etc. are being manufactured in various plants of IDPL. The implementation of schedule-M at Rishikesh and Gurgaon Plants has been partly completed and the remaining work is in progress. The Company is engaged in in-house production and its in-house turnover has been growing. During year 2011-12, IDPL manufactured medicines worth Rs. 49.75 crore in-house at its 4 Plants, and IDPL Rishikesh produced more than Rs. 18 crores, its highest ever.

The Company is also actively participating in supporting the Jan Aushadhi Programme of Govt. of India under which generic medicines are supplied for sale through Jan Aushadhi outlets.


39

asked to give their proposals. Meanwhile, SBI Caps have also been appointed for preparation of Bid/RFP document for subsequent bidding by the 5 short listed companies. SBI Caps has since submitted its report which is under examination.

However, Hon’ble High Court of Calcutta upheld the decision of Liquidation on 02.08.2012. The Govt. of India and the Company have opined to file an appeal against the verdict of the Hon’ble High Court of Kolkata and the draft appeal is under process for approval.

Vii) sMith stanistreet pharMaceuticals liMited (sspl)

It was a sick company in the private sector in the name and style of Smith Stanistreet Company Limited set up in 1821 and its management was taken over by the Government of India with effect from 4th May, 1972. The company was nationalized on 1st October, 1977, and a new public sector company in the name and style of Smith Stanistreet Pharmaceuticals Limited (SSPL) was incorporated on 19th July, 1978. The company has its registered office at 18, Convent Road, Kolkata (West Bengal).

The company was formally declared sick by the Board for Industrial and Financial Reconstruction (BIFR) on 21st December, 1992. The BIFR approved a revival package for the company on 31st August, 1994. The revival package was for a period of ten years beginning from 1994-95. The same was declared as having failed during the hearing on October, 17, 2000.

The BIFR heard the case on 3rd December, 2001 and confirmed its prima facie opinion that it was just, equitable and in public interest that the company should be wound up. With the approval of the Cabinet, VSS was introduced in the company. The company has since relieved all the employees under VSS as on 30th September, 2003. The company is closed.

The Hon’ble High Court, Kolkata vide its Order dated 4.01.2006 directed that the Company be wound up and the Official Liquidator shall forthwith take possession of the assets of the Company. Accordingly,

the Official Liquidator took possession of the assets and documents including books of accounts of the Company with effect from 01.02.2006. Ultimately, the company has been liquidated and the assets have been auctioned to M/s. Pataka Industries Ltd. vide Hon’ble Calcutta High Court dated 09.01.2010.

5.2 Joint sector undertaKings

i) Maharashtra antiBiotics & pharMaceuticals ltd (Mapl)

This is a Joint Sector Undertaking promoted by Hindustan Antibiotics Limited (HAL) and State Industrial & Investment Corporation of Maharashtra (SIICOM) based at Nagpur (Maharashtra). HAL holds 52% of the equity shares, 38% is with SIICOM and 10% with IDBI. The company was incorporated in November, 1979, and the commercial production started in May, 1981.

After initial operations, the company could not be run profitably and had to incur continuous losses. Accordingly, BIFR formally declared MAPL as sick on 14.1.1997. BIFR has since heard the case from time to time. In the hearing held on 04.07.2000, BIFR formed opinion for winding up of the company under Section 20(1) of the SICA, 1985. Appeals filed in AAIFR by M/s Environmental Engineers Inc. and a group of employees were also dismissed. At present, the company is closed and is before the High Court of Mumbai, Nagpur Bench for appointing a Liquidator. However, Writ Petitions have been filed by M/s Environmental Engineers Inc. in the Nagpur Bench of the Mumbai High Court against the liquidation proceedings of MAPL. No further order has been issued by the Bench in this connection.

Meanwhile, as winding up requirements and additionally in accordance with the direction of the Nagpur Bench of the High Court of Mumbai, Government introduced VSS in MAPL. Accordingly all employees were released under VSS.

ii) Manipur state drugs & pharMaceuticals liMited (Msdpl)

This is a joint sector undertaking promoted by Hindustan Antibiotics Limited (HAL) in collaboration


40

with Manipur Industrial Development Corporation (MANIDO). HAL holds 51% of the equity shares and 49% is with MANIDO. The company was incorporated on the 18th July, 1989. The manufacturing unit and the registered office are at Imphal (Manipur).

After initial operations, there were losses on account of law & order and connected reasons. The Company has since been closed as per recommendations of the State Govt. of Manipur. Consequently, there has been separation of employees with retrenchment benefits under the Industrial Disputes Act / Worksmen’s Compensation Act. At present, the company is closed.

iii) orissa drugs & cheMicals ltd. (odcl)

This is a joint sector undertaking promoted by Indian Drugs & Pharmaceuticals Limited (IDPL) and the Industrial Promotion and Investment Corporation of Odisha (IPICOL). IDPL holds 51% of the equity shares and 49% is with IPICOL. The company was incorporated in 1979 and commissioned fully for production from September, 1983. The company has its manufacturing unit and its registered Office in Mancheshwar Industrial Area, Bhubaneshwar in the State of Odisha. The company is engaged in the manufacture of Pharmaceutical formulations in the form of Tablets, Capsules, Powders, ORS, Injectables etc.

After initial profitable operations, ODCL was formally declared sick by the Board of Industrial and Financial Reconstruction (BIFR) on 26th October, 1992. On the basis of the report of the Operating Agency, appointed by the BIFR and the support extended by the promoters, the BIFR approved a revival package for ODCL on 18th August, 1994. However the package could not be implemented due to lack of support from the State Government. BIFR heard the case from time to time.

BIFR in its order dated 8th April, 2003 has finally passed orders for winding up of the company under the provisions of Sick Industrial Companies (Special Provisions) Act, 1985. The appeal filed by ODCL employees against the winding up order of BIFR has been dismissed by the AAIFR vide its order dated

23.6.2005. High Court of Orissa had appointed a provisional Liquidator. This has since been stayed by a larger Bench of the Odisha High Court.

After intervention of IDPL in the marketing activities of ODCL from March 2007 the production and sales have significantly gone up and the last year’s turnover of Rs. 11.6 crores was highest ever achieved by ODCL. This year Company is likely to surpass last year’s production achieved. The unit has stated generating profit since 2010-11. Last year’s profit was Rs. 85 lacs. ODCL is taking all steps to complete Schedule-M work.

5.3 WHOLLY OWNED SUBSIDIARIES

a. idpl (taMil nadu) liMited, chennai.

IDPL (Tamil Nadu) Ltd, Chennai incorporated in September 1965, is a wholly owned subsidiary and a sick unit of IDPL. In terms of the revival package approved by BIFR in 1994 in the case of IDPL, the Surgical and Formulation Unit of IDPL at Chennai was converted into a wholly owned subsidiary in the name and style of IDPL (Tamil Nadu) Limited, Chennai with effect from the 1st April, 1994. IDPL holds the entire equity capital of this unit. At present, it is engaged in the manufacture of pharmaceutical formulations. The production for the year 2011-12 was Rs. 1047.25 Lakhs and for the year 2012-13 (until Nov. 12 provisionally) amounted to Rs. 806.93 Lakhs. The implementation of Schedule-M has been partly completed and the balance work is in progress.

B. Bihar drugs & organic cheMicals ltd (Bdocl), MuZaffarpur

Bihar Drugs & Organic Chemicals Ltd (BDOCL), Muzaffarpur was earlier a Organic Chemicals and Drug Manufacturing unit of IDPL at Muzaffarpur (Bihar). It was incorporated in November 1979. In terms of the revival package approved by the Board for Industrial & Financial Reconstruction (BIFR), the Organic Chemicals and Drug Manufacturing unit of IDPL at Muzaffarpur (Bihar), was converted into a wholly owned subsidiary in the name and style of Bihar Drugs & Organic Chemicals Limited, Muzaffarpur with effect from the 1st April, 1994.


41

IDPL holds the entire equity capital of this Unit. The past long-term liabilities amounting to Rs 36 crore as on 31.3.1994 were taken over by IDPL. At present there is no production activity in the unit and is closed since November 1996.

5.4 status of annual accounts

Details of Annual Accounts finalized till date are as under:-

Karnataka Antibiotics & Pharmaceuticals Limited

2011-12

Rajasthan Drugs & Pharmaceuticals Limited

2010-11

Hindustan Antibiotics Limited 2010-11Indian Drugs & Pharmaceuticals Limited 2009-10Bengal Chemicals & Pharmaceuticals Limited

2008-09

Bengal Immunity Limited 2005-06Smith Stani-Street Pharmaceuticals Limited

2004-05

5.5 generic drugs caMpaign – the Jan aushadhi caMpaign

Access to quality medicines at affordable prices is a key challenge for the Government. The prices of branded medicines are generally higher than generic medicines due to various reasons as having patent protection and having limited regulation through the Drug Prices Control Order, 1995 etc.

For fulfilling this goal, a Campaign in the name of ‘Jan Aushadhi Campaign’ has been launched. The purpose of this campaign is to make available medicines at affordable prices for all, especially the poor and the disadvantaged. Under this campaign, less priced quality unbranded generic medicines will be made available through Jan Aushadhi Stores which inherently are less priced but are of same and equivalent quality, efficacy and safety as compared to branded generic medicines.

Under this Scheme, the State Government has to provide space in Government Hospital premises for the running of the Jan Aushadhi Stores (JAS). Government hospitals, NGOs, Charitable Organizations and public

societies like Red Cross Society, Rogi Kalyan Samitis typically constituted for the purpose can be operating agencies for the JAS. The operating agency for JAS is nominated on the basis of the recommendations of the State government. Operational expenditure is met from trade margins admissible for the medicines. The State Government has to ensure prescription of unbranded generic medicines by the Government doctors.

The Bureau of Pharma Public Sector Undertakings of India (BPPI), comprising of all the Central Pharma PSUs (CPSUs), namely, IDPL, RDPL, KAPL, HAL and BCPL, was set up on 1st December 2008 with the objective to have a focused & empowered structure to implement the Jan Aushadhi Campaign initiated by the Department of Pharmaceuticals. Initially it was as an independent, unincorporated body but subsequently, it has been registered as a Society under the Societies Registration Act, 1860 by the Govt. of NCT of Delhi on 21st April, 2010. BPPI is monitoring the opening of Jan Aushadhi Stores. It is also involved in promotion of the unbranded generic drugs and the Generic Drug Campaign.

The first Jan Aushadhi Generic Drug Store was opened in Civil Hospital, Amritsar on 25th November, 2008 and with the active support and cooperation of the State Government of Punjab, the stores were opened not only in all districts of Punjab but also being opened at block level too. The campaign has now been spread besides in Punjab, also in the States of Haryana, Uttrakhand, Rajasthan, Andhra Pradesh, Odisha, West Bengal, Jammu & Kashmir, Himachal Pradesh, Jharkhand & UT of Delhi and Chandigarh by having opened 147 Jan Aushadhi Generic Drug Stores so far (till 14.02.2013). Efforts are on to open more number of stores.

The Jan Aushadhi Campaign will help:

(i) Improve access to healthcare in as much as cost of treatment would come down substantially. This would enable the Public Health System to increase the coverage.

(ii) Secure a socio- economically viable mechanism / institutional arrangement for efficacious sales of


42

Pharma CPSU products, thereby improving their viability.

(iii) Promote & encourage private industry to sell their quality unbranded generic products through these retail outlets.

(iv) Ensure successful implementation of the Jan Aushadhi campaign would dispel the myth that quality of medicines is linked to price and demonstrate that quality medicines can be sold at substantially lower prices.

(v) Educate doctors that unbranded generic medicines provide a better option than branded products since quality of generic medicines can be equally efficacious and safe at much lower prices.

(vi) Create Consumer awareness & involve private & charitable bodies & NGOs by making them part of the campaign.

(vii) Reduce promotional cost and profits for the benefit of patients etc.

Chapter 6nAtIonAl InstItute of PhArmAceutIcAl Education & REsEaRch (niPER)


45

ChAPter – 6nAtIonAl InstItute of PhArmACeutICAl eduCAtIon & reseArCh (nIPer), s.A.s. nAgAr, mohAlI

NIPER, SAS Nagar, Mohali was initially registered as a society under the Societies Act. The faculty for the institute was appointed in 1994. In 1998, Parliament enacted National Institute of Pharmaceutical Education & Research Act, 1998. NIPER was declared as an “Institute of National Importance” under the Act of Parliament on 26th June 1998. NIPER is a member of Association of Indian Universities.

The main objectives of the Institute:

1. Nurture and promote quality and excellence in pharmaceutical education & research.

2. Toning up the level of pharmaceutical education and research by training the future teachers, research scientists and managers for the industry and profession.

3. Creation of National Centers to cater to the needs of the pharmaceutical industry and other research and teaching institutes.

4. Collaboration with Indian industry to help it meet global challenges.

5. National/International collaborative research.

6. Study of sociological aspects of drug use and abuse and rural pharmacy etc.

7. Running programmes in drug surveillance, community pharmacy and pharmaceutical management.

niper has nine departments and one centre:

1. Medicinal Chemistry2. Pharmaceutics3. Natural Products4. Pharmacology & Toxicology5. Pharmaceutical Analysis6. Biotechnology7. Pharmaceutical Technology8. Pharmacy Practice9. Pharmaceutical Management10. Pharmacoinformatics

disciplines:

The first batch of students was admitted in 1998. NIPER offers Masters’ and ph.d. degrees in following 15 streams that caters to the various needs of pharmaceutical industry:

1. Medicinal Chemistry2. Natural Products3. Traditional Medicine4. Pharmaceutical Analysis5. Pharmacology & Toxicology6. Regulatory Toxicology7. Pharmaceutical Technology (Biotechnology)8. Pharmaceutical Technology (Formulations)9. Pharmaceutical Technology (Process Chemistry)10. Pharmaceutics11. Biotechnology12. Pharmacy Practice13. Clinical Research14. Pharmacoinformatics15. Pharmaceutical Management

infrastructure:NIPER conducts regular education programmes for academia and industry in various disciplines and helps the Indian Pharmaceutical Industry in solving their R&D related requirements. NIPER has upgraded facilities for achieving the highest level of efficiency in imparting education and events.

There are state-of-art classrooms with installation of TV panels and laptop systems. NIPER laboratories are fully equipped with modern equipments that are equivalent to other state-of-the-art laboratories in the world. All the available facilities are of international level and standards. A Technology Development Centre has also been set up. In addition, there has been significant improvement in research infrastructure as several high value sophisticated instruments have been added which has helped in increased thrust in R&D activities.

central research facilities:

Following central facilities provide support to the research groups within the Institute as well as from outside:


46

1. Central Instrument Laboratory2. Computer Centre3. Library and Information Centre4. Central Animal facility5. National Toxicology Centre (GLP compliant)6. Technology Development Centre7. National Bioavailability Centre (WHO accredited)8. Impurity Profiling & Stability Testing Laboratory9. Pharmacological & Toxicological (GLP compliant)

Screening Facilities

seats for admission to p.g. courses, ph.d in niper, s.a.s. nagar:

Since 2010, NIPER, S.A.S. Nagar, has increased seats for admission to postgraduate courses and Ph.D. programme:

courses students admitted in year

2011

students admitted in year

2012Ph.D. 34 39M.S. 239 271M.B.A. 58 65total 331 375

In July 2012, 230 Masters’ students [including M.S. (Pharm.), M. Pharm. and M.Tech. (Pharm.)], 56 M.B.A. (Pharm.) and 22 Ph.D. candidates graduated from the Institute.

academic excellence: A new course leading to M. Pharm. in Clinical Research has been started in 2011 with an initial intake of 9 students. During 2012 (till date), the Institute has published 120 articles in journals of repute. As on date, NIPER has filed 152 patents, out of which 41 patents have been granted. Since the inception of academic programme, 1,570 students have passed out (Masters-1,127, MBA-303 & Ph.D.-142). Presently, 901 students are studying in NIPER, S.A.S. Nagar.

International collaborations: The Institute entered into several International collaborations and a number of visitors from abroad and within the country visited the Institute, thus highlighting the ever-rising status of the Institute. NIPER started conducting training programs at the newly established Small and

Medium Pharmaceuticals Industry Centre (SMPIC) for Small and Medium Pharmaceuticals industry on the aspects of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), Instrumental analysis and manufacturing of APIs and Formulations. The centre will also provide a focal point to industry academia interaction.

recent developments at niper, s.a.s. nagar

(general)

1. The Institute has played mother role to all the new NIPERs started in different parts of the country by helping them in variety of ways including centralized admissions.

2. A Technology Development Centre has been set up in the NIPER, S.A.S. Nagar.

3. The WHO accredited National Bioavailability centre has been established with support of Deptt. of Science & Technology, Govt. of India, which is one of the two centers of the world to conduct the bioavailability studies for oral fixed-dose combination of anti-tubercular drugs.

4. The Institute has also set up the Good Laboratory Practices (GLP) compliant National Toxicology Centre, National Centre of Pharmacoinformatics, National Centre for Safety Pharmacology and Centre for Nanotechnology with the support of Department of Science & Technology (DST) under Pharmaceutical Research & Development Support Fund (PRDSF programme).

5. NIPER, S.A.S. Nagar, has now started training programmes for Small and Medium Pharmaceutical industry on the aspects of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), Instrumental analysis and manufacturing of APIs and Formulations. An important aspect of the training programs is the demonstration in the Technology Development Center (TDC), Central Instrument Laboratory (CIL), and Central Animal Facility (CAF), etc. Separate hands-on training modules are available for High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Atomic Absorption Spectroscopy (AAS).


47

6. NIPER has more than 1500 publications, most of them in reputed, peer-reviewed, international journals. In 2012, NIPER has filed 15 patents and 4 patents have been granted till date.

7. The Plan budget proposal for Rs. 24.00 cr for the year 2012-13 has been submitted to Deptt. of Chemicals & Petrochemicals, Ministry of Chemicals & Fertilizers, Govt. of India.

8. Non-Plan budget proposal of Rs. 34.91 crore has been submitted out of which Rs. 21.14 crore has been released by the Ministry for meeting the expenses for the third quarter for the year 2012-13.

9. New projects worth Rs. 1.25 crore were sanctioned by various funding agencies to NIPER.

(research)

1. neglected diseases

• Two of the most active dihydroartemisinin derivatives synthesized in the Institute, which were proven to be strongly more active (blood schizontocidal activity) than artemisinin against P. berghei in mice, are being studied for their toxicity.

• Derivatives of 8-aminoquinoline have been synthesized which exhibit activity in the range of 15-20 ng/mL against drug-sensitive and resistant strains of malaria parasite. Dose optimization of the most potent analogues in in vivo evaluation is under progress.

• Synergistic activity of 3, 3’ diindolylmethane and miltefosine was observed at low doses of 3, 3’ diindolylmethane. Antagonistic activity at higher doses. The combination groups were found to have higher activity than single doses as well as control groups.

• Around 78 semisynthetic derivatives based on berberine, curcumin, carboline and tryptanthrin templates have been synthesized and are currently being evaluated for in vitroantileishmanial activity.

• Using DOS (diversity-oriented synthesis) approach, various small molecules have been

designed to target the FtSZ (bacterial cell division protein) and protein synthesis in Mycobacteria. 162 such compounds have been synthesized and evaluated for anti-TB activity at AstraZeneca, Bangalore. Eight compounds have shown promising anti-TB activity (MIC = 16 µg/mL).

2. other diseases

• Biological evaluation of the anti isomers formed after aldol reactions of 5-methyl-3-(substituted phenyl)-4-oxo-2-thioxoimidazolidines in PC-3 and LNCaP prostate cancer cells demonstrated inhibition of cell growth. The highly potent compounds demonstrated cytotoxicity better than doxorubicin and flutamide on PC-3 and LNCaP cells, respectively.

• Screening of 18 compounds from four medicinal plants, viz. Ajugabracteosa, Dysophyllastellata, Inulacuspidata and Rumexnepalensis for in vitro COX-1, COX-2 and anti-inflammatory activity in vivo showed five compounds to be highly active and provided stellatin as a lead molecule.

• Semi-synthetic modification of stellatin resulted in 18 compounds of which three exhibited better in vivo anti-inflammatory activity than positive control indomethacin.

• Neuroprotective effect of GW1929, a PPAR-g agonist in cerebral ischemia/reperfusion injury induced brain damage and associated neurobehavioral deficits, has been shown.

• Melatonin and nicotinamide alone as well as in combination were shown to ameliorate the functional deficits along with improvement in pain parameters in diabetic neuropathy.

• Investigation of insulin treatment under high glucose condition leading to the generation of reactive oxygen species has been shown to alter multiple histone H3 modifications in L6 myoblasts.

• Genotoxicity testing using different end points (CA, MN, COMET, NRF2, p53, NF-kB, H2AX etc.) has been developed to screen New Chemical Entities (NCEs) as well as for the existing drugs in the market.


48

• Direct role of the neurotoxin MPTP in the aggregation of a-synuclein, the protein implicated in Parkinson’s disease, has been demonstrated.

• Some synthetic peptides, derived from full-length apolipoproteins, have been shown to exhibit unique binding specificity towards particular oxidized phospholipid species without binding to normal, non-oxidized phospholipids. This indicates their potential to be developed as drug candidates in cardiovascular and other chronic inflammatory diseases.

3. Drug development and formulation

• LDPE packs have been demonstrated to exhibit higher sorption of preservatives, as compared to polypropylene packs. An excipient has been identified that retarded the loss of parabens in LDPE containers.

• Novel role of antimicrobial preservatives, viz. benzalkonium chloride, benzyl alcohol and m-cresol, as inhibitors of protein aggregation, has been reported.

• Biomimetic polymeric particulate scaffolds for tissue engineering have been developed. These have been for osteoblasts for bone tissue engineering.

• Oral bioavailability of poorly water soluble/ poorly permeable drugs (e.g. anticancer drugs like tamoxifen, paclitaxel and doxorubicin; antifungal drugs like amphotericin B and cyclosporine A; antioxidants, etc.) and acid-labile drugs using different types of nano formulations has been carried out.

4. other areas

• 3 - [5 - (4 - Fluorophenyl) - 5 (S) - hydroxypentanoyl] - 4 (S) - 4 - phenyl - 1, 3 - oxazolidin - 2 - one, a crucial intermediate for ezetimibe synthesis, was prepared by lipase-mediated transesterification and ester hydrolysis of the corresponding precursors

• Biocatalytic synthesis of silver and selenium nanoparticles has been carried out for evaluation

of antimicrobial and anticancer activities, respectively. Both areas have shown positive results.

• Overexpression of recombinant proteins in bacterial systems has been achieved without formation of inclusion bodies, resulting in higher yields of functional target proteins.

• A database of Adverse Drug Reactions (ADRs) spotted in different settings over a long period of time has been developed.

(events and activities)

1. The following awardshave been granted to the Institute:

a. OPPI Scientist Award in pharmacology and toxicology

b. Ranbaxy Science Scholar Award for Pharmaceutical Sciences.

c. In addition, students have received awards at various national and international symposia, in recognition of the work carried out by them.

2. The following events were conducted by the Institute:

a. Seminar on Current Good Manufacturing Practices (CGMP) (April 2-3, 2012)

b. Good Laboratory Practice (GLP) Training Programme “GLP in India: Present and Future” (April 13-15, 2012)

c. Seminar on “Environment, Hazard and Waste Management in Pharmaceutical Industries” (Sept. 29, 2012)

d. Intensive Course on Quality Assessment of Drugs and Pharmaceutical for Export – “ITEC-2012” (Oct. 8-19, 2012)

e. 3rd Biennial International Conference held on “New Development in Drug Discovery from natural products and traditional medicines (DDNPTM-2012) (Nov. 22-24, 2012)

f. Sixth Convocation (Oct. 13, 2012)


49

Photographs, NIPER, S.A.S. Nagar

Student receiving gold medal from the Chief Guest, Padma Vibhushan, Dr. M.S. Gill, during the sixth

Convocation (Oct. 13, 2012)

Inauguration of Academic Session 2012-2013 by Prof. M. K. Surappa, Director, IIT Roper

Inauguration of 3rd Biennial Conference on DDNPTM 2012 (Nov. 22-24, 2012)

Some of the degree recipients of the sixth Convocation (Oct. 13, 2012)

Dr. S.S. Sharma receiving the OPPI Scientist Award (Sept. 15, 2012)

Participants in the workshop on Advanced Analytical Techniques, organized under ITEC/SCAAP

programme (Oct. 8-19, 2012)


50

Establishment of New NIPERs:

In terms of the amended National Institute of Pharmaceutical Education and Research (NIPER) Act, 1998, the Government of India has set up six new NIPERs at Hajipur, Hyderabad, Ahmedabad, rae Bareli, guwahati and Kolkata. These New

NIPERs will cater to the growing demand of the pharmaceutical industry for highly trained man power for continuous growth of the pharmaceuticals sector with increased focus on R&D, particularly after the amendment of Indian Patent Act. At present, new NIPERs are functioning with the assistance of the Mentor Institutes.

sl. no. new nipers Mentor institute

1. NIPER, Ahmedabad B.V. Patel Pharmaceutical Education and Research Development (PERD) Centre, Ahmedabad.

2. NIPER, Hajipur Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna.

3. NIPER, Hyderabad Indian Institute of Chemical Technology (IICT), Hyderabad.

4. NIPER, Guwahati Guwahati Medical College and Hospital, Guwahati.

5. NIPER, Kolkata Indian Institute of Chemical Biology (IICB), Kolkata.

6. NIPER, Rae Bareli Central Drug Research Institute (CDRI), Lucknow.

starting of classes at new nipers:

Pursuant to the approval of the Cabinet to the setting up of six new NIPERs, classes were started from the academic Session 2007-08 with the help of Mentor Institutes at Ahmedabad, Hyderabad, Kolkata and Hajipur. The classes were started at NIPER, Guwahati and Rae Bareli in 2008-09.

The students are selected through Common Admission Test conducted by NIPER, SAS Nagar, Mohali in association with these new NIPERs.

An Apex Committee under the chairmanship of Secretary (Pharma) has been formed to oversee the smooth functioning of new NIPERs till the Board of Governors of each new NIPER is formed. Likewise, State level Coordination Committee under the Chairmanship of an officer of the level of Principal Secretary of the concerned State Government has been formed for each NIPER to oversee the functioning of the new NIPERs.

Ms (pharm) course: stream wise details:

sl. no.

name of institute existing disciplines

1. Ahmedabad Natural Products, Pharmaceutics, Biotechnology, Pharmaceutical Analysis, Medicinal Chemistry, Pharmacology and Toxicology, Medical Device.

2. Guwahati Pharmacology & Toxicology, Pharmacy Practice, Biotechnology.

3. Hajipur Biotechnology, Pharmacy Practice, Pharmacoinformatics.

4. Hyderabad Medicinal Chemistry, Pharmaceutical Analysis, Pharmacology & Toxicology, Pharmaceutics.

5. Kolkata Medicinal Chemistry, Natural Products, Phamacoinformatics.

6. Rae Bareli Medicinal Chemistry, Pharmaceutics, Pharmacology & Toxicology.


51

niper ahMedaBad

acadeMic actiVities

adMission of students to M.s pharM IN 2012-2013

The institute had Masters level programme in six different disciplines till the fifth academic year leading

to M.S Pharm in Pharmaceutics, Natural Products, Biotechnology, Pharmaceutical Analysis, Medicinal Chemistry and Pharmacology streams.

NIPER Ahmedabad stepped into sixth academic year from July 2012, introducing Medical Device as a new stream, and in the sixth academic year, 53 students were admitted to seven streams.

discipline no. of students admitted(Batch 2011-13) (Batch 2012-14)

Natural Products 09 09Pharmaceutics 12 13Biotechnology 10 10Pharmaceutical Analysis 06 05Medicinal Chemistry 05 05Pharmacology and toxicology 05 06Medical Device - 05total 47 53

teaching schedule for the academic year 2012-13

1st semester

Teaching started with the orientation week on the 4th week of July 2012. Regular teaching schedule followed the week after.

Weekly, four seminars were scheduled for the First semester students.

The Mid-term exams were scheduled from 15th to 29th October 2012 and the Final Exams are scheduled in December 2012.

3rd semester

Third Semester started form the third week of June 2012. The students submitted their Project proposals in the third week of July 2012 followed by the Project Proposal Defense. The Project Progress Evaluation is scheduled in January 2013.

NIPER-Ph. D. Program

NIPER-Ph. D. program was started at NIPER-Ahmedabad during the academic year 2011-2012 with six Ph. D. fellows, three each in Natural products stream and Biotechnology. The students have finished

their course work and the synopsis presentation is scheduled in December 2012.

In the academic year 2012-2013, nine Ph. D. fellows, three each in Pharmaceutics, Natural products stream and Biotechnology, have been enrolled on the basis of common NIPER-Ph. D. entrance test conducted in June 2012. The fellows have been assigned their Ph.D. mentors and are pursuing their course work.

conference/WorKshop’s organiZed

1. Mammalian Cell Culture: Hands-On Training Programme, Organized at B. V. Patel PERD Centre, from June 18 – June 22, 2012

2. National Seminar on Opportunities and Challenges in Academic Research (with special reference to Life science, Drug and Pharmaceutical research), Organized by B. V. Patel PERD Centre and NIPER-Ahmedabad in association with Department of Science and Technology (DST), Govt. of India, from March 2 – 4, 2012.

proJects

• dop funded project titled ‘Development and Clinical Evaluation of Novel fixed dose combination of Rifampicin and Isoniazid to


52

improve Bioavailability of Rifampicin for the treatment of Tuberculosis’ in collaboration with AIIMS- New Delhi.

• dBt funded project titled ‘Synthesis and Development of Antitubercular 1,4-Naphthoquinone Congeners as Mycobacterium tuberculosis Methionine Aminopeptidases Inhibitors’.

• inspire fellowship from department of Science and Technology to Dr. Manju Misra. ‘In-situ gelling mucoadhesive system for brain delivery of p-Glycoprotein (P-gp) substrates via nasal route: Effect of a novel lipidic agent on drug release and P-gp inhibition’

• RGYI, Department of Biotechnology to Dr. Manju Misra, Dr. Abhijeet Joshi and dr. p. Venkatesh. ‘Design of Oral delivery

system for macromolecules using gastrointestinal patch system: Role of fatty acid as penetration enhancer’.

honours/aWards

1. Tejas Vyas, Ranjeet Dash, Sheetal Anandjiwala, Manish Nivsarkar. Formulation and pharmacokinetic evaluation of hard gelatin capsule encapsulating lyophilized Vasa Swaras for improved stability and oral bioavailability of vasicine. Fitoterapia 2011; 82: 446-453. Selected as one of the papers for the Certificate of Merit Award – “Dr. P.D. Sethi Annual Award – 2011 for Best Research Papers on “Application of TLC/HPTLC in Pharma, Herbal and other Chemical Analysis” 2011; September 2012.

2. Dr. Anita Mahapatra received Prof. A.R. Rao Memorial Best young researcher award for

Participants during Practical sessions of the Workshop

Floral Welcome of Chief Guest, Dr. G. J. Samathanam by Prof. C. J. Shishoo.

Dr. Neeta Shrivastava delivering a lecture during the seminar


53

the presentation at International Conference on Recent Advances in Cancer Research Therapeutics to Chemoprevention, during 8-9th February, 2012 by Central University of Gujarat, Gandhinagar.

placeMent actiVities

• To provide placement to student at reputed Pharma companies, a placement Cell (including the faculty members as well as the students of

NIPER-A) has been created which is responsible for publishing a placement brochure and sending it to various Pharma companies.

• Various companies have been visiting our organization for Campus Interviews.

• Our students have been placed in about 16 Pharma companies. About 80 % of the students have been placed from the third that recently passed out in June 2012.

EXTRACURRICULAR ACTIVITIES

‘Hindi Pakhwada’ (1st to 14th September 2012) Celebration of Independence Day, Speech on Independence day by Dr. Manish Nivsarkar, Director,

PERD Centre

Navratri Celebration, Students playing Garba

niper, hyderaBad

National Institute of Pharmaceutical Education and Research (NIPER) is an autonomous body established under the aegis of Department of Pharmaceuticals

(DOP), Ministry of Chemicals & Fertilizers as a Centre of Excellence for higher education, research and development in pharmaceutical sciences. In pursuance of the decision of the Government of India, NIPER – Hyderabad started functioning as one of the six new NIPERs in September 2007, in the premises of IDPL R & D centre, Balanagar, Hyderabad. In terms of the MOU between the DOP and CSIR (Council for Scientific and Industrial Research), Indian Institute of Chemical Technology, Hyderabad, a reputed R & D institute under CSIR, was bestowed with the responsibility of Mentorship of NIPER-H. The institute has been functioning with the mission of developing human resource with excellence through conducting 2 year Post Graduate course M.S (Pharm) and MBA (Pharm) for the students enrolled based on the Joint Entrance Examination for all the NIPERs every


54

year. NIPER-H is conducting the courses in five (5) disciplines i.e. Medicinal Chemistry, Pharmaceutical Analysis, Pharmacology & Toxicology, Pharmaceutics and Pharma Management based on semester system. The students have to undertake the course work during 1st& 2nd semesters and to carry out dissertation work in reputed industry/R&D institutes like IICT, NIN, ILS and various Pharma Industries during 3rd& 4th semesters to get exposure to the best R&D practices. Some of the dissertation works have been published as peer reviewed papers and a good number of students have been placed through campus placement. Ph.D programme has also been initiated in Pharmaceutical Sciences in the year 2011.

The main objectives of the Institute:

• Enhancing creativity, motivation & drive and inculcating professionalism

• Bringing synergy between academic, R&D, technology and industry through training and exposure for such environment.

• Bridging collaborations between pharmacy, biotechnology, information technologies and preparing for meeting global challenges.

• Preparing professionals to suit to the need of pharmaceutical industry

• Developing and practicing e-learning for the professionals and training for teachers, researchers, regulators in the respective fields

• Creating a world class institute of teaching and research in the field of Pharmaceutical Sciences

• Expand research activities in new avenues and emerging segments

• Explore national and international collaboration in pharmaceutical sciences

NIPER, Hyderabad is offering MS (Pharm) degrees in the following disciplines:

1. Medicinal Chemistry2. Pharmaceutical Analysis3. Pharmacology & Toxicology4. Pharmaceutics

Enrolment of Students in 2011-12The total number of students who have been enrolled to pursue M. S (Pharm) in NIPER Hyderabad during academic year 2011-12

department no. of students admitted (2011-12) 1st semester

No. of Senior students (2010-11) 3rd semester

total

Medicinal Chemistry 29 30 59Pharmaceutical Analysis 15 14 29Pharmacology and Toxicology

15 15 30

Pharmaceutics 16 16 32total 75 75 150

NIPER, Hyderabad is offering Ph.D programme in following disciplines:

1. Medicinal Chemistry2. Pharmacology & Toxicology3. Pharmaceutics

Enrolment of Students in 2011-12

The total number of students who have been admitted to pursue Ph.D in NIPER Hyderabad during academic

year 2011-12 was:

department no. of students admitted

Medicinal Chemistry 3

Pharmacology and Toxicology 3

Pharmaceutics 3

total 9


55

year Wise placeMent details:

placement status for the academic year 2011-12 (2010-12) Batch

Total No. of students (2010-12 batch)

: 75

Total No. of students registered at placement cell

: 54

Total No. of students placed : 47 (Phd/PA-15; Job-32)



: 57


: 51




: 45


: 38




: 41

Total No. of students placed : 22 (PhD/PA-11; Job-11)

*pa: project assistant fellowship

The results of earlier batches of NIPER Hyderabad (2007-11) and their placement in reputed pharmaceutical organizations reflect the sincere efforts of Placement Committee, faculty and indispensable support of mentor institute, IICT Hyderabad. In 2010-12 batch, during 2011-12 academic year about 75% (47 out of 54 registered); in 2009-2011 batch, above 65% of the students (32 out of 51 registered); in 2008-

10 batch 60% of the students (24 placed out of 40 registered); in 2007-09 batch 60% of the students (11 out of 19) are placed.

higher studies:

Apart from industrial placements, NIPER - H also encourages the students to go for higher studies. Some students have also been selected by the prestigious institutes like IIM, IITs, and reputed National Institutes.

infrastructure and facilities:

The Institute has good faculty. The institute is having spacious, ventilated and well-furnished class rooms and laboratory rooms; an excellent auditorium for seminars; a large library within the campus. Furnished hostel accommodation is provided to the students. The ratio of Faculty to Student is 1:10. In addition, lectures by eminent guest faculty on specialized subjects in the concerned discipline, and various invited lectures by experts from the academia, research establishments and the industry are arranged for the benefit of students. A number of conferences/workshops have been organized to provide best exposure to the advances of knowledge in pharmaceutical sciences to NIPER students and faculty. Participation of students in the seminars organized by professional bodies is encouraged for interaction with persons in the field of their specialization.

NIPER-Hyderabad has acquired state-of-art facilities and well equipped with good number of instruments worth Rs.62,40,301/-.

Library and Information Facility:

NIPER Hyderabad library serves as a source of information centre for pharmaceutical industry and academic institutions. NIPER library has a rare collection of old chemical and biological abstracts since the year 1907 to 1983. NIPER-H library has 9476 titles of books, total no of copies is 18,499, 14 national scientific journals, 12 pharmacy journals, magazines, good number of news papers& employment news. NIPER-H library provides the facilities such as books and journal borrowing, literature search, photo copying, news clipping service etc. The online database Reaxys facility is also available at NIPER-H.


56

Computer Lab Facility:

Computer centre at NIPER-Hyderabad serves the needs of faculty, staff and students in updating the literature and communication. In this institute, we are maintaining LAN \ WAN infrastructure consisting of 110 desktops and 6 Servers ( Web, Mail, Proxy, FTP etc.) with Windows and Linux enterprise environments. In addition to windows 7, Vista and Windows XP operating system, this centre has general software like MS Office 2007, Antivirus and other free software.

For day to day computer practicals and litera-ture retrieval from internet, 50 desktops are in use. For Molecular modelling / Drug discovery activities, NIPER-Hyderabad procured license for:

• Molecular Operating Environment (MOE), • SCHRODINGER• BIO Solve Lead IT• Gaussian 09w• VLife MDS 3.5 Suite

For high performance computing, two work stations are available and are used for free modelling software like AUTODOCK, NAMD etc. This centre is equipped with 4Mbps (1:1) leased line internet connectivity with six servers set up in a rack which allows the users to have access to the email, internet and etc. These servers were installed with windows Server 2003 and Linux (Red hat) operating system. We are maintaining NIPER Hyderabad website (www.niperhyd.ac.in) and mail server (Send mail, Open webmail) on our own. Other computer related accessories including high speed data transfer and network laser printer (colour and black & white: 25nos) and scanners are also available.

latest achievements:

1) The Institute has published about 45 articles in reputed national and international journals and presented about 6 posters at different conferences and symposiums. Since the inception of academic programmes, 218 Master students have been graduated. Some of the students are working as research project assistants to gain an insight in to their future research career.

2) Collaborations between NIPER and other Institutions (IICT, NIN, ILS, etc) and industries (USP-Hyd, Incogen therapeutics, Novartis, Mylan, Daiichi, etc)

3) Apart from international delegations, a good number of foreign visitors have visited the Institute during this period for developing mutual collaborations and for scientific deliberations.

4) Creation of Molecular Modeling Lab, Pharmacological Screening Lab, Bioanalytical instrumentation Lab, Biochemistry Lab, Isolated Tissue Experimentation Lab, Cell Culture Lab and Animal House facility

5) One of the faculty Dr. M.V.N. Kumar Talluri, Lecturer, Department of Pharmaceutical Analysis, Elected as an Associate & Received Associate Ship Award from the Institute of Chemist for the high quality research contributions in the area of Drugs and Pharmaceutical Analysis.

6) One of the faculty, Dr. Kolupula Srinivas, Assistant Professor, Department of Medicinal Chemistry achieved the prestigious Organization of Pharmaceutical Producers of India–Young Scientist Award-2011 for his outstanding research contribution in Pharmaceutical Sciences. Dr. Srinivas carried out the research work for new chemical entities of anticancer agents in drug discovery.

7) The Grant–in-aid General and Grants for Creation of Capital Assets budget proposal for Rs.9.71 crores for the year 2011-12 submitted to Department of Pharmaceuticals, Govt.of India out of which Rs.8.10 Crores actual was released.

8) The Grant–in-aid General and Grants for Creation of Capital Assets budget proposal for Rs.26.66 crores for the year 2012-13 has been submitted to Department of Pharmaceuticals, Govt. of India.

areas of research activities:

1. Drug impurity profiling, Stability studies, Analysis and standardization of herbal drugs, Drug metabolism studies, Bioanalytical method development


57

2. Diabetic complications, Pain, Rheumatoid arthritis (RA), Hepatic encephalopathy, Alcoholic Hepatitis, Screening of new chemical entities as Anti-Cancer drugs.

3. Improving the bioavailability of poorly soluble drugs

4. Oral disintegrating extended release formulations for geriatrics and paediatrics

5. Nanostructured lipid carriers for topical delivery6. Plasma protein binding studies

7. Invitro metabolism and distribution studies of enantiomers

8. Anticancer agents9. Infectious diseases10. Anti-Inflammatory agents11. Synthesis of New Chemical Entities (NCES)12. Peptidomimetics13. Computer Aided Drug Design14. Molecular Recognition

Seminars / Events Conducted in NIPER Hyderabad during the Academic Year 2011-12

date title of the talk delegate3rd & 4th Sep. 2011

International symposium 2nd PharmsSci@India :: AAPS – 2011High throughput Pharmaceutical manufacturing: Key attributes for success

Dr. Bhaskar K. Arumugam, CEO, Granules India Limited

MUPS : Impact and Compact Prof Paul Heng Wan Sia, NUSRecent Advances in Medicinal Chemistry: Development of Cancer Therapeutics

Dr. Ahmed Kamal, NIPER-H & IICT, Hyderabad

Nanostructured synthetic hydrogels as scaffolds for cell and gene delivery

Dr. EePui Lai, Rachel, NUS

Quality by Design : Concept, Design and Control Dr. Nalini Sastri, NIPER-HNew Drug Targets in Cancer Dr. V. Swaroop Kumar,

CEO, Incogen Therapeutics Pvt Ltd.Developing fused 1,3,5-triazines into bioactive agents with potential therapeutic value

Prof. Wai Keung CHUI

Carnosic acid attenuates renal injury in an experimental model of rat cisplatin- induced nephrotoxicity

Dr. S. Ramakrishna, NIPER-H & IICT, Hyderabad

Pharmacists Improving Outcomes in the Management of Infectious Diseases

Dr. Christine Teng, NUS

An Introduction to Process of Drug Discovery and Development Today

Dr. A. KrishnamRaju, NIPER-H

7th Sep. 2011

Clinical trials-Intro, Prospects, Procedures and a Real time Example

Dr. MohiIqbal Mohammed Abdul

12th Oct. 2011

Career Development in the Global Biotechnology Industry through The Professional Science Masters (PSM)

Prof. Graham B. Jones, Barnett Institute of Chemical & Biological Analysis at Northeastern University in Boston

21st Oct. 2011

Lightening Dr. Vidyadhar Peesapati, Knowledge Transfer Fellow, School of Electrical and Electronic Engineering, University of Manchester, U.K


58

date title of the talk delegate12th Nov. 2011

National Conference Scope & Relevance of Ancient Indian Sciences

Scope & Relevance of Ancient Indian Sciences Prof. K.V. KrishnaMurty Chairman, I-SERVE

Ancient Indian Chemistry Smt. Dr. A. Gayatri Devi, I-SERVE

Fundamental Particles Dr. S. Sivarambabu, I-SERVE

Ancient Indian Agriculture Dr. K. Srinivasula Reddy, I-SERVE

Ancient Indian Mathematics Sri. M. Seetha Rama Rao, I-SERVE

Scope - Composite Ayurveda Dr. M.A. Virinchi, I-SERVE

20th Nov. 2011

50th National Pharmacy Week Celebrations

22nd Nov. 2011

Interaction of Magnesium with Nucleic Acid : From RNA bases to the Ribosome

Dr. Sanyasi Sitha, School of Chemical & Metallurgical Engineering , University of the Witwatersrand, Johannesburg, S.A

2nd Dec. 2011

Therapeutic Targets Based on Cell Signaling - Focus on Cancer

Dr. V. Lakshmipathi, Retd. Professor, Kakatiya University

20th January 2012

The Drug Discovery Process Dr. Sunanda R Dastidar Director Biological Daiichi Sankyo Life Science Research Centre (DMPK)

3rd February 2012

Biology, Chemistry and Medicine Dr. CH. Mohan Rao, FNA, FASc; Director, CCMB

7th February 2012

Creating Markets Across the Globe covering the Globalization, Global drivers technology, market barriers, culture open markets etc

Dr. E. Murali Darshan, IIFT

9th February 2012

Workshop Bioinformatics@BioAsia 2011

Protein Crystallography : implications in drug discovery and modern biology

Anthony Addlagatta, Senior Scientist, IICT, Hyderabad

Genomes to Hit Molecules in Silico : A Country Path Today, A Highway Tomorrow

Prof. B. Jayaram, IIT, Delhi

Construction of 3-D model of the Plasmodium falciparum 20S core proteasome – exploring the biological and chemical space in the catalytic subunits compared with yeast 20S proteasome inhibitor complexes for rational drug design

Dr. K. Guruprasad, CCMB, Hyderabad

Emerging scenario in structure determinations and predictions

Dr. Ravindranath S. Rathore, University of Hyderabad

Visiting molecular docking algorithms and the challenges in predictive abilities

Dr. Madhavi Sastry D.E. Shaw India Software, Hyderabad.


59

date title of the talk delegate11th February 2012

Impurity Profiling in Pharmaceuticals Dr. M.V. Surya Narayana, Vice President, Mylan

24th February 2012

Drug Discovery Dr. Mandip Singh Sachdeva Editor in Chief CRC Critical Reviews in Therapeutic Drug Carrier Systems, Tallahassee

1st March 2012 & 21st, 28th February 2012

Applications of XRD, Crystallography & Structure Determination of Small & Biomacromolecules

Dr. Y.V.N Swamy, IICT, Hyderabad

19th March 2012

Lipids as Potential Anti Cancer Drug Prof U.N. Das, MD FAMS FICP Editor in Chief Lipids in Health & Diseseas, USA

29th March 2012

New Trend in Chiral Seperations Dr. Ch. Lakshmi Narayana Vice President Daicel Chiral Technologies, India

30th March 2012

Emergence of Chiral Drugs Dr. V. Malla Reddy General Manager - R&D Divis Laboratories Limited

3rd April 2012

Potential Utility of Material Studio Software in Pharmaceutical Field

Dr. Nihant Sinha Scientist, Materials Modeling & Simulations Accelrys, India

10th April 2012

Challenges & Opportunities in Pharma Industry Dr. J.B. Gupta Vice President GVK Biosciences

10th April 2012

Maternal Undernutrition and Pharmacokinetics in Adult Offspring

Dr. Ganesh Cherala Assistant Professor Oregon State University, USA

19th April 2012

CANCER Awareness Dr. Sadashivudu Dept. of Pharmacology NIMS, Hyderabad


60niper, KolKata

Establishment of NIPER-Kolkata:

The National Institute of Pharmaceutical Education and Research-Kolkata (NIPER-Kolkata) was established by the Government of India under the NIPER Act 1998 as amended in 2007. The Institute is presently housed at the Indian Institute of Chemical Biology (IICB) – a premier Institute of the Council of Scientific & Industrial Research (CSIR), India, which is the Mentor Institute of NIPER-Kolkata.

NIPER-Kolkata was inaugurated on November 05, 2007. Since its inception, the Institute has been

Photographs, NIPER – Hyderabad

Workshop on Bioinformatics@ Bio Asia 2012

OPPI Young Scientist Award 2011 Dr. Kolupula Srinivas, Assistant Professor

NIPER-Hyderabad

Blood Donation Camp, 2012

IDMA Young Pharmaceutical Analyst Award Dr. M.V.N Kumar Talluri

Lecturer, Pharmaceutical Analysis

conducting Masters’ level programmes in three different disciplines, Medicinal Chemistry, Natural Products and Pharmacoinformatics, leading to M.S. (Pharm.) degree.

Admission of students in 2012-2013

Counseling for admission of students took place in NIPER-Mohali in the month of July, 2012. The orientation programme of the students took place on 1st August, 2012 and the first year first semester classes commenced from 3rd August, 2012.


61

discipline no. of studentsMedicinal Chemistry 17Natural Products 15Pharmacoinformatics 10

academic programme

• The first batch of twenty nine Masters Students graduated in June, 2009 and they received their degrees in the first annual convocation of National Institute of Pharmaceutical Education and Research (NIPER), Kolkata held on 11th June, 2010.

• The second batch of thirty two Masters Students graduated in June, 2010 and the third batch of forty students graduated in June, 2011 and they received their degrees in the second convocation of NIPER-Kolkata held on 18th May, 2012. Sixty students received their M.S. (Pharm.) degree scrolls from Sri. Dilsher Singh Kalha, IAS, Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India & Chairman, Steering Committee of

NIPER-Kolkata. Twelve students were awarded the degrees in absentia. Prof. Goverdhan Mehta, National Research Professor & Lilly-Jubilant Chair, School of Chemistry, Hyderabad, was the Guest-in-Chief.

• The fourth batch of 49 students graduated in June, 2012.

• The fifth batch of 47 students has completed their 2nd semester in June, 2012 and will be completing the third semester in January, 2013. At present they are engaged in their respective project work under the supervision of Faculties/ Scientists of Universities, Research institutes and Industries. Their final examination is scheduled to be held in the month of June, 2013.

• The sixth batch of 39 students will be completing their 1st semester examination in January’ 2013.The 2nd semester examination for them is scheduled to be held in May- June, 2013.

• A total of 371 books have been purchased by NIPER-Kolkata. The Institute subscribes for SciFinder.

Address by the Guest-in- Chief, 2nd Convocation at NIPER, Kolkata

Second batch (2008-2010) recipients of degrees

Address by the Chairman, 2nd Convocation at NIPER, Kolkata

Third batch (2009-2011) recipients of degrees


62

placement activities:

• Most of the students of the first three batches have been absorbed in the Industries, Colleges and Research institutes. Placement was achieved for these students according to their options for employment in companies as well as in centres for teaching and higher studies.

• The campus placement for the fourth batch of students has been not up to expectation. However, a number of the students have secured openings in colleges, research institutes and industries.

• The placement activities for the fifth batch of students have been initiated and the placement brochure has already been brought out.

events & activities:

a) A symposium on carbohydrates at the interface of chemistry and biology was jointly organized by NIPER-Kolkata and IICB, the mentor institute, during November 23-25, 2011. Apart from the NIPER-Kolkata students, 300 delegates from all over the country participated in the symposium.

b) Each second year student is allowed to attend one scientific conference.

c) A professional development course in English (Workshop) was conducted by British Council, Kolkata during 9th October, 2012 to 29th November, 2012 for the second year students of NIPER-Kolkata.

The faculty:

The faculty involved in teaching the M.S. (Pharm.) courses consists of visiting Teachers from Calcutta University, Jadavpur University, West Bengal State University at Barasat and West Bengal University of Technology and Scientists from Bose Institute, Central Research Institute of Ayurveda, Indian Association for the Cultivation of Science, Indian Institute of Chemical Biology, Institute of Post Graduate Medical Education & Research, and Saha Institute of Nuclear Physics and industries like TCG Life Sciences.

staff and officers:

NIPER-Kolkata does not have any permanent staff and officers. Retired persons have been appointed on

contract basis for running the academic programme, administration, examination activities, and placement of students, students’ hostel and other activities. The following are the officials:

Director, IICB & Chairman, Advisory Committee, NIPER-Kolkata

: Prof. Siddhartha Roy

Project Director : Dr. Asish Kr. BanerjeeHonorary Advisor : Dr. Pradip Kr. SenguptaRegistrar : Dr. J. Rajan VedasiromoniOfficer on Special Duty

: Dr. S.R. Sarkar

Student Counsellor : Dr. Probal ChattopadhyayCourse Coordinators

: Dr. Anup Bhattacharjya: Dr. Chabbinath Mondal: Dr. Sibabrata Mukhopadhyay

Placement Cell Coordinator

: Dr. Sukhendu Bikas Mandal

Purchase, finance and other related activities are looked after by Indian Institute of Chemical Biology, the Mentor Institute.

grants received:

financial year

Grant received from Ministry till date

2012-2013 Rs.175 lakhs.

hostel accommodation and facilities: The NIPER-Kolkata students (total 86) are accommodated in the CSIR Scientists Apartment, 428 Prince Anwar Shah Road, Kolkata -700045. The hostels are self-sufficient with canteens, common rooms, facilities and desktop computers with wireless Internet service enabling access to all International and National Journals.

Library, NIPER, Kolkata


63

games & sports activities

Facilities have been provided in the Hostel campus for out-door games like Cricket, Badminton and Volleyball and indoor games like carom and chess. The annual sports and games of NIPER-Kolkata are held in January/February every year.

NIPER, Raebareli

acadeMic actiVities

The National Institute of Pharmaceutical Education and Research (NIPER), Raebareli created on November 14, 2008 under the mentorship of CSIR-Central Drug Research Institute, NIPER, Raebareli. The institute started two P.G. Courses in the area of Medicinal Chemistry and Pharmaceutics. From the current academic year 2012-2013, a new stream of M.S. (Pharm.) Pharmacology and Toxicology has been introduced. The 4th batch students have completed their I and II Semester here in Raebareli and are now doing lab work under the able supervision of different scientists of CDRI for the III and IV semester. The present status is given below.

courses no. of students

in 4th Batch (2011-13)

no. of students

in 5th Batch (2012-14)

M.S. (Pharm.) Medicinal Chemistry

16 16

M.S. (Pharm.) Pharmaceutics

15 16

M.S. (Pharm.) Pharmacology & Toxicology

- 7

total 31 39

eVents and actiVities

4th NIPER (RBL) - CDRI SYMPOSIUM on Medicinal cheMistry and pharMaceutical sciences” (feBruary 23 -25, 2012)

As in previous years, “4th NIPER (RBL)-CDRI Symposium on Medicinal Chemistry and Pharmaceutical Sciences” was organized during February 23 -25, 2012 at CSIR-CDRI, Lucknow to enable the students in updating their knowledge and awareness about recent scientific developments. About 95 posters were presented and over 25 lectures on various research topics were delivered by eminent speakers from pharma industry and academia during two days of scientific deliberations. The poster session was spread over two days where the students displayed their project based presentations.

pharMacy day

Rx Pharmacy Day, 2012 was organized at NIPER, Raebareli on 22nd September, 2012. Scientific session included very informative lecture by Dr. D.K. Dikshit, Ex-Chief Scientist, CSIR-CDRI, Lucknow and Ex-project Director, NIPER, Raebareli on “Drug Research - A Historical Perspective”, The second lecture was delivered by Dr. Ashok Kumar, President, IPCA Lab., Mumbai on the topic “Innovations”, while the third talk was on the topic “PK-PD in drug discovery& development”, delivered by Prof. J.K. Paliwal, Deptt. of Pharmaceutics, NIPER, Mohali.

annual day

The 4th Annual Day celebration of NIPER, Raebareli was held on 9th November, 2012 under the chairmanship of Dr. C.M. Gupta FNA, FASc, FNASc, Ex-Director, CSIR-Central Drug Research Institute who delivered the very innovative lecture titled “Biopharmaceuticals & Biosimilars: Present Position & Emerging Trends” The function was attended by eminent scientists, technologists and academia of Uttar Pradesh. Students were also given awards for their participation in various extracurricular activities during the year.

Students, NIPER, Kolkata


64

puBlications

The students were inspired for scientific publication and presentation to bring NIPER, Raebareli on scientific research platform which led to publications

in reputed journals with inputs from project work and presentation of papers in conferences. A total of 39 publications in research Journal and conferences were carried out.

4th NIPER, Raebareli- CDRI Symposium.

Dr. Ashok Kumar, President, IPCA Laboratories, delivering lecture on the occasion of “Rx” Pharmacy

Day 2012 celebrations

NIPER, Raebareli Laboratory Winners of Annual Sports-2012 of NIPER, Raebareli

(L to R) Dr. Achint Jain, Faculty, NIPER, Raebareli, Dr. P.K. Shukla, Project Director, NIPER, Raebareli; Dr. C.M. Gupta, Ex-Director, CSIR-CDRI and Dr. S.K. Puri, Chief Scientist, CSIR-CDRI and Dr. B.Kundu, Dean, NIPER, Raebareli releasing the Annual Magazine 2011-12 of

NIPER, Raebareli.


65

NIPER-HAJIPUR

NIPER Hajipur was established under the NIPER Act,1998 as amended in 2007 under the mentorship of Rajendra Memorial Research Institute of Medical Sciences (an ICMR institution) Patna. Since its inception, NIPER Hajipur developing into a professional centre of higher learning and research in pharmaceutical sciences.

departments

From the beginning NIPER Hajipur has been entrusted with the responsibility of teaching and research in the following three disciplines:

BiotechnologyPharmacy Practice Pharmacoinformatics

intake of the students:

Numbers of M Pharm / MS Pharm students admitted and passed during 2009 to 2012 are as follows

year admitted passed left niper2009-11 34 32 2

2010-12 42 40 2

2011-13 43 continuing 2

2012-14 21 continuing -

Number of students admitted in PhD programme

year phd (Biotechnology)

phd (pharmacoinformatics)

2011 3 22012 3 2

examination:

Examinations are being conducted as per the declared academic calendar. Students of the session 2010-12 have already left after successfully completing the course and most of them are either employed (academia + industries+ administration) or pursuing higher studies in different institutes/universities in India or abroad. Two of these students have been selected for PhD at NIPER Hajipur.

ph. d programme:

As per the decision of Department of Pharmaceuticals, GOI, New Delhi, the Ph. D programme was introduced NIPER-Hajipur from the session 2011 onward. So far 10 students have enrolled for the PhD. They have been assigned to experts and the required course works for those programmes have been initiated and is in progress.

Infra-structure

Being in its infancy, infra structure is being developed a little slowly due to some unavoidable factors (particularly land). Currently NIPER, Hajipur has well appointed trained teachers. Class rooms accommodating a maximum of sixty students, a fully air-condition seminar cum examination hall having a capacity of 200 persons, a fully air-conditioned and networked computer lab, a lab for Biotechnology, an air conditioned well stocked library with internet and facilities for indoor as well as outdoor games. The well equipped laboratories at mentor institute (RMRIMS) are always accessible to NIPER students, procurement of some more instruments for NIPER is also under active consideration. For high end computing, tools like Schordinger Suite, SPSS, Micromedixetc are already installed. Institute is working towards getting some more sofwares to further strengthen Pharmacoinformatics division.

Adjunct Faculty:

Prof. Bhaskar Saha, National Centre of Cell Science, Pune, has been inducted as Adjunct Professor in Biotechnology in NIPER Hajipur.

Guest faculty and special lectures:

From RMRIMS faculties namely, Dr. V.N.R. Das, Dr. K. Pandey, Dr. C.S. Lal, Dr. G. Sahoo, Dr. V. Ali, Dr. R.N. Pandey, Dr. Shubhankar, Dr. S. Bimal, Dr. Shyam Narayan, and others regularly take classes. A number of eminent academic personalities from different places like Prof. R.N Mishra, Prof G.P. Singh, Dr. Alok Kumar of BHU, Prof. Bishwajit Mukherjee of Jadavpur University Kotkatta, Dr. AmitGhosh of NICED, Dr. Shakti Patnayak of BIT-Mesra, Prof. S.P. Gupta,


66

Meerut Institute of Engineering and Technology, Dr. Anthony Addlagatta from IICT Hyderabad, Prof. P.V. Bhartham, NIPER Mohali, Dr. Oommen John, New Delhi, Dr. M. Kartikeyan, NCL Pune, Dr. S.C. Roy, CNLU Patna, etc. are actively involved in teaching students of different streams. Moreover, a number of prominent scientists from India and abroad visited NIPER, Hajipur and delivered lectures on the various topic of modern Pharmaceutical research. Some of the prominent one were Dr. Shubhadeep Sinha MD of Vimta Lab. Hyderabad , Dr. Satishkumar of Manich, Germany, Prof. R.N Mishra of BHU, Varanasi, Prof. Amit Ghosh, NICED, Kolkata, Dr. Ashish Ganguly of IMTECH, Chandhigarh and Dr. Chandan Roy Chaudhary of Bengaluru, Dr. Arvind Kumar of CCMB Hyderabad.

events and activities:

Foundation Day

NIPER, hajipur celebrated its 5th Foundation Day on 26th November 2012. A number of scientific and cultural events were organized. Prof. Anil K. Bhowmick, Director, Indian Institute of Technology, Patna delivered the 5th Foundation Day Orientation lecture on “Role of Nanotechnology in pharmaceutical research”. This function was

presided by Prof. JanakPandey, Vice Chancellor of Central University of Bihar. Prof. Jeremy C. Mottram from University of Glasgow, Scotland, UK presented a special lecture on “Is drug-induced cell death in leishmania regulated or incidental?” Among the other luminaries and distinguished guests Prof. Simon Croft, London School of Hygiene & Tropical Medicine, London, UK, Prof. P. Bhartam, Prof. and Head of Pharmacoinformatics, all senior scientists and eminent physicians from RMRIMS-Patna, have also attended the ceremony.

Sports Day

NIPER, Hajipur has also arranged the Annual Sports Meet-2012 from 5th to 8th November in which students, teachers, office staffs participated in various sports events like cricket, volley ball, kabadi, gully cricket, badminton, chess, carom, arm wrestling etc. The prize giving ceremony for the sports meet has also been a part of the foundation day program.

hindi pakhwara

Hindi Pakhwara was celebrated from 14th to 28th September 2012, during which several competitions like Nibandh, Vaad-Vivaad, etc were held and prizes were distributed among the winners.

Foundation Day celebration, NIPER, Hajipur Oration Medal to Prof. Anil K. Bhowmick presented by Dr.Pradeep Das, NIPER, Hajipur


67

Foundation Day celebration, NIPER, Hajipur

Sports at NIPER, Hajipur Cultural events on farewell, NIPER, Hajipur

Cultural events on Foundation Day, NIPER, Hajipur

niper guWahati

NIPER-Guwahati is the fifth institute to be included in the list of premium institutes under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India. NIPER-Guwahati started functioning from the month of September, 2008. The institute was inaugurated by the former Hon’ble Union Minister for Fertilizers and Chemicals and Steel, Shri Ram Vilas Paswan on September 16,2008 in the presence of several distinguished persons, like the Hon’ble Chief Minister of Assam Shri Tarun Gogoi, then the Hon’ble Union Minister of State for Chemicals Shri Bijoy Krishna Handique, Hon’ble Minister of Health & Family Welfare of Assam Dr. Himanta Biswa Sarma, Hon’ble Union Secretary for Pharmaceuticals Shri Ashok Kumar and the then Principal of GMCH, Dr. M.M. Deka among others.

ACADEMIC EXCELLENCE:

NIPER, Guwahati offers P.G. Courses in three disciplines viz. Pharmacology and Toxicology, Biotechnology and Pharmacy Practice. It is a matter of great satisfaction and pride that NIPER, Guwahati stepped into fifth academic year. The 5th batch was started on 1st of August 2012 with 19 students in M.S. Pharmacology & Toxicology, 09 students in M.S. Biotechnology and 09 students in M. Pharm Pharmacy Practice. The 4th batch students have completed their 2nd semester and currently doing project works under the supervision of different faculties for the 3rd and 4th semester. A total of four Ph.D. students were enrolled for their Doctoral Research at NIPER-Guwahati in the year 2012. The present status is given below.


68

eVents and actiVities Foundation Day

Like every year NIPER-Guwahati has celebrated its 4th foundation day on 16th September, 2012. Numerous dignitaries and delegates from various educational institutes attended the function. On this occasion, Director, Project Director, Chief Academic Coordinator of NIPER-Guwahati and HOD of Psychiatry Deptt., GMCH have delivered the lectures and addressed the staff members, students of NIPER and all other participants. Students were also given awards for their participation in various extracurricular activities during the calender year.

Pharmacy Day

NIPER – Guwahati has participated in Pharmacy day celebration held on 25th November 2012 which was collaboratively organized by GIPS, Guwahati and NIPER- Guwahati at Sankardeva Kalakhetra, Guwahati, Assam with the support of all the faculty and staff members. The programmes included a scientific session and oral presentation of NIPER Guwahati students.

Publications

The students were inspired for scientific publication and presentation to explore NIPER-Guwahati on scientific research platform in National as well as International level. They made publications in reputed journals with inputs from project work and presentation of papers both posters as well as oral in conferences/symposium in National and International level. A total of 06 publications in research Journal were carried out in this year.

placement

In addition to providing quality education and research as its priority, NIPER-Guwahati having placement cell

for the placement of its students. NIPER-Guwahati has contacted different reputed Biotech and Renowned Pharma industries and CRO Companies like Parexel, Clinigene, GVK BioSciences, Quintiles, Roche Scientific, Strides, Matrix Laboratory, Advinus Therapeutics, Johnson & Johnson and Hetero etc. to have better opportunities in National as well as International platform.

recent academic advancement:

• NIPER-Guwahati has got a great opportunity to host Institutional Level Biotech hub (IB Thub), Under the Department of Biotechnology, Ministry of Science and Technology, Govt. of India. It was inaugurated on 29th September 2012. During the tenure, One SRF (Senior Research Fellow) was recruited as man-power and basic equipments required for biotechnology research were procured under DBT project.

• IB Thub, National Institute of Pharmaceutical Education & Research, Guwahati in collaboration with Gauhati Medical College & Hospital, Guwahati, Assam organized a “National Workshop on Biotechnology” under sponsorship of DBT, Govt. of India on 29th September 2012.

• Indian Pharmacological Society, Assam branch in collaboration with College of Veterinary Science, Khanapara, Gauhati Medical College & Hospital and NIPER-Guwahati organized “Eastern Zonal Indian Pharmacological Society (EZIPS) Conference- Assam” with a theme on “Emerging Horizons in Therapeutics” on 3rd and 4th November 2012.

• Appointment of one faculty in the Department of Biotechnology, NIPER-Guwahati under Memo No: NIPER/GHY/2008/27/673-77, Dated Guwahati the 12.10.2012.

courses no. of students in 1st year (2012 -13)

no. of students in 2nd year (2012-13)

M.S. (Pharmacology & Toxicology) 19 20

M.S. (Biotechnology) 09 09

M. Pharm. (Pharmacy Practice) 09 09

Ph.D. (Pharmacology & Toxicology) 04 04


69

Foundation day celebrations, NIPER Guwahati Faculty along with students of batch -2012

Inauguration of IBT – HUB at NIPER–G by Director of NIPER cum Principal GMC, Guwahati

IBT Laboratory, NIPER Guwahati

Library, NIPER Guwahati Fresher’s day celebration, NIPER Guwahati

Chapter 7new InItIAtIves


73

ChAPter – 7new InItAtIves

7.1 DRUG DISCOVERY AND PHARMA INNOVATION HUB 2020

To develop a roadmap to enhance the national potential for Drug Discovery and Innovation, a number of action points and future commitments have been enshrined in the 12th Five Year Plan. The Department engaged M/s Ernst & Young to prepare a Detailed Project Report (DPR) in this regard. M/s Ernst & Young has submitted a Draft Report. The draft Report would be finalized after consultation with the stakeholders viz. industries and scientific departments of the Government of India.

7.2 COLLABORATIVE TB RESEARCH proJect proposal of niper, ahMedaBad and aiiMs

The Department has sanctioned the project for collaborative TB Research at NIPER Ahmedabad. The project aims at “Development and Clinical evaluation of novel fixed dose combination of Rifampicin and isoniazid designed to improve stability

and bioavailability of Rifampicin for the treatment of tuberculosis.” The project is in collaboration with All India Institute of Medical Sciences (AIIMS), New Delhi. The project is likely to be completed in 2013.

7.3 NATIONAL CENTRE FOR RESEARCH & deVelopMent in drugs at niper, hyderaBad

It is proposed to set up a National Centre for R&D in bulk drugs at Hyderabad NIPER. The Centre would aim at development of technologies and process for cost competiveness, environmental impact management, risk management and development of safety in manufacturing operations, knowledge transfer platform between industry and academia. The research avenues for bulk drugs are: Drugs process innovation, Drug discovery and development, Analytical chemistry, Process engineering, cleaner technology, Polymorphism, Nanotechnology etc. The proposal has been accorded in principle approval by the Planning Commission subject to certain conditions.

ChapterImPlementAtIon of rAjbhAshA

8


77

ChAPter – 8ImPlementAtIon of rAjbhAshA

Hindi Prayog Protsahan Pakhwara

Hindi Prayog Protsahan Pakhwara was observed in the Department during 14th to 28th September, 2012 with the objective to encourage the officers and members of the staff of the Department to progressively increase the use of Hindi in their official work and also to help the Department to create an atmosphere conducive to use of Hindi.

use of hindi in official work

Every possible effort was made for implementation of the various provisions of the Official Language Policy of the Union of India including those of Official Languages Act, 1963 as well as Official Languages (Use for Official Purposes of the Union) Rules, 1976 and orders issued thereunder. All the documents mentioned in Sub Section (3) of Section 3 of the Official Languages Act, 1963 were issued bilingually i.e. in Hindi as well as in English. Letters received in Hindi and representations etc. signed in Hindi were replied to in Hindi as per provisions of the Rule 5 and Rule 7(2) of the Official Languages (Use for Official Purposes of the Union) Rules, 1976 (as amended in 1987).

official language implementation committee

Department is having Official Language Implementation Committee working under the chairmanship of Joint Secretary (Pharma) to periodically review the progressive use of Hindi in the official work and suggest suitable measures to increase the use of Hindi in the official work. Its meetings were held on regular intervals and implementation status of the various targets set in the Annual Programme for transaction of the official work of the Union in Hindi for the year 2012-13 issued by the Department of Official Language, Ministry of Home Affairs was reviewed. Standard and routine letters being used by the various divisions/sections of the Department in their day to day correspondence were translated in Hindi to facilitate them to increase the use of Hindi language in the official work.

Secretary (Pharma) while distributing the prizes to the prize winners in the Hindi Prayog Protsahan

Pahkwara Prize Distribution Function

In addition to the message issued by the Secretary (pharma) requesting, inter-alia, all the staff members to make a commitment to use of Hindi, various Hindi competitions were held during the Pakhwara and winners were awarded cash prizes. As a part of the Pakhwara, three Hindi workshops on different topics were also organized to train the personnel of the Department and also remove their hesitation to work in Hindi.

review of the status of use of hindi in the offices under the department

Periodical review of the use of Hindi in the offices under the Deptt. wasmade through the quarterly reports on progressive use of Hindi received from them. In compliance with the targets set in the Annual Programme for use of Hindi for the year 2012-13, Official Language officials of the Department visited three offices under the Deptt. viz. NIPER, Hyderabad, NIPER Kolkata and BCPL, Kolkata with the objective to review the implementation status of the OL Policy of the Union of India and also to guide and help them implement the various provisions of the Policy including OL Act & Rules and motivate them to increase the use of Hindi in their official work.

Secretary (Pharma) while addressing the Hindi Prayog Protsahan Pahkwara Prize Distribution Function

Chapter 9generAl AdmInIstrAtIon9.1 OrganisationSetUpoftheDepartment9.2 recordManagement9.3 GrievanceCell


81

ChAPter – 9generAl AdmInIstrAtIon

9.1 ORGANISATION SET UP OF THE departMent

The main activities of the Department are policy making, sectoral planning promotion and Development of Pharmaceutical industries. The administrative and managerial control of the public sector undertakings engaged in the manufacture of various, pharmaceutical items and some other organization is a major function of the Department.

2. The Department is headed by Secretary to the Government of India who is assisted by two Joint Secretaries one Economic Adviser and one Deputy Director General.

3. There is an attached office namely “National Pharmaceutical Pricing Authority” which looks after Price fixation/revision of pharmaceuticals and other related matters. It also monitors the prices of decontrolled drugs and formulation and oversees the implementation of the provisions of the Drug (Price Control) Order. In addition, there are 5 public sector undertaking and 8 other organizations under the administrative control of the Department. The names of these are given in annexure iii.

EMPLOYMENT OF SCHEDULED CASTES /SCHEDULED TRIBES/ PHYSICALLY HANDICAPPED IN THE MAIN SCERETARIAT OF THE DEPARTMENT OF PHARMACEUTICALS

The status of employment of Scheduled Castes / Scheduled / Tribes / Physically handicapped in the main Secretariat of the Department of Pharmaceuticals, as on 15.01.2013 is as under:-

4. Officers in Group A include officers belonging to Central Secretariat Service besides officers on deputation from All India Services, Central Services and other Departments/ Undertakings. Appointment to posts in Group B and C is mostly done on the basis of nominations made by the Department of Personnel & Training.

5. The Department also monitors the progress of filling up of the posts reserved for the members of Scheduled Castes, Scheduled Tribes and other Backward Classes in the Public Sector Undertaking under the administration control of the Department.

group total no. of posts

scheduled castes

scheduled Tribes

other Backward castes

Physically handicapped

A 19 1 3 2 2B 34 4 - 4 -C 5 1 - 1 -D 14 6 - - -total 72 12 3 7 2

list of personnel in the departMent of pharMaceuticals

sl. no. name designation1. Shri Dilsher Singh Kalha Secretary

2. Sh. Shambhu Kallolikar Joint Secretary3. Sh. Pradeep Yadav Joint Secretary4. Shri Kailash Pati Economic Adviser5. Shri Binay Kumar Singh Director6. Shri S.C. Sharma Director7. Ms. Monika Verma Director


82

sl. no. name designation8. Shri Ravinder Mathur Director (Cost)9. Shri Rakesh Kumar Maggo Deputy Secretary

10. Shri M. L. Sidana Deputy Secretary 11. Shri S.D. Maurya Joint Director (Cost) 12. Shri A.K. Karn Under Secretary13. Shri Roshan Lal Under Secretary14. Shri A.K. Sah Under Secretary15. Shri Seeta Ram Meena Under Secretary16. Shri Anil Jain Under Secretary17. Shri Raj Kumar Under Secretary18. Shri V.K. Tyagi Deputy industrial Advisor19. Shri Brij Lal Sharma Assistant Director (OL)20. Shri Shah Faiz Ahmed Section Officer21. Shri Sanjay Gupta Section Officer22. Shri P.K. Singh Section Officer23. Smt Seema Agrawal Section Officer24. Shri T.K. Munshi Section Officer25. Shri N.N. Ahuja Section Officer26. Shri Yogeshwar Sharma Section Officer27. Shri Mrutyunjay Tripathy Section Officer

organisational chart of departMent of pharMaceuticals

108

ORGANISATIONAL CHART OF DEPARTMENT OF PHARMACEUTICALS

* One of the posts of Joint Secretary is vacant, all the works in the Department at present is being looked after by ShriShambhuKallolikar, who joined the Department w.e.f. 5.2.2013.

Shri Dilsher Singh Kalha, Secretary

Shri Pradeep Yadav

JS

Shri M.L. Sidana,

DS (PSU, PTUAS, Parliament)

Shri A.K. Karn,US (PI-IV, PSU)

Shri S.R. Meena, US

(Admin.,IT, Media, Parliament, Estt.)

Ms. Monika Verma, Director (O&M, Coord., OL, RTI)

Shri R.K. Maggo

DS (IT, Media, Admn.,DPEA/ DPCO, Court Cases, NPPA)

Shri Roshan Lal, US (NPPA, PI-I)

Shri S.D. Maurya, J.D. (Cost)

NPPA

Shri Anil Jain,

US

(DPEA)

Shri Shambhu Kallolikar

JS

Shri S.C. Sharma,

Director

(NIPER, R&D,Envm. Cell)

Shri A.K. Sah, US (NIPER,Environmental

Cell,R&D)

Shri V.K. Tyagi,

DIA

Shri Binay Kumar Singh, Director

(PI-II,III Estt.,Vig.)

Shri V.K. Tyagi,

DIA Shri Raj Kumar, US

(PI-II, III, Vig,,)

Shri A.K. Mathur, DDGShri Kailash Pati,

Economic Adviser

Shri Ravindra Mathur,

Director (Cost)

Shri Raj Kumar, US

(NORMS)

Shri S.K. Kundia

(AS & FA)

Shri V.K. Mehta, Director (Finance)

Mr. R.K. Kureel, US (Finance)


83

9.2 RECORD MANAGEMENT

The Parliament had enacted “The Public Records Act 1993” to regulate the management, administration and Preservation of Public Records of the Central Government, Union Territory Administrations, Public Sector Undertakings, statutory bodies and corporations etc. The Central Government has also made the rules to carry out the provisions of the Act. In terms of the provisions and terms contained in Section 5(1) of the Act, the Under Secretary Incharge of General Administration has been nominated as Records Officer in the Department. The requisite reports and returns are being sent to National Archives of India (NAI) regularly.

9.3 GRIEVANCE CELL

The Grievance Cell is monitoring grievances related to all Pharmaceuticals viz. their availability, quality, pricing, policy matters etc. One of the main objectives for opening of this cell was to make available medicines to common man at affordable prices.

Publicity about the setting up of this Grievances Cell was given through the National daily newspapers of Hindi, English and Regional Languages. The on line Grievance Redressel Mechanism, Public Grievances Redressal and Monitoring System (PGRAMS) has been brought into operation w.e.f. 1st August, 2005. Recently an online Centralized Public Grievance Redressal and Monitoring System (CPGRAMS) has also been introduced by Department of Administrative Reforms and Public Grievances (DARPG).

For giving wide publicity to the Grievance Cell, information has been uploaded on the websites of Department of Pharmaceuticals and also on the websites of the Institutions/Organizations falling under their purview. Links are given with the home pages of Department of Chemicals and Petrochemicals and Department of Pharmaceuticals to access CPGRAMS with the websites of the Institutions/Organizations under Department of Chemicals & Petrochemicals and Department of Pharmaceuticals. Grievance Cell plays a vital role in the redressal of grievances of common man.

Chapter 10PerformAnce evAluAtIon And mAnAgement system10.1 OurVision10.2 OurMission10.3 OurObjective10.4 Functions


87

The Department of Pharmaceuticals has prepared its Result Framework Document (RFD) for the year 2012-2013 as required under the “Performance Monitoring and Evaluation System (PMES) for Government Departments”. Results Framework Document for the year 2011-2012 and 2012-2013 are placed on its website http://pharmaceuticals.gov.in. As per the score approved by the High Powered Committee, the Department has been given 45.11 for its performance in the year 2011-12.

Based on the mandate given to the Department of Pharmaceuticals through the allocated functions a Vision, Mission, Objectives and Functions have been fixed in concurrence with the Cabinet Secretariat.

10.1 Our Vision:

“India: The largest global provider of quality medicines at reasonable prices.”

10.2 Our Mission:

• Ensure availability of drugs at reasonable prices as per provisions of the Drug Prices Control Order 1995





10.3 Our Objectives:

The objectives are based on the functions allocated to the Department as per “The Allocation of Business Rules, 1961” vide Notification of Cabinet Secretariat dated 1st July 2008:

1. Ensure availability of drugs at reasonable prices as per provisions of the Drug Prices Control Order 1995

2. Ensure proper functioning of the Central Pharma Undertakings in control of the Department.

3. Project Based Support and Revival Schemes for CPSUs

4. Ensure proper management of M Pharma and PhD programs in NIPERs

5. Develop Human Resources, Infrastructure for Pharma R&D and Industry including Public-Private-Partnerships (PPP)

6. Formulate Scheme/ Project for promoting Pharma Brand India

7. Formulate Scheme/ Project for promoting environmentally sustainable development of Pharmaceutical Industry

8. Formulation of Annual Plan, Budget and Monitoring of Budget Expenditure

9. Start preparation of Strategy Paper for the Department

10.4 Functions:

The Functions of the Department of Pharmaceuticals arise from the following work allocated to it as per “The Allocation of Business Rules, 1961” vide Notification of Cabinet Secretariat dated 1st July 2008:

1) Drugs and Pharmaceuticals, excluding those specifically allotted to other departments.

2) Promotion and co-ordination of basic, applied and other research in areas related to the Pharmaceuticals sector.

3) Development of infrastructure, manpower and skills for the Pharmaceuticals sector and management of related information.

4) Education and training including high end research and grant of fellowships in India and abroad, exchange of information and technical guidance on all matters relating to pharmaceutical sector.

5) Promotion of public – private – partnership in pharmaceutical related areas.

6) International cooperation in pharmaceutical research, including work related to international conferences in related areas in India and abroad.

ChAPter – 10PerformAnCe evAluAtIon And mAnAgement system


88

7) Inter-sectoral coordination including coordination between organizations and institutes under the Central and State Governments in areas related to the subjects entrusted to the Department.

8) Technical support for dealing with national hazards in pharmaceutical sector.

9) All matters relating to National Pharmaceuticals Pricing Authority including related functions of price control/monitoring.

10) All matters relating to National Institutes for Pharmaceutical Education and Research.

11) Planning, development and control of; and assistance to, all industries dealt with by the Department.

12) Bengal Chemicals and Pharmaceuticals Limited.

13) Hindustan Antibiotics Limited.

14) Indian Drugs and Pharmaceuticals Limited.

15) Karnataka Antibiotics and Pharmaceuticals Limited.

16) Rajasthan Drugs and Pharmaceuticals Limited

Chapter 11cItIzen centrIc governAnce11.1 OurVision11.2 OurMission11.3 OurClients11.4 OurCommitment11.5 OurServices11.6 OurActivities11.7 rTI-200511.8 CPGrAMS


91

ChAPter – 11CItIzen CentrIC governAnCe

11.1 our Vision

Based on the mandate given to the Department of Pharmaceuticals through the allocated functions a vision has been fixed in concurrence with the Cabinet Secretariat, which isas follows:

“India: The largest global provider of quality medicines at reasonable prices.”

11.2 our Mission

• Ensure availability of drugs at reasonable prices as per provisions of the Drug Prices Control Order 1995





11.3 Our Clients

• Consumers and users of the products and by-products of the Pharma Industry

• Entrepreneurs of pharmaceuticals sectors

• Industry Associations

• Central government ministries/departments/organizations

11.4 our commitment

• We are committed to provide impartial, sympathetic and prompt services to the public in matters relating to the pharmaceuticals industries.

• Our commitment is to take prompt steps to provide quick redressal of the grievances of our personnel and public at large.

• Our commitment is to formulate policies and initiate consulations with all Industry Associations/

stakeholders and to amend them whenever so required.

11.5 our services

We formulate and implement policies relating to drugs and pharmaceuticals, dyestuff and dye intermediates.

11.6 our activities

The key activities of the Department focus on:

1. Ensure availability of drugs at reasonable prices as per provisions of the Drug Prices Control Order 1995

2. Ensure proper functioning of the Central Pharma Undertakings in control of the Department.

3. Project Based Support and Revival Schemes for CPSUs

4. Ensure proper management of M Pharma and PhD programs in NIPERs

5. Develop Human Resources, Infrastructure for Pharma R&D and Industry including Public-Private-Partnerships (PPP)

6. Formulate Scheme/ Project for promoting Pharma Brand India

7. Formulate Scheme/ Project for promoting environmentally sustainable development of Pharmaceutical Industry

8. Formulation of Annual Plan, Budget and Monitoring of Budget Expenditure

The Citizen Charter of the Department has been placed on the website of the Department.

11.7 Right to Information Act 2005

As per the provisions of the RTI Act 2005, All the relevant information relating to Department of Pharmaceuticals has been available on the web site in a manner, which is easily accessible and comprehensible to the public.

Central Public Information Officers have been nominated in the department to provide information to the public.


92

11.8 CPGRAMS (Centralized Public Grievances and Monitoring System)

A portal of CPGRAMS has been uploaded on the

website of the Department. Public Grievances received on CPGRAMS are monitor and disposed regularly. Shri M.L. Sidana, Deputy Secretary, is the Public Grievances Officer of the Department

Chapter 12InformAtIon And technology12.1 LocalAreaNetwork(LAN)12.2 ITInfrastructure12.3 Website12.4 VideoConferencing12.5 FileTrackingSystem12.6 VoiceMailFacility12.7 E.Governance


95

Information and Technology

With the increased use of the internet, the need for better awareness and information flow has also increased. Also the usage of Information and Communication Technologies (ICT) has instigated the desire of various users and stakeholders of the department to be more familiar with the rules, protocols and policies which govern their proper functioning. Understanding these concerns, the Department of Pharmaceuticals has taken sincere initiatives towards adoption of best practices and organized useful information not only to improve administrative operations but also to enhance the overall efficiency of the department

12.1 local area network (lan):

A local Area Network (LAN) is functioning in the Department inter-connecting all the Windows based computers of officers, personal staff and sections. All computers are equipped with the facility of Internet and easy accessibility of applications from the server.

An IT based Computer Centre, set up by National Informatics Centre (NIC) is operational in the Department and is equipped with latest Servers, Client machines for providing Internet and E-mail facilities for local and global connectivity. LAN of Department is being upgraded as per IPv6 guidelines.

12.2 it infrastructure:

Department of Pharmaceuticals in close association with NIC has focused on building up the IT infrastructure within the Ministry with the following objectives:

• Improve workflow, work management and monitoring.

• Assist in analyzing, decision making and scheduling through Management Information Systems (MIS).

• Storage of data, analysis and handling of databases.

• Provide Graphical User Interface (GUI) based environment.

• LAN for sharing the resources among users.• Simplify dissemination of information to public

and make it interactive.

• Train all personnel in making most of this technology.

12.3 Website:

As Website is an electronic medium to provide information and enhance government citizen interaction, a Web Site in English and in Hindi has been launched by the Department (http://pharmaceuticals.gov.in) and is hosted at NIC to ensure maximum reach of information and services to the citizens. It provides details of organizational set up of the department, its functions, subordinate offices, policies, publications, statistical data/information on functional parameters. It is also a medium for interacting with citizens for taking decisions for making policies like NPPP 2012. Another website for Jan Aushadhi Scheme of the Department is also launched (http://janaushadhi.gov.in). It provides details of the scheme, list of generic medicines (unbranded) which are being dispensed through the Jan Aushadhi Stores (JAS) being setup in various districts of India. It facilitates the visitors to know the locations of the JAS already opened. It also provides comparative prices of Generic Medicines sold at Jan Aushadhi Stores and Branded Products.

12.4 Video conferencing:

Video Conferencing facility is operational for Joint Secretary and above level Officers. PSUs of the department and Educational Institutes (NIPERs) have also initiated installation of the Video Conferencing facility. With the facility already implemented at a few of the PSUs and NIPERs, Department is able to interact with them frequently to monitor their performance and communicate the decisions.

12.5 File Tracking System:

Department has implemented a web based File Tracking system (FTS) to keep record of its receipts being received at various locations in the department and to maintain a consistent watch over the movement of various important Files and Receipts at different levels in the process of decision-making. The system is used as a tool to curb down pendency at all levels in the Department. It is upgraded to new version for enhanced functionality.

ChAPter – 12InformAtIon And teChnology


96

12.6 Voice Mail Facility:

Voice Mail facility is successfully implemented in the Dept. through the landline telephone system at all levels to ensure high availability, enhance accountability and efficiency of the officials of the department at work.

12.7 E. Governance:

Taking advantage of latest ICT enabled tools, Department of Pharmaceuticals with the support of NIC has taken sincere initiatives towards adoption of best practices. Various applications have been developed and implemented by NIC to strengthen, monitor and decision making and high availability of right information at right time.

• Activity Monitoring System- A web based MIS has been developed and implemented to monitor time bound important activities and tasks assigned to officials/sections of Department.

• Intra portal for Department of Pharma:- An intranet portal ‘Intrapharma’ with electronic Notice Board is available to officials of the Department for

ready reference of various circulars, office orders, letters etc. It is also a gateway of application like digital library for Parliament Questions and presentation material etc.

• Centralized Public Grievance Redress Monitoring System (CPGRAMS) : CPGRAMS is implemented in the Department and all the attached office to address Public grievances received online with minimum delay.

• E-publishing of Tenders – E-publishing of tenders is implemented by uploading tenders on Central Public Procurement Portal. It has improved the accessibility of tenders.

• Other e-Governance applications like RTI Request & Appeal Management Information System, Composite Payroll System (Comp DDO), Result Framework Management System, ACC Vacancy Monitoring System are functional in the Department to facilitate various sections.

To enhance e-Governance further various applications in various domains such as G2C, G2B, G2G & G2E have been envisaged to be developed & implemented with assistance of NIC.

Chapter 13AnnexureAnnexure–IAnnexure–IIAnnexure–IIIAnnexure-IVAnnexure-V


99

Annexure – I

production of selected BulK drugs Monitored By nppa Based on the production return RECEIVED FROM THE COMPANIES FOR THE YEAR 2009-10, 2010-11, 2011-12 AND 2012-13 (PROVISIONAL)

(Ref: Chapter 4)

sl. no.

name of the therapeutic group and Bulk drugs

unit 2009-10 2010-11 2011-12 2012-13 upto sept

(prov.)i anaesthetics1 Lignocaine / Xylocaine / Lidocaine MT 85.760 106.750 57.300 28.2502 Procaine MT N.A. N.A. N.A. N.A.

ii analgesics & antipyretice3 Analgin / Metamizole (s) MT 186.708 243.757 157.559 88.1324 Aspirins (s) MT 1018.737 1151.436 1364.745 461.1505 Ibuprofen (s) MT 4687.000 4822.000 4654.000 789.0006 Oxyphenylbutazone MT N.A N.A N.A N.A7 Paracetamol MT 11209.612 13669.802 7146.000 3566.0008 Pethidine MT N.A N.A N.A N.A9 Phenylbutazone MT 42.242 33.255 0.000 N.A10 Piroxicam MT N.A N.A N.A N.A

iii ANTI-ASTHAMATICS11 Aminophylline (s) MT 5.445 8.035 3.375 0.00012 Ephedrine (s) MT 413.716 472.803 411.512 107.78213 Salbutamol (s) MT 7.115 9.543 7.562 3.13314 Terbutaline MT 0.576 0.602 0.531 0.09615 Theophylline (s) MT 80.980 N.A N.A N.A

iV ANTI-BIOTICS16 Amoxycilline MT 1545.670 1219.608 1150.323 565.12817 Ampicilline MT 90.260 64.410 113.820 49.86018 Cephalexin MT 1088.787 1259.667 1042.118 386.47519 Chloramphenicol Palmitate MT 42.943 34.509 29.939 8.59020 Chloramphenicol Powder MT 24.554 31.113 33.631 8.86321 Cloxacillin (s) MT 29.920 3.000 20.340 10.26022 Doxycycline (s) MT 1.929 6.248 3.356 0.00023 Erythromycin (s) MT 480.457 492.853 555.283 303.16524 Framycetin (s) MT N.A N.A N.A N.A25 Gentamycin (s) MT N.A N.A N.A N.A26 Griseofulvin (s) MT N.A N.A N.A N.A27 Oxytetracycline (s) MT N.A N.A N.A N.A


100

sl. no.


unit 2009-10 2010-11 2011-12 2012-13 upto sept

(prov.)28 Penicillin (s)

a. Penicillin G 1st Crystal MMU 1789.000 2000.000 876.086 0.000b. Penicillin G Procaine MMU N.A. N.A. N.A. N.A.c. Penicillin G Sodium MMU N.A. N.A. N.A. N.A.d. Penicillin G Benzathine MMU 4.170 0.000 N.A N.A

29 Rifampicin (s) MT 369.735 407.714 213.765 165.11930 Streptomycin (s) MT N.A. N.A. N.A. N.A.31 Tetracycline (s) MT N.A. N.A. N.A. N.A.

V ANTI-DIABETICS32 Chlorpropamide (s) MT 4.100 8.525 2.720 10.07733 Glibenclamide MT 2.421 1.686 1.336 0.88834 Insulin (s) KG N.A. N.A. N.A. N.A.35 Tolbutamide MT 44.800 52.135 70.058 33.402

Vi ANTI-DYSENTRY DRUGS36 DiloxanideFuroate MT 48.750 38.647 71.622 34.07937 IodoChloroHydroxyQuinoline (s) MT 185.427 220.242 77.197 23.14038 Metronidazole (s) MT 374.122 326.094 224.855 66.37639 Tinidazole MT 76.501 73.500 79.000 8.500

Vii ANTI-FILARIALS40 Diethyl Carbamazine (DEC Citrate) MT 24.800 9.015 22.995 5.825

Viii ANTI-HELMENTICS41 Mebandazole MT N.A N.A N.A N.A42 Piperazine and Salts MT N.A N.A N.A N.A43 PyrantelPamoate (s) MT N.A N.A N.A N.A44 Tetramisole / Levamisole MT N.A N.A N.A N.A

IX ANTI-HISTAMINS45 Diphenhydramine MT 52.415 51.946 65.310 6.181

46 Pheniramine Maleate (s) MT 35.429 53.430 52.946 27.024

X ANTI-LEPROTICS47 Clofuzamine MT N.A N.A N.A N.A48 Dapsone MT N.A N.A N.A N.A


101

sl. no.


unit 2009-10 2010-11 2011-12 2012-13 upto sept

(prov.)XI ANTI-MALARIALS49 Amodiaquin (s) MT 17.400 0.587 2.448 2.04550 Chloroquine (s) MT 168.194 119.888 54.115 22.308

XII ANTI-T.B. DRUGS51 Ethambutol MT 931.401 935.192 924.854 469.33052 INH MT N.A N.A N.A N.A53 Pas & its Salts MT 37.687 51.578 97.500 22.91154 Pyrazinamide MT 299.186 339.248 303.959 222.98155 Thiacetazone MT N.A N.A N.A N.A

XIII cardioVascular drugs56 Digoxin MT N.A N.A N.A N.A57 Methyl Dopa (s) MT N.A N.A N.A N.A58 Propranolol MT N.A N.A N.A N.A59 XanthinolNicotinate MT N.A N.A N.A N.A

XIV cns stiMulants60 Caffeine MT N.A N.A N.A N.A61 Nikethamide MT N.A N.A N.A N.A

XV corticosteroids62 Betamethasone (s) MT 5.101 4.886 2.997 0.26163 Dexamethasone (s) MT N.A N.A N.A N.A64 Hydrocortisone MT N.A N.A N.A N.A65 Prednisolone (s) MT N.A N.A N.A N.A

XVI diuretics66 Acetazolamide MT N.A N.A N.A N.A67 Frusemide (s) MT N.A 2.433 7.666 0.52768 Hydrochlorothiazide MT 44.564 65.723 75.256 19.956

69 Spironolactone MT 3.550 2.246 3.794 2.034

XVII gastro intestinal70 Ranitidine (s) MT 1254.709 1686.114 1559.384 704.171


102

sl. no.


unit 2009-10 2010-11 2011-12 2012-13 upto sept

(prov.)XVIII OTHER ANTI-BACTERIALS71 Nalidixic Acid (s) MT 182.299 174.411 81.030 13.34372 Trimethoprim (s) MT 275.699 299.557 271.202 152.536

XIX sulpha drugs73 Sulphacetamide MT N.A N.A N.A N.A74 Sulphadiazine (s) MT N.A N.A N.A N.A75 Sulphadimidine (s) MT N.A N.A N.A N.A76 Sulphaguanidine MT N.A N.A N.A N.A77 Sulphamethoxazole (s) MT N.A N.A N.A N.A78 Sulphamoxole (s) MT N.A N.A N.A N.A79 Sulphaphenazole MT N.A N.A N.A N.A80 Sulphasomidine MT N.A N.A N.A N.A

XX tranquiliZers & sedatiVes81 Diazepam MT 6.155 6.956 8.041 4.07082 Imipramine MT N.A. N.A. N.A. N.A.83 Nitrazepam MT 0.259 0.076 0.206 0.01884 Phenobarbitone MT 31.194 22.092 0.000 0.00085 Trifluperazine MT N.A. N.A. N.A. N.A.

XXI VitaMins86 Folic Acid MT 81.120 39.340 39.990 0.00087 Nicotinamide MT N.A. N.A. N.A. N.A.88 Niacotinic Acid MT N.A. N.A. N.A. N.A.89 Vitamin A (s) MT 38.268 36.203 13.429 0.00090 Vitamin B1 / Thiamine(s) MT N.A N.A N.A N.A91 Vitamin B12 MT N.A N.A N.A N.A92 Vitamin B2 (s) MT N.A N.A N.A N.A93 Vitamin B6 MT N.A N.A N.A N.A94 Vitamin C/Ascorbic Acid(s) MT N.A N.A N.A N.A

95 Vitamin D3 MT N.A N.A N.A N.A96 Vitamin E (s) MT 354.000 392.960 103.520 0.000


103

Annexure – II

(Ref: Chapter 4)

PRICES OF SCHEDULED BULK DRUG/DERIVATIVES FIXED /REVISED BY NPPA SINCE ITS INCEPTION

sl. no.

naMe of the drug existing revised %

1 PCMX 762(E) 305.00 12.06.2009 309.00 09.04.2012 1.31

2 Vitamin C Plain 761(E) 613.00 20.01.2010 409.00 09.04.2012 (33.28)

3 Vitamin C Coated 761(E) 600.00 20.01.2010 419.00 09.04.2012 (30.17)

4 Vitamin C - Sodium Ascorbate

761(E) 645.00 20.01.2010 469.00 09.04.2012 (27.29)

5 Ibuprofen 2741(E) 498.00 20.09.2011 527.00 16.11.2012 5.82

6 Rifampicin 2742(E) 4,111.00 20.09.2011 4,485.00 16.11.2012 9.10

7 Iodochlorohydroxyquinoline (ICHQ)

2743(E) 1,158.00 20.09.2011 1,526.00 16.11.2012 31.78

8 Metronidazole 2744(E) 514.00 01.07.2011 588.00 16.11.2012 14.40

9 Metronidazole Benzoate 2744(E) 450.00 01.07.2011 525.00 16.11.2012 16.67

10 Glipizide 2745(E) 26,114.00 24.04.2009 15,946.00 16.11.2012 (38.94)

First Time 17 cases* Since Inception of NPPA

No Change 10 cases Bulk Drug - 342

Increases 158 cases Derivative - 190

Decreases 347 cases Total 532

532 cases

* Notification of Oxcarbazapine is withdrawn


105

Annexure-III

List of Public Sector Undertaking and other Organisation under the administration Control of the Department of Pharmaceuticals

attached office

NATIONAL PHARMACEUTICAL PRICING AUTHORITY

puBlic sector undertaKings

1. Karnataka Antibiotics & Pharmaceuticals Limited (KAPL), Bangalore.

2. Rajasthan Drugs & Pharmaceuticals Limited (RDPL), Jaipur.

3. Hindustan Antibiotics Limited (HAL), Pimpri, Pune, Maharashtra

4. Bengal Chemicals & Pharmaceuticals Limited (BCPL), Kolkata, West Bengal

5. Indian Drugs & Pharmaceuticals Limited (Idpl), Dundahera, Gurgaon, Haryana

6. Bengal Immunity Limited (BIL), Kolkata, West Bengal – Since Closed

7. Smith Stanistreet Pharmaceuticals Limited (SSPL), Kolkata, West Bengal – Since Closed

other organisations

1. National Institute of Pharmaceuticals Education and Research (NIPER) at Mohali, SAS Nagar (Punjab)

2. National Institute of Pharmaceuticals Education and Research at Hyderabad (Andhra Pradesh).

3. National Institute of Pharmaceuticals Education and Research at Kolkata (West Bengal)

4. National Institute of Pharmaceuticals Education and Research atRai Bareli (Uttar Pradesh).

5. National Institute of Pharmaceuticals Education and Research at Hajipur (Bihar)

6. National Institute of Pharmaceuticals Education and Research at Ahmedabad (Gujarat)

7. National Institute of Pharmaceuticals Education and Research at Guwahati (Assam)

(Ref: Chapter - 9)


107

Annexure – III(A).

Address and Name of Head of various Organizations & PSUs under the Department of Pharmaceuticals

sl. no.

Address and Organizations name designation

1. Indian Drugs & Pharmaceuticals Limited (IDPL), Gurgaon Shri Praveen Kumar Chairperson & Managing Director

2. Hindustan Antibiotics Limited (HAL), Pune - 411010 Shri K.V. Varkey Managing Director

3. Karnataka Antibiotics & Pharmaceuticals Limited (KAPL), Bangalore - 560 010 (Vacant) Managing Director

4. Bengal Chemicals & Pharmaceuticals Limited (BCPL), Kolkata - 700 013 Shri S. Kundu Managing Director

5. Rajasthan Drugs & Pharmaceuticals Limited (RDPL), Road No. 12 V.K.I Area Jaipur - 302 013 Shri M.K. Nagendra Managing Director

6. Bengal Immunity Limited (BIL), Kolkata (since closed) Sh. S. Kundu Managing Director

7. Smith Stanistreet Pharmaceuticals Limited (SSPL), Kolkata (Since Closed), under liquidation)

(Ref. Chapter 9)


109

Annexure – III(b)

(Ref. Chapter 9)

List of Responsibility Centers and Subordinate Organisations for the Year 2012-13

sl. no.

Responsibility Centers and Subordinate Organizations description

landline Number

email address

1. Dr. K. KBhutani, Officiating Director

1722214692 [email protected] National Institute of Pharmaceuticals Education & Research (NIPERS) Sector- 67, SAS Nagar, Punjab 160062

2. Dr. Neeta Shrivastava, Project Director

07927450449 [email protected] NIPER Ahmedabad, B.V. Patel Pharmaceutical, Education and Research Development (PERD) Center Thaltej- Gandinagar Highway, Thaltej, Ahmedabad - 380054

3. Dr. Ahmed Kamal, Project Director

04023073751 [email protected] NIPER Hydrabad IDPL Township, Balangar, Hyderabad - 500007

4. Dr. Pradeep Das, Project Director

0612263437 [email protected]

NIPER Hajipur Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) Agam Kuan, Patna - 800 007

5. Dr. Asish Kumar Banerjee, Project Director

3324735197 [email protected]

NIPER Kolkata Indian Institute of Chemical Biology 4, Raja S.C. Mullick Road, Jadavpur, Kolkata - 700032

6. Dr. B.K. Bezbaruah 03612132751 [email protected] NIPER Guwahati, Guwahati Medical College and Hospital (Guwahati) - 781032

7. Dr. P.K. Shukla 05222620713 [email protected] NIPER Rai Bareli, Central Drug Research Institute Chatter Manzil P.O Box 173, Lucknow - 226001

8. Mr. C.P. Singh, Chairman, National Pharmaceuticals Pricing Authority

01123389866 [email protected] NPPA, YMCA Cultural Centre Building, 3rd Floor, 1, Jai Singh Road, New Delhi - 110001


111

Annexure – Iv

organisational chart of nppa (Ref. Chapter 4)

dire

ctor

Mis

div

isio

n

1.G

ener

atio

n an

dva

lidat

ion

ofM

onth

ly

Rep

ort

base

d on I

MS

Data

.2.

Coor

dina

tion

work

rela

ted

to A

utho

rity

Mee

tings

- Age

nda/

Minu

tes

3.Pr

ice L

ist co

llect

ion

& ex

amin

atio

n4.

Prod

uctio

n & Im

port

Data

of B

ulk

Drug

s&

Form

ulat

ions

5.An

nual

exe

rcise

inre

spec

t of m

arke

tstr

uctu

re/n

umbe

r of

NLEM

man

ufac

tur-

ers

for e

ach

NLEM

form

ulatio

ns6.

Stor

age

&Pr

eser

vanc

e of

Data

and

pro

vidin

gin

puts

to th

e co

n-ce

rned

Divs

ions

of

NPPA

7.Up

datio

n of N

PPA'

swe

bsite

.8.

Rela

ted P

arlia

men

tQ

uesti

ons/m

atte

rs.

dire

ctor

pric

ing

divi

sion

1.Fix

ation

/Rev

ision

of pr

ices

of N

LEM

for

mul

atio

nsba

sed o

n inp

uts re

cd. fr

omMI

S Di

vn, M

&E D

ivn a

ndAp

plica

tions

/Req

uests

from

manu

factur

ers.

2.W

orkin

g out

factor

s/ no

rms

relat

ed to

pric

ing fo

rmula

given

in D

PCO,

201

3 an

dits

revis

ion fro

m tim

e to t

ime

3.Co

llecti

on of

mar

ket b

ased

data

for fix

ation

of pr

ices o

fNL

EM fo

rmul

atio

ns fo

rwh

ich IM

S da

ta is

not a

vail-

able.

4.An

nual

revis

ion of

price

s of

NLEM

form

ulatio

ns ba

sed

on W

PI on

or af

ter 1s

t Apr

il,ev

ery y

ear.

5.An

nual

revis

ion o

f pric

eswh

enev

er th

ere i

s a ch

ange

in ma

rket s

tructu

re in

re-

spec

t of

NLEM

form

ula-

tions

6. P

rice

fixati

on/ r

evisi

on o

fno

n-NL

EM fo

rmul

atio

nswh

erev

er co

nside

red n

ec-

essa

ry.7.

Notifi

catio

n of p

rices

in th

eoff

icial

Gaza

tte a

nd m

ain-

taini

ng th

e pr

ice d

ata

ofNL

EM fo

rmula

tions

8.Re

lated

Par

liame

nt Qu

es-

tions

/matt

ers.

dire

ctor

Mon

.& e

nf. d

ivis

ion

1.En

forc

ing a

nd im

plem

enta

tion

of th

epr

ices

of N

LEM

form

ulatio

ns fi

xed

byNP

PA.

2.Mo

nitor

ing of

the p

rice m

ovem

ent o

f non

-NL

EM fo

rmula

tions

base

d on m

onthl

y re-

ports

of IM

S an

d acti

on th

ereo

f, if fo

und

more

than

10%

.3.

Proc

essin

g of S

DCs r

epor

ts re

ceive

d in

resp

ect o

f non

-imple

men

tatio

n of

the

price

s of N

LEM

formu

lation

s and

othe

rDP

CO re

lated

matt

ers.

4.Sa

mplin

g of N

LEM

formu

lation

s fro

m dif

-fer

ent p

laces

and

ana

lysis

on a

regu

larba

sis.

5.Co

mplai

nts

rece

ived

from

indivi

duals

,NG

Os, in

stitut

es re

lated

to pr

icing

/ mar

-ke

ting a

t pric

es hi

gher

than

the p

rice f

ixed

by N

PPAo

r pric

e inc

rease

more

than

10%

.6.

Send

ing re

ports

to O

verch

argin

g Divi

sion

for re

cove

ry of

over

char

ged a

moun

t.7.

Send

ing re

ports

to P

ricing

Divi

sion t

o fix

the p

rices

in re

spec

t of N

LEM

formu

la-tio

ns, if

price

is no

t fixe

d.8.

Inter

actio

n/ co

rresp

onde

nce

with

State

Drug

s Con

trolle

rs in

the m

atter

relat

ed to

enfor

ceme

nt of

DPCO

prov

ision

s.9.

Shor

tage

and

avail

abilit

y of N

LEM

and

non-

NLEM

form

ulatio

ns10

.Po

licy m

atter

relat

ed to

new

DPCO

.11

.VI

P Re

feren

ces

12.

Relat

ed P

arlia

ment

Ques

tions

/matt

ers.

dire

ctor

over

char

ging

divi

sion

1.Iss

ue no

tice t

o the

com-

panie

s for

over

char

ging

and

subs

eque

nt fol

lowup

.2.

Issue

sho

w ca

use

no-

tice,

wor

king

out t

heov

erch

arge

d am

ount

and

raise

dem

and

for

reco

very

of t

he o

ver-

char

ged a

moun

t.3.

Reco

very

of

over

-ch

arge

d am

ount

unde

rDP

CO, 1

995.

4.Gr

ant p

erso

nal h

earin

gan

d pas

s spe

aking

/ rea-

sone

d or

der w

hene

ver

need

ed.

5.Ex

amina

tion o

f othe

r is-

sues

rela

ted

to o

ver-

char

ging

unde

r DPC

O,20

13 fo

r rec

over

y of th

eov

erch

arge

d amo

unt.

6.Ex

amina

tion o

f othe

r is-

sues

rela

ted

to o

ver-

char

ging

unde

r DPC

O,19

95 fo

r rec

over

y of th

eov

erch

arge

d amo

unt.

7.Ex

amina

tion o

f othe

r is-

sues

rela

ted

to o

ver-

char

ging

unde

r DPC

O,19

87 fo

r rec

over

y of th

eov

erch

arge

d amo

unt.

8.Pr

ovidi

ng in

put to

Lega

lDi

vision

for c

ourt c

ases

.9.

Rela

ted

Parli

amen

tQu

estio

ns/m

atter

s.

dire

ctor

lega

l div

isio

n

1.Co

urt c

ases

unde

rDP

CO, 1

987

and

1995

2.Co

urt c

ases

unde

rDP

CO, 2

013

3.Ad

vice t

o oth

er D

i-vis

ions

of N

PPA

relat

ed to

inte

rpre

-ta

tion a

nd ap

plica

-tio

ns o

f va

rious

prov

isio

ns

ofDP

CO.

4.Le

gal m

atte

rs re

-la

ted

to e

stab

lish-

men

t m

atte

rs /

NP

PA

's

acco

mod

ation

5.NP

PA's

work

ing

guide

lines

/ pro

ce-

dure

s etc

.6.

Laun

chin

g pr

os-

ecut

ion

agai

nst

the

defa

ultin

gco

mpa

nies f

or vi

o-la

tion o

f the p

rovi-

sions

of D

PCO

.7.

Rel

ated

Par

lia-

men

t Que

stio

ns/

mat

ters

.

dire

ctor

adm

n. d

ivis

ion

1.Es

tabl

ishm

ent

mat

ters

2.G

ener

al A

dmn.

3.Ca

sh/B

udge

t4.

Coor

dinat

ion5.

R &

I Sec

tion

6.Vi

gilan

ce7.

Wor

k re

late

d to

Parlia

men

t Com

-m

ittees

8.C

onso

lidat

ion

and

com

pila

tion

of

Parli

amen

tqu

estio

ns/ r

eply/

mat

ters

.9.

ISO

Aud

it10

.An

y ot

her

sub-

ject

s no

t lis

ted

elsew

here

.

chai

rman

nppa

Mem

ber S

ecre

tary

advi

sor


113

Annexure – v

RFD for the year 2011-12 (Ref. Chapter 10)

Section 1:Vision, Mission, Objectives and Functions

Results-Framework Document (RFD) for Department of Pharmaceuticals-(2011-2012)

India: The Largest Global Provider of Quality Medicines at Reasonable Prices.

Mission

Ensure availability of quality drugs at reasonable prices as per the Pharma Policy.Development of Pharma Infrastructureand Innovative Development in Pharma Sector including through PPP.Promote Pharma Brand IndiaEncourageenvironmentally sustainable development of Pharmaceutical Industry

Objective

1 Ensure availability of drugs at reasonable prices as per the Pharma policy

2 .Facilitate growth of Central pharma PSUs with required support

3 Develop Pharma Infrastructure and Catalyze Drug Discovery and Innovation

4 Launch and Position Pharma India Brand

5 Develop Pharma Human Resources through M.Pharma and Ph.D programmes in NIPERS

6 Provide Infrastructure and staff for new NIPERs

7 Strengthening of NIPER Mohail

8 Jan Aushadi Campaign and implementation of Business Plan for setting up of 3000 Jan Aushadhi Stores (upto Subdivisionlevel in the country)

9 Incentivising Private Sector for development of new Drugs for diseases endemic to India

Functions

Drugs and Pharmaceuticals, excluding those specifically allotted to other departments1

Promotion and co-ordination of basic, applied and other research2

Development of infrastructure, manpower and skills3

Education and training including high end research and grant of fellowships in India and abroad and technical guidance4

Promotion of Public – Private – Partnership5

International cooperation in pharmaceutical research, including work related to international conferences in India and abroad6

Inter-sectoral coordination including coordination between organizations and institutes under the Central and State Governments7

Vision

page : 2 of 18 Generated on : 14/02/2012


114

Section 1:Vision, Mission, Objectives and Functions

Results-Framework Document (RFD) for Department of Pharmaceuticals-(2011-2012)

Technical support for dealing with national hazards in pharma sector.8

All matters relating to National Pharmaceuticals Pricing Authority including related functions of price control/monitoring.9

All matters relating to National Institutes for Pharmacy Education and Research.10

Planning, development and control of; and assistance to, all industries dealt with by the Department11

CPSUs: BCPL, HAL, IDPL, KAPL & RDPL12



115

Secti

on 2

:In

ter s

e Pr

ioritie

s am

ong

Key O

bjecti

ves,

Succ

ess i

ndica

tors

and

Tar

gets

Resu

lts-F

ram

ewor

k Doc

umen

t (RF

D) fo

r Dep

artm

ent o

f Pha

rmac

eutic

als -(

2011

-201

2)

Objec

tive

Weig

htAc

tion

Unit

Tar

get /

Crit

eria

Value

Weig

ht 8

0%10

0% 7

0% 6

0%90

%Ve

ry G

ood

Fair

Poo

rEx

celle

nt G

ood

Succ

ess

Indic

ator

Ensu

re a

vaila

bility

of d

rugs

at r

easo

nable

price

s as p

er th

e Ph

arm

a po

licy

3.00

Proc

essin

g of

new

revie

wap

plica

tions

und

er D

PCO

rece

ived

upto

31.

1.20

12 fo

ror

ders

by c

ompe

tent

auth

ority

No.o

f rev

iewap

plica

tions

dispo

sed

in 90

day

sof

rece

ipt in

the

Depa

rtmen

t

days

and

%90

110

120

100

803.

00[1

][1

.1]

[1.1

.1]

.Fac

ilitat

e gr

owth

of C

entra

l pha

rma

PSUs

with

requ

ired

supp

ort

18.0

0Pr

ovidi

ng a

ssist

ance

toCe

ntra

l Pha

rma

PSUs

as

per M

OU o

bliga

tion

Achie

vem

ent o

fde

sired

resu

lts a

sen

visag

ed th

roug

has

sista

nce

%90

6050

8010

03.

00[2

][2

.1]

[2.1

.1]

Proje

ct ba

sed

supp

ort t

oPS

Us fo

r WHO

- GM

Pco

mpli

ance

Ass

istan

ceSc

hem

e

Tim

ely fu

nd re

lease

%90

6050

8010

03.

00[2

.2]

[2.2

.1]

Proje

ct ba

sed

supp

ort t

oHA

L fo

r tak

ingup

/Imple

men

tatio

n of

Eryth

rom

icin

Proje

ct, M

ulti

Prod

uct S

terile

facil

ities f

orBe

talac

tum

Ant

ibiot

ics a

ndLa

rge

Volum

Par

ente

ral

Tim

ely fu

nd re

lease

%90

6050

8010

02.

00[2

.3]

[2.3

.1]

Proje

ct ba

sed

supp

ort t

oBC

PL fo

r Im

plem

enta

tion

ofPr

ojects

und

erta

ken

inRe

vival

Sche

me

Tim

ely fu

nd re

lease

%90

6050

8010

02.

00[2

.4]

[2.4

.1]

Proje

ct ba

sed

supp

ort t

oRD

PL fo

r the

pro

jects

for

WHO

-GM

P Co

mpli

ance

(Cap

ital S

uppo

rt)

Tim

ely fu

nd re

lease

%90

6050

8010

02.

00[2

.5]

[2.5

.1]

Reviv

al of

IDPL

To ta

ke fin

al vie

wDa

te31

/08/

2011

31/1

0/20

1130

/11/

2011

30/0

9/20

1130

/06/

2011

2.00

[2.6

][2

.6.1

]

Appr

oval

from

the

Cabin

et/C

CEA

Date

31/0

1/20

1228

/02/

2012

31/0

3/20

1215

/02/

2012

31/1

2/20

112.

00[2

.6.2

]

Tim

ely fu

nd re

lease

%90

6050

8010

02.

00[2

.6.3

]

page

: 4

of 1

8Ge

nera

ted

on :

14/0

2/20

12


116

Secti

on 2

:In

ter s

e Pr

ioritie

s am

ong

Key O

bjecti

ves,

Succ

ess i

ndica

tors

and

Tar

gets

Resu

lts-F

ram

ewor

k Doc

umen

t (RF

D) fo

r Dep

artm

ent o

f Pha

rmac

eutic

als -(

2011

-201

2)

Objec

tive

Weig

htAc

tion

Unit

Tar

get /

Crit

eria

Value

Weig

ht 8

0%10

0% 7

0% 6

0%90

%Ve

ry G

ood

Fair

Poo

rEx

celle

nt G

ood

Succ

ess

Indic

ator

Deve

lop P

harm

a In

frastr

uctu

re a

nd C

ataly

zeDr

ug D

iscov

ery a

nd In

nova

tion

15.0

0De

velop

men

t of n

ew d

rugs

for T

B &

Kalaz

ar b

y NIP

ERAp

prov

al o

f sch

eme

for d

evelo

pmen

t of

new

drug

s by

NIPE

R inc

luding

PPP/

Joint

Colla

bora

tion

Date

15/0

2/20

1215

/03/

2012

31/0

3/20

1228

/02/

2012

31/0

1/20

124.

00[3

][3

.1]

[3.1

.1]

Fina

lizat

ion o

fSc

hem

e/Pr

oject

for W

orld

Clas

s Pha

rma

Infra

struc

ture

, Fina

lizat

ionof

Sch

eme/

Proje

ct fo

r R&D

and

Fina

lizat

ion o

fSc

hem

e/Pr

oject

for I

ndus

trysu

ppor

t for

WHO

/Inte

rnat

ional

Stan

dard

s Man

ufac

turin

gso

as t

o ca

talyz

e th

eGr

owth

of P

harm

a In

dustr

y

Appr

oval

ofSc

hem

e/Pr

oject

byPl

annin

gCo

mm

ission

for

supp

ortin

gIn

tern

ation

alSt

anda

rdM

anuf

actu

ring-

Phar

mac

eutic

alsTe

chno

logy

Upgr

adat

ionAs

sista

nce

Sche

me

(PTU

AS)

Date

15/0

2/20

1215

/03/

2012

31/0

3/20

1228

/02/

2012

31/0

1/20

123.

00[3

.2]

[3.2

.1]

Rece

ipt o

f pro

ject

repo

rts f

rom

the

cons

ulant

s for

deve

loping

infra

struc

ture

for

Phar

ma

R&D

(GLP

Com

plian

tlab

s/Anim

al Ho

use)

Date

15/0

2/20

1221

/03/

2012

31/0

3/20

1215

/03/

2012

15/0

1/20

124.

00[3

.2.2

]

Appr

oval

ofSc

hem

e/Pr

oject

by

the

Plan

ning

Com

miss

ion fo

rDe

velop

men

t of

Infra

struc

ture

a

spe

r det

ailed

pro

ject

repo

rt to

be

subm

itted

by th

eglo

bal le

vel

cons

ultan

t

Date

15/0

2/20

1215

/03/

2012

31/0

3/20

1228

/02/

2012

31/0

1/20

124.

00[3

.2.3

]

page

: 5

of 1

8Ge

nera

ted

on :

14/0

2/20

12


117

Secti

on 2

:In

ter s

e Pr

ioritie

s am

ong

Key O

bjecti

ves,

Succ

ess i

ndica

tors

and

Tar

gets

Resu

lts-F

ram

ewor

k Doc

umen

t (RF

D) fo

r Dep

artm

ent o

f Pha

rmac

eutic

als -(

2011

-201

2)

Objec

tive

Weig

htAc

tion

Unit

Tar

get /

Crit

eria

Value

Weig

ht 8

0%10

0% 7

0% 6

0%90

%Ve

ry G

ood

Fair

Poo

rEx

celle

nt G

ood

Succ

ess

Indic

ator

Laun

ch a

nd P

ositio

n Ph

arm

a In

dia B

rand

7.00

Laun

ch a

nd P

ositio

nPh

arm

a In

dia b

rand

inta

rget

coun

tries

Laun

ch a

nd P

ositio

nPh

arm

a In

dia B

rand

in ta

rget

coun

tries

ina

phas

ed m

anne

raf

ter r

eceiv

ing “i

npr

incipl

e” a

ppro

val

from

Plan

ning

Com

miss

ion

Date

07/0

3/20

1221

/03/

2012

31/0

3/20

1215

/03/

2012

28/0

2/20

122.

00[4

][4

.1]

[4.1

.1]

Follo

w up

acti

on o

f Sec

ond

India

Pha

rma

Sum

mit h

eldin

Nove

mbe

r 201

0

Imple

men

tatio

n of

2Fi

naliz

ed p

ropo

sals

for f

ollow

up

actio

nof

pha

rma

sum

mit

2010

::1

A Se

mina

r on

regu

lator

y iss

ues o

nm

edica

l dev

ices..

.2

A T

ask f

orce

for

repo

rt on

dru

gdis

cove

ry, w

ith fo

cus

on re

gulat

ory i

ssue

sof

clini

cal tr

ials i

nIn

dia

Date

31/1

2/20

1128

/02/

2011

31/0

3/20

1231

/01/

2012

30/1

1/20

115.

00[4

.2]

[4.2

.1]

Deve

lop P

harm

a Hu

man

Res

ourc

es th

roug

hM

.Pha

rma

and

Ph.D

pro

gram

mes

inNI

PERS

14.0

0In

take

of s

tude

nts f

orM

aste

rs a

nd P

h.D

degr

ees

by N

IPER

, Moh

ali:

PhD-

46,M

S-25

0,M

BA-6

1;%

9070

6080

100

2.00

[5]

[5.1

][5

.1.1

]

Inta

ke o

f stu

dent

s for

Mas

ters

deg

ress

by N

ewNI

PERs

Ahm

edab

ad- 6

,Gu

waha

ti- 4

0,Ha

jipur

- 46,

.Hy

dera

bad-

75,

Kolka

ta -

50, R

aiBa

reli -

35

%90

7060

8010

012

.00

[5.2

][5

.2.1

]

Prov

ide In

frastr

uctu

re a

nd st

aff f

or n

ewNI

PERs

6.00

Prep

arat

ion a

nd A

ppro

val

of C

abine

t Not

es fo

res

tabli

shm

ent o

f New

NIPE

Rs b

y the

Appr

oval

of th

eCa

binet

Date

14/0

5/20

1101

/06/

2012

15/0

7/20

1230

/04/

2011

21/0

4/20

112.

00[6

][6

.1]

[6.1

.1]

page

: 6

of 1

8Ge

nera

ted

on :

14/0

2/20

12


118

Secti

on 2

:In

ter s

e Pr

ioritie

s am

ong

Key O

bjecti

ves,

Succ

ess i

ndica

tors

and

Tar

gets

Resu

lts-F

ram

ewor

k Doc

umen

t (RF

D) fo

r Dep

artm

ent o

f Pha

rmac

eutic

als -(

2011

-201

2)

Objec

tive

Weig

htAc

tion

Unit

Tar

get /

Crit

eria

Value

Weig

ht 8

0%10

0% 7

0% 6

0%90

%Ve

ry G

ood

Fair

Poo

rEx

celle

nt G

ood

Succ

ess

Indic

ator

Effic

ient F

uncti

oning

of t

he R

FD S

yste

m3.

00Ti

mely

subm

ission

of D

raft

for

Appr

oval

On-ti

me

subm

ission

Date

08/0

3/20

1110

/03/

2011

11/0

3/20

1109

/03/

2011

07/0

3/20

112.

0*

* Man

dato

ry O

bjecti

ve(s

)

Cabin

et

Cons

titutio

n of

BoG

of N

ewNI

PERs

and

issu

e of

ord

erof

cons

titutio

n of

BOG

Issue

of O

rder

of

cons

titutio

n of

BOG

Date

15/1

0/20

1107

/11/

2011

15/1

2/20

1131

/10/

2011

15/0

9/20

112.

00[6

.2]

[6.2

.1]

Appo

intm

ent o

f Dire

ctors

of

New

NIPE

Rs b

y filli

ng u

p of

posts

of D

irecto

rs.

Issue

of

Adve

rtise

men

t inNe

ws P

aper

s,se

lectio

n of

Dire

ctors

and

issu

eof

app

ointm

ent le

tter

Date

15/1

2/20

1121

/01/

2012

07/0

2/20

1231

/12/

2011

15/1

1/20

112.

00[6

.3]

[6.3

.1]

Stre

ngth

ening

of N

IPER

Moh

ail2.

00Co

nstitu

tion

of B

oG o

fNI

PERs

and

issu

e of

ord

erof

cons

titutio

n of

BOG

Issue

of O

rder

of

cons

titutio

n of

BOG

.Da

te15

/05/

2011

07/0

7/20

1115

/07/

2011

15/0

6/20

1130

/04/

2011

2.00

[7]

[7.1

][7

.1.1

]

Jan

Aush

adi C

ampa

ign a

nd im

plem

enta

tion

of B

usine

ss P

lan fo

r set

ting

up o

f 300

0 Ja

nAu

shad

hi St

ores

(upt

o Su

bdivi

sion

level

inth

e co

untry

)

12.0

0fra

ming

of p

ropo

sal a

nd in

princ

ipal a

ppro

val o

fPl

annin

g Co

mm

ission

Achie

vem

ent o

fde

sired

resu

ltDa

te31

/10/

2011

31/0

1/20

1231

/03/

2012

30/1

1/20

1131

/08/

2011

3.00

[8]

[8.1

][8

.1.1

]

Inte

racti

on w

ith S

tate

Gove

rnm

ents

and

settin

gup

of J

an A

usha

di St

ores

Settin

g up

of 1

00sto

res

%80

5040

6010

07.

00[8

.2]

[8.2

.1]

Prep

ared

ness

of C

PSUs

etc.

for t

he su

pply

chain

man

agem

ent

Tim

ely su

pply

ofM

edici

nes o

f Jan

Aush

adhi

Stor

es

%80

5040

6010

02.

00[8

.3]

[8.3

.1]

Ince

ntivi

sing

Priva

te S

ecto

r for

dev

elopm

ent

of n

ew D

rugs

for d

iseas

es e

ndem

ic to

India

8.00

Settin

g up

of v

entu

re fu

ndAp

prov

al of

sche

me

/pro

posa

l by

Plan

ning

Com

misi

on

Date

28/0

2/20

1221

/03/

2012

31/0

3/20

1215

/03/

2012

31/0

1/20

128.

00[9

][9

.1]

[9.1

.1]

page

: 7

of 1

8Ge

nera

ted

on :

14/0

2/20

12


119

Secti

on 2

:In

ter s

e Pr

ioritie

s am

ong

Key O

bjecti

ves,

Succ

ess i

ndica

tors

and

Tar

gets

Resu

lts-F

ram

ewor

k Doc

umen

t (RF

D) fo

r Dep

artm

ent o

f Pha

rmac

eutic

als -(

2011

-201

2)

Objec

tive

Weig

htAc

tion

Unit

Tar

get /

Crit

eria

Value

Weig

ht 8

0%10

0% 7

0% 6

0%90

%Ve

ry G

ood

Fair

Poo

rEx

celle

nt G

ood

Succ

ess

Indic

ator

Tim

ely su

bmiss

ion o

f Res

ults

On- t

ime

subm

ission

Date

03/0

5/20

1205

/05/

2012

06/0

5/20

1204

/05/

2012

01/0

5/20

121.

0

Impr

oving

Inte

rnal

Effic

iency

/Re

spon

siven

ess /

Ser

vice

deliv

ery o

fM

inistr

y / D

epar

tmen

t

10.0

0Im

plem

enta

tion

of S

evot

tam

Resu

bmiss

ion o

f rev

ised

draf

t of C

itizen

s’ / C

lient

s’Ch

arte

r

Date

20/1

2/20

1128

/12/

2011

31/1

2/20

1125

/12/

2011

15/1

2/20

112.

0*

Inde

pend

ent A

udit o

fIm

plem

enta

tion

ofGr

ievan

ce R

edre

ssM

echa

nism

%95

8580

9010

02.

0

Ensu

re co

mpli

ance

with

Sec

tion

4(1)

(b) o

f the

RTI

Act,

200

5No

. of it

ems o

n wh

ichinf

orm

ation

is u

pload

ed b

yFe

brua

ry 1

0, 2

012

No15

1312

1416

2.0

Iden

tify p

oten

tial a

reas

of

corru

ption

relat

ed to

depa

rtmen

tal a

ctivit

ies a

ndde

velop

an

actio

n pla

n to

mitig

ate

them

Fina

lize

an a

ction

plan

tom

itigat

e po

tent

ial a

reas

of

corru

ption

.

Date

15/0

2/20

1224

/02/

2012

29/0

2/20

1220

/02/

2012

10/0

2/20

122.

0

Deve

lop a

n ac

tion

plan

toim

plem

ent I

SO 9

001

certi

ficat

ionFi

naliz

e an

acti

on p

lan to

imple

men

t ISO

900

1ce

rtific

ation

Date

15/0

2/20

1224

/02/

2012

29/0

2/20

1220

/02/

2012

10/0

2/20

122.

0

Ensu

ring

com

plian

ce to

the

Fina

ncial

Acco

unta

bility

Fra

mew

ork

2.00

Tim

ely su

bmiss

ion o

f ATN

S on

Audit

Par

as o

f C&A

GPe

rcen

tage

of A

TNS

subm

itted

with

in du

e da

te (4

mon

ths)

from

dat

e of

pres

enta

tion

of R

epor

t to

Parlia

men

t by C

AG d

uring

the

year

.

%90

7060

8010

00.

5*

Tim

ely su

bmiss

ion o

f ATR

s to

the

PAC

Sectt

. on

PAC

Repo

rts.

Perc

entg

e of

ATR

ssu

bmitte

d wi

thin

due

date

(6m

onth

s) fr

om d

ate

ofpr

esen

tatio

n of

Rep

ort t

oPa

rliam

ent b

y PAC

dur

ingth

e ye

ar.

%90

7060

8010

00.

5

Early

disp

osal

of p

endin

g AT

Nson

Aud

it Par

as o

f C&A

G Re

ports

pres

ente

d to

Par

liam

ent b

efor

e31

.3.2

011.

Perc

enta

ge o

f out

stand

ingAT

Ns d

ispos

ed o

ff du

ring

the

year

.

%90

7060

8010

00.

5

* Man

dato

ry O

bjecti

ve(s

)

page

: 8

of 1

8Ge

nera

ted

on :

14/0

2/20

12


120

Secti

on 2

:In

ter s

e Pr

ioritie

s am

ong

Key O

bjecti

ves,

Succ

ess i

ndica

tors

and

Tar

gets

Resu

lts-F

ram

ewor

k Doc

umen

t (RF

D) fo

r Dep

artm

ent o

f Pha

rmac

eutic

als -(

2011

-201

2)

Objec

tive

Weig

htAc

tion

Unit

Tar

get /

Crit

eria

Value

Weig

ht 8

0%10

0% 7

0% 6

0%90

%Ve

ry G

ood

Fair

Poo

rEx

celle

nt G

ood

Succ

ess

Indic

ator

Early

disp

osal

of p

endin

g AT

Rson

PAC

Rep

orts

pres

ente

d to

Parlia

men

t bef

ore

31.3

.201

1

Perc

enta

ge o

f out

stand

ingAT

Rs d

ispos

ed o

ff du

ring

the

year

.

%90

7060

8010

00.

5

* Man

dato

ry O

bjecti

ve(s

)

page

: 9

of 1

8Ge

nera

ted

on :

14/0

2/20

12


121

Secti

on 3

:Tr

end

Value

s of t

he S

ucce

ss In

dicat

ors

Resu

lts-F

ram

ewor

k Doc

umen

t (RF

D) fo

r Dep

artm

ent o

f Pha

rmac

eutic

als -(

2011

-201

2)

Targ

et V

alue

Proje

cted

Value

for

Objec

tive

Proje

cted

Value

for

Actio

nSu

cces

s Ind

icato

r

FY 0

9/10

Unit

FY 1

1/12

FY 1

0/11

FY 1

2/13

Actu

al Va

lueAc

tual

Value

FY 1

3/14

300

90da

ys a

nd%

No.o

f rev

iewap

plica

tions

disp

osed

in 90

day

s of r

eceip

t in

the

Depa

rtmen

t

Ensu

re a

vaila

bility

of d

rugs

at

reas

onab

le pr

ices a

s per

the

Phar

ma

polic

y

Proc

essin

g of

new

revie

wap

plica

tions

und

er D

PCO

rece

ived

upto

31.

1.20

12fo

r ord

ers b

y com

pete

ntau

thor

ity

9090

300

[1]

[1.1

][1

.1.1

]

100

90%

Achie

vem

ent o

fde

sired

resu

lts a

sen

visag

ed th

roug

has

sista

nce

.Fac

ilitat

e gr

owth

of C

entra

l pha

rma

PSUs

with

requ

ired

supp

ort

Prov

iding

ass

istan

ce to

Cent

ral P

harm

a PS

Us a

spe

r MOU

obli

gatio

n

100

100

89[2

][2

.1]

[2.1

.1]

165

90%

Tim

ely fu

nd re

lease

Proje

ct ba

sed

supp

ort t

oPS

Us fo

r WHO

- GM

Pco

mpli

ance

Ass

istan

ceSc

hem

e

100

100

100

[2.2

][2

.2.1

]

9590

%Ti

mely

fund

relea

sePr

oject

base

d su

ppor

t to

HAL

for t

aking

up/Im

plem

enta

tion

ofEr

ythro

mici

n Pr

oject,

Mult

i Pro

duct

Ster

ilefa

cilitie

s for

Bet

alactu

mAn

tibiot

ics a

nd L

arge

Volum

Par

ente

ral

100

100

100

[2.3

][2

.3.1

]

100

90%

Tim

ely fu

nd re

lease

Proje

ct ba

sed

supp

ort t

oBC

PL fo

r Im

plem

enta

tion

of P

rojec

ts un

derta

ken

inRe

vival

Sche

me

100

100

100

[2.4

][2

.4.1

]

--90

%Ti

mely

fund

relea

sePr

oject

base

d su

ppor

t to

RDPL

for t

he p

rojec

ts fo

rW

HO-G

MP

Com

plian

ce(C

apita

l Sup

port)

-- --

--[2

.5]

[2.5

.1]

--31

/08/

2011

Date

To ta

ke fin

al vie

wRe

vival

of ID

PL --

-- --

[2.6

][2

.6.1

]

--31

/01/

2012

Date

Appr

oval

from

the

Cabin

et/C

CEA

-- --

--[2

.6.2

]

--90

%Ti

mely

fund

relea

se --

-- --

[2.6

.3]

page

: 10

of 1

8Ge

nera

ted

on :

14/0

2/20

12


122

Secti

on 3

:Tr

end

Value

s of t

he S

ucce

ss In

dicat

ors

Resu

lts-F

ram

ewor

k Doc

umen

t (RF

D) fo

r Dep

artm

ent o

f Pha

rmac

eutic

als -(

2011

-201

2)

Targ

et V

alue

Proje

cted

Value

for

Objec

tive

Proje

cted

Value

for

Actio

nSu

cces

s Ind

icato

r

FY 0

9/10

Unit

FY 1

1/12

FY 1

0/11

FY 1

2/13

Actu

al Va

lueAc

tual

Value

FY 1

3/14

--15

/02/

2012

Date

Appr

oval

of s

chem

efo

r dev

elopm

ent o

fne

w dr

ugs b

y NIP

ERinc

luding

PPP

/ Join

tCo

llabo

ratio

n

Deve

lop P

harm

a In

frastr

uctu

re a

ndCa

talyz

e Dr

ug D

iscov

ery a

ndIn

nova

tion

Deve

lopm

ent o

f new

drug

s for

TB

& Ka

lazar

by N

IPER

-- --

--[3

][3

.1]

[3.1

.1]

--15

/02/

2012

Date

Appr

oval

ofSc

hem

e/Pr

oject

byPl

annin

g Co

mm

ission

for s

uppo

rting

Inte

rnat

ional

Sta

ndar

dM

anuf

actu

ring-

Phar

mac

eutic

alsTe

chno

logy

Upgr

adat

ionAs

sista

nce

Sche

me

(PTU

AS)

Fina

lizat

ion o

fSc

hem

e/Pr

oject

for

Wor

ld Cl

ass P

harm

aIn

frastr

uctu

re,

Fina

lizat

ion o

fSc

hem

e/Pr

oject

for R

&Dan

d Fi

naliz

ation

of

Sche

me/

Proje

ct fo

rIn

dustr

y sup

port

for

WHO

/Inte

rnat

ional

Stan

dard

s Man

ufac

turin

gso

as t

o ca

talyz

e th

eGr

owth

of P

harm

aIn

dustr

y

-- --

--[3

.2]

[3.2

.1]

--15

/02/

2012

Date

Rece

ipt o

f pro

ject

repo

rts f

rom

the

cons

ulant

s for

deve

loping

infra

struc

ture

for

Phar

ma

R&D

(GLP

Com

plian

t labs

/Anim

alHo

use)

-- --

--[3

.2.2

]

--15

/02/

2012

Date

Appr

oval

ofSc

hem

e/Pr

oject

by t

hePl

annin

g Co

mm

ission

for

Dev

elopm

ent

ofIn

frastr

uctu

re

as p

erde

taile

d pr

oject

repo

rtto

be

subm

itted

by th

eglo

bal le

vel c

onsu

ltant

-- --

--[3

.2.3

]

--07

/03/

2012

Date

Laun

ch a

nd P

ositio

nPh

arm

aLa

unch

and

Pos

ition

Phar

ma

India

Bran

dLa

unch

and

Pos

ition

Phar

ma

India

bra

nd --

-- --

[4]

[4.1

][4

.1.1

]

page

: 11

of 1

8Ge

nera

ted

on :

14/0

2/20

12


123

Secti

on 3

:Tr

end

Value

s of t

he S

ucce

ss In

dicat

ors

Resu

lts-F

ram

ewor

k Doc

umen

t (RF

D) fo

r Dep

artm

ent o

f Pha

rmac

eutic

als -(

2011

-201

2)

Targ

et V

alue

Proje

cted

Value

for

Objec

tive

Proje

cted

Value

for

Actio

nSu

cces

s Ind

icato

r

FY 0

9/10

Unit

FY 1

1/12

FY 1

0/11

FY 1

2/13

Actu

al Va

lueAc

tual

Value

FY 1

3/14

India

Bra

nd in

targ

etco

untri

es in

a p

hase

dm

anne

r afte

r rec

eiving

“in p

rincip

le” a

ppro

val

from

Plan

ning

Com

miss

ion

in ta

rget

coun

tries

--31

/12/

2011

Date

Imple

men

tatio

n of

2Fi

naliz

ed p

ropo

sals

for

follo

w up

acti

on o

fph

arm

a su

mm

it 201

0::

1 A

Sem

inar o

nre

gulat

ory i

ssue

s on

med

ical d

evice

s...

2 A

Tas

k for

ce fo

rre

port

on d

rug

disco

very

, with

focu

son

regu

lator

y iss

ues o

fcli

nical

trials

in In

dia

Follo

w up

acti

on o

fSe

cond

India

Pha

rma

Sum

mit h

eld in

Nove

mbe

r 201

0

-- --

16/1

1/20

10[4

.2]

[4.2

.1]

100

90%

PhD-

46,M

S-25

0, M

BA-

61;

Deve

lop P

harm

a Hu

man

Res

ourc

esth

roug

h M

.Pha

rma

and

Ph.D

prog

ram

mes

in N

IPER

S

Inta

ke o

f stu

dent

s for

Mas

ters

and

Ph.

Dde

gree

s by N

IPER

,M

ohali

:

100

100

100

[5]

[5.1

][5

.1.1

]

9690

%Ah

med

abad

- 6,

Guwa

hati-

40,

Haji

pur-

46,.

Hyde

raba

d- 7

5,Ko

lkata

- 50

, Rai

Bare

li- 3

5

Inta

ke o

f stu

dent

s for

Mas

ters

deg

ress

by N

ewNI

PERs

9810

096

[5.2

][5

.2.1

]

--14

/05/

2011

Date

Appr

oval

of th

eCa

binet

Prov

ide In

frastr

uctu

re a

nd st

aff f

orne

w NI

PERs

Prep

arat

ion a

nd A

ppro

val

of C

abine

t Not

es fo

res

tabli

shm

ent o

f New

NIPE

Rs b

y the

Cab

inet

-- --

--[6

][6

.1]

[6.1

.1]

page

: 12

of 1

8Ge

nera

ted

on :

14/0

2/20

12


124

Secti

on 3

:Tr

end

Value

s of t

he S

ucce

ss In

dicat

ors

Resu

lts-F

ram

ewor

k Doc

umen

t (RF

D) fo

r Dep

artm

ent o

f Pha

rmac

eutic

als -(

2011

-201

2)

Targ

et V

alue

Proje

cted

Value

for

Objec

tive

Proje

cted

Value

for

Actio

nSu

cces

s Ind

icato

r

FY 0

9/10

Unit

FY 1

1/12

FY 1

0/11

FY 1

2/13

Actu

al Va

lueAc

tual

Value

FY 1

3/14

05/0

3/20

1007

/03/

2011

Date

On-ti

me

subm

ission

Effic

ient F

uncti

oning

of t

he R

FDSy

stem

Tim

ely su

bmiss

ion o

f Dra

ft fo

rAp

prov

al --

--09

/03/

2010

*

* Man

dato

ry O

bjecti

ve(s

)

--15

/10/

2011

Date

Issue

of O

rder

of

cons

titutio

n of

BOG

Cons

titutio

n of

BoG

of

New

NIPE

Rs a

nd is

sue

of o

rder

of c

onsti

tutio

n of

BOG

-- --

--[6

.2]

[6.2

.1]

--15

/12/

2011

Date

Issue

of A

dver

tisem

ent

in Ne

ws P

aper

s,se

lectio

n of

Dire

ctors

and

issue

of

appo

intm

ent le

tter

Appo

intm

ent o

f Dire

ctors

of N

ew N

IPER

s by f

illing

up o

f pos

ts of

Dire

ctors

.

-- --

--[6

.3]

[6.3

.1]

--15

/05/

2011

Date

Issue

of O

rder

of

cons

titutio

n of

BOG

.St

reng

then

ing o

f NIP

ER M

ohail

Cons

titutio

n of

BoG

of

NIPE

Rs a

nd is

sue

ofor

der o

f con

stitu

tion

ofBO

G

-- --

--[7

][7

.1]

[7.1

.1]

--31

/10/

2011

Date

Achie

vem

ent o

fde

sired

resu

ltJa

n Au

shad

i Cam

paign

and

imple

men

tatio

n of

Bus

iness

Plan

for

settin

g up

of 3

000

Jan

Aush

adhi

Stor

es (u

pto

Subd

ivisio

n lev

el in

the

coun

try)

fram

ing o

f pro

posa

l and

in pr

incipa

l app

rova

l of

Plan

ning

Com

miss

ion

-- --

--[8

][8

.1]

[8.1

.1]

3680

%Se

tting

up o

f 100

store

sIn

tera

ction

with

Sta

teGo

vern

men

ts an

d se

tting

up o

f Jan

Aus

hadi

Stor

es

200

272

52[8

.2]

[8.2

.1]

8.23

80%

Tim

ely su

pply

ofM

edici

nes o

f Jan

Aush

adhi

Stor

es

Prep

ared

ness

of C

PSUs

etc.

for t

he su

pply

chain

man

agem

ent

379.

8051

8.52

159.

74[8

.3]

[8.3

.1]

--28

/02/

2012

Date

Appr

oval

of sc

hem

e/p

ropo

sal b

y Plan

ning

Com

misi

on

Ince

ntivi

sing

Priva

te S

ecto

r for

deve

lopm

ent o

f new

Dru

gs fo

rdis

ease

s end

emic

to In

dia

Settin

g up

of v

entu

refu

nd --

-- --

[9]

[9.1

][9

.1.1

]

page

: 13

of 1

8Ge

nera

ted

on :

14/0

2/20

12


125

Secti

on 3

:Tr

end

Value

s of t

he S

ucce

ss In

dicat

ors

Resu

lts-F

ram

ewor

k Doc

umen

t (RF

D) fo

r Dep

artm

ent o

f Pha

rmac

eutic

als -(

2011

-201

2)

Targ

et V

alue

Proje

cted

Value

for

Objec

tive

Proje

cted

Value

for

Actio

nSu

cces

s Ind

icato

r

FY 0

9/10

Unit

FY 1

1/12

FY 1

0/11

FY 1

2/13

Actu

al Va

lueAc

tual

Value

FY 1

3/14

--03

/05/

2012

Date

On- t

ime

subm

ission

Tim

ely su

bmiss

ion o

f Res

ults

-- --

02/0

5/20

11

--20

/12/

2011

Date

Resu

bmiss

ion o

f rev

ised

draf

tof

Citiz

ens’

/ Clie

nts’

Char

ter

Impr

oving

Inte

rnal

Effic

iency

/Re

spon

siven

ess /

Ser

vice

deliv

ery o

fM

inistr

y / D

epar

tmen

t

Imple

men

tatio

n of

Sev

otta

m --

----

*

--95

%In

depe

nden

t Aud

it of

Imple

men

tatio

n of

Grie

vanc

eRe

dres

s Mec

hanis

m

-- --

--

--15

NoNo

. of it

ems o

n wh

ichinf

orm

ation

is u

pload

ed b

yFe

brua

ry 1

0, 2

012

Ensu

re co

mpli

ance

with

Secti

on 4

(1) (

b) o

f the

RTI

Act,

2005

-- --

--

--15

/02/

2012

Date

Fina

lize

an a

ction

plan

tom

itigat

e po

tent

ial a

reas

of

corru

ption

.

Iden

tify p

oten

tial a

reas

of

corru

ption

relat

ed to

depa

rtmen

tal a

ctivit

ies a

ndde

velop

an

actio

n pla

n to

mitig

ate

them

-- --

--

--15

/02/

2012

Date

Fina

lize

an a

ction

plan

toim

plem

ent I

SO 9

001

certi

ficat

ion

Deve

lop a

n ac

tion

plan

toim

plem

ent I

SO 9

001

certi

ficat

ion

-- --

--

--90

%Pe

rcen

tage

of A

TNS

subm

itted

with

in du

e da

te (4

mon

ths)

from

dat

e of

pres

enta

tion

of R

epor

t to

Parlia

men

t by C

AG d

uring

the

year

.

Ensu

ring

com

plian

ce to

the

Fina

ncial

Acco

unta

bility

Fra

mew

ork

Tim

ely su

bmiss

ion o

f ATN

S on

Audit

Par

as o

f C&A

G --

----

*

--90

%Pe

rcen

tge

of A

TRs s

ubm

itted

with

in du

e da

te (6

mon

ths)

from

dat

e of

pre

sent

ation

of

Repo

rt to

Par

liam

ent b

y PAC

durin

g th

e ye

ar.

Tim

ely su

bmiss

ion o

f ATR

s to

the

PAC

Sectt

. on

PAC

Repo

rts.

-- --

--

--90

%Pe

rcen

tage

of o

utsta

nding

ATNs

disp

osed

off

durin

g th

eye

ar.

Early

disp

osal

of p

endin

gAT

Ns o

n Au

dit P

aras

of C

&AG

Repo

rts p

rese

nted

to

-- --

--

* Man

dato

ry O

bjecti

ve(s

)

page

: 14

of 1

8Ge

nera

ted

on :

14/0

2/20

12


126

Secti

on 3

:Tr

end

Value

s of t

he S

ucce

ss In

dicat

ors

Resu

lts-F

ram

ewor

k Doc

umen

t (RF

D) fo

r Dep

artm

ent o

f Pha

rmac

eutic

als -(

2011

-201

2)

Targ

et V

alue

Proje

cted

Value

for

Objec

tive

Proje

cted

Value

for

Actio

nSu

cces

s Ind

icato

r

FY 0

9/10

Unit

FY 1

1/12

FY 1

0/11

FY 1

2/13

Actu

al Va

lueAc

tual

Value

FY 1

3/14

Parlia

men

t bef

ore

31.3

.201

1.

--90

%Pe

rcen

tage

of o

utsta

nding

ATRs

disp

osed

off

durin

g th

eye

ar.

Early

disp

osal

of p

endin

gAT

Rs o

n PA

C Re

ports

pres

ente

d to

Par

liam

ent b

efor

e31

.3.2

011

-- --

--

* Man

dato

ry O

bjecti

ve(s

)

page

: 15

of 1

8Ge

nera

ted

on :

14/0

2/20

12


127

Section 4: Description and Definition of Success Indicators and Proposed Measurement Methodology

Results-Framework Document (RFD) for Department of Pharmaceuticals -(2011-2012)

The success indicators have been defined on the basis of appropriate measurable parameters such as for Timewherever applications for disposal are concerned or preparation of proposals for various schemes and projects andconcerning approvals from concerned central Ministries is concerned. It is defined in values in Rs crores wherever fundsexpenditure is involved. Care has been taken so as each of the activities is measurable in respect of performancemonitoring and evaluation.


Results-Framework Document (RFD) for Department of Pharmaceuticals -(2011-2012)

Section 5: Specific Performance Requirements from other Departments

1. Receipt of timely approval from the Planning Commission and budgetary sanctions from the Ministry of Financerelating to the proposed schemes of the Department. Accordingly Planning Commission and Finance Department areexpected to approve the proposed outlays and related budget for fulfillment of targets / project proposals. 2. Sl-2 of Objective: As regards the performance of CPSUs, the Department in its periodic monthly reviews can guidethe CPSUs towards achieving the targets. However actual target achievement would depend on the efforts of the MDsconcerned. 3. Subject to approval of the Competent Authority {Honourable M(C&F)}



128

Secti

on 6

:Ou

tcom

e/Im

pact

of D

epar

tmen

t/Mini

stry

Resu

lts-F

ram

ewor

k Doc

umen

t (RF

D) fo

r Dep

artm

ent o

f Pha

rmac

eutic

als -(

2011

-201

2)

Outco

me/

Impa

ct of

Depa

rtmen

t/Mini

stry

Joint

ly re

spon

sible

for

influe

ncing

this

outco

me

/im

pact

with

the

follo

wing

depa

rtmen

t (s)

/ m

inistr

y(ies

)

Succ

ess

Indic

ator

FY 0

9/10

FY 1

1/12

FY 1

0/11

FY 1

2/13

FY 1

3/14

Unit

8.65

--Gr

owth

of P

harm

aceu

ticals

Prod

uctio

n in

the

Coun

tryHi

gher

gro

wth

ofPh

arm

aceu

ticals

Indu

stry i

nth

e Co

untry

-- --

--1

%

Vecto

r bor

ne d

iseas

es a

ndPa

rasit

ic Di

seas

es fo

r whic

hDr

ugs a

re n

ot a

vaila

ble

Grea

ter a

vaila

bility

of D

rugs

for e

ndem

ic dis

ease

s, Ve

ctor

born

e an

d pa

rasit

ic dis

ease

sfo

r whic

h ind

igeno

us a

ndef

fecti

ve d

rugs

are

not

avail

able

Mini

stry o

f Hea

lth a

nd F

amily

Welf

are

2No

s

Quan

tity o

f Spu

rious

dru

gsde

tecte

d in

the

mar

ket b

y the

inspe

ctors

Redu

ction

in S

purio

us D

rugs

Mini

stry o

f Hea

lth a

nd F

amily

Welf

are

3No

4.1

Skille

d m

anpo

wer p

assin

gou

t of N

IPER

s eve

ry ye

ar w

ithP.

G de

gree

s and

Ph.

D in

Phar

mac

eutic

als sc

ience

Deve

lopm

ent o

f Hum

anre

sour

ces i

n Ph

arm

a In

dustr

y4

No

1.17

Price

Ind

ex o

fPh

arm

aceu

ticals

Med

icine

s in

the

Coun

try (C

ompa

rison

vis a

vis p

revio

us ye

ar w

ill re

veal

the

trend

s)

Avail

abilit

y of

Phar

mac

eutic

als a

tre

ason

able/

Lowe

r pric

e in

the

coun

try

2.38

5%

page

: 18

of 1

8Ge

nera

ted

on :

14/0

2/20

12

A Report 201213

Documents

Transcript of A Report 201213