Modern Pharma 16-31 August 2013

32
16-31 August 2013 I Vol 2 I No 4 I `1 00 www.modernpharma.in In Conversation With 12 Georg Sparschuh President, Schott Glass India Pvt Ltd Special Focus 14 Clinical trials and research How to sustain growth momentum in India? Special Focus Roundtable 18 Do we need stringent regulations to streamline CRO operations? Insight & Outlook 20 Policies & Regulations FDI in pharma: Apprehensions deter growth prospects Scan this code on your smart phone to visit www.modernpharma.in iocon’s revenue growth in Q1 FY’14 reflected strength of its product portfolio. The biopharma business grew by 21 per cent year-on-year to ` 439 crore. The branded formulations grew by 17 per cent year-on-year to ` 101 crore, while research services, Syngene and Clinigene grew by 26 per cent to year- on-year to ` 155 crore. Group Earnings before Interest, Taxes, Depreciation, and Amortization (EBITDA) and Profit after Tax (PAT) margins were at 24 per cent and 13 per cent respectively. Biocon made an R&D investment of ` 43 crore. Commenting on the results, Chairman and Managing Director, Kiran Mazumdar-Shaw stated, “We are pleased to report a strong set of numbers for Q1 FY’14. The new organisational structure has enabled us to deliver superior results with the core business performing strongly. Biocon’s insulin business continues to do well, riding on the back of an increased geographical footprint in the emerging markets. India-focussed branded formulations vertical as well as the research services divisions continue to grow at a steady pace. Our research programmes are making good progress. I am very excited about the upcoming launch of Alzumab®, our second novel biologic. We look forward to bringing this first-in-class molecule for the treatment of psoriasis to the Indian market. The current fiscal will see us consolidate our various initiatives whilst we continue our investments in our biosimilars and novel molecules, to deliver a sustainable growth platform. ” Biopharma’s sales grew 19 per cent year-on-year at Constant Exchange Rate (CER), with broad based growth across the small molecules and biosimilars portfolio. The small molecules portfolio delivered a strong performance this quarter, led by immunosuppressants and specialty molecules like Fidaxomicin and Orlistat. The statins portfolio has remained stable, despite the changing market dynamics. Commenting on the biopharma business performance, Arun Chandavarkar, Chief Operating Officer, Biocon said, “The sustained growth in our small molecules business reflects the robustness of our diversified and differentiated portfolio. Commercialisation of insulin in emerging markets continues to be a significant growth driver and we are on track with capacity expansions to address these medium term opportunities. We remain focussed on developing our pipeline of products that address significant global opportunities across our business segments to sustain long- term growth.” Commenting on the current landscape and the vertical’s performance, Rakesh Bamzai, President-Marketing Biocon, said, “Biocon’s branded formulations business has created a significant presence in the Indian pharma market with our top of the line quality products, by focussing on patients’ therapeutic needs and driving better patient compliance to treatment regimes. Although there are challenges in the industry due to recent changes in the pricing guidelines, we are optimistic that the branded formulations business will overcome these challenges and continue to register high growth by improving market shares on existing products supported by the launch of new products.” rug major Lupin has received the US health regulator’s approval to market generic version of Gilead Sciences, Ranexa ® tablets, a drug used to treat heart disease in the American market. The company’s US-based subsidiary Lupin Pharmaceuticals, Inc has received final approval for the ranolazine extended-release tablets, 500 mg and 1000 mg from the United States Food and Drugs Administration (USFDA), according to a statement by Lupin Ltd. “Lupin believes that it is the first applicant to file an Abbreviated New Drug Application (ANDA) for Ranexa ® extended-release tablets of 500 mg and 1000 mg strengths and as such will be entitled to 180-days of marketing exclusivity,” it added. Ranolazine extended-release tablets are indicated for treatment of chronic angina. According to IMS Health data, the tablets posted sales of around $ 443.4-million in the US for twelve months ending March, 2013. Biocon delivers a healthy business growth rate Lupin gets USFDA nod for heart disease drug Editor’s Pick 16 Special Focus Modern Pharma | 16-31 August 2013 linical research is an indispensable part of the drug discovery process and clinical trials form the mainstay for bringing new and better drugs to the market. India has become an important hub for pharmaceutical drug discovery and development process for a variety of reasons. The country is an attractive destination for conducting clinical research because it has an appropriate environment and requisite facilities such as large patient population, diverse ethnic and genetic makeup, speciality hospitals with good infrastructure, good investigators and medical staff with English speaking professionals and above all, lower operational costs. The fundamentals are in place to enable pharmaceutical/ biotechnology organisations, academia and medical institutions to outsource trials to India. India continues to be a potentially an ideal hub to undertake and conduct ethical and good quality clinical trials. India: A clinical research hub Due to the key success factors at a macro-level being in place, clinical research is now perceived as a new service growth engine, which could contribute significantly to the global requirements of the drug discovery process. This has resulted in a swift uptake of clinical research in India dovetailed with some hype as well. While growth momentum on this front, provided opportunities to home-grown talent, the regulations, self- governance, infrastructure and mindset of the populace are not in sync with the demands of the evolving segment. While, a majority of stakeholders undertook clinical research responsibly, the mismatch in pace has allowed several players to perceive this opportunity as a transactional one. This sub-section lacked appropriate processes, governance and mindset to take on clinical research responsibly, thereby resulting in adverse events. Over the last few years, India has been witnessing an increasing number of controversies with consequent negative publicity and adverse developments in clinical research. The controversies emanated from a host of issues related to ethics, law, human rights and scientific development, lack of information and training, regulation etc. This has been exaggerated by the lack of understanding of clinical research in general, the negative general public perception and the consequent political reactions. A few defaulters have been responsible for tarnishing the image of the whole industry, which by and large operated to the international standards. The Supreme Court has taken an extremely serious view of the 2,868 deaths that have been reported during the period 2005-2012 due to clinical trials. There have been several queries and opinions exchanged among key stakeholders regard the composition of ethics committee, their registrations and the compensation for patients participating in the clinical trials, the process of informed consent especially for Bachelor of Engineering (BE)/ Bachelor of Arts (BA) studies, which has further reduced the clarity on the subject. Impact on India The intervention of the Supreme Court has triggered a chain of events, which may lead to the much needed regulatory reform. At the same time, it has also temporarily but significantly slowed down trial approvals in India. As a result, till April 2013, only 12 clinical trials have been approved by the authority, as compared to almost a three-digit figure last year. Currently, the clinical research industry is viewed with scepticism, fear and uncertainty. Few trials are being conducted, patients are fearful, the regulatory reform is sluggish and the industry perception is overall sceptical. On the other hand, there is an impending positive impact generated by a collective debate through various forums on means to internally improve the standards and governance for undertaking clinical trials. One of the key takeaways from the resulting debate is the need for a greater role of the ethics committees in conducting clinical trials. There is an urgent need for training programmes at various levels to increase the pool of competent ethics professionals. A wide representative group of industry, academia and regulator is required to champion established benchmarks of international standards and the good news is that this process has begun informally at various levels. The emphasis on laws governing the functioning of ethics committee and important issues such as compensation to patients, in case of adverse events is now even more critical for the future of clinical research. This need is now being addressed carefully by the regulator through a consultative process with the relevant stakeholders. Overall, the stakeholders have been prompted to pause, review the current status, formulate solutions for improvements and support creation of a robust plan for the future. What is at stake? Owing to excessive reactions to the adverse reports, the regulatory reform process has been slow, thus leading to uncertainty. The large and established organisations have little clarity regarding the timelines, with respect to the reforms being put in place. Due to lack of consistency on the regulatory front over the last 2 years, reputed organisations have become hesitant regard expansion and are even considering temporary reduction of their operations. Also, drug innovators have temporarily stopped and are being sceptical about outsourcing trials to India, until the situation improves. In fact, the pharmaceutical, biotech companies and Clinical Research Organisations (CROs) are considering completion of global studies in new destinations such as Malaysia, Thailand, etc. This downward trend in trials will result in low exposure of clinicians to new and advanced drugs, hence lower availability of new treatments to Indian patients. Only after trials are being conducted and behaviour of new treatments and drugs in controlled conditions are learnt, would clinicians be convinced and recommend these drugs further for better treatment of Indian patients. Also, the vision of India as a global destination for clinical research will be at stake and the country will lose its attractiveness, despite having a talented resource pool and good infrastructure. What the future beholds? Conducting clinical trials is a very scientific and diligent process. If undertaken in a well regulated and enforced environment, and the stakeholders involved are undertaking trials with the right intent, then it is in fact difficult to deviate and commit mistakes in the process. The adverse consequences that are surfaced have largely been due to a minority subset of defaulters and the entire industry should not be viewed with the same lens. However, the recent controversies and negativity cannot be wished away. It may prove good in the long term, if it brings about a reform in the process of undertaking clinical trials in India. All stakeholders are hopeful that this churning would result in a comprehensive process for clinical trials, which is effective yet efficient. Such an evolution is much needed for ethical, sensitive, well meaning and sophisticated clinical research in India.. What is at stake? Clinical research in India Clinical trials in India have always remained under lens by various expert committees and several healthcare stakeholders, with a continuous demand and scope for improvement at the operational level. This part of the drug development process is now being seriously attended by experts and strict adherence to the standard guidelines is being practised across the country, with significant efforts from the researchers and policymakers. C Conducting clinical trials is a scientific and diligent process. If undertaken in a well regulated and enforced environment, and the stakeholders involved are undertaking trials with the right intent, then it is in fact difficult to deviate and commit mistakes in the process. Seemant Jauhari Chief Executive Officer, Apollo Hospitals Educational and Research Foundation [email protected] ? y , e s e , D B Strides Arcolab receives approval for Tenofovir Disoproxil Fumarate and Emtricitabine tablets Snippets Strides Arcolab Ltd has received a tentative approval from the USFDA for its anti- aids combination drug, Tenofovir Disoproxil Fumarate and Emtricitabine tablets, 300mg and 200mg. The company is among the six generic companies to have received the USFDA approval. This Abbreviated New Drug Application (ANDA) has been reviewed under the expedited provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR). The company supplies Antiretroviral drug (ARV) products to global procurement agencies and this approval adds to the overall basket of medicines available.This combination drug is the generic equivalent of Gilead Sciences Inc’s Truvada tablets and falls under the ARV segment. It is indicated in combination with other anti-retroviral agents for the treatment of HIV-1 infection in adults. Dr Reddy’s Laboratories announced launch of Donepezil Hydrochloride tablets, 23 mg, a therapeutic equivalent generic version of ARICEPT ® , 23 mg in the US market on July 26, 2013, following the approval by the United States Food & Drug Administration (USFDA) of Dr Reddy’s Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride tablets, 23 mg. The ARICEPT ® , 23 mg brand had US sales of approximately $ 92.6 million for the most recent twelve months ending in May 2013 according to IMS Health. Dr Reddy’s Donepezil Hydrochloride tablets, 23 mg is available in bottle count sizes of 30 and 90. Dr Reddy’s launches Donepezil Hydrochloride tablets Kiran Mazumdar-Shaw

TAGS:

description

 

Transcript of Modern Pharma 16-31 August 2013

Page 1: Modern Pharma 16-31 August 2013

16 - 31 A u g u s t 2 013 I Vo l 2 I N o 4 I `10 0

www.modernpharma.in

In Conversation With 12 Georg Sparschuh

President, Schott Glass India Pvt Ltd

Special Focus 14Clinical trials and research

How to sustain growth momentum in India?

Special Focus Roundtable 18Do we need stringent regulations to

streamline CRO operations?

Insight & Outlook 20Policies & Regulations

FDI in pharma: Apprehensions deter growth prospects

Scan this code onyour smart phoneto visit www.modernpharma.in

iocon’s revenue growth in Q1 FY’14 reflected  strength of its product portfolio.

The biopharma business grew by 21 per cent year-on-year to ̀439 crore. The branded formulations grew by 17 per cent year-on-year to ` 101 crore, while research services, Syngene and Clinigene grew by 26 per cent to year-on-year to ̀ 155 crore.  Group Earnings before Interest, Taxes, Depreciation, and Amortization (EBITDA) and Profit after Tax (PAT) margins were at 24 per cent and 13 per cent respectively. Biocon made an R&D investment of ̀43 crore.

Commenting on the results, Chairman and Managing Director, Kiran Mazumdar-Shaw stated, “We are pleased to report a strong set of numbers for Q1 FY’14. The new organisational structure has enabled us to deliver superior results with the core business performing

strongly. Biocon’s insulin business continues to do well, riding on the back of an increased geographical footprint in the emerging markets. India-focussed branded formulations vertical as well as the research services divisions continue to grow at a steady pace. Our research programmes are making good progress. I am very excited about the upcoming launch of Alzumab®, our second novel biologic. We look forward to bringing this first-in-class molecule for the treatment of psoriasis to the Indian market. The current fiscal will see us consolidate our various initiatives whilst we continue our investments in our biosimilars and novel molecules, to deliver a sustainable growth platform. ”

Biopharma’s sales grew 19 per cent year-on-year at Constant Exchange Rate (CER), with broad based growth across the small molecules and biosimilars portfolio. The small molecules

portfolio delivered a strong performance this quarter, led by immunosuppressants and specialty molecules like Fidaxomicin and Orlistat. The statins portfolio has remained stable, despite the changing market dynamics.

Commenting on the biopharma business performance, Arun Chandavarkar, Chief Operating Officer, Biocon said, “The sustained growth in our small molecules business reflects the robustness of our diversified and differentiated portfolio. Commercialisation of insulin in emerging markets continues to be a significant growth driver and we are on track with capacity expansions

to address these medium term opportunities. We remain focussed on developing our pipeline of products that address significant global opportunities across our business segments to sustain long-term growth.”

Commenting on the current landscape and the vertical’s performance, Rakesh Bamzai, President-Marketing Biocon, said, “Biocon’s branded formulations business has created a significant presence in the Indian pharma market with our top of the line quality products, by focussing on patients’ therapeutic needs and driving better patient compliance to treatment regimes. Although there are challenges in the industry due to recent changes in the pricing guidelines, we are optimistic that the branded formulations business will overcome these challenges and continue to register high growth by improving market shares on existing products supported by the launch of new products.”

rug major Lupin has received the US health regulator’s approval to market generic version of

Gilead Sciences, Ranexa® tablets, a drug used to treat heart disease in the American market.

The company’s US-based subsidiary Lupin Pharmaceuticals, Inc has received final approval for the ranolazine extended-release tablets, 500 mg and 1000 mg from the United States Food and Drugs Administration (USFDA), according to a statement by Lupin Ltd.

“Lupin believes that it is the first applicant to file an Abbreviated New Drug Application (ANDA) for Ranexa® extended-release tablets of 500 mg and 1000 mg strengths and as such will be entitled to 180-days of marketing exclusivity,” it added.

Ranolazine extended-release tablets are indicated for treatment of chronic angina. According to IMS Health data, the tablets posted sales of around $ 443.4-million in the US for twelve months ending March, 2013.

Biocon delivers a healthy business growth rate

Lupin gets USFDA nod for heart disease drug

Editor’s Pick 16 Special Focus M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3

linical research is an indispensable part of the drug discovery process and clinical

trials form the mainstay for bringing new and better drugs to the market. India has become an important hub for pharmaceutical drug discovery and development process for a variety of reasons. The country is an attractive destination for conducting clinical research because it has an appropriate environment and requisite facilities such as large patient population, diverse ethnic and genetic makeup, speciality hospitals with good infrastructure, good investigators and medical staff with English speaking professionals and above all, lower operational costs.

The fundamentals are in place to enable pharmaceutical/ biotechnology organisations, academia and medical institutions to outsource trials to India. India continues to be a potentially an ideal hub to undertake and conduct ethical and good quality clinical trials.

India: A clinical research hubDue to the key success factors at a macro-level being in place, clinical research is now perceived as a new service growth engine, which could contribute significantly to the global requirements of the drug discovery process. This has resulted in a swift uptake of clinical research in India dovetailed with some hype as well. While growth momentum on this front, provided opportunities to home-grown talent, the regulations, self-governance, infrastructure and mindset of the populace are not in sync with the demands of the evolving segment. While, a majority of stakeholders

undertook clinical research responsibly, the mismatch in pace has allowed several players to perceive this opportunity as a transactional one. This sub-section lacked appropriate processes, governance and mindset to take on clinical research responsibly, thereby resulting in adverse events.

Over the last few years, India has been witnessing an increasing number of controversies with consequent negative publicity and adverse developments in clinical research. The controversies emanated from a host of issues related to ethics, law, human rights and scientific development, lack of information and training, regulation etc. This has been exaggerated by the lack of understanding of clinical research in general, the negative general public perception and the consequent political reactions. A few defaulters have been responsible for tarnishing the image of the whole industry, which by and large operated to the international standards. The Supreme Court has taken an extremely serious view of the 2,868 deaths that have been reported during the period 2005-2012 due to clinical trials. There have been several queries and opinions exchanged among key stakeholders regard the composition of ethics committee, their registrations and the compensation for patients participating in the clinical trials, the process of informed consent especially for Bachelor of Engineering (BE)/Bachelor of Arts (BA) studies, which has further reduced the clarity on the subject.

Impact on IndiaThe intervention of the Supreme Court has triggered a chain of events, which may lead to the much needed regulatory reform. At the same time, it has also temporarily but significantly slowed down trial approvals in India. As a result, till April 2013, only 12 clinical trials have been approved by the authority, as compared to almost a three-digit figure last year.  Currently, the clinical

research industry is viewed with scepticism, fear and uncertainty. Few trials are being conducted, patients are fearful, the regulatory reform is sluggish and the industry perception is overall sceptical.

On the other hand, there is an impending positive impact generated by a collective debate through various forums on means to internally improve the standards and governance for undertaking clinical trials. One of the key takeaways from the resulting debate is the need for a greater role of the ethics committees in conducting clinical trials. There is an urgent need for training programmes at various levels to increase the pool of competent ethics professionals. A wide representative group of industry, academia and regulator is required to champion established benchmarks of international standards and the good news is that this process has begun informally at various levels.

The emphasis on laws governing the functioning of ethics committee and important issues such as compensation to patients, in case of adverse events is now even more critical for the future of clinical research. This need is now being addressed carefully by the regulator through a consultative process with the relevant stakeholders. Overall, the stakeholders have been prompted to pause, review the current status, formulate solutions for improvements and support creation of a robust plan for the future.

What is at stake?Owing to excessive reactions to the adverse reports, the regulatory reform process has been slow, thus leading to uncertainty. The large and established organisations have little clarity regarding the timelines, with respect to the reforms being put in place. Due to lack of consistency on the regulatory front over the last 2 years, reputed organisations have become hesitant regard expansion and are even considering temporary

reduction of their operations. Also, drug innovators have temporarily stopped and are being sceptical about outsourcing trials to India, until the situation improves.

In fact, the pharmaceutical, biotech companies and Clinical Research Organisations (CROs) are considering completion of global studies in new destinations such as Malaysia, Thailand, etc. This downward trend in trials will result in low exposure of clinicians to new and advanced drugs, hence lower availability of new treatments to Indian patients. Only after trials are being conducted and behaviour of new treatments and drugs in controlled conditions are learnt, would clinicians be convinced and recommend these drugs further for better treatment of Indian patients. Also, the vision of India as a global destination for clinical research will be at stake and the country will lose its attractiveness, despite having a talented resource pool and good infrastructure.

What the future beholds? Conducting clinical trials is a very scientific and diligent process. If undertaken in a well regulated and enforced environment, and the stakeholders involved are undertaking trials with the right intent, then it is in fact difficult to deviate and commit mistakes in the process. The adverse consequences that are surfaced have largely been due to a minority subset of defaulters and the entire industry should not be viewed with the same lens.

However, the recent controversies and negativity cannot be wished away. It may prove good in the long term, if it brings about a reform in the process of undertaking clinical trials in India. All stakeholders are hopeful that this churning would result in a comprehensive process for clinical trials, which is effective yet efficient. Such an evolution is much needed for ethical, sensitive, well meaning and sophisticated clinical research in India..

What is at stake?Clinical research in India

Clinical trials in India have always remained under lens by various expert committees and several healthcare stakeholders, with a continuous demand and scope for improvement at the operational level. This part of the drug development process is now being seriously attended by experts and strict adherence to the standard guidelines is being practised across the country, with significant efforts from the researchers and policymakers.

C

Conducting clinical trials is a scientific and diligent process. If undertaken in a well

regulated and enforced environment, and the stakeholders involved are undertaking trials

with the right intent, then it is in fact difficult to deviate and commit mistakes in the process.

Seemant Jauhari Chief Executive Officer, Apollo

Hospitals Educational and Research Foundation

[email protected]

?y ,

e s e ,

D

B

Strides Arcolab receives approval for Tenofovir Disoproxil Fumarate and Emtricitabine tablets

Snippets

Strides Arcolab Ltd has received a tentative approval from the USFDA for its anti-aids combination drug, Tenofovir Disoproxil Fumarate and Emtricitabine tablets, 300mg and 200mg.

The company is among the six generic companies to have received the USFDA approval. This Abbreviated New Drug Application (ANDA) has been reviewed under the expedited provisions of the President’s

Emergency Plan for AIDS Relief (PEPFAR).The company supplies Antiretroviral drug

(ARV) products to global procurement agencies and this approval adds to the overall basket of medicines available.This combination drug is the generic equivalent of Gilead Sciences Inc’s Truvada tablets and falls under the ARV segment. It is indicated in combination with other anti-retroviral agents for the treatment of HIV-1 infection in adults.

Dr Reddy’s Laboratories announced launch of Donepezil Hydrochloride tablets, 23 mg, a therapeutic equivalent generic version of ARICEPT®, 23 mg in the US market on July 26, 2013, following the approval by the United States Food & Drug Administration (USFDA) of Dr Reddy’s Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride tablets, 23 mg.

The ARICEPT®, 23 mg brand had US sales of approximately $ 92.6 million for the most recent twelve months ending in May 2013 according to IMS Health. Dr Reddy’s Donepezil Hydrochloride tablets, 23 mg is available in bottle count sizes of 30 and 90.

Dr Reddy’s launches Donepezil Hydrochloride tablets

Kiran Mazumdar-Shaw

Page 2: Modern Pharma 16-31 August 2013
Page 3: Modern Pharma 16-31 August 2013
Page 4: Modern Pharma 16-31 August 2013

Contents

In Conversation With Georg Sparschuh

President, Schott Glass India Pvt Ltd

Printed by Mohan Gajria and published by Lakshmi Narasimhan on behalf of Network18.Senior Editor: Manas R BastiaPrinted at Infomedia 18 Ltd, Plot no.3, Sector 7, off Sion-Panvel Road, Nerul, Navi Mumbai 400 706, and published at Network18, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai - 400 028. Modern Pharma is registered with the Registrar of Newspapers of India under No. MAHENG / 2008 / 27125. Network18 does not take any responsibility for loss or damage incurred or suffered by any subscriber of this magazine as a result of his/her accepting any invitation/offer published in this edition.*Ownership of this magazine stands transferred from Infomedia18 Ltd (Infomedia18) to Network18 Media & Investments Ltd (Network18) in pursuance of the scheme of arrangement between Network18 and Infomedia18 and their respective shareholders and creditors, as approved by the Hon’ble High Court of Delhi and the necessary approval of Ministry of Information and Broadcasting is being obtained.

Views and opinions expressed in this magazine are not necessarily those of Network18 Media & Investments Ltd (Network18)*, its publisher and/or editors. We at Network18 do our best to verify the information published but do not take any responsibility for the absolute accuracy of the information. Network18 does not accept the responsibility for any investment or other decision taken by readers on the basis of information provided herein. Network18 does not take responsibility for returning unsolicited material sent without due postal stamps for return postage. No part of this magazine can be reproduced without the prior written permission of the publisher. Network18 reserves the right to use the information published herein in any manner whatsoever.

Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise

5 Editorial / Guest Editorial

6 News, Views & Analysis

21 Projects

22 Tenders

23 Event List

24 Book Review

25 Products

29 Marketplace

30 List of Products & Advertisers

M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3

Regular Sections

www.modernpharma.in

12

Highlights of

Next Edition

Special Focus:

Biotech

Clinical trials and research How to sustain growth momentum in India? 14Clinical research in India What is at stake? 16Roundtable Do we need stringent regulations to streamline CRO operations? 18

FOUNDER & EDITOR, NETWORK 18Raghav Bahl

PRESIDENT & EDITORIAL DIRECTOR, TV 18Senthil Chengalvarayan

EDITOR-IN-CHIEF, WEB & PUBLISHINGR Jagannathan

SENIOR EDITORManas R Bastia

EDITORIAL TEAMSavita V Jayaram, Pallavi Mukhopadhyay,

Anubhav Sharma,Rishab Kothari, Nikunj Sharma (Delhi)

ART DIRECTORVaruna Naik

DESIGNVarghees Tharakan

CHIEF PHOTOGRAPHERMexy Xavier

PHOTOGRAPHYJoshua Navalkar, Kuldeep Chaudhari

BUSINESS CONTROLLERSSurekha Karmarkar, Lovey Fernandes, Akshata Rane,

Deepak Bhatia, Ashish Kukreti, Shwetha ME, Jayashree N, Sugandha Kulkarni, Shefali Mahant, Varsha Nawathe

PRODUCTION TEAMSurekha Karmarkar,

Ravikumar Potdar, Ravi Salian, Sanjay Shelar

GROUP CEO, NETWORK 18B Sai KumarCEO-NETWORK 18 PUBLISHINGSandeep KhoslaEVP-HUMAN RESOURCESSanjeev Kumar SinghASSOCIATE VICE PRESIDENTSudhanva JategaonkarADVERTISING SALESShashin Bhagat (Ahmedabad)[email protected] B (Bengaluru)[email protected] Hara Subramaniam (Chennai)[email protected] S (Coimbatore)[email protected] Surendra Agarwal (Delhi)[email protected] Sunil Dakur (Hyderabad)[email protected] Gokhale (Indore)[email protected] Arora (Jaipur)[email protected] Abhik Ghosal (Kolkata)[email protected] Dhingra, Surajit Bhattacharjee (Ludhiana)[email protected]@network18publishing.comOlwin Dsouza (Mumbai)[email protected] Dass (Pune)[email protected] Modha (Rajkot)[email protected] Pathak (Vadodara)[email protected]

OVERSEAS CONTACTRingier Trade Media Ltd CHINA

1001 Tower 3, Donghai Plaza, 1486 Nanjing Road, West, Shanghai 200040, China Tel: +86-21 6289 – 5533 Ext. 368, Fax: +86-21 6247 – 4855

(Craig Shibinsky) Email: [email protected] Trade Media Ltd HONG KONG

9/F, Cheong Sun Tower, 118 Wing Lok Street, Sheung Wan, Hong Kong Tel: +852 2369 – 8788 Ext. 21, Fax: +852 2869 – 5919

(Octavia Au-Yeung) Email: [email protected] Trade Media Ltd TAIWAN

Room 3, Fl. 12, No. 303, Chung Ming S. Rd., Taichung, TaiwanTel: +886-4 2329 – 7318 Ext. 16, Fax: +886-4 2310 – 7167

(Sydney La) Email: [email protected] Trade Media Ltd GERMANY, AUSTRIA, SWITZERLAND

Tel: +41-44 734 0472, Fax: +41 44 734 0680Email: [email protected]

USA Tel: (513) 527-8800 Fax: (513) 527-8801

Email: [email protected]@g USA

Alfredo Domador, 6505 Blue Lagoon Drive, Suite 430 Miami, FL. 33126, USATel: (305) 448-6875, Fax: (305) 448-9942

MARKETING TEAMGanesh Mahale, Akshaya Jadhav

NEWSSTAND AND SUBSCRIPTIONSDISTRIBUTION HEADSunil Nair

DEPUTY GENERAL MANAGERManoj Palsay

SENIOR MANAGER - SUBSCRIPTIONSSheetal Kotawdekar

CO-ORDINATORSRahul Mankar, Anant Shirke, Sarita Quadros,Chaitali Parkar, Kamlesh Mathkar, Vaibhav Ghavale

SERVICESSUBSCRIPTION SERVICES For subscription queries, write [email protected] or call +91 22 30034631-34 or toll free 1800 200 1021

PERMISSIONS For subscription to copy or reuse material from Modern Pharma, Write to [email protected]

` 100 ` 1200

20

1614

Special Focus

Clinical Research Organisations (CROs)

Policies & Regulations FDI in pharma: Apprehensions deter growth prospects 20

Insight & Outlook

Page 5: Modern Pharma 16-31 August 2013

M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3 5Editorial

Bitter pill for generics… his seems to be the season of swallowing bitter pills for Indian pharma and how! In

the latest development, the US health regulator, Food and Drug Administration (USFDA) has announced to hike the fees for generics drug makers by up to 48 per cent. This hike which will come into effect from October 2013 would be reviewed after a year. This steep slab will undoubtedly lead to higher costs for sale of these products in American markets.

While the apparent reason behind this step is to ensure that the companies pay user fees to supplement the costs of reviewing generics drug applications and inspecting facilities in line with the US regulations, its impact on pushing up the prices of pharmaceuticals is obvious. Here is a glimpse of the proposed revised fee figures. The new Abbreviated New Drug Application (ANDA)

fee has been fixed at $ 63,860, which is nearly 24 per cent higher than the existing $ 51,520. The Prior Approval Supplement (PAS) fees for the period from October 1, 2013 to September 30, 2014 have been hiked by 24 per cent to $ 31,930. The Drug Master File (DMF) fees have seen the highest increase, by 48 per cent to $ 31,460.

Further, the USFDA has increased the annual facility fees for Finished Dosage Forms (FDF) by about 25 per cent with the domestic FDF facility fee being revised to $ 220,152 and foreign FDF facility fee to $ 235,152. Only difference in these hiking provisions is that of the annual Active Pharmaceutical Ingredient (API) fees, which (for both domestic and foreign API facilities) have been lowered.

To get a clear perspective on this, it may be noted that India is the second largest drug exporter to the US and

Indian drug makers have well-established expertise in manufacturing generic versions of innovative drugs at a fraction of cost after their patent expiry. In terms of market share, Indian drugs are estimated to account for one-tenth of the $ 30-billion US generics drug market.

From the USFDA’s viewpoint these fees help in multiple ways such as reducing the backlog of pending applications, saving the average time required to review generic drug applications for safety and improving the risk-based inspections. However, the writing is on the wall for the Indian generics drugs makers to face this emerging challenge by leveraging greater innovation and higher efficiency in the product value chain and thereby offset the hikes as much as possible.

[email protected]

Indian pharma: Gearing up for a rapid transformation

ndian pharmaceutical industry is witnessing a rapid transformation in the recent times. Customers are now

becoming increasingly conscious about quality, regulators are enforcing stricter norms, price control and competition are forcing the prices down, continuous improvements required in Current Good Manufacturing Practice (cGMP), new technologies and expenses in R&D, need for more competent resources and the challenge here is to become a leader in the international pharmaceutical industry.

Quality is the key to enrich the effectiveness of pharmaceuticals. However quality comes with efforts, resources, investment and technology that come with a price. On the other hand, affordability and availability to the concerned customer are factors that cannot be compromised. Quality cannot be compromised either and balance has to be struck between the two.

The question is - how to strike a balance between the two? Government, drug regulators, doctors, healthcare centres and the pharmaceutical companies have to abridge themselves to achieve the balance. Social security policies, medical insurance, public healthcare centres, distribution channels, awareness of consumers, harmonisation of drug regulations, R&D and technology

initiatives, quality incentives can definitely help achieve the noble cause. However, policies of price control, polarised tax incentive schemes, greasy marketing practices, poor healthcare infrastructure has created negative impact on the industry at large.

Policies of social security benefit people near and below the poverty line, while assuring trust of the masses on the importance of human life. Medical insurance scheme will further facilitate availability of drugs to the middle-class sections of society at little or no R&D incentives, initiatives, training bases and collaboration between educational institutes and pharmaceutical industry would increase innovations, provide competent human resources, synergise efforts and reduce time-lag for new products and technologies.

Harmonisation of drug regulations will further simplify the procedures and improve the standards of cGMP. Quality incentives offered to Small and Medium Enterprises (SME) sector will help improve the standards of manufacturing plants and service sector to elevate standards at par with the international standards of cGMP.

Distribution of quality generics through public healthcare system has reduced the cost of medicine in many places with classic example being in the State of Rajasthan. This distribution model provides for affordable medicines to all

consumers in need, which in turn connects the consumer to the manufacturer.

Price control system needs to be evaluated as manufacturing drugs should be affordable to the manufacturers as well, bearing the quality parameters and the costs incurred. The pharmaceutical majors may rethink their interests to manufacture a pharmaceutical product considering the cost to sustain, upgradation, infrastructure and quality costs etc.

Also, greasy marketing practices increase the cost of drugs to the actual consumer, even though the cost of manufacturing is not that high. Polarised tax incentive regime has taken the pharmaceutical industry to extreme geographical locations with constraint for quality resources, transportation, etc.

However, against all odds many Indian pharmaceutical companies are at par with the international standards of cGMP. India is now set to become the largest hub for pharmaceutical manufacturing and services. Indian pharmaceutical companies have right composition of elements such as resources, knowledge base, and technology and above all, a firm determination to emerge as ‘pharmacist’ of the world.

To emerge and become a global leader, it is important to face this rapid evolution and strike a right balance, while putting the oars in the right direction and take up the challenge.

Guest Editorial

EDITORIALADVISORY BOARD

Ajit SinghChairman,

ACG Worldwide & Head, ISPE

Dr Abraham Patani Past President, IDMA & CMD, Inga Laboratories

Dr Gopakumar G Nair IPR Consultant & Advisor

Dilip G Shah Chairman, IGPA &

Secretary General, IPA Daara Patel

Secretary General, IDMA

T

Samir ShahDirector, Ciron Drugs and Pharmaceuticals Pvt Ltd

Manas R Bastia

I

Page 6: Modern Pharma 16-31 August 2013

6 News, views & analysis M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3

ognex Corporation has introduced a range of low cost pharma code

readers. The ‘L (Linear)- series’ of Cognex low cost readers has quickly become the preferred barcode reader due to its outstanding read rate performance, ease of use and cost effectiveness.

“We have come up with this range bearing on

mind the price-conscious customers. The L-series is carefully designed after a lot of thorough research, meeting both the demands of cost and quality for the customers,” said Carl Gerst, Vice President and Business Unit Manager, ID Products.

Pharma code reading plays an integral part in the pharma industry. Within the pharmaceutical industry,

stringent legislation exists to combat counterfeit goods by ensuring each product can be

traced throughout the supply chain. In order to achieve the required levels of traceability, manufacturers are increasingly reliant on printed 2-D codes combined with advanced code reading technology.

Cognex DataMan 50L and 300L series has quickly become the preferred barcode reader owing to its outstanding read rate performance and ease of use.

Cognex launches low cost pharma code readers

Government to set up central drug controller for AYUSH drugsThe Government plans to set up a central drug controller of Ayurveda, Siddha, Unani and Homeopathy (AYUSH) drugs. The proposal in this regard was sent to the Department of Expenditure, Ministry of Finance. 13 posts comprising of one drug controller general (AYUSH), five deputy/assistant drug controllers and seven drug inspectors have been agreed to. Allocation of

` 102 crore has been provided for this initiative in the 12th five-year plan, with a budget including ` 7.60 crore for the current financial year. The steps taken by the Government to establish safety and efficacy of AYUSH drugs and medicines and develop standards include, under intramural and extramural research initiatives of the central AYUSH research councils

and Department of AYUSH research projects have been undertaken for safety and efficacy studies of AYUSH medicines, quality certification scheme for ASU drugs have been introduced in collaboration with the Quality Council of India and legal provisions have been made for display of shelf life or expiry date of various categories of Ayurveda, Siddha and Unani drugs for the use of

preservatives, additives, etc during the process of manufacture.

The Pharmacopoeia Commission of Indian Medicine (PCIM) has been set up to accelerate the work of developing pharmacopoeial standards of ayurveda, siddha and unani drugs and also good clinical practices guidelines for clinical trials and essential drug lists of AYUSH have been published.

anbaxy Laboratories has not been fined $ 500 million by the United States Food and Drug Administration

(USFDA). However, Ranbaxy USA, Inc has pleaded guilty in the US District Court of Maryland for manufacture and distribution of certain drugs, not in conformity with the Good Manufacturing Practices (GMP) regulation, which is hence considered as adulterated drugs, as per the US law and agreed to pay a fine of $ 500 million. 

The honourable Supreme Court of India has not admitted the Public Interest Litigation (PIL).  According to the US law, any drug is considered adulterated, if it is not manufactured, processed, packed, etc in conformity with the Current Good Manufacturing Practice (cGMP) regulations of the USFDA. However, as per the Drugs and Cosmetic Act and Rules, in India, manufacturing of drugs not in conformity with the GMP is viewed as non-compliance under the said Act and Rules.

The Drug Controller General of India (DCGI) has been ordered to review the GMP compliance on the manufacturing facilities of Ranbaxy in India, as well as to ascertain the quality, safety and efficacy of drugs manufactured for the domestic market at these facilities. 

upreme Court once again came down on the Centre for its apathy in controlling the prices of essential drugs and

decided to examine the new national pharmaceutical pricing policy.

While hearing Public Interest Litigation (PIL), a bench headed by justice G S Singhvi said it would examine the policy that fixed the prices of essential medicines in the country. The court asked the Centre to file its response on the issue.

“Margin of profit for manufacturers and dealers has become 10 per cent to 1,300 per cent of the cost of manufacture of the drug,” the bench said after going through a data provided by the petitioner in the PIL.

The bench also pulled up the Centre for dilly dallying on the issue of price fixation for the last 10 years and further added that nothing has been done by the Centre, despite various committees including parliamentary committee  deliberating on the issue.

The assessment was done by the petitioner after analysing the market price, price fixed by the government and the cost of production of the drug.

The court had made it clear to the Centre that it should not form a pharma policy, which may cause increase in the price of essential drugs.

The court earlier said that the drugs prescribed by doctors were beyond the reach of a common man and “any formula for price fixation which goes against common man should be quashed.”

Ranbaxy penalised for selling adulterated drugs by USFDA

National pharmaceutical pricing policy under Supreme Court review

RC

S

DataMan® 300 series of industrial barcode readers

Page 7: Modern Pharma 16-31 August 2013

7M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3News, views & analysis

Valeant Pharma acquires Bausch + Lomb

Lupin plans to launch 20 products in the US

In Brief

V a l e a n t P h a r m a c e u t i c a l s International, Inc, has completed the previously announced acquisition of Bausch + Lomb Holdings Incorporated.

Bausch + Lomb is a leading global eye health company that has a broad portfolio of eye health products, including well-known prescription and over-the-counter (OTC) brands, Besivance, Lotemax, O c u v i t e a n d P r e s e r V i s i o n and vision care brands such as Biotrue ONEday,PureVision, renu and Boston, and surgical b r a n d s , e n V i s t a , S t o r z , Stellaris and VICTUS.

Lupin plans to launch around 20 products in the next fiscal (2014-15) in the US market, according to a mention made by Vinita Gupta, President and CEO, Lupin Group.

The company aims to sharpen focus on segments like oral contraceptives and ophthalmology. The company has 26 first-to-file opportunities in the US market, out of which 12 are exclusive opportunities. Meanwhile, the company also gets the USFDA nod for heart disease drug in the US market.

enus Medicine Research Centre (VMRC), the R&D wing of Venus Remedies Ltd has been

accredited for Good Laboratory Practices (GLP) and norms on Organisation for Economic Cooperation and Development (OECD) principles by the National GLP and Compliance Monitoring Authority (NGCMA). With this, VMRC has joined the list of top 25 testing laboratories in India and eight Indian pharmaceutical companies to have received GLP approval.

Dr Manu Chaudhary, Joint Managing Director, Venus

Remedies Ltd, and Director, Research, VMRC, said, “This GLP accreditation is one of the most coveted certifications for R&D capabilities and will further ensure product quality, safety, reliability and excellence, while preserving and improving human life through innovation. It gives our research an international credibility, which will translate into more business opportunities for the company and add to the reputation of our products and personnel.”

The GLP certification meets the company’s strategic vision to bring to the world

novel breakthroughs that cater to critical care and super-speciality segments, including anti-infective (anti-microbial resistance), anti-cancer, neurology, and pain management and wound care.

“Venus is now the eighth pharmaceutical company in India with GLP accreditation. This accreditation follows the

grant of full membership to India as an OECD member country. Thus, any R&D-related data generated in VMRC will be acceptable by the registration authorities of all the OECD member countries such as USA, Japan and various European countries,” said Dheeraj Aggarwal, Chief Financial Officer (CFO), Venus Remedies Ltd. The company has a robust pipeline of research products. Many of these products are out-licensed and others have already been approved in regulated and emerging markets.

Venus receives GLP accreditation for its R&D centre

V

USP announces new Senior Vice President of Developmenthe US Pharmacopeial Convention (USP) announces the appointment of

Michael D Maves, MD, MBA, FACS, as Senior Vice President of Development. Dr Maves brings a depth and breadth of medical, global health and management experience to this newly-created position at USP, which is designed to extend the organisation’s standards-setting expertise into the worldwide philanthropic arena. Dr Maves, who previously served on the USP’s board of trustees, has resigned from the

previous position to take on new responsibilities.

“I am delighted that Mike Maves has accepted this key, strategic role,” said Roger L Williams, MD, Chief Executive Officer, USP. “He is uniquely qualified to lead USP’s initiatives in development, and in the execution of capacity-building activities in resource-constrained parts of the world. His understanding of USP’s mission as a global standards-setting organisation from his time on our board builds on his extensive experience as a physician,

teacher, global health leader and visionary executive.”

Dr Maves, a board-certified surgeon, served most recently as the executive vice president of project HOPE, a global non-profit health education and humanitarian assistance organisation with more than 400 employees worldwide and programs in more than 35 countries. Prior to this, he was an executive vice president and chief executive officer of the American M e d i c a l A s s o c i a t i o n (AMA), the largest medical professional association,

representing nearly 225,000 physician members.

Dr Maves joined AMA after serving as a president of the Consumer Healthcare Products Association, the major US trade association representing manufacturers of over-the-counter (OTC) medicines and dietary supplements. Dr Maves has served on numerous boards of trustees, and has published extensively. He has been recognised as a leader in the medical and healthcare space, and was elected to Alpha Omega Alpha, the national medical honour society.

T

Dr Manu Chaudhary

Page 8: Modern Pharma 16-31 August 2013

8 News, views & analysis M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3

ayer HealthCare has entered into a new oncology collaboration

and license agreement with Compugen Ltd. This partnership targets the research, development, and commercialisation of antibody-based therapeutics for cancer immunotherapy against two novel immune checkpoint regulators discovered by Compugen. As per the terms of the agreement, the partners will jointly pursue a precl in ica l research program. Subsequently, Bayer will have complete control over further development and worldwide commercialisation rights for potential cancer therapeutics.

“Bayer is committed to translating the science of cancer research into effective therapies helping people affected by cancer live longer and improve their quality of life,” said Prof Andreas Busch, member of the Bayer HealthCare Executive Committee and Head of Global Drug Discovery. “Antibody-based immunotherapies

are promising approaches in oncology, which can stimulate the body’s own immune cells to fight cancer cells. Immunotherapy is one of the focus areas in oncology research. We are looking forward to expanding our portfolio in this area through partnering with Compugen.”

The immunotherapy approach aims at combating

cancer by stimulating the body´s own immune cells. The tumour and its environment suppress the ability of cancer patients to develop an effective anti-tumour immune response and through this approach,

both the tumour growth and survival can be protected. Compugen has discovered two novel immune checkpoint regulators that potentially play a key role in immunosuppression. Researchers at Compugen are developing specific therapeutic antibodies that are geared to block the immunosuppressive function of these targets

and to reactivate the patient’s anti-tumour immune response in order to fight cancer.

“We are very excited to initiate this collaboration with Bayer, a leading global life science company

with a broadening oncology franchise, for the development of antibody-based cancer immunotherapies against these two promising novel immune checkpoint targets,” said Anat Cohen-Dayag, PhD, President and Chief Executive Officer of Compugen. “Additionally, we believe that the prediction and validation of these two targets, through the use of our broadly applicable predict ive discover y infrastructure, provides additional validation for our long-term commitment to establishing this unique capability.”

In addition to an upfront payment of $ 10-million, Compugen is eligible to receive over $ 500 million in potential milestone payments for both the programmes, not including milestone payment of up to $ 30 million, associated with preclinical activities. Furthermore, Compugen is also eligible to receive mid to high single digit royalties on worldwide net sales of any resulting products under the collaboration.

Bayer enters into new cancer immunotherapy collaboration with Compugen

ubilant Biosys Ltd, a Bengaluru-based entity of Jubilant Life Sciences Ltd, has announced the USFDA

acceptance of the Investigational New Drug (IND) filing for a novel molecule targeting prostate cancer with Endo Pharmaceuticals. The new IND relates to a novel molecule targeting prostate cancer, which will now progress towards the next stage of development, with clinical trials expected next year. This molecule will now progress towards the next phase of development and is anticipated to go into clinical trials by late 2013.

Speaking on the development, Dr Subir Kumar Basak, President, Global Drug Discovery Services, Jubilant Life Sciences said, “We are very pleased and elated with this successful outcome, which is the result of excellent collaboration between the scientists at Endo and Jubilant Biosys. Being at the forefront of pharmaceutical, life sciences and healthcare innovation, Jubilant pursues its goal to enable affordable healthcare to patients worldwide.”

The multi-target oncology collaboration between Jubilant and Endo began four years ago, and is focussed on developing best-in-class, differentiated therapies that address the unmet needs of cancer patients worldwide. The collaboration has delivered on multiple milestones across the discovery continuum.

Jubilant Biosys files new IND with Endo Pharmaceuticals

B

Bayer HealthCare’s research site at Berlin, Germany

J

Page 9: Modern Pharma 16-31 August 2013

9M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3News, views & analysis

here is a huge difference in the prices of non-branded generic medicines being sold at the Jan Aushadhi Stores (JAS)

and the prices of branded medicines sold in the open market in the country. 

The prices of branded medicines are generally higher than the prices of equivalent generic medicines due to promotional efforts made in selling of such products. Besides some branded drugs enjoy patent protection and a number of drugs are not covered under the regulation through the Drug Prices Control Orders (DPCO). In the case of generic drugs sold at Jan Aushadhi Stores, the medicines are directly supplied through  stockists/CPSUs  at actual cost plus limited margins. It is a conscious decision of the Government to keep the prices of the medicines at affordable levels for the benefit of all.

  Under the provisions of DPCO, 1995, the prices of 74 bulk drugs and the formulations containing any of these scheduled drugs were under price control.

Variation in prices of branded and generic drugs

The Medicines Patent Pool and healthcare company, Roche have entered into an

agreement to increase access to Valcyte® (valganciclovir hydrochloride), a key medicine to treat cytomegalovirus (CMV). CMV is a viral infection that can result in loss of vision and greater risk of death in people living with HIV. This infection affects around 1 in 10 people living with HIV, in low-and middle-income countries.

The supply agreement between the Medicines Patent Pool and Roche will substantially improve access to an easy-to-take oral medicine to treat CMV, Valcyte® – by making it up to 90 per cent cheaper in 138 developing and emerging countries than it is currently available. The

companies will now consider adding more countries to the initial scope, if there is a need and will also explore licensing and technology transfer, as a second step to help local production of Valcyte® and increase access to Valcyte® in developing countries.

“This agreement will make an oral treatment for CMV available at lower prices, to help break a cycle of lack of screening and treatment in many countries. With medicines available, HIV treatment providers can work on wider diagnosis and treatment, and prevent avoidable blindness in people living with HIV,” said Greg Perry, Executive Director, Medicines Patent Pool.

“This agreement demonstrates how working together can improve the

availability of treatments for people in resource-limited countries. Roche is committed to making Valcyte® available to patients suffering from HIV-related CMV infections in developing countries. Our aim is to provide access to affordable Valcyte® that is produced under quality conditions and increase the number of people who access and benefit from our products,” said Daniel O’Day, Chief Operating Officer, Roche Pharma.

Treatment of CMV is typically difficult to administer, requiring several injections to the eye. This requires hospitalisation of patients and care by highly trained staff, which is often not sufficiently available in developing countries. The oral treatment Valcyte® is an alternative, but

due to a number of reasons, including lack of screening and high prices; patients in developing countries have not been able to receive it.

The lower price of this oral drug should help create a new market for Valcyte® stimulating greater treatment of CMV. With Roche now supplying lower-cost Valcyte®, government, treatment providers and funds can now ramp up efforts to ensure screening for CMV. This becomes a part of routine HIV care and people can now access treatments to preserve their sight and extend lives.

Roche has also agreed to licence another medicine for use in HIV-related conditions to the Medicines Patent Pool, Saquinavir, in case the need arises.

TRoche enters into an agreement with Medicines Patent Pool

Campaign for affordable Trastuzumab welcomes dismissalThe campaign for affordable Trastuzumab welcomes the decision of the patent controller, Kolkata, to dismiss the divisional applications for patents on trastuzumab (Herceptin®) the life-saving breast cancer drug controlled by Swiss-pharma major, Roche.

Faced with misleading statements by Roche and factually incorrect reporting by the international media, the Kolkata patent office took the unusual step of explaining its stand clarifying that the divisional applications, filed in 2005 and 2008 were dismissed because Genentech/Roche missed the stipulated deadline for filing of applications. They further failed to appear and make their case, when requested to do so by the patent controller.

Hailed as a major breakthrough in cancer treatment, Trastuzumab has a dramatic impact on the HER2+ variant of breast cancer, significantly reducing the risk of recurrence and expanding the possibility of a disease-free life. However, the drug is priced exorbitantly and, at ` 9 lakh for a minimum course of 12 injections, is out of reach for the majority of Indian women. According to official statistics, more than 25,000 Indian women (increasingly in the under-45 age group) are diagnosed with HER2+ breast cancer every year, of whom less than 5 per cent are able to access Trastuzumab.

The campaign for affordable Trastuzumab, launched in November 2012 and endorsed by over 200 Indian and global patient associations, cancer survivors, health movements, women right activists and eminent jurists has been demanding that the Government of India (GoI) intervene to enable the production of biosimilars and ensure that the drug is made available to all those, who can benefit from it.

Page 10: Modern Pharma 16-31 August 2013

10 News, views & analysis M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3

harmaceutical firm, Claris Lifesciences Ltd has completed transfer of two of its infusion businesses to a joint venture,

formed with Japanese pharma firms, for a consideration of ` 1,050 crore.  Ahmedabad-based drugmaker, entered into a joint-venture (JV) agreement last year with two Japanese firms namely, Otsuka Pharmaceutical and Mitsui & Co Ltd for its injectable business in India and emerging markets.

As per the terms of the deal, the company has transferred common solutions, anti-infective, plasma volume expanders and parenteral nutrition therapies business for India and

emerging markets to the new JV, Claris-Otsuka.  Claris will continue to hold a 20 per cent stake in the joint-venture, while Otsuka and Mitsui will hold 60 and 20 per cent stake respectively.

The Indian company received ` 1,050 crore, as a part of the transaction from Claris-Otsuka. The joint venture is valued at ` 1,313 crore.  Claris said, it will use part of the cash consideration towards debt prepayment of around ` 360 crore.

Subject to regulatory approvals, the company intends to reward shareholders via buyback of shares. It has allocated ` 300 crore for the buyback of shares, according to a statement by the company.

n a strategic shift, drug maker, Dr Reddy’s Laboratories (DRL)  plans to move away from traditional generics to

value-added drug making and expects 70 per cent revenues from partnerships and non-oral solid medicines.

According to Abhijit Mukherjee, President Global Generics, Dr Reddy’s Laboratories, the company would look for more acquisitions of research-oriented pharma companies.“Going ahead, I think it will be a testing time for a lot of generic industries in the US market. Because plain vanilla oral dosage not likely to return value.  It is going to put pressure on returns of capital employed and erode margins, if we don’t graduate ourselves from plain vanilla drugs to limited competition and high value products,” Mukherjee added.

“In this context, what we are trying to do in the short to mid-term is a string of capability based acquisitions such as Octoplus. We are working with partnerships and eventually the outcome, what we are looking for is by financial year 2017, we move towards this front and our total revenue roughly about 40 per cent would be from various forms of partnerships and 30 per cent of the revenues would be from non-oral solids.”

At the moment, the revenue contribution from external partnerships is in teens and the same from non-oral solids is in single digits. DRL’s net profit rose by over 7 per cent to Rs 361 crore for the quarter ended June 30, primarily

driven by North American revenues. The company’s net profit after tax stood at ` 336 crore during the same quarter last fiscal.  Net income from sales and services stood at ` 2,845 crore during the quarter under discussion against ` 2,541 crore, an increase of 12 per cent.

Revenues from the emerging markets that include Russia and CIS countries stood at ` 600 crore registering 9 per cent growth year-on-year. Generic sales income from Europe declined by 28 per cent to ` 160 crore, being primarily pulled down by decline in German revenues.

In the Russian markets, the company expects better growth in the second quarter. As the  European markets are moving towards tender-based sales, the company is working out a strategy, which will be implemented in the months to come to mitigate the negative effect.

Revenues from generic sales of India remained flat at ̀ 350 crore, due to the implementation of new Drug Pricing Policy 2012, which led to destocking in the trade coupled with the strike by Maharashtra traders, DRL said in a statement.

Mukherjee further added that the new drug pricing policy would put pressure on pharma companies’ revenues.  The 348 essential drugs that were brought under control would account of ` 1600 crore sales.  The individual drug price notifications are being released in a phased manner by the National Pharmaceutical Pricing Authority (NPPA).

DRL to move away from generics and concentrate on growth in value-added manufacturing

P

I

Claris transfers two businesses to Japan JV for ` 1,050 crore

he new Drug Price Control Order (DPCO) that slashed the prices of essential drugs  would incur a massive loss to the

tune of ` 600 crore for drug retailers in Kerala, as they have already taken the drugs on a higher price, medical-shop owners complained.

The order should not be implemented before selling off the current stock of medicines, which had been purchased on older rates, V Ajith Kumar, a member of All Kerala Chemists & Drugs Association (AKCDA) told at a press meet. “The government has reduced the maximum selling price of 153 medicines. The implementation of the order will cause a huge loss of around ` 600 crore for drug retailers in the state,” Kumar added.

However, the retail drug shop owners were not against the price reduction of essential medicines but requested the authorities to show some humanitarian consideration to small-scale medical shop owners as well.

“The price control of drugs is really a good one. But, its immediate implementation will cause huge capital loss to us. So, we need at least three months time to clear the present stock,” Kumar informed that if the plea of chemists will not be given due consideration by the authorities, the drug retailers would go on stroke and close shops. The  Department of Pharmaceuticals had notified the DPCO 2013 in May, reducing the price of 348 essential medicines.

TDrug retailers need more time to sell old stock

Page 11: Modern Pharma 16-31 August 2013

11M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3News, views & analysis

lite has purchased from Mikah Pharma, LLC, twelve approved and one pending, Abbreviated New Drug

Applications (ANDAs) to add to its pipeline of products.

The pharma company further announced the appointment of long-time industry veteran, Nasrat Hakim as President, Chief Executive Officer and member of Elite’s board of directors. As part of his employment agreement, Hakim has elected to receive his salary in restricted common stock in lieu of cash. Jerry Treppel remains Chairman on the Board of Directors.

Nasrat Hakim has more than 30 years of pharmaceutical and medical industry experience in quality assurance, analytical research and development, technical services and regulatory compliance. Hakim brings along proven management experience, in-depth knowledge of manufacturing systems, development knowledge in immediate and extended release formulations and extensive regulatory experience of GGMP and FDA regulations. With Hakim joining the company, Mikah has sold to Elite thirteen ANDAs for generic pharmaceutical products. Of the thirteen products, which represent six different chemical entities, twelve of these products are already FDA approved ANDAs, with one already on the market and one ANDA is under active review by the FDA. Of the thirteen products, two products are in the market wherein there is only one other generic competitor. Elite will submit filings to the FDA for each of the product for the manufacturing site transfer.

“The acquisition of the Mikah products is expected to eventually significantly enhance our revenue base over time with a commensurate increase in cash flow that will be utilised to decrease our operating losses and then support R&D,” said Jerry Treppel, Chairman, Elite Pharmaceuticals.

anbaxy Malaysia Sdn Bhd (RMSB) has been allocated site for setting up its greenfield manufacturing facility in

Malaysia. The company signed a ‘letter of offer’ agreement with Kulim Hi Tech Park (KHTP), a wholly-owned state agency and industrial park that houses various other leading industries. KHTP is located at Kulim in the state of Kedah, Malaysia.

The agreement was signed by T Jeyabalan Thangarajah, Managing Director, RMSB and Tuan Haji Muhammad Sobri, President , KHTP in the presence of representatives of the Ministry of Investment Development Authority (MIDA) and Arun Sawhney, Chief Executive Officer and Managing Director, Ranbaxy.

Ranbaxy’s greenfield facility will be built on an area of around 15 acres with an investment of around $ 35-million providing employment to over 200 people. This will be Ranbaxy’s second manufacturing plant in Malaysia. Last year

in September, the Government of Malaysia provided an approval to RMSB for setting up a greenfield manufacturing facility in Malaysia, as an Entry Point Project (EPP).

On the occassion, T Jeyabalan said, “Ranbaxy established its foothold in Malaysia three decades back and since then, has been offering high quality, affordable generic medicines to the Malaysian healthcare system. The new greenfield facility reinforces our long term commitment.” Jeyabalan further added, “In addition to serving the local market, the new facility will also export products to the ASEAN markets, Middle East, Europe, Sri Lanka, China and other selected nations.”

The RMSB’s new facility would manufacture dosage forms including tablets and capsules primarily in the cardiovascular, anti-diabetic, anti-infective and gastrointestinal segments. Ranbaxy’s total output in Malaysia will be increased from 1-billion doses/annum to 3 billion doses/annum, when the new facility is fully operational.

ctavis Specialty Brands has acquired worldwide rights to Palau Pharma’s Albaconazole development

product, an oral antifungal agent for the treatment of vulvo-vaginal candidiasis, onychomycosis and other antifungal applications. Albaconazole is a new oral triazole discovered at Palau Pharma, with a potent broad-spectrum antifungal activity, and an excellent safety profile, that has demonstrated high efficacy in patients suffering from vulvo-vaginitis, and onychomycosis.

Under the terms of the agreement, Palau receives an initial cash payment and will receive additional future payments based on milestones to be reached during the development of the product. Financial terms of the agreement have not yet been disclosed. “Based on clinical results to date, we believe that Albaconazole

has the potential to be a best-in-class therapy for the treatment of vulvo-vaginal candidiasis and onychomycosis conditions,” said Enrique Uriach, Chairman, Palau Pharma. “This transaction recognises and validates, once more, the quality of science developed at Palau. Furthermore, Actavis, as a

leader in the women health sector, will provide the resources, leadership and expertise to rapidly advance the development of Albaconazole, and make

it a commercial success”. “The addition of Albaconazole to our pipeline provides an excellent opportunity for Actavis to build on its leadership position in women’s health and to expand the dermatology portfolio on a worldwide basis,” said Fred Wilkinson, President, Actavis Specialty Brands. “Currently in Phase-II trials, Albaconazole could potentially launch in the US and the EU in 2017.”

Ranbaxy allocated site for its greenfield manufacturing facility in Malaysia

Actavis acquires worldwide rights for Palau Pharma’s Albaconazole antifungal agent

E

R A

Elite Pharmaceuticals adds twelve approved products to its pipeline

Page 12: Modern Pharma 16-31 August 2013

12 In Conversation With M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3

and effectiveness in standard medicines are also rising sharply. Also, a need for advanced and even customised medication is emerging. The industry has to anticipate such developments by focussing on quality and extended research. Companies focussing on highest quality standards, and developing own patents, will emerge as winners in the longer run.

What are the future plans for SCHOTT?SCHOTT’s core business is into highly advanced special materials and their applications. With new innovations and changing market demands, SCHOTT continues to invest in R&D and develop new products. We strive to be at the front edge of specialised solutions in all markets, including India. In 2006, we established a new tank to produce FIOLAX® tubing with an investment of ` 40 crore in Jambusar, Gujarat. Within two years, we have set up another high technology tank to boost production. Currently, the plant has a capacity to manufacture more than 50 tonne of pharmaceutical tubing per day. SCHOTT is the only manufacturer of amber neutral tubing and controls about two-thirds of the market for white (neutral) tubing used in pharmaceutical applications in India.

Also, we are the only supplier to produce premium customised glass tubing as per the highest international standards directly in India. The plant in situated at Jambusar, Gujarat, which is the only FIOLAX® manufacturing site of SCHOTT in Asia. The Jambusar, Gujarat site functions as a production hub for the entire region, which helps to manifest the company’s role as the Asia’s leading supplier of special glass tubing.

What are the innovations you foresee in the glass tubing industry?It is proven that the products made from glass tubing are the best for pharmaceutical packaging. The company needs to focus its efforts on tightening tolerance levels for advanced products such as prefilled syringes. The industry is facing a steep increase in the energy costs thereby resulting in increased energy efficiency during production. This will be another important challenge.

Shed light on your professional journey and achievements in the industry.On completion of Masters of Applied Science in Electronics, I joined the

German National Service in 1979. My knowledge helped me become the squad leader of a radio unit until I went back to the university. After more than three years of gaining additional theoretical knowledge, I felt I was ready to implement my expertise practically and joined an R&D project on electro chromic mirrors at SCHOTT in 1984. However after six years, a sudden realisation dawned upon me that, even though I was enjoying R&D, my personal preference being engineering, had taken a back seat.

Herein at SCHOTT, I was provided with an opportunity to develop highly advanced online inspection system for controlling glass production, along with a valuable management experience, while heading a team of engineers.In 2005, I moved to Singapore to set up SCHOTT’s greenfield semiconductor clean room factory for highly advanced processing of glass and silicon wafers for image sensors. Back in Germany, I was made in-charge of glass melting activities at the Schott’s plant in Northern Germany.

After sometime one day, I received a call from Schott HR asking me to go to India to head the tubing factory at Gujarat and Baroda became my new home.

Tell us about the book co-authored by you titled, ‘Optical Properties’.I started my career with a R&D project for electro chromic thin film layers. These layers enable the design of optical systems that change their properties by application of an electrical voltage. During this period, a renowned publisher of scientific books was planning for sequence of a book about ‘Optical Properties’. When I was asked for co-authoring the chapters, addressing the unique technology of switchable optical properties, I was made aware of it, because of working with SCHOTT R&D expertise and involved into research work at the front edge of technology.

How do you balance work and family life?Living in India with my wife and a grown-up daughter, who is living independently, my wife has been the strong pillar of support throughout. Besides, my working association with Schott is my extended family and manufacturing plant is my second home.

…says Georg Sparschuh, President, Schott Glass India Pvt Ltd, He further shares his views on the company’s growth plans for the Indian market and challenges faced to maintain standards of expertise in glass tubing and manufacturing during the 125 years of existence along with transformations witnessed in the Indian pharmaceutical sector.

How has SCHOTT been able to maintain its standards of expertise during the span of 125 years in glass tubing and manufacturing?

For more than a century now ie, 125 years to be precise, SCHOTT has been shaping the future of glass technology. Producing the best quality of glass is not just business but our passion as well. The Otto Schott Research Centre at Mainz, Germany, is one of the world’s leading glass research institutions. Treading on the footsteps of Otto Schott (the father of specialised glass), this centre has served as a convergence point for the world’s top glass scientists, engineers and craftsmen for developing new glass compositions and guiding in the day-to-day operations. This dedication to improve specialised glass differentiates SCHOTT from its competitors.

What are the transformations in R&D witnessed by Schott during the years?R&D department of an industry is where scientists need to convert money into knowledge and engineers, knowledge into money. I have only seen this cycle accelerating with the world shrinking and becoming faster. Scientists, working within the industry, need to focus more on achieving fast and tangible results. While, there is some more room for fancy ideas at the universities than in industry. However, the money involved for such investments only lies with the latter. I hope, both, industries and universities will sense the need for fundamental research and support the same.

Another change is the increasing complexity of new developments. The image of a lonely scientist, locked up in a lab in his ivory tower does not work any longer. Scientists also need to develop skills in team work and project management.

Looking back and till date, how do you think the Indian pharmaceutical market can be improved?India’s pharmaceutical market is at the doorstep of change. So far, it has catered to the people’s basic needs in standard medicines. As India, becomes a major pharmaceutical export country, the demand for high quality, purity

It is proven that the products made from glass tubing are best for pharmaceutical packaging

Since there are many drugs coming off patent in the next few years, a number of leading Indian pharma companies are looking forward to

enter the nutraceuticals market.

Anubhav Sharmaanubhav.sharma @network18publishing.com

Page 13: Modern Pharma 16-31 August 2013
Page 14: Modern Pharma 16-31 August 2013

14 Special Focus M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3

he scenario of clinical research in India has transitioned over the last few years. India is a global hub for conducting clinical trials

owing to the existence of a large treatment-naïve population, disease patterns, availability of English-speaking skilled

doctors, and further cost-savings. Over 100 companies are currently conducting clinical trials in India and the top multinational pharmaceutical majors to name a few include, Pfizer, GlaxoSmithKline, Aventis, Novartis, Novo Nordisk, Astra Zeneca, Eli Lilly are conducting clinical trials in India,

apart from the Indian companies such as Dr Reddy’s, Nicholas Piramal, Cipla and Lupin.

ChallengesThough India continues to be the preferred location for conducting clinical trials, a perceptible slow down is being

witnessed, owing to challenges at different levels including those at the policy level. The current clinical trial market size is just $ 400-million and the growth rate is flat. The fact can be attributed to reasons such as high costs, slow results, lack of funding, regulatory burdens, fragmented infrastructure, incompatible databases, and shortage of qualified investigators and willing participants.

A large number of deaths have been witnessed in the past, owing to unregulated clinical trials and adverse drug reactions. Public interest litigation to the Supreme Court recently stated that illiterate and impoverished Indians were being treated as guinea pigs. Unethical practices have been followed on a regular basis with little sensitivity shown by the staff. This lack of supervision and regulation gave rise to the need for fabricating stringent norms. The Drugs and Cosmetics Rules, 1945 has been through a serious review and many amendments were proposed in the sections G S R 53 (E), G S R 63 (E) and GSR 72 (E) in January 2013.

G S R 53(E) specifies procedure to analyse the reports of serious adverse events including deaths occurring during clinical trials and procedures for payment of compensation in case of trial related injury or death. G S R 63 (E) specifies various conditions for conducting clinical trials, while G S R 72(E) provides for the requirements and guidelines for the registration of an ethics committee. The amendment has proposed that no ethics committee can review and approve any clinical trial protocol, unless it is registered with the Central Drugs Standard Control Organisation (CDSCO).

These sudden changes came as a blow to the industry and approval processes began having longer waiting periods with an increased level of uncertainty coming into place. Shekhar Gupta, Co-Founder and Chief Operating Officer, D2L Pharma Research Solutions, Bengaluru states, “One of the major challenges faced by the Indian clinical research industry includes slow approvals. According to the data provided by the Union Ministry for Health, the number of clinical trials approved by the CDSCO has decreased by more than 50 per cent from 529 in the year 2010 to 253 in 2012. This sharp and steep decline in the number of clinical trials approved by the Drug Controller General of India (DCGI) has been witnessed due to the several measures undertaken by the drug

How to sustain growth momentum in India?

Clinical trials and research

The clinical research industry in India has witnessed an evident transformation in the recent times with involvement by many pharma majors to support the clinical trials in the country. Explore reasons why India has a competitive edge over its other Asian counterparts as the preferred destination for conducting clinical trials and approval challenges involved during the process.

T

Pallavi Mukhopadhyay pallavi.mukhopadhyay @network18publishing.com

Page 15: Modern Pharma 16-31 August 2013

15M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3Special Focus

authorities to strengthen the clinical trial approval procedures and the monitoring mechanism for clinical trials in India.”

Expressing its concern with regard to the slowdown in granting approvals for clinical trials in the country, a spokesperson from ISCR said, “This slowdown has the greatest impact on patients for many of those, whom clinical trial provides early access to a new treatment and for others, the last option or hope of cure. Without clinical trials there can be no new therapies.”

Need for regulatory reformsWhile, the regulatory authorities of the Supreme court have acknowledged steps taken by the Ministry of Health to strengthen regulation of clinical trials in India and granted time to the petitioners,  National  Human Rights    Commission (NHRC), NGOs and  other proposed intervenors to  submit  their  suggestions  to  the  secretary, Ministry of Health.

To facilitate fair conduction of clinical trials in India, there must be a balance between regulatory norms and amendments suggested to foster the growth of this sector. To expedite the approval process, the Union Ministry of Health has constituted 12 New Drug Advisory Committees (NDACs) comprising of experts from the government medical colleges and institutes from all over the country to advice CDSCO in the matters, related to approval of clinical trials and new drugs. The government has also mandated the registration of an ethics committee. According to the CDSCO website, nearly 500 ethics committee have already been registered till date.

Evolving clinical data managementThe global pharma majors and drug discovery companies are exploring the huge potential available with Indian information technology (IT) companies by availing the six-sigma advantage and powerful integrated tools management system. Data driven, computer based, intelligent drug development is slowly taking centre stage. Electronic data systems will reduce paperwork, enhance continuous monitoring and promote communication between the industry and regulatory authorities.

There is focussed effort to increase training of research professionals thereby generating a large base of investigators and support staff. Well-trained and certified data managers will form the crux of any self sustainable clinical trial going forward. Convergence of clinical trials and healthcare data will be observed. In a nut shell, it will become obligatory to streamline the entire clinical research process to retain transparency and provide clinical trial approvals in a reasonable time frame.

As complexity of clinical studies increase and timelines shrink, the ability to effectively manage both technology and human resource requires new modus operandi. Thus leveraging capabilities of Indian IT for data management and allied services is the need of the hour.

Reforms to transformIndia has witnessed a large number of mergers and collaborations in the clinical research sector. Competition with other Asian countries such as Korea, China and Singapore coupled with shaky regulatory ecosystem has

put India in a tight spot at the moment.Gupta further adds, “Apart from the

government role and responsibilities, other external support from pharma companies and media is needed to strengthen the Indian clinical research industry. Approval processes need to be streamlined to expedite the process as in other countries. It is important to safeguard the interest of patients with more transparent environment, strict regulations and awareness. It is required that all new initiatives by the government such as encumbrance certificate (EC) registrations, additional staffs and committees, monitoring processes, etc be implemented on a priority basis.”

Also, continuous training of all stakeholders that include investigators, site staff, clinical research professionals on ICH-GCP (International Conference on Harmonisation – Good Clinical Practice), new regulatory regulations and other core functions is crucial. Developing infrastructure at hospitals and research centers to conduct trials as per guidelines to ensure patient safety and fastening up the industry-academic collaborations is essential for growth.

Social media tools for better reporting of adverse events by general public can create more awareness and effective recruitment processes in trials. Further building an ecosystem that supports innovation in India and provide safe patent environment for pharmaceutical companies to bring new drugs to India will reap in good harvests.

According to an ICSR spokesperson, “The Government of India (GoI) sponsored working group on disease burden for the 12th five-year plan refers

to the ‘triple burden of disease’ that encompasses all diseases right from communicable diseases, emerging non-communicable diseases related to lifestyles and emerging infectious diseases. India’s unique healthcare requirement makes it mandatory for clinical research, to develop new and effective medicines and vaccines to tackle the country’s mammoth disease burden and unmet medical need.”

One of the major challenges faced by the Indian clinical research industry includes slow approvals. According to the data provided by the Union Ministry for Health, the number of clinical trials approved by the CDSCO has decreased by more than 50 per cent from 529 in the year 2010 to 253 in 2012.

Shekhar Gupta Co-Founder and Chief Operating Officer,

D2L Pharma Research Solutions

Page 16: Modern Pharma 16-31 August 2013

16 Special Focus M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3

linical research is an indispensable part of the drug discovery process and clinical

trials form the mainstay for bringing new and better drugs to the market. India has become an important hub for pharmaceutical drug discovery and development process for a variety of reasons. The country is an attractive destination for conducting clinical research because it has an appropriate environment and requisite facilities such as large patient population, diverse ethnic and genetic makeup, speciality hospitals with good infrastructure, good investigators and medical staff with English speaking professionals and above all, lower operational costs.

The fundamentals are in place to enable pharmaceutical/ biotechnology organisations, academia and medical institutions to outsource trials to India. India continues to be a potentially an ideal hub to undertake and conduct ethical and good quality clinical trials.

India: A clinical research hubDue to the key success factors at a macro-level being in place, clinical research is now perceived as a new service growth engine, which could contribute significantly to the global requirements of the drug discovery process. This has resulted in a swift uptake of clinical research in India dovetailed with some hype as well. While growth momentum on this front, provided opportunities to home-grown talent, the regulations, self-governance, infrastructure and mindset of the populace are not in sync with the demands of the evolving segment. While, a majority of stakeholders

undertook clinical research responsibly, the mismatch in pace has allowed several players to perceive this opportunity as a transactional one. This sub-section lacked appropriate processes, governance and mindset to take on clinical research responsibly, thereby resulting in adverse events.

Over the last few years, India has been witnessing an increasing number of controversies with consequent negative publicity and adverse developments in clinical research. The controversies emanated from a host of issues related to ethics, law, human rights and scientific development, lack of information and training, regulation etc. This has been exaggerated by the lack of understanding of clinical research in general, the negative general public perception and the consequent political reactions. A few defaulters have been responsible for tarnishing the image of the whole industry, which by and large operated to the international standards. The Supreme Court has taken an extremely serious view of the 2,868 deaths that have been reported during the period 2005-2012 due to clinical trials. There have been several queries and opinions exchanged among key stakeholders regard the composition of ethics committee, their registrations and the compensation for patients participating in the clinical trials, the process of informed consent especially for Bachelor of Engineering (BE)/Bachelor of Arts (BA) studies, which has further reduced the clarity on the subject.

Impact on IndiaThe intervention of the Supreme Court has triggered a chain of events, which may lead to the much needed regulatory reform. At the same time, it has also temporarily but significantly slowed down trial approvals in India. As a result, till April 2013, only 12 clinical trials have been approved by the authority, as compared to almost a three-digit figure last year.  Currently, the clinical

research industry is viewed with scepticism, fear and uncertainty. Few trials are being conducted, patients are fearful, the regulatory reform is sluggish and the industry perception is overall sceptical.

On the other hand, there is an impending positive impact generated by a collective debate through various forums on means to internally improve the standards and governance for undertaking clinical trials. One of the key takeaways from the resulting debate is the need for a greater role of the ethics committees in conducting clinical trials. There is an urgent need for training programmes at various levels to increase the pool of competent ethics professionals. A wide representative group of industry, academia and regulator is required to champion established benchmarks of international standards and the good news is that this process has begun informally at various levels.

The emphasis on laws governing the functioning of ethics committee and important issues such as compensation to patients, in case of adverse events is now even more critical for the future of clinical research. This need is now being addressed carefully by the regulator through a consultative process with the relevant stakeholders. Overall, the stakeholders have been prompted to pause, review the current status, formulate solutions for improvements and support creation of a robust plan for the future.

What is at stake?Owing to excessive reactions to the adverse reports, the regulatory reform process has been slow, thus leading to uncertainty. The large and established organisations have little clarity regarding the timelines, with respect to the reforms being put in place. Due to lack of consistency on the regulatory front over the last 2 years, reputed organisations have become hesitant regard expansion and are even considering temporary

reduction of their operations. Also, drug innovators have temporarily stopped and are being sceptical about outsourcing trials to India, until the situation improves.

In fact, the pharmaceutical, biotech companies and Clinical Research Organisations (CROs) are considering completion of global studies in new destinations such as Malaysia, Thailand, etc. This downward trend in trials will result in low exposure of clinicians to new and advanced drugs, hence lower availability of new treatments to Indian patients. Only after trials are being conducted and behaviour of new treatments and drugs in controlled conditions are learnt, would clinicians be convinced and recommend these drugs further for better treatment of Indian patients. Also, the vision of India as a global destination for clinical research will be at stake and the country will lose its attractiveness, despite having a talented resource pool and good infrastructure.

What the future beholds? Conducting clinical trials is a very scientific and diligent process. If undertaken in a well regulated and enforced environment, and the stakeholders involved are undertaking trials with the right intent, then it is in fact difficult to deviate and commit mistakes in the process. The adverse consequences that are surfaced have largely been due to a minority subset of defaulters and the entire industry should not be viewed with the same lens.

However, the recent controversies and negativity cannot be wished away. It may prove good in the long term, if it brings about a reform in the process of undertaking clinical trials in India. All stakeholders are hopeful that this churning would result in a comprehensive process for clinical trials, which is effective yet efficient. Such an evolution is much needed for ethical, sensitive, well meaning and sophisticated clinical research in India..

What is at stake?Clinical research in India

Clinical trials in India have always remained under lens by various expert committees and several healthcare stakeholders, with a continuous demand and scope for improvement at the operational level. This part of the drug development process is now being seriously attended by experts and strict adherence to the standard guidelines is being practised across the country, with significant efforts from the researchers and policymakers.

C

Conducting clinical trials is a scientific and diligent process. If undertaken in a well

regulated and enforced environment, and the stakeholders involved are undertaking trials

with the right intent, then it is in fact difficult to deviate and commit mistakes in the process.

Seemant Jauhari Chief Executive Officer, Apollo

Hospitals Educational and Research Foundation

[email protected]

y ,

es e ,

Page 17: Modern Pharma 16-31 August 2013
Page 18: Modern Pharma 16-31 August 2013

18 Special Focus: Roundtable M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3

Do we need stringent regulations to streamline CRO operations?

Clinical Research Organisations (CROs) provide a platform to bridge the gap between laboratory success and actual outcomes of a drug or

device. Hence, a set of stringent and globally recognised standards are a must for this sector. Our experts opine on the existing industry practices and norms established by the regulators that govern the CROs, posing

challenges to growth.

ROs) provide a platform to bridge Clinical Research Organisations (C

With the current regulatory framework presenting a set of challenges, along with a careful blend of positives and negatives existing together in the clinical research space, the regulatory bodies have to be extra cautious in terms of setting up practice guidelines for the industry. The laws to be enacted to streamline the industry

operations must have room for flexibility, to upgrade as per the changing market demands.

takeEditorial

ndian regulatory guidelines are now in a state of flux and constantly evolving. It is required that the guidelines be more aligned with the global norms including USFDA and European Medicines Agency (EMA) Post updating the subject compensation norms that was

a serious industry concern, it has been rationalised by the Central Drugs Standard Control Organization (CDSCO) office.  Hence, it cannot be said that the regulatory guidelines are too stringent for CROs. In fact, CROs and pharma companies welcome some recent moves around Institutional Review Board (IRB)/Independent Ethics Committee/IEC registration, site inspections, etc. These factors could drive overall clinical standards in the industry.

However, the industry continues to face challenges around two critical aspects that involve rapidly and sometimes arbitrarily changing guidelines without taking into account global standards, scientific rationale and/or administrative impact. The other important factor being the execution issues with respect to delayed approvals. Discussions by New Drug Advisory Committee (NDAC) panel on pending clinical trial approvals get deferred by weeks and months. There seems to be no time-bound formula and no accountability for the said delays and this is severely hurting the business. In a nutshell, while the industry does not have many issues regard the policy framework and

are ready to accept tighter regulatory norms, rapid change in regulatory guidelines and a more time bound

formula has to be implied.

ill April 2013, only 12 clinical trials have been approved by the authority. This certainly raises a concern for the future of clinical research in India. The clinical research industry in India is estimated at $ 500-million and is projected to more than double and cross the $ 1-billion mark by 2016.

However, due to strict compliances and uncertain approval process the number of clinical research coming to India has decreased significantly in the recent past. The unreasonable demands of authorities like protocol amendments, site selection, etc further increases the time and cost involvement.

CROs not just contribute to the scientific research and development but also ensure better patient care than normal clinical practice and in the long run, prove to be a boon for the society. This eventually leads to the development of new generic drugs and medicines. It is unfortunate that India is losing out on the opportunity to other nations, because of the uncertainties in the regulatory framework and mechanism. Some recommendations for changes in the existing law include improvement in the system of obtaining informed consent from the subjects, need for institutionalisation and registration of clinical research, requirement of quick and timely approval mechanism, removing

loopholes and establishing an ethical committee and regulatory authority to look into the matters along with expert involvement,

when required.

he  Indian  regulatory  guidelines  are similar in approach to the  international  regulatory  authorities, the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency

(MHRA). Framing of these new rules with regard to compensation, registration of ethics committee and inspection of clinical trial sites is in a response to the Supreme Court order. For several years, the pharma / CRO industry has been highlighting the need for such regulations in place. However, the current spate of regulations has come into effect within a short span of time, leaving many questions unanswered. Some of the conditions on compensation rules appear difficult to comply with, thereby leading to uncertainties in the minds of industry about the process and the quantum of compensation.

The inspections at the clinical trial sites are conducted with little notice, and the approach is not in sync with the professionally conducted inspections by USFDA. The conditions for registration on independent

ethics committee mandate that they can only approve bio-equivalence studies. This would result in closing of all clinical trial sites managed

by private practitioners and reduction on the number of sites available for clinical trials. Also, the process of review by NDAC is inefficient

leading to long delays in  the regulatory approval process up to 9 months.

ndia is poised to take the lead in the global clinical development process. With a strong reputation to meet the global professional parameters, the Indian regulatory agencies are working closely with most of the international bodies to update the processes and smooth

out kinks in the system. Considering the fact, that English is one of the official primary languages, gives India a distinct advantage over many Asian and Eastern European countries. With a proper strategy in place and strong partnerships, meaningful cost savings and quality data can be made possible. Recent strategic plans such as registration of the ethics committee and recording of informed consent for clinical trials, video recording and fixing volunteer compensation initiatives will lead the way in ensuring safe and efficient clinical trials. There should be more focus on economic liberalisation, global acceptance of India’s information technology capabilities, improvements in travel communication and support service. The quality and international training of medical

professionals, quality of private medical institutes and availability of investigators with experience of global trials should be incorporated as

an integral aspect of the regulatory guidelines. India needs to have a well-planned policy for developing research such that we stay ahead

in R&D, while reducing the time invested into learning of how to

develop new drugs.

pcotw

Nidhi SaxenaChief Executive Officer, Karmic Lifesciences

Dr Hitendra AhoojaMedical Director, Ahooja Eye and Dental Institute, and Honourable Medical Director, Niramaya Charitable Trust

Dr Arun BhattPresident, Clininvent Research

Dr Pradeep ChowbeyVice-Chairman, Max Healthcare and Director, Max Institute of Minimal Access, Metabolic and Bariatric Surgery

I

T

T

I

Nikunj [email protected]

Page 19: Modern Pharma 16-31 August 2013
Page 20: Modern Pharma 16-31 August 2013

20 Inside & Outlook: Policies & Regulations M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3

harmaceutical industry in India is currently abuzz over the latest media reports on the

government’s contemplation to introduce restrictive measures on Foreign Direct Investments (FDI) in the ‘brownfield’ pharma acquisitions.

As observed in many other countries, the consolidation process involving the domestic pharmaceutical sector has started gaining momentum in India, with the first major post-product patent regime merger and acquisition that happened in 2006, as Mylan acquired Matrix Lab.

The year 2008 witnessed one of the biggest acquisitions in the Indian pharmaceutical market, when the third largest drug maker of Japan, Daiichi Sankyo acquired 63.9 per cent stake of Ranbaxy Laboratories for $ 4.6-billion. This merger and acquisition activity was widely believed to be a win-win deal, with Daiichi Sankyo leveraging the cost arbitrage of Ranbaxy. While Ranbaxy benefitted from the innovative product range of Daiichi Sankyo. It is a different story though, that this deal does not seem to have helped the acquirer much. This is mainly due to the number of scandalous regulatory issues raised by the United States Food and Drug Administration (USFDA).

Another major acquisition that took place in May 2010 was, when Chicago-based Abbott Laboratories acquired the branded generic business of Piramal Healthcare for $ 3.72-billion. This particular acquisition triggered the Government’s thought for new restrictions on FDI for ‘brownfield’ acquisitions in the pharmaceutical sector of India.

Close on heels of the above acquisition, the Department of Industrial Policy and Promotion (DIPP) in its ‘discussion paper’ dated August 24, 2010, expressed some of the apprehensions towards foreign acquisitions of the Indian pharmaceutical companies. These include:

Creation of oligopolistic market with adverse impact on ‘public health interest’:

Indian pharmaceutical market has more than 23,000 players and around 60,000 brands. After consideration of all the recent acquisitions, the top ranked pharmaceutical company of India, Abbott enjoys a market share of just 6.6 per cent. The top 10 group of companies, each belonging to the same promoter group and not of the individual companies contribute just over 40 per cent of the Indian pharmaceutical market (Source: AIOCD/AWACS – April 2013). Thus, the market is highly fragmented, nocompany or group of companies enjoy any clear market domination.

In such a scenario, the apprehension of ‘oligopolistic market’ being created through brownfield acquisitions by the multinational companies is indeed unfounded.May limit the power of government to grant Compulsory Licensing (CL):

With more than 20,000 registered pharmaceutical producers in India, there will always be enough skilled manufacturers available to make needed medicines during anemergency. For example, during H1N1 influenza pandemic, several local companies stepped forward to supply the required medicine to the patients.

This idea of creating a legal barrier by fixing a cap on the FDIs to prevent domestic pharma players from selling their respective companies at a price, which they would otherwise consider lucrative, from the compulsory licensing point of view, sounds unreasonable and highly protectionist in a globalised economy.

Lesser competition will push up drug prices:

Equity holding of a company has no bearing on pricing or access, especially when medicine prices are controlled by the National Pharmaceutical Pricing Authority (NPPA) guidelines and competitive pressure.

In such an environment, the thought of any threat to ‘public health interest’ due to irresponsible pricing, would be imaginary in nature, especially when the medicine prices in India are cheapest in the world, in comparison to Bangladesh, Pakistan and Sri Lanka.

The positive falloutsMergers and acquisitions, both ‘greenfield’ and ‘brownfield’, and joint ventures contribute not just to the creation of high-value jobs for Indians but also access to high-tech equipment and capital goods. Technology transfer by the multinational companies stimulate growth in manufacturing and R&D spaces of the domestic industry, but also positively impact patients’ health, with increased access to breakthrough medicines and vaccines.

Any restriction to FDI in the pharmaceutical industry could make overseas investments into India, even in the R&D sector of the country to seem less inviting.

As listed in the United Nation’s World Investment Report, the pharmaceutical industry in India offers great prospects for future FDI, relative to other industries. Thus, restrictive policies on pharmaceutical FDI could promote disinvestments and encourage foreign investors to look elsewhere.

While the Government of India is contemplating modification of pharma FDI policy, other countries have stepped forward to attract FDI in pharmaceuticals. Between October 2010 and January 2011, more than 27 countries and economies have adopted policy measures to attract foreign investments.

At a time when the global companies are sitting on a huge cash pile and waiting for the

Euro zone crisis to melt away, before considering overseas investment opportunities, any retrograde steps from the Indian government with regards to FDI in the pharmaceutical sector may not augur well for the nation.

While the Indian government has been publicly debating policies to restrict FDI in the ‘brownfield’ pharma sector, other countries have stepped up their efforts to attract FDI in their respective countries. 

It is worth mentioning that the Government of India has also publicly expressed its views against the concept of ‘protectionism’ in business.

Pranab Mukherjee, the former Union Finance Minister and now President of India aptly comments, “Protectionism is harmful,” as in the context of moves by the US to hike visa fees and clamp down on outsourcing.

Partnering with multinational companies, the local drug companies have now begun to gain access to international expertise, resources and good manufacturing practice. A number of local companies have already entered into alliances with multinationals to leverage these opportunities.

It is worth noting that, any possible adverse impact of mergers and acquisitions on the competition will now be effectively taken care of by the Competition Commission of India (CCI). Also, apprehensions regard unreasonable price increases will be appropriately addressed by the NPPA, as is the current practice. Drug Price Control Order (DPCO) 2013 has also taken enough measures to avoid shortages of essential medicines.

Thus, limiting FDI in the brownfield sector of the pharmaceutical industry at this stage without any substantive reason and just based on unfounded apprehensions, when the Government in fact, is debating on the need to open up telecom, defense, insurance and other sectors to foreign investments, this move will indeed prove to be a retrograde step.

Apprehensions deter growth prospects

FDI in pharma

With recent government contemplation on restricting Foreign Direct Investments (FDIs) in the ‘greenfield’ and ‘brownfield’ pharma acquisitions in India, there are apprehensions in the pharmaceutical sector in India. Is restricting mergers and acquisitions without any substantial reason, the way to go?

PTapan Ray

Director General, Organisation of Pharmaceutical

Producers of India

[email protected]

While the Government is contemplating modification of pharma FDI policy, more

than 27 countries have adopted the policy measures to attract foreign investments between October 2010 and January 2011.

Page 21: Modern Pharma 16-31 August 2013

21M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3Projects

Altman Clinical and Translational Research Institute (CTRI)Project typeNew facilityProject newsThe CTRI will provide laboratory and clinical researchers with an environment for collaboration and resource-sharing to better understand and treat diseases such as cancer, arthritis and diabetes. The building will have a total floor space of 359,000 square. It will include about 189,000 square of space for research and core laboratories, 66,000 sq of space for the dry research, multiple conference rooms, a large lecture hall and other facilities.

Project locationLa Jolla, San DiegoProject cost$ 269-millionImplementation stagePlanning

Contact details:The University of California and San Diego (UCSD)UC San Diego, 9500 Gilman Dr, La Jolla, CA 92093 Tel: +1-858-534-2230--------------------------------------------------AstraZeneca - Taizhou pharmaceutical manufacturing facilityProject typeNew facility

Project newsThe Taizhou pharmaceutical manufacturing facility involves construction of a facility to produce intravenous and oral solid medicines in China Medical City (CMC), Taizhou City, Jiangsu province, China. This new pharmaceutical manufacturing plant will also include the construction of laboratory, production unit, storage space, and a warehouse and office space.

Project locationChinaProject cost$ 200 millionImplementation stagePlanning

Contact details:ASTRAZENECA43/F CITIC Square1168 Nan Jing Xi Road Shanghai- 200041, China Tel: +86 21 525 645 55Website: http://www.astrazeneca.com --------------------------------------------------Biopolis biomedical research hub - Phase 5Project typeNew facilityProject newsThe Biopolis campus was created in order to provide space for biomedical research, which could promote collaboration

between private companies and public scientific/educational bodies. JTC Corporation announces the fifth phase of Biopolis in June 2010, with an intention to cater to the increasing demand for biomedical research. This phase will comprise twin towers spread across a 9,621.4 square metre area, providing a gross floor area of 46,182 square metres. The phase five will also feature a 1,000 square metre readymade laboratory known as ‘Shell-Plus’ that will consist of basic laboratory facilities and finished vinyl flooring.

Project locationOne-North, Buona Vista, SingaporeProject cost$ 700-millionImplementation stagePlanning

Contact details:JTC CorporationThe JTC Summit 8 Jurong Town Hall RoadSingapore- 609 434Tel: 1800-5687000 Fax: +65 -6565 5301--------------------------------------------------BioMalta life sciences park in San Gwann, MaltaProject typeNew facility

New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesciences industry.

Information courtesy: www.tendersinfo.com1, Arch Gold, Next to MTNL Exchange, Poisar, S.V. Road, Kandivali (W), Mumbai - 400067, Maharashtra, India

Tel: +91 22 28666134 Fax: +91-22-28013817 Email: [email protected]

Project newsThis new life sciences centre will provide laboratory space to new as well as existing companies. It will also extend business advisory services, financial incentives and tangible support to companies intending to set up operations. The BioMalta campus is being built over ex-Yorkie and disused VF jeans factories in the San Gwann Industrial Estate. Malta Enterprise also has an office building at the site. The office will be relocated to create space for the BioMalta campus. The existing buildings are being demolished to make way for the construction of the research and development park. The project site is strategically located in proximity to the University of Malta and Mater Dei Hospital, enabling operating companies to work in collaboration with the university staff and the hospital.

Project locationMaltaProject cost$ 50-millionImplementation stagePlanning

Contact details:Government of MaltaDepartment of Information, Castille Place, Valletta VLT 2000 Malta

Page 22: Modern Pharma 16-31 August 2013

22 Tenders M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3

Laminar air flow unitOrg : Indian Council of Agricultural ResearchTRN : 17467890Desc : Supply of laminar air flow unitBOD : 25 August, 2013Loc : New DelhiBT : Domestic (NCB)

Refrigerated centrifugeOrg : Indian Agricultural Research Institute (IARI)TRN : 17389742Desc : Purchase of refrigerated centrifugeBOD : 26 August, 2013Loc : New DelhiBT : Domestic (NCB)

High speed ultra centrifugeOrg : Indian Institute of Technology, RoorkeeTRN : 17477580Desc : Purchase of high speed ultra centrifugeBOD : 26 August, 2013Loc : Roorkee, UttarakhandBT : Domestic (NCB)

Fourier Transform Infra-Red (FTIR) spectrometerOrg : Research Design and Standards Organisation (RDSO)TRN : 17286529Desc : Supply, installation and commissioning of Fourier Transform Infra-Red (FTIR) spectrometer and accessories for measurement of gaseous emissions from diesel locomotives of Indian RailwaysBOD : 27 August, 2013Loc : Lucknow, Uttar PradeshBT : Domestic (NCB)

NMR spectrometerOrg : Indian Institute of Technology, RoorkeeTRN : 17477652Desc : Purchase of 400 MHz NMR spectrometerBOD : 27 August, 2013Loc : UttarakhandBT : Domestic (NCB)

Digital refractometerOrg : Nuclear Power Corporation of India Ltd

TRN : 17420661Desc : Supply of digital refractometerBOD : 27 August, 2013Loc : Surat, GujaratBT : Domestic (NCB)

High speed sterile eye ointment filling and sealing machineOrg : Essential Drugs Company LtdTRN : 17389975Desc : Supply and installation of high speed sterile eye ointment filling and sealing machineBOD : 27 August, 2013Loc : DhakaBT : Global (ICB)

Atomic fluorescence spectrometerOrg : National Centre for Antarctic and Ocean ResearchTRN : 17443645Desc : Supply, installation and commissioning of atomic fluorescence spectrometerBOD : 27 August, 2013Loc : Vasco-da-Gama, GoaBT : Domestic (NCB)

Brought to you by www.tendersinfo.com

Information courtesy: www.tendersinfo.com

1, Arch Gold, Next to MTNL Exchange, Poisar, S.V. Road, Kandivali (W),

Mumbai - 400067, Maharashtra, India Tel: +91 22 28666134 Fax: +91-22-28013817

Email: [email protected]

Inductively coupled plasma-mass spectrometerOrg : Indian Space Research Organisation (ISRO)TRN : 17110560Desc : Provision of inductively coupled plasma-mass spectrometerBOD : 29 August, 2013Loc : Ahmedabad, GujaratBT : Domestic (NCB)

Laminar air flow unitsOrg : Tamil Nadu Livestock Development Agency (TNLDA)TRN : 17420620Desc : Supply and delivery of laminar air flow units to various places in Tamil NaduBOD : 30 August, 2013Loc : Chennai, Tamil NaduBT : Domestic (NCB)

Raman spectro photometerOrg : Food and Drugs Control AdministrationTRN : 17482840Desc : Tenders are invited for supply of Raman spectro photometerBOD : 31 August, 2013Loc : Vadodara, GujaratBT : Domestic (NCB)

Injection Meropenem and tablet dispensing coverOrg : Government of KeralaTRN : 17193896Desc : Supply of injection Meropenem and tablet dispensing cover for medical college hospital at ThiruvananthapuramBOD : 31 August, 2013Loc : Thiruvananthapuram, KeralaBT : Domestic (NCB)

Ion mobility spectrometer

Org : Food and Drugs Control AdministrationTRN : 17492628Desc : Supply of ion mobility spectrometerBOD : 31 August, 2013Loc : Vadodara, GujaratBT : Domestic (NCB)

Near infrared analyser

Org : Food and Drugs Control AdministrationTRN : 17490207Desc : Supply of near infrared analyserBOD : 31 August, 2013Loc : Vadodara, GujaratBT : Domestic (NCB)

Org: Organisation’s name; TRN: Tendersinfo Ref No; Desc: Description; DSLD: Doc Sale

Last Date; BOD: Bid Opening Date; Loc: Location; BT: Bidding Type

Page 23: Modern Pharma 16-31 August 2013

23M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3Event List

National Events International EventsPHARMAbiotikaPharmabiotika 2013 is an exhibition that facilitate buyer and seller meet to network with 10000+ business visitors, 600 delegates and 400+ exhibitors, attending the global exhibition. There are around 30+ thought leaders from across the world sharing their valuable experiential learning in the 3 days conference. The event will help in meeting the potential customer requirements mapping for developing new trade leads and analysing the exhibiting plan and execute trade objectives; September 16-18, 2013, Mahatma Mandir Convention & Exhibition Center, Gandhinagar

For details contact:Human Crayon Management Services Pvt LtdTel: +91- 120 – 6528801Email: [email protected] Website: www.pharmabiotika.com

Indian Pharma ExpoThe Indian Pharma Expo 2013 will serve as a perfect platform for pharma entrepreneurs and investors, eager to be a part of the pharmaceutical business through franchisee and distributorship opportunities in the India pharma market. The two-day expo will bring together drug manufacturers, pharma companies and suppliers and distributors of pharma products under one roof to exchange ideas; September 20-21, 2013, Pragati Maidan, New Delhi

For details contact:UBM Medica India Pvt LtdTel: +91-22-66122600 / 66122673Fax: +91-22-66122626Email: [email protected]: www.ubmindia.in

Asia-ArvoSome of the primary highlights of this conference will be interactive session, papers, abstracts and programme. Masses from all over the world are welcome to be part of this conference. Topics that will be discussed in Asia Arvo include genetics of AMD, understanding AMD, reprogramming and regeneration, gene therapy, small molecule screening and drug discovery, model organisms, gene regulation during development and disease, eye development inherited eye diseases, diabetic retinopathy, common eye diseases, signaling pathways, angiogenesis, crystallins, chaperons and heat shock proteins, oxidative stress, ageing and eye disease; October 28-31, 2013, Ashok Convention Centre, New Delhi

For details contact:The Association for Research in Vision and OphthalmologyTel: +12402212900Fax: +12402210370Website: www.arvo.org

CPhI IndiaCPhI India will bring pharma professionals from all over the world to Mumbai and facilitate, initiate and close business deals. It will be a great opportunity for the industry to  showcase their products and services while enhancing their brand at South Asia’s leading pharma industry event. Exhibitors will include manufacturers

of Active Pharmaceutical Ingredients, Alkaloids, Amino acids, Antibiotics, Antibodies, Antimicrobial preservatives, Antioxidants, Biocatalysts, Biotechnology, Capsules/encapsulation, Chemical synthesis/analysis, Chira intermediates and lots more; December 3-5, 2013, Bombay Exhibition Centre, Mumbai

For details contact:International UBM  LiveTel: +91-22-67692415Fax: +91-22- 66122626 / 66122627Email: [email protected]: www.pmec-india.com

P-MEC IndiaWith India’s pharmaceutical machinery and equipment market growing, decision makers from all over the world are increasingly looking at India for sourcing pharmaceutical machinery and equipment. At P-MEC India, visitors will have the unique opportunity to showcase their products in front a large audience, building brand awareness and gaining new leads from over 85 countries. P-MEC India is co-located with CPhI India, a sister brand of CPhI Worldwide - the ‘must attend’ event in the international pharmaceutical industry. It is a great platform for visitors to showcase high-quality pharma machinery and equipment, meet with key decision makers in pharmaceutical industry from countries, including India, China, US, UK, France, Italy, etc and network and build the brand in one of the world’s fastest growing pharmaceutical markets; December 3-5, 2013, Bombay Exhibition Centre, Mumbai

For details contact:International UBM  LiveTel: +91-22-67692415Fax: +91-22- 66122626 / 66122627Email: [email protected]: www.pmec-india.com

34th International Conference on Bioscience, Biochemical and Pharmaceutical EngineeringThe main focus of this conference is to bring scientists, researchers and scholars together to exchange and share experiences and research results about bioscience, biochemical and pharmaceutical engineering, and discuss the practical challenges encountered and the solutions adopted. The conference will deal with topics such as bioscience, biochemical and pharmaceutical engineering, affective neuroscience, astrobiology; December 5-6, 2013, Sheraton, Bengaluru

For details contact:World Academy of Science Engineering and TechnologyTel: +44-782-4879405Website: www.waset.org/conferences/2013/bangalore/icbbpe/

3rd International Conference on Environmental, Biomedical and Biotechnology This conference is sponsored by the Asia-Pacific Chemical, Biological & Environmental Engineering Society. It is one of the leading international conferences for presenting novel and fundamental advances in the fields of environmental, biomedical and biotechnology. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving environmental, biomedical and biotechnology-related techniques; August 24-25, 2013, Royal Hotel, Singapore

For details contact:Asia-Pacific Chemical, Biological & Environmental Engineering SocietyTel: +86-28-86528465 (China Branch)Email: [email protected]: www.icebb.org

Fifth Annual Consumer Genetics Conference The conference will draw together a dynamic community of scientists, clinicians, technology innovators, and patients to discuss the burning issues around the analysis and delivery of genomics results directly to patients and consumers. Attendees will hear about disruptive diagnostic technologies, cognitive barriers to patients and medical professionals, ethical, regulatory, privacy issues, the issue of reimbursement, and the challenges of building relationships to realise the potential of personal genomics and individualised medicine. CGC will provide an opportunity for all stakeholders to come together at one venue, share viewpoints and engage in dialogue; September 25-27, 2013, Seaport Hotel, Boston, USA

For details contact:IlluminaTel: 781-972-1359Email: [email protected]   Website: www.consumergeneticsconference.com

4th Global Drug Safety Conference and ExpositionThe 4th Global Drug Safety Conference and Exposition will be based on the theme,  ‘Revitalising Drug Safety – The Decade of the Patient.’ Drug safety has become one of the most challenging public health issues of this time. It is everyone’s responsibility to take action to address the serious threat to global public health posed by the pressing issues relating to unsafe medicines and the unsafe use of medicines. The exposition will bring together government leaders, drug regulatory agencies, drug safety specialists, healthcare professionals, pharmaceutical industry, healthcare technology providers, health insurance providers, patient safety advocates, and consumer groups from

all over the globe; October 14-16, 2013, Brisbane Convention and Exhibition Centre, Brisbane, Australia

For details contact:Ozaccom+ Conference ServiceTel : +61 (0)7 3854 1611 Fax: +61 (0)7 3854 1507 Email:  [email protected]: www.gds2013.org

Drug Discovery Re-Invented: Emerging Role of Biotechs, Academics and Non-ProfitsThe conference will center on new approaches to drug discovery in an industry where the landscape is changing rapidly. With large pharma reducing investment in internal early stage research, drug pipelines will increasingly be filled by alternative sources. These players include: government, academic labs, non-profits, biotech companies, and pharmaceutical “open innovation” models. The conference will also provide examples of successful strategies for advancing new drug candidates in this era of distributed discovery; October 16–19, 2013, Hilton Scottsdale Resort & Villas, Scottsdale, Arizona, USA

For details contact: Fusion ConferencesTel: +44 (0) 1638 724137Fax: +44 (0) 1638 724135Email: [email protected]: www.fusion-conferences.com

5th Pan Arab Human Genetics ConferenceThe conference will focus on topics ranging from cancer genomics and NexGen sequencing to molecular profiling and pharmacogenomics. International and regional experts will take to the platform to deliver their lectures on these topics. Researchers will be encouraged to submit their abstracts for oral or poster presentation at the conference. Also, a special feature of the conference will be a workshop on rare disorders; November 17-19, 2013, Al Bustan Rotana, Dubai, UAE

For details contact:Meeting Minds ExpertsTel: +9714-4270492Fax: +9714-4270493Email: [email protected]: www.pahgc.org

2013 International Conference on Pharmaceutical and Biological Sciences The aim of the International Conference on Pharmaceutical and Biological Sciences is to provide a platform for researchers, engineers, academicians as well as industrial professionals from all over the world to present their research results and development activities in pharmaceutical and biological Sciences; November 17-18, 2013, Cristal Hotels & Resorts, Abu Dhabi, UAE.

For details contact:Asia-Pacific Chemical, Biological & Environmental Engineering Society (APCBEES)Tel: +86-28-86528465Email: [email protected]: www.icpbs.com

For detailsNetwork18 Media & Investments Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028.

India’s premier industrial trade fair on products and

technologies related to Machine Tools, Hydraulics

& Pneumatics, Process Machinery & Equipment,

Automation Instrumentation, Packaging & Auxiliaries,

IT Products, Electrical & Electronics, Material

Handling and Safety Equipment.

AHMEDABADGujarat

March 07-10, 2014

LUDHIANAPunjab

December 20-23, 2013

AURANGABADMaharashtra

January 10-13, 2014

INDOREMadhya Pradesh

Jan 31 – Feb 03, 2014

KOLKATAWest Bengal

February 21-24, 2014

PUNEMaharashtra

October 18-21, 2013

CHENNAI Tamil Nadu

November 14-17, 2013

JAIPUR Rajasthan

Nov 29 - Dec 02, 2013

Page 24: Modern Pharma 16-31 August 2013

24 Book Review M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3

Nanotoxicity: From In Vivo and In Vitro Models to Health Risks

Principles and Practice of Disinfection, Preservation and Sterilization

anotechnology and its applications promise to lead us into the perfect future in the years to come. Nano medicine has encouraging results

in the labs, many of which have entered the clinical field as well. As applications of nanotechnology enter medical field, there is a need for better understanding of the potential toxicities generated by these preparations. The editors have brilliantly compiled text from a wide array of experts in the field of application of nanotechnology with regard to clinical toxicity.

Spread over twenty six chapters, this book delves into the details of toxicity to the respiratory system, nervous system, GI systems and the haematological system. There are dedicated chapters on the methods of toxicity evaluation both in vivo and in vitro. Not only are the potential toxicities discussed, but reverse scenarios wherein nano particles are less toxic than the conventional formulations are also discussed. The chapter on nano-size red elemental selenium highlights the same. A rich text that is fairly technical and in-depth with valid examples is not for the initiate. It is a great book for researchers in nano medicine and for the next generation scientists.

Microbes are ubiquitous. There has always been a fight by mankind against these microbes for a healthy living. This has given rise to concepts of anti-

microbial activity, disinfection, sterilisation and preservation of organic materials. Considered as the pioneering text in the field, this treasure trove of knowledge is a must read for anyone in the field of biological sciences. The text is divided into two sections. The initial elaborates on the various principles of microbicides, while the later part discusses on the practical applications of the same. The first half begins with the history and further proceeds to discussing on the basic properties of microbicidal agents and sensitivity of various bacteria, fungi, protozoa, viruses and prions to them.

A dedicated chapter on prion diseases puts across the large threat of such poorly understood diseases. The second half of the book describes various agents, techniques and steps in disinfection and sterilisation procedures. Special scenarios such as endoscopes, dentistry, hospital laundry and contact lens disinfection provides for a better insight. A chapter dedicated to hand hygiene and hand rubs deserves a special mention. The book also discusses on the regulatory aspects of microbicidal agents. A great text, easy to understand and implement, recommended for all!!

Editors: Saura C Sahu and Daniel A Casciano

Price: ` 12,300

Editors: Adam P Fraise, Jean-Yves Maillard and Syed A Sattar

Price: ` 14,750

Publisher: WileyDistributor: Wisdom Book

Distributors, Hornby Building, 1st Floor, 174, D N Road,

Mumbai -400 001, Tel: 022-2207 4484/6631 8958,

Telefax: 022-2203 4058 Email: [email protected]

Publisher: Wiley - BlackwellDistributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai-400 001, Tel: 022-2207 4484/6631 8958, Telefax: 022-2203 4058 Email: [email protected]

Reviewer: Dr Mandar Kubal, Director, Infectious Diseases & Pulmonary Care Pvt Ltd

N C

1 year (24 issues) `1200/-

Fill all details in capital letters

Name : Mr/ Ms. : ........................................................................................................................................

Organisation : ............................................................................................................................................

Please send my copy to : Residence Factory ( Kindly tick only one )

Mailing Address : ........................................................................................................................................

City : ...................................................................... State : ..........................................................................

Pin : ................................................................................

Telephone : (O) .................................. (R) ..................................... Mobile :..............................................

E - mail : ................................................... Subscriber’s Signature : ........................................................

..........................................................................................................

drawn on (name of bank) .........................................................................................................................

dated ................................................ or `..................................................................................................

favouring Network18 Media & Investments Limited payable at Mumbai.

OR charge my VISA Mastercard American Express

Card No. : ..................................................................... ................................................

............................................................................. CardHolder’s Signature :......................................

Modern Pharma, Subscription Department, Network 18, A Wing, Ruby House, JK Sawant Marg, Dadar West, Mumbai 400 028.

E-mail: [email protected] or [email protected]

Terms & Conditions : Your subscription will start from the next available issue. Network 18 will take utmost care to dispatch the copies safely. Network 18 does not take the responsibility of any postal delays and damaged copies dispatched. For more information contact Network 18 subscription department. Above rates are valid in India only.“Disclaimer: Network18 Media & Investments Limited is proposing, subject to market conditions and other considerations, an offer of its equity shares on rights basis and has filed a Draft Letter of Offer with the Securities and Exchange Board of India. The Draft Letter of Offer is available on the website of SEBI at www.sebi.gov.in and the websites of the Lead Managers at www.icicisecurities.com and www.rbs.in. Investors should note that investment in equity shares involves a high degree of risk and are requested to refer to “Risk Factors” in the Draft Letter of Offer. The Equity Shares have not been and will not be registered under the US Securities Act of 1933, as amended (the “US Securities Act”), or any state securities laws in the United States and may not be offered or sold in the United States or to, or for the account or benefit of, “U.S. persons” (as defined in Regulation S under the US Securities Act) except in a transaction exempt from the registration requirements of the US Securities Act and in accordance with any applicable U.S. state securities laws.”

Yes! I would like to subscribe to Modern Pharma for...

http://eshop.network18publishing.com

1 - 15 A u g u s t 2 013 I Vo l 2 I N o 3 I `10 0

www.modernpharma.in

In Conversation With 16 Dr Muhammed Majeed Founder and Managing Director, Sami Labs Ltd

Special Focus 18CRAMS in India Opening up avenues with regulations

Special Focus Interface 23Dr Ravi Sobti Independent pharmaceutical consultant

Energy Management 26Renewable energy sourcesHow can the pharma industry benefit?

Scan this code onyour smart phoneto visit www.modernpharma.in

ccording to a study by Export-Import Bank of India (Exim Bank), the size of the Indian pharmaceutical industry was around $ 29 billion in 2011-12, but in value terms, it constituted only 1.2 per cent of the global pharmaceutical market. To boost the export capability

of Indian pharmaceutical companies, Exim Bank has decided to expand the scope of its finance to pharmaceutical companies for extended repayment periods. Eligible export oriented companies can avail finance from Exim Bank for a maximum repayment period of 10 years with a moratorium of upto 36 months.The cost of compliance

with USFDA norms is high, for example, an USFDA approved Active Pharmaceutical Ingredient (API) manufacturing facility can cost up to

` 300-million to ` 400 million and formulations manufacturing plant may cost about ` 500 million to ` 600 million. Furthermore, the average gestation period required for setting up these plants is in the range of 18-24 months.Despite possessing

potential to increase share in global exports, many Indian pharmaceutical companies suffer due to their inability to meet the stringent compliance norms of European countries and the US. To increase market share, the industry needs to penetrate deeper into the regulated markets, which calls for accreditation of more and more facilities of Indian manufacturers.To meet the expectations of

the Indian industry and to cope with longer average gestation period to meet the USFDA or other similar regulatory

requirements, Exim Bank has decided to provide long-term finance to pharmaceutical companies, with a maximum repayment period of 10 years. The expenses would cover inter-alia, all expenditure incurred/to be incurred for establishment of a USFDA approved facility.

Exim Bank has been closely associated with the growth of the Indian pharmaceutical industry. The Bank has been helping pharmaceutical units in the entire value chain starting from bulk-drug manufacturing to APIs and formulations, while supporting R&D and other activities. In 2012-13, the Indian pharmaceutical industry spent around 5 per cent of the total sales on R&D activities. Though it is higher than the average R&D expenditure in manufacturing sector (estimated to be around 1 per cent), as in comparison to developed countries, such as

US or Germany, it is very low. Thus, it is imperative for the Indian pharmaceutical industry to scale up its R&D intensity and strengthen its position in the global market sphere.In order to assist the industry

to emerge stronger in terms of the R&D capabilities, Exim Bank also extends term finance for both capital and revenue expenditure to eligible export oriented firms/companies under the Bank’s Research & Development lending programme. Under this programme, finance is provided up to 80 per cent of the eligible expenditure. The normal tenure of the loan is 7 years, however, longer tenures with suitable interest resets are also allowed in specific cases.Exim Bank continues to work

closely with the Ministry of Commerce and Industry to meet the various requirements of the Indian pharmaceutical industry.

ydus and Infectious Disease Research Institute (IDRI), a Seattle-based non-profit research and product development organisation are collaborating on the production and clinical development of IDRI’s visceral leishmaniasis (VL) vaccine candidate, designed to prevent the deadly parasitic disease.Known as Kala-Azar in India,

VL is transmitted by the bite of an infected sand fly. There are over 500,000 new VL cases and associated deaths every year. VL is the most severe form of leishmaniasis, affecting vital organs and if left untreated, the disease can be fatal. A vaccine is considered essential to control and eliminate the disease. Currently, visceral leishmaniasis (VL) occurs in four continents and is considered to be endemic in 88 countries; 72 of these are developing countries, with the disease being most common in India, Nepal, Bangladesh, Sudan and Brazil. While there are drugs to treat the disease, they are expensive and often toxic. Till date, a safe and efficacious vaccine to prevent this disease does not exist.Zydus and IDRI will collaborate

to conduct clinical development activities in India with the goal of developing, registering and marketing this vaccine candidate for the prevention of VL, which will achieve the objective of global access - to ensure that the vaccine is affordable and accessible by all the people in need. Conducting trials in India is critical to determining the effectiveness of IDRI’s VL, vaccine candidate and ensuring that it is approved and available within endemic countries.

rug major, Lupin has inked an in-licensing agreement with pharma company MSD. As per the terms of the agreement, Lupin will market MSD’s pneumonia prevention vaccine under a different brand name in India.Mumbai-based Lupin will

have a non-exclusive licence to market, promote and distribute MSD’s 23-valent Pneumococcal polysaccharide vaccine (PPSV) under a different brand name in the country.“We believe that the partnership

is an important step forward as both companies share a common

passion and commitment to make a meaningful difference to the lives of patients suffering from pneumococcal diseases in India,” said Shakti Chakraborty, Group President, India & CIS countries, Lupin Ltd. “Our strong presence across diverse therapies places us in a unique position from where we can consolidate and grow into being a top 3 player within the Indian

market. Powered with a passionate field force, Lupin’s domestic

formulations business is all set to take a giant leap forward.”MSD India, which is an affiliate of Merck & Co Inc, operates in more than 140 countries. It would also continue to sell the vaccine in the country.Further, Lupin’s India business grew by 23 per cent clocking

in revenues of ` 23,840 million during 2013. The 3rd largest Indian pharma

player by sales globally, the company has been consistently outperforming the Indian pharmaceutical market with CAGR of 20.2 per cent over the last five years. Powered by a 5,200 specialty sales force, Lupin has in-licensed 37 drugs in the past four years, eight out of which were first-of-its-kind drugs for the Indian market. Lupin has successfully executed similar such arrangements with Eli Lily for Diabetes and Novartis earlier. It seems to have become a partner of choice for such deals within the Indian market.

Exim Bank pitches unique long-term product for Indian pharma firms

Lupin to market MSD’s pneumonia prevention vaccine in India

Zydus and IDRI collaborate for clinical development activities in India

Editor’s Pick 25

M o d e r n P h a r m a | 1 -1 5 A u g u s t 2 0 1 3

Inside & Outlook: Automation Trends

ndia has more than 900 million users of mobile handset technology and it is rapidly growing every day. Such technologies have empowered the consumers to seek and share information on a real-time basis. Even with such empowerment, our policy makers are not doing enough to harness such technologies to build the capacity of the Small and Medium Enterprises (SMEs). This will help build a strong regulatory framework to address issues on health and safety of the consumers in India. Regrettably, to counter the prevalence of spurious and not-of-standard medicines that often impact the most vulnerable and poorest Indian populations; this can be easily tackled through implementation of technology, which is yet to get mandated for all the manufacturers of pharma products in India. On the other hand, it is projected that the SMEs do not wish to adopt such technologies and are against the rights of the patients to access safe and quality medicines.

The purchase of suspect drugs from community and locally-based pharmacies can have a devastating impact on Indian consumers including patient injury and death. In order to further address this important patient safety issue, consumers must be empowered to report suspected spurious medicines to public health and law enforcement officials for further investigations.

Role of SMEsLegitimate sellers should be highlighted to patients for their high quality, while illicit sellers should be identified for patient safety and consumer protection against these poor quality vendors. Beyond clear identification of legitimate and suspected medicine sellers, patients also need, easily accessible information regarding the dangers and how to detect counterfeit medicines. To be able to achieve this objective, the policy makers and the manufacturers of pharma products in India must adopt IT-based automation processes and technologies. This is the future for SMEs in India, to demonstrate their commitment towards the consumers and integrate with their existing Good Manufacturing Processes (GMP) and also Good Distribution Practices (GDP).

The existing policies in India have encouraged the emergence of the SME sector as a strong player and in the coming years they would get further benefitted from various provisions in favour of the SMEs like provision of finance, training, technical marketing and other support measures, access to raw materials etc. These strategic interventions have been instrumental in ensuring the rapid growth of SMEs in the pharmaceutical industry. The SMEs play a pivotal role in supplying diversified portfolio of essential lifesaving drugs at affordable prices. It is appropriate to create the demand for use of technologies, which will enable consumers to establish trust and faith on the products manufactured by SMEs, while making them most accessible and affordable to the masses at large. Thus, the SMEs will undoubtedly be the future demand drivers in promoting and ensuring safe drug delivery.

Modern information technology could be used in an extensive manner for this purpose. In addition to the scientif ic and technological measures, it must be emphasised that there is a need to strengthen the existing monitoring mechanisms, to upgrade and modernise the drug testing laboratories. The latter should be provided with state-of-the-art technologies to sensitively and speedily test the samples sent to them for analysis. This would require equipments like mass spectrometers and others, along with training of personnel, within the country and if required, even abroad, to utilise the modern facilities to their optimum capacity. There is a need to create centralised ‘database’ of all drug and drug manufacturing units in the country, which could help trace the origin of a drug (e-pedigree) through the entire supply chain. Simultaneously, there is a need to streamline the law enforcement system, as already proposed by the Mashelkar Committee in 2003 and the Parliament of India recently.

Future projectionsProjected to be the 10th largest market by 2015 with 20 billion dollars, Indian SMEs engaged mainly in generic drugs are playing an important role in the global consolidation process and making strides across the world. The country has also emerged as one of the preferred global supplier of high-quality drugs and intermediates at cost-effective prices. The growth of domestic pharmaceutical industry has in fact outperformed the growth of the global pharmaceutical industry. Exports have been the major growth enabler of the Indian pharmaceutical industry in recent years. The domestic demand is also

increasing because of lifestyle-associated diseases showing a growth, least expected from a country like India. It is expected that around 80 million Indians will be above 67 years of age. This group spends around 3 to 4 times more on drugs than those in younger age groups. This has also incentivised SMEs to start functioning in rural locations of India, which can be attributed to rising rural incomes and better distribution channels. With patents coming in place, SMEs are increasingly looking towards spending more on research and development efforts. The R&D division of pharma companies are slowly moving from reverse engineering to discovering and development of new formulations. India is in fact gearing up to launch its own patented molecules in future, globally. Many Indian firms are today collaborating with multi-nationals through agreements, which will help sharing costs and ensure better results.Further, in the drug research

value chain, there exists an opportunity to capture the market share in global clinical research and development market such as clinical trials, data management, testing, etc. By 2014, nearly half of all newly approved prescription drugs will be biologics. Several patents have expired on branded biologics with $ 15 billion in annual sales. In my view, it is the most opportune time for SMEs to adopt user-friendly technologies to capture the domestic and global opportunities, to trigger the use of IT-based automation technologies that build credibility and trust in the Indian manufactured pharmaceutical products, sold to the consumers in India and globally.

Will SMEs be the new demand drivers?

IT-based automation in pharma

The role of Small and Medium Enterprises (SMEs) as key

demand drivers in promoting the growth of the pharma

industry in India is undeniable. However, integration of

advanced technologies helps SMEs address challenges

faced in the daily operations. It is time that the contributions

of these SMEs are projected in the right light to provide

patients with safe access to quality medicines.

I

It is the most opportune time for SMEs to

adopt user-friendly technologies to capture the domestic and global opportunities,

to trigger the use of IT-based automation

technologies that build credibility and trust in the Indian pharmaceutical products.

Bejon MisraFounder,

Partnership for Safe Medicines (PSM-I) India Initiative [email protected]

Z

A

D

Ranbaxy’s Mohali and Toansa units under USFDA scanner

Snippets

The US drug regulator, US Food and Drug Administration (USFDA) has issued warnings

on two of Ranbaxy’s facilities last year. If Ranbaxy fails to address the concerns properly, an import ban could follow.The USFDA reportedly wrote to Ranbaxy in December 2012, red-flagging certain

manufacturing practices at its main Active Pharmaceutical Ingredient (API) plant in

Toansa, Punjab.

Also, through ‘Form 483’ USFDA raised concerns in September 2012, on the Japanese, Dai ichi Sankyo-o w n e d d r u g manufacturer’s Mohali unit. Form 483 is used to warn

drug manufacturers of any concerns by the regulator before taking the next step of issuing an

import ban. Ranbaxy was quoted saying that, “All 483s have been satisfactorily responded by the

company.” But it remains unclear if the issues raised were properly addressed.

The board of directors of Unichem Laboratories Ltd approved the

first-Quarter (Q1) unaudited results for financial year, 2013-14.

The company recorded a total income of ` 265.57 crores for

the quarter ended June 30, 2013 as against ` 264.86 crores in

the corresponding quarter of the previous year, thus recording

a marginal increase.Profit after tax for the current quarter stood at ` 36.09 crores

as against ` 33.14 crores recorded in the corresponding quarter

of the previous year. This shows an increase of 8.90 per cent.

Unichem Lab posts Q1 results at ` 360.9-million

Shakti Chakraborty, Group President, India & CIS countries, Lupin Ltd

Anubhav Sharma

Page 25: Modern Pharma 16-31 August 2013

25M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3Products

Looking for a specific product?Searching and sourcing products were never so easy.

Just type MPH (space) Product Name and send it to 51818eg, MPH Laboratory software and send it to 51818

Case packer and palletiser Case packer and palletiser features utmost hygiene, compactness and transparency, offering the operator a clear and full view of the production flow. The main advantages and features of the machine are reduced footprint, clean and ergonomic design, easy accessibility to the product, innovative case pick up and forming, easy changeover, easy cleaning, accessibility to the mechanical units and optimal visibility during the whole packaging process.

Marchesini Group India Pvt LtdMumbai – MaharashtraEmail: [email protected]: 022-67082755/64Fax: 022-67082761

Planetary gear headPlanetary gear box for Servo Motor offers high precision and low backlash units. It is available as both inline unit and in right angle c o n f i g u r a t i o n . This unit is available in 3 levels of backlash precision, which is less than 3 arc minutes. Low backlash is less than 5 arc minutes and standard is less than 15 arc minutes. This gear head comes in various frame sizes which range from A to E with allowable torques upto 92 Nm and peak torques upto 274 Nm. The motor-mounting side is made-to-order to match the Servo Motor. This gear head is readily available to match common brands like Panasonic, Mitsubishi and Sanyo Denki, etc. Gear ratio is available from 1:3 to 1:100 which can also be customised to suit any other motor brand specifications. It has lifetime lubrication and it requires no periodic maintenance. Applications abound in packaging, pharma, machine tools, etc.

Strategi Automation Solutions Pvt LtdBengaluru –KarnatakaTel: 080-32329798,32467879Fax: 080-41163047Email: [email protected]: www.strategiautomation.com

Plastic bearing

This is a self-aligning bearing that is made of tribo-optimised plastic. It comprises rod-end bearings, flange,

pivoting and pedestal bearings as well as ball and socket joints. In many cases, this maintenance-free bearing can replace metallic components. The amount of weight saved can be as high as 80%. The parts provide excellent vibration dampening. The self-adjusting ‘igubal’ bearing is easy-to-fit and can adapt to all angular misalignments. It is suitable for dry use, is contamination-free, can run in liquids and even in chemicals and is absolutely corrosion-resistant. The application temperature range is from -30°C to +80°C. There is also a high-temperature version available for permanent use at temperatures of up to +200°C. It can also absorb very high forces. The damping characteristics are

due to the fact that the plastic material of the two-part or two-part combined bearings can absorb vibrations in contrast to steel.

igus (India) Pvt LtdBengaluru - KarnatakaTel: 080- 39127827Mob: 09379517885Email: [email protected]: www.igus.in

Pilot roll compactorThe compactor has multiple roll configurations available like sine curve, interlocking. Easily disassembled product contact parts are manufactured

of stainless steel. The machine can bring into account a wide range of process possibilities. It has a working capacity of 1kg to 15kg/hr with approximately 70 kg net weight. Dimensions of the compactor are 725mmX455mmX555mm and it requires 230 V single phase electricity.

Cronimach MachineryAhmedabad – Gujarat Tel: 079-25861418Email: [email protected]: www.cronimach.com

Page 26: Modern Pharma 16-31 August 2013
Page 27: Modern Pharma 16-31 August 2013

27M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3Products

BOD incubatorThe temperature range of the machine is from 10° C to 60 °C with + 0.2 °C accuracy and + 1.0 °C u n i f o r m i t y . It features 21 CFR PART-11 c o m p l i a n c e ,

log data, event data, audit trail data, e-records and e-signatures, graphical analysis and data acquisition. Other optional features such as scanner, GSM technology, extra tray, hooter systems are also available.

Wet granulator Wet granulator is suitable to manufacture wet granules of various granule sizes. Parts are made of stainless steel and each apparatus is supplied with one sieve. It has a working capacity of 25-30 kg/hr, net weight 18 kg, gross weight 40 kg, dimension 38cm x 35cm x 60 cm. Power requirements are 230 V 0.15 HP 1 phase.

Cronimach MachineryAhmedabad - GujaratTel: 079-25861418Email: [email protected]: www.cronimach.com

Fluid bed dryer bagA variety of Fluid Bed Dryer (FBD) bags are available. The usage of anti-static cloth in the preparation of these bags overcome the limitations posed by the carbon loaded epitropic yarn. It is independent of the air humidity, chemical resistant, non brittle and wash-proof. It can withstand continuous temperature of 450°C in presence of oxygen and upto 550°C without oxygen.

N K Filter Fabrics Pvt Ltd Mumbai - Maharashtra Tel: 022-25786870, 25786927, 25794161Fax: 022-25784400Email: [email protected]: www.nkfilter.com

Steam steriliserSteam steriliser is available in two basic models - gravity d i s p l a c e m e n t system and vacuum sterilisers. Gravity displacement systems is suitable only for sterilisation of liquids [in open containers], vacuum sterilisers can sterilise liquids and variety of other materials / components. Customised chamber size ensures flexible loads and load patterns. It features cabinet enclosure for GMP installation, contamination seal to prevent cross-flow of air between the clean and unclean area, loading / unloading carts & trolleys for easy and convenient operation, mechanical vacuum pump for pre-pulsing [for air removal], post sterilisation vacuum drying, sterile air filter for vacuum break, in-built test programs for vacuum leak test, pressure leak test and bowie-dick test for higher process assurance, automatic FO calculator with facility for control

in case of heat labile materials. It is 0.2 bacteria retentive.

MachinfabrikNavi Mumbai - MaharashtraTel: 022-67368200Email: [email protected] Website: www.machinfabrik.com

Mack Pharmatech Pvt Ltd Nashik - Maharashtra Tel: 2551-230877 Fax: 2551-230877Email: [email protected]: www.mackpharmatech.com

Pharma refrigeratorThe pharma refrigerator has double walled chamber, with two different inner chambers. The two chambers are connected with common wall between the two chambers. Interior and exterior is made of stainless steel. Upper chamber temperature is –

20° C, lower chamber temperature is 2 to 8°C and temperature uniformity is ± 1°C.

Newtronic Equipment Company Pvt LtdMumbai - MaharashtraTel: 022-28679326Mob: 09821089932Email: [email protected]: www.newtronic.in

Stainless spray valveThe 784S-SS spray valve can dispense precise, consistent amount of stent coatings, saline solutions, silicone oils and many other fluids used in medical and p h a r m a c e u t i c a l production processes. The 784S-SS valve is precision machined from 316L stainless steel for excellent compatibility with a wide range of low-to-medium viscosity fluids. In addition, it also features a unique aseptic design with a fluid flow path that is free of any entrapment areas, a critical consideration in sterile and aseptic fluid applications. The 784S-SS valve incorporates EFD’s proven Low Volume Low Pressure (LVLP) precision spray technology, which reduces production costs through fast, controlled fluid application without waste or overspray. Instead of a standard spray nozzle, fluid is routed through a ¼” long disposable dispensing tip with a small (0.013” – 0.004”) internal diameter.

Nordson EFDRhode Island - USATel: +1 401-431-7065Fax: +1 440-892-9507Email: [email protected]: www.nordson.com

Page 28: Modern Pharma 16-31 August 2013

28 Products M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3

The information published in this section is as per the details furnished by the

respective manufacturer/distributor. In any case, it does not represent the views of

Modern Pharma

Temperature data loggerData logger for pharmaceutical industries has m e a s u r i n g c a p a c i t y ranging from - 3 5 - 8 0 ° C ,

accuracy of ±0.5°C and resolution of 0.1°C with sensor Pt1000. The measuring rate is selected from 1 min to 8 hours. It can store 4,000 value data in memory. The measuring mode is automatic with loop, start/stop or start with set measuring rate. It comes with a battery life of 3-5 years. The data logger is housed in stainless steel, PEEK. It has IP68 protection class/housing for pharmaceutical industries.

AmbetronicsMumbai - MaharashtraTel: 022-28371086Email: [email protected]: www.ambetronics.com

FBD inflatable gasketFBD inflatable gasket is available in t r a n s p a r e n t silicone rubber and white food-grade neoprene rubber. The gasket functions like a cycle tube. When inflated, it seals the bowl and ensures proper sealing. Being made of neoprene rubber or transparent silicone rubber, these gaskets can be inflated by 6-10 mm, when 4 Kg pressure is applied on silicone rubber and when 2 kg pressure is applied, in the case of neoprene rubber. The quality and craftsmanship of this inflatable gasket is at par with the international standards and looks aesthetically good. The FBD inflatable gaskets find applications in powder and bulk solid handling machineries, processing equipment, food processing

equipment, conveyors, fluid sealing, robotics, material handling, medical sterilisers, electronic/wafer semiconductor processing, nuclear door seal, industrial washing and extractor machine and pharmaceutical applications.

AMI Polymers Pvt Ltd Thane, Maharashtra Tel: 022-28555107/631Fax: 022-28555378Email: [email protected]: www.amipolymer.com

Air shower systemAir showers are self contained c h a m b e r s installed at entrances to clean rooms and other c o n t r o l l e d

environments. They minimise particulate matter from entering or exiting the clean room. Enviro designed and filed, this latest programmable technology based controller to offer maximum application flexibility for every unit. The standard features are electromagnetic door interlocking, swing type doors with view panels, door open indicator, optional UV lamp on/off, hour meter for measuring the UV light life, fluorescent /white light on/off, blower on/off, alarm system, digital pressure measurement system and velocity measurement system.

Enviro Technologies Thane - Maharashtra Tel: 022-64646500Email: [email protected]: www.enviroworld.in

Laminar air flowLaminar air flow unit is MOC- SS 304/ SS 316 customised. It has imported mini pleat HEPA filter with hot melt technology that conform to EU-13/EU-14 grade at the supply position. The laminar air flow unit makes fresh air prefilter and conforms to EU 6 grade, with efficiency of 95 per cent down to 5-micron. Motor blower provided, is statically and dynamically balanced with sufficient capacity. Also static pressure is maintained to take care of the airflow requirement for entire life to HEPA. Dwyer makes Magnehelic® differential pressure gauge across supply HEPA filter. It has on/off switches for motor and lights, DOP test port at upstream of HEPA filter. Technical specifications are air cleanliness- ISO class 5 (ISO 14644-1: 1999(E)), air velocities- 0.45 ± 0.05 mps, air flow- vertical, noise level and vibration level stays minimum with power supply 230V ac 1- 50Hz. The air flow unit can be either ceiling suspended or stand mounted.

Fabtech Technologies International LtdMumbai - Maharashtra Tel: 022-61592915Email: [email protected]: www.fabtecheng.com

Aerosol generatorThe aerosol generator (fogger machine) is used for sterilising air in the production shops of pharma, food, biotech and healthcare industry.

This fogger machine takes care of 5,000 cu ft volume in single fill giving 100 per cent efficacy. The portable fogger machine is tested for droplet size of aqueous formulations in sub-microns. It generates droplet size in sub-microns and is approved by nuclear division of BARC, nuclear power stations and is patronised by leading hospitals and pharmaceutical industries. The machine comes with a 5 ltr capacity tank made out of best grade disinfectant tank & wetted parts.

Gouri Engineering Pvt LtdNavi Mumbai - MaharashtraTel: 022-27701285Email: [email protected]

Aqueous film coating system

Four models for coating application have been developed. Instacoat EHP 250 is a single polymer PVA based coating system which has excellent water solubility and ability to perform at very high reconstitution level of 25%. Instacoat EMB is a single polymer (PVA) based tablet coating system and has excellent moisture barrier properties at 20% reconstitution level. Instacoat EEN is Methacrylic acid co-polymer (Type A or Type B or mixture of both) based optimised weight gain enteric coating system with 8-10% reconstitution level. Instacoat EHA is a high adhesion HPMC based film coating system at reconstitution level of 15%. The whole E-series film coating system has excellent adhesion, moisture barrier and high spray rate without gun choking and in minimum possible time.

Ideal Cures Pvt LtdMumbai – MaharashtraTel: 022-4268 8700Fax: 022-4268 8713Email: [email protected]: www.idealcures.co.in

Knife edge rolls

Knife edge rolls for lubrication-free belt deflection are used in the conveyor technology, especially in conveyor belts for the food and beverage industry. The knife edge rolls help deliver goods carefully to the following haulage requirements. Users can dispose of a specially developed standard program from igus® knife edge rolls that are tailored for specific demands such as operating temperature and FDA-conformity. This maintenance and lubrication-free machine’s elements are made of highly wear-resistant iglidur® materials to easily cope with the set tasks.

The universal and robust iglidur® P210 that is standard for igus® knife edge rolls distinguishes itself with features such as low humidity consumption, proper material resistance and a high service life. iglidur®A180 is used up to 90 °C and iglidur®A350 is applicable up to 180 °C.

igus (India) Pvt LtdBengaluru - Karnataka Tel: 080-39127812Email: [email protected]: www.igus.in

CentrifugeLabtop large v o l u m e c e n t r i f u g e s are designed for separating blood and blood components from whole blood like platelet, plasma, RBC and Cryoprecipitate and it is ideal for blood banks and hospitals. It is used in pharmaceutical industry, research centres, vaccine manufacturing industry and universities. The heavy duty steel fabricated centrifuge is provided with stainless steel inner chamber and effectively insulated to provide sufficient cooling of the chamber. It is a CFC free refrigeration system with pre-cooling facility, maintenance free brushless induction motor with low level of vibration and noise with smooth acceleration and deceleration. Also present is an electronic motorised door lock facility to open in case of power failure. RCF, acceleration and deceleration time can be set as per user requirement. Imbalance cut off, safe door open and mechanical lid lock is provided for increased safety.

Labtop Instruments Pvt LtdThane - MaharashtraTel: 0250-6457376/99Email: [email protected]: www.labtopinstruments.com

CheckweigherA checkweigher is an important part of a quality control program and is a means to provide benefits to the company. Anritsu Checkweighers are installed on food, industrial and pharmaceutical production lines for various quality control purposes. Often, the installation of an accurate checkweigher provides profit benefits to the user by controlling filler or scale accuracy to minimise product give away. Systems are also used to assure compliance with label weight regulations and to eliminate consumer complaints associated with missing item or low-weight packaging conditions. Line efficiencies can be tracked and ‘give away’ can be calculated providing an opportunity to streamline production and save costs within the process.

M/s Jay Instruments & Systems Pvt Ltd Mumbai – MaharashtraMob: 09004279992.Email: [email protected] Website: www.jayinst.com

Cold roomRemi cold room is designed for precise cold storage requirement of industries such as pharmaceuticals, biotech, food, dairy, hospitals, etc. It is made of modular panels with PUF insulation. Capacity is 3,000 litre onwards and made-to-order. Encorporated microprocessor PID controller ensures precise temperature control. It features condensing unit located outside lab which emits hot air beyond working area, forced air circulation, alarm for temperature and facility to open the door from inside in case of accidental lock. Optional accessories include intelligent PLC controller, stand-by refrigeration system, datalogger for multipoint recordings, GSM mobile alert, biometric door access system, data acquisition software complying 21CFRpart11 guidelines.

Remi Elektrotechnik LtdMumbai – MaharashtraTel: 022-40589888Mob: 09820627422Email: [email protected]: www.remilabworld.com

Page 29: Modern Pharma 16-31 August 2013

29M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3Marketplace

MODERN MEDICARE

Modern Medicare

For further enquiry, write to:[email protected] OR

Call us on: 022- 3003 4650

To source product from this magazine SMS: MM (Space) Product Name to 51818

Heartbeat of theHealthcare Industryyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyyy

PLUS:

`

for chronic ALSO INSIDE

Nephrology and urology devices market

Where does

India stand?Nep

WWI

Scan this codeon your smart phoneto visit www.modernmedicare.co.in

Page 30: Modern Pharma 16-31 August 2013

30 Products & advertisers list M o d e r n P h a r m a | 1 6 -3 1 A u g u s t 2 0 1 3

Looking for a specific product?Searching and sourcing products was never so easy.

Just type MPH (space) Product Name and send it to 51818eg, MPH Laboratory software and send it to 51818

Access control .......................................................29

Acoustic enclosure ............................................................8,21

Aerosol generator ...............................................................28

Air handling unit ................................................................... 13

Air shower controller ..........................................................29

Air shower system...............................................................28

Air sterilisation .....................................................................BC

Analytical instrument ........................................................19

Aqueous film coating system ..........................................28

Biomaterial dispensing component .................25

Bio-statistics and programming ..................................... 14

Blow-fill seal machine ......................................................... 9

BOD incubator ......................................................................27

Cable management system ...............................29

Car washing hose ..................................................................17

Case packer and palletiser ............................................... 25

Centrifuge .............................................................................28

Checkweigher.......................................................................28

Chromatography instrument ..........................................29

Clean room accessories ...................................................... 13

Clean room door.................................................................FIC

Clinical data management ............................................... 14

Cold room ..............................................................................28

Container sterilisation .......................................................BC

Content uniformity testing .................................................7

Controller and software .......................................................3

Cooling tower solution ......................................................29

D&C colour ...............................................................6

Data logger series for humidity .......................................26

Deep freezer ..........................................................................10

Dispersion ............................................................................... 6

Dissolution testing.................................................................7

Door interlock system ........................................................29

Dry van pump.....................................................................8,21

Dynamic pass box ..............................................................FIC

Exhibition - Plastivision 2013.............................22

FBD inflatable gasket ......................................... 28

Fire alarm ..............................................................................29

Fire resistant door ..............................................................FIC

Fluid bed dryer bag..............................................................27

Fluid management component ..................................... 25

FRP cross arm ......................................................................29

FRP epoxy pultruded profile ............................................29

FRP trefoil clamp ................................................................29

FRP/GRP handrail and fencing .......................................29

FRP/GRP ladder ..................................................................29

FRP/GRP luminaries ...........................................................29

FRP/GRP moulded grating ...............................................29

FRP/GRP profile ..................................................................29

FRP/GRP pultruded grating .............................................29

FRP/GRP step tread ...........................................................29

FRP/GRP tank ......................................................................29

Garden hose/power spray ................................... 17

Heart valve frame ................................................. 11

Humidity chamber ..............................................................10

HVAC all rounder .................................................................26

HVAC and MEP ....................................................................BC

Hydraulic accessories ...........................................................17

Institute of Pharmaceutical Education and Research .......27

Indian printing and packaging solutions industry .........1

Knife edge roll ......................................................................28

Lab furniture ..........................................................13

Laboratory equipment ......................................................29

Laboratory glassware .........................................................19

Lake pigment ......................................................................... 6

Laminar air flow ..................................................................28

Laminar air flow unit.........................................................FIC

Large diameter welded pipe............................................29

Light pole and utility pole ................................................29

Liquid handling product .............................................. 19,29

Medical writing ..................................................... 14

Metal doorset .....................................................................FIC

Methacrylic acid co-polymer ..........................................BIC

Modular clean room ..........................................................FIC

Multipostion stirrer .............................................................. 15

Natural food colour ................................................6

Oven ........................................................................ 10

Pass-box inter lock system.................................29

Pharma refrigerator ............................................................27

Pharmaceuticals excipient .............................................BIC

Photostability chamber .....................................................10

Physical testing ......................................................................7

Pilot roll compactor ........................................................... 25

Piping system .......................................................................29

Planetary gear head .......................................................... 25

Plastic bearing ..................................................................... 25

Pneumatic tools and accessories .....................................17

Portale hygrometer ............................................................26

Pressure tank .......................................................................29

Pressure vessel ....................................................................29

Professional humidity meter ...........................................26

Pump ....................................................................................8,21

Regular HSE /pesticide spray hose .................... 17

Regulators and final control element/system ..............3

Reverse laminar air flow ..................................................FIC

Roots blower ......................................................................8,21

Seamless pipe .......................................................29

Special TPU gas hose ..........................................................17

Spectrophotometer ...........................................................29

Stainless spray valve ...........................................................27

Stainless steel pipe ............................................................29

Steam steriliser .....................................................................27

Stirring hot plate .................................................................. 15

Tablet coating material drugcoat ................... BIC

Temperature data logger .................................................28

Three parameter display ..................................................29

Tube ........................................................................................29

Turnkey solutions for biotech and pharma industry BC

Twin - screw co-rotating extruder ................................... 11

Twin - screw element .......................................................... 11

Twin - screw extruder .......................................................... 11

‘U’ tube ...................................................................29

Vacuum booster pump..................................... 8,21

Vacuum system .................................................................8,21

Valves, regulator and final control element...................3

Walk in humidity chamber ................................. 10

Walk in incubator .................................................................10

Water analysis instrument ...............................................29

Water soluble synthetic dye .............................................. 6

Welded pipe .........................................................................29

Wet granulator .....................................................................27

BC-Back cover, BIC-Back inside cover, FIC-Front inside cover

Product Pg No Product Pg No Product Pg No Product Pg No

Advertiser’s Name & Contact Details Pg No Advertiser’s Name & Contact Details Pg No Advertiser’s Name & Contact Details Pg No Advertiser’s Name & Contact Details Pg No

Aeron Composite Pvt Ltd 29

T: +91-79-65258500

E: [email protected]

W: www.aeroncomposite.com

All India Plastics Mfrs Association 22

T: +91-22-28217324

E: [email protected]

W: www.plastivision.org

Ansapack Private Ltd 1

T: +91-022- 23020260

E: [email protected]

W: www.ansapack.com

Clinnex 14

T: +91-79-40066000

E: [email protected]

W: www.clinnex.com

Cole-Parmer India 15

T: +91-22-67162222

E: [email protected]

W: www.coleparmer.in/3125

Eltech Services Pvt Ltd 29

T: +91 - 40 27759895

E: [email protected]

W: www.eltechservices.com

Emerson Process Management (I) Pvt Ltd 3

T: +91-22-66620566

E: [email protected]

W: www.emersonprocess.com

Everest Blower Systems 21

T: +91-11-45457777

E: [email protected]

W: www.everestblowers.com

Everest Blowers 8

T: +91-11-45457777

E: [email protected]

W: www.everestblowers.com

Fabtech Technologies Intl Pvt Ltd BC

T: +91-22 61592900

E: [email protected]

W: www.fabtecheng.com

GMP Technical Solutions Pvt Ltd FIC

T: +91-22 66083790

E: [email protected]

W: www.gmptech.net

Indian Institute of Pharmaceutical Education & Research 27

T: +91-020-25410464

E: [email protected]

W: www.pharmadiplomas.com

Integrated Cleanroom Technologies Ltd 13

T: +91 40 27165311 / 5316

E: [email protected]

W: www.icleantech.com

Loba Chemie Pvt Ltd 19

T: +91-022 66636663

E: [email protected]

W: www.lobalife.com

Mack Pharmatech Pvt Ltd 10

T: +91-2551-230877

E: [email protected]

W: www.mackpharmatech.com

Nordson India Pvt Ltd 25

T: +91-80-40213524

E: [email protected]

W: www.nordson.com

Roha Dychem Pvt Ltd 6

T: +91 22 4077 3333

E: [email protected]

W: www.rohagroup.com

Salesworth (Romellag) 9

T: +91-80-25274495

E: [email protected]

W: www.rommelag.com

Samson Extrusion Ind Pvt Ltd 17

T: +91-022-23422238

E: [email protected]

W: www.samson-grp.com

Sotax India Pvt Ltd 7

T: +91-022-42950191

E: [email protected]

W: www.sotax.com

Steer Engineering Pvt Ltd 11

T: +91-80-23723309

E: [email protected]

W: www.steerworld.com

Sunjay Technologies Pvt Ltd 29

T: +91- 22 6662 4330

E: [email protected]

W: www.sunjaytechnologies.com

Suraj Ltd 29

T: +91-79-27540720

E: [email protected]

W: www.surajgroup.com

Testo India Pvt Ltd 26

T: +91-20-65600203

E: [email protected]

W: www.testo.in

Vikram Thermo (India) Ltd BIC

T: +91-79-27543745

E: [email protected]

W: www.vikramthermo.com

Page 31: Modern Pharma 16-31 August 2013
Page 32: Modern Pharma 16-31 August 2013

RNI No: MAHENG / 2008 / 27125,

32


Modern Pharma - 16-31 December 2012

Modern Pharma - 16-31 December 2012

Modern Tire Dealer August 2011

Modern Tire Dealer August 2011

Modern Plastics & Polymers - August 2011

Modern Plastics & Polymers - August 2011

APL August 2015 - Aurobindo Pharma...Investor Presentation August 2015. ... Oral Rx AuroLife Pharma Manufacturing / R&D AuroMedics Injectables AuroHealth Pharma OTC Natrol Nutraceuticals

APL August 2015 - Aurobindo Pharma...Investor Presentation August 2015. ... Oral Rx AuroLife Pharma Manufacturing / R&D AuroMedics Injectables AuroHealth Pharma OTC Natrol Nutraceuticals

Modern Gymnast - August/September 1966

Modern Gymnast - August/September 1966

Modern Plastics & Polymers - August 2012

Modern Plastics & Polymers - August 2012

Modern Food Processing - August 2011

Modern Food Processing - August 2011

Modern Food Processing - August 2013

Modern Food Processing - August 2013

The Mazada Pharma Guide 4th August 10th August

The Mazada Pharma Guide 4th August 10th August

Crizalk Capsules by Modern times-helpline-pharma

Crizalk Capsules by Modern times-helpline-pharma

August 2012 – Modern Media – TTh YellowBluerlsbluedevils.org/Documents/Classes/ModernMedia/Calendar/August… · AUGUST 2012 – MODERN MEDIA – TTH (YELLOW & BLUE) SUNDAY! MONDAY!

August 2012 – Modern Media – TTh YellowBluerlsbluedevils.org/Documents/Classes/ModernMedia/Calendar/August… · AUGUST 2012 – MODERN MEDIA – TTH (YELLOW & BLUE) SUNDAY! MONDAY!

Modern Aquarium August 2010

Modern Aquarium August 2010

Modern Plastics & Polymers - August 2010

Modern Plastics & Polymers - August 2010

Modern Gymnast - August/September 1968

Modern Gymnast - August/September 1968

Modern Test & Measure: August 2015

Modern Test & Measure: August 2015

The Mazada Pharma Guide 28th July to 3rd August 2014

The Mazada Pharma Guide 28th July to 3rd August 2014

PSS Herbs India: Synergy of Ayurveda & Modern Pharma for Global Healthcare/Nutrition

PSS Herbs India: Synergy of Ayurveda & Modern Pharma for Global Healthcare/Nutrition

Modern Pharma - 16-31 March 2013

Modern Pharma - 16-31 March 2013

Modern Pharma - 1-15 April 2013

Modern Pharma - 1-15 April 2013

Pharma Modern Times Helpline// Modern Times Helpline pharmais is Located in Delhi.We are emerging Pharma company . About Us Modern Times Helpline Pharma is the fastest growing Exporter,

Pharma Modern Times Helpline// Modern Times Helpline pharmais is Located in Delhi.We are emerging Pharma company . About Us Modern Times Helpline Pharma is the fastest growing Exporter,