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Press Information Bureau Government of India

Chennai *****

Ministry of Health & Family Welfare

New Delhi, December 31, 2014

There have been several notable achievements of the Ministry of Health & Family

Welfare during 2014.

These are enumerated below:

Department of Health &Family Welfare

1. National Health Mission

Under NHM, there have been significant improvements in health outcomes in terms

of mortality rates as well as improvements in service delivery in health facilities. But

the most important has been eradication of polio from the country.

Eradication of Polio

India has reported no polio case for the last more than three years and has also been

certified as ‘Polio-free’ by WHO in 2014. This is monumental considering that India

accounted for over 50 percent of the world’s polio incidence in 2009.

Improvements in Health Outcomes

Decline of Infant Mortality Rate: There has been a sharper decline in IMR

during 2005-12 as compared to decline during 2000-05, with the annual

compound rate of decline of IMR accelerating by 45 % from 3.1% (2000-2005)

Year End Review

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to 4.5% (2005-2013). IMR in India declined from 68 per 1000 live births in 2000

to 58 in 2005 and further to 40 in the year 2013. The urban rural divide has

declined from 24 points in 2005 to 18 points in 2012.

Decline in Total Fertility Rate: TFR in India declined from 3.2 in 2000 to 2.9

in 2005 and further to 2.4 in 2012. The percentage annual compound rate of

decline in TFR for the period of 2000- 2005 was 1.9%. This increased to 2.7%

during 2005-2012.

Decline in Maternal Mortality Ratio (MMR): Similarly decline in Maternal

Mortality Ratio has shown a significant improvement in the post NHM

period. MMR in India declined from 254 in 2004-06 to 178 in 2010-12 and the

annual compound rate of decline increased from 5.5% during the period from

2001-03 to 2004-06 to 5.7% during the period from 2007-09 to 2010-12.

Improvements in Health Service Delivery

(Between 2009-10 to 2013-14 )

Annual OPD in government institutions has increased from 54.66 croreto

103.65 crore (90 % increase)

Annual IPD increased from 2.28 crore to 4.74 crore (107 % increase)

Number of General Surgeries performed annually increased from 46.49 lakh

to 106.14 lakh (128 % increase)

Number of C-Sections performed in public facilities annually increased from

8.19 lakh to 12.47 lakh (52% increase)

Number of JSY beneficiaries rose from 7.38 lakh in 2005-06 to over 1.06 crore

in 2013-14.

Increased Public Health Spending

Ministry of Health & Family Welfare has been increasing its support under

NHM to the State Governments to strengthen their health systems. Since

inception, a total of Rs. 116641.63 crorehave been released under NHM.

Approvals under NHM issued to all the States/UTs, worth Rs. 21,700 crore. It

includes approval of over 7,800 new infrastructure works and over 2 lakh

human resource for health.

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Infrastructure Upgradation

A total of 28147 new construction works and 32024 renovation/upgradation

works of health facilities have been sanctioned under the Mission. In a new

initiative, 477 MCH wings have been sanctioned in the last two years at the

cost of Rs. 3933.55 crores. This would add more than 29000 beds for women

and children. With NHM support the numbers of FRUs has increased

significantly to 2793 and the number of 24x7 PHCs has now gone up to 8848.

Human Resources

Total number of technical HR approved under NHM increased to 2lakhs.

These include Specialists, Doctors, Staff Nurses, Para-medics including

AYUSH paramedics, ANMs, District Programme Managers, District Accounts

Managers, District Data Managers, Block Managers, Accountants at Block

level etc.

To improve effectiveness and efficiency of over 2.20 lakh Multi-Purpose

Workers (women), a guidebook for enhancing their performance has been

prepared and disseminated.

Accredited Social Health Activist (ASHA)

Total number of ASHAs including link workers engaged by States/UTs has

increased to 8.96 lakhs.

Recently, provision has been made for assessment and Certification of

knowledge and skills of ASHAs by National Institute of Open Schooling

(NIOS).

National Mobile Medical Unit Services

To render services to underserved population, capital and operational costs of

Mobile Medical Units are supported under NHM. Till date, 1685 MMUs have

been approved for 369 districts.

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National Ambulance Services

Prior to launch of NHM, Call Centre based ambulance network was virtually

non-existent. Now 28 States have the facility where people can dial 108 or 102

telephone number for calling an ambulance. The total number of vehicles for

emergency response services/ patient transport systems has now reached to

over 18000.

108 is emergency response system, primarily designed to attend to patients

of critical care, trauma and accident victims etc.

102 services essentially consist of basic patient transport aimed to cater the

needs of pregnant women and children though other categories are also

taking benefit and are not excluded. JSSK entitlements e.g. free transfer

from home to facility, inter facility transfer in case of referral and drop back

for mother and children are the key focus of 102 service.

National Free Drugs Service Initiative

To address the issue of high out of pocket expenditure on health care due to

high cost of drugs, NHM Free Drugs Service Initiative has been launched

under which substantial funding is provided to States/UTs to provide

essential drugs free of cost in public health facilities subject to the state

declaring free drug policy and putting in place robust systems of

procurement, supply chain management, quality assurance and prescription

audit.

High Priority Districts

To ensure equitable health care and to bring about sharper improvements in

health outcomes, at least 25% of all districts in each state have been identified

as high priority districts based on a composite health index. These also

include all tribal districts which are below the State’s average of composite

health index

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These districts receive higher per capita funding, enhanced monitoring,

focused supportive supervision and encouraged to adopt innovative

approaches to address their unique healthcare challenges.

Universal Health Coverage Pilots

The Ministry has shared broad guidelines with all States and they have been

requested to undertake UHC pilot in one/ two districts of the state under the

National Health Mission (NHM).

Improving Quality

To provide high quality healthcare services in public health facilities, the

National Quality Assurance Programme was launched, under which the

Quality Standards and Framework of Quality Assurance Guidelines for the

PHCs, CHCs and the District Hospitals were issued after holding a two-day

national consultation on Quality Assurance.

Maternal & Child Tracking System (MCTS) & Mother and Child Tracking

Facilitation Centre (MCTFC)

A web based Maternal & Child Tracking System (MCTS) was introduced in

2010 to capture details such as name, address, mobile number etc. of every

pregnant woman and child upto 5 years of age and of health services

provided to them. MCTS aims to ensure that every pregnant woman gets

complete and quality antenatal and post natal care and every child receives

the full range of immunization services.Over 14.24 crore pregnant women and

children have been registered in MCTS till now.

A Mother and Child Tracking Facilitation Centre (MCTFC) has been set up at

NIHFW, Delhi. It is an 80-seater Call Centre to independently validate MCTS

data, assesses the beneficiaries’ satisfaction about services, create awareness

about government’s welfare programmes and provide a direct channel of

communication with ANMs, ASHAs and beneficiaries.

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To reach out with weekly voice messages to over 5 crore pregnant women

and parents of infants, relevant to the stage of pregnancy/ age of the infant,

the first phase of Kilkari service was rolled out.

Reproductive, Maternal, Newborn, Child and Adolescent Health services

(RMNCH+A) –

A Continuum of care approach has been adopted under NHM with the articulation

of ‘Strategic approach to Reproductive Maternal, Newborn, Child and Adolescent

health (RMNCH+A) in India, bringing focus on all the life stages, notably the

adolescents. Under this approach, the following major interventions are

implemented:

JananiSurakshaYojana is a conditional cash transfer scheme, providing

incentives to mothers and ASHAs in order to promote institutional deliveries.

This is a safe motherhood intervention under NHM with the objective of

reducing Maternal and new-born mortality in the country. Under

JananiSurakshaYojana (JSY), the number of beneficiaries receiving cash

assistance has risen to over 1.06 crores per year.

Building on JSY, JananiShishuSurakshaKaryakaram (JSSK) was launched on 1st

June, 2011 which entitles all pregnant women delivering in public health

institutions and accredited facilities to absolutely free and no expense

delivery including caesarean section. The entitlements include free drugs and

consumables, free diet, free diagnostics, free blood, Free transport from home

to facility between facilities in case of a referral and drop back home. Similar

entitlements are also put in place for all infants accessing public health

institutions for treatment till one year after birth.

RashtriyaBalSwasthyaKaryakram (RBSK): This is a new initiative launched in

February 2013 which entails provision for Child Health Screening and Early

Intervention Services through early detection and management of 4 Ds i .e

Defects at birth, Diseases, Deficiencies, Development delays including

disability and free management of 30 identified health conditions including

surgery at tertiary health facilities. 27 crore children between 0-18 years of age

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are expected to be covered in a phased manner across the country. More than

4.22 crore children have been screened under RBSK during 2014-15 (up to Sep,

2014).

National Iron + Initiative is another new initiative to prevent and control iron

deficiency anaemia, a grave public health challenge in India. It has introduced

IFA Supplementation for children (above six months of age) adolescents and

women in the reproductive age group besides those who are pregnant or

lactating.

Delivery Points (DPs): Health facilities which have a high demand for services

and performance above a certain benchmark have been identified as

“Delivery Points” with the objective of providing comprehensive

reproductive, maternal, newborn, child and adolescent health services

(RMNCH+A) services at these facilities. Funds have been allocated to

strengthen these DPs in terms of infrastructure, human resource, drugs,

equipments, etc.

Support for establishing Special Newborn Care Units (SNCUs), Newborn

Stabilization Units (NBSU) and Newborn Care Corners (NBCCs) is provided

to States to improve essential newborn care and care to the sick newborns

specially the pre-terms and low birth weight babies. Till now 548 SNCUs,

1810 NBSUs and 14135 NBCCs have been made operational across the

country.

To treat severe acute malnutrition cases, 872 Nutritional Rehabilitation

Centres (NRCs) have been established in the country.

Universal Immunization Programme: 13.5 crore children are given free

vaccination for seven vaccine preventable diseases through 90 lakh

immunization sessions each year. Maternal Neonatal tetanus elimination

through vaccination has been achieved in 18 states. India has also committed

for Elimination of measles and control of Rubella by 2020. The Pentavalent

vaccine has also been introduced in 8 states and proposing to expand to

whole of the country.

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RashtriyaKishorSwasthyaKaryakram (RKSK), a new initiative was launched on 7th

January 2014 to reach out to 253 million adolescents in the country. RKSK seeks to

reach adolescents in their own spaces and introduces peer-led interventions at the

community level, supported by augmentation of facility based services. This

initiative broadens the focus of the adolescent health programme beyond

reproductive and sexual health and brings in focus on life skills, nutrition, injuries

and violence (including gender based violence), non-communicable diseases, mental

health and substance misuse.

2. National Health Assurance Mission

The Government is considering rolling out of a National Health Assurance Mission.

This is a novel step in that it looks at and seeks to address health needs

comprehensively as a continuum. The proposed Mission seeks to improve health

outcomes, reduce avoidable death and disease, and reduce high Out of Pocket

Expenditures and impoverishment on account of expenditure on healthcare. The key

components of the proposed Mission include preventive and promotive health care,

assured access to free essential drugs, assured access to free essential

diagnostics,assuredhealth care services that include comprehensive primary health

care and assured secondary care as a continuum with primary care and assured

select tertiary care services. This would be supplemented by access to free

ambulance service and emergency care. The draft memorandum on the proposed

NHAM for approval of the Expenditure Finance Committee (EFC) Memo has been

prepared and has been circulated for comments of Ministries.

3. Indian Newborn Action Plan (INAP)

The India Newborn Action Plan (INAP) was launched on September 18. It is India’s

first commitment to end preventable newborn deaths. It also identifies ways to

accelerate progress and scale up interventions that are high-impact and cost-

effective, driven by epidemiological causes. India strives to achieve single-digit

newborn mortality rate by 2030. INAP has been designed in response to the Global

Every Newborn Action Plan launched at the 67th World Health Assembly in June

2014.

4. Integrated Diarrhoea Control Fortnight (IDCF)

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IDCF will lead to avoiding 11 percent of cases of child mortality. It was launched on

July 28, 2014 across all 36 states and union territories. During the first week the focus

was on oral rehydration and Zinc, while the second week was used for highlighting

the goodness of breastfeeding and appropriate nutrition. It involved home visits by

frontline workers, counselling and demonstration. The Ministry of Women and

Child Development, Departments of School Education, and Water and Sanitation

participated in the effort.

5. National Tobacco Control Programme

(1) The Ministry of Health & Family Welfare in collaboration with World Health

Organization commissioned a study titled “Economic Burden of Tobacco

Related Diseases in India” (2014). The study mapped the estimated direct

and indirect cost of four tobacco use attributable diseases namely cardio-

vascular diseases, cancer, tuberculosis and respiratory diseases, and found

that the total economic costs attributable to tobacco use from all the four

diseases in India in the year 2011 for persons aged 35-69 years amounted to

Rs. 1,04,500 crores. This estimated cost is 1.16% of the GDP and is 12 % more

than the combined state and central government expenditures on health in

2011-12.

(2) The Food Safety and Standards (Prohibition and Restrictions on Sales)

Regulations, 2011 dated 1st August 2011, issued under the Food Safety and

Standards Act, 2006 lays down that tobacco and nicotine shall not be used as

ingredients in any food products. Currently, 34 states / UTs have issued

orders for implementation of the Food Safety Regulations banning

manufacture, sale and storage of Gutka and Pan Masala containing tobacco

or nicotine. The Ministry has also written to all the states to consider issuing

necessary notification under the Food Safety & Standards Act 2006 to

implement the ban on all forms of processed /flavoured/scented chewing

tobacco, whether going by the name or form of gutkha, zarda etc.

(3) The Ministry of Health & Family Welfare organized a roundtable in July,

2014 to discuss the current evidence around the existing and potential

impact of Electronic Nicotine Delivery Systems (ENDS) on public health,

explore global efforts in combating ENDS and decide measures as

appropriate for India.

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(4) The Ministry has consistently advocated for higher taxes and reduction of

duty free allowance on all tobacco products. This led to following action in

the Union Budget for 2014- 15:

Increase in Excise Duty

Cigarettes of length not exceeding 65mm – by 72%

Cigarettes of other lengths by – 11% to 21%

Pan Masala – from 12% to 16%

Unmanufactured Tobacco – from 50% to 55%

Zarda scented tobacco, gutkha and chewing tobacco – from 60% to 70%

Reduction in duty free allowance

Cigarettes – from 200 sticks to 100 sticks

Cigars - from 50 sticks to 25 sticks

Tobacco – from 250 gms to 125 gms

(5) Ministry notified the new rules on tobacco pack pictorial warnings on 15th

October, 2014, to come into effect from 1st April, 2015. The new rules

mandate display of pictorial health warnings on 85% of principal display

area of tobacco packs on both sides. With this notification, India has moved

from 136th rank to the 1st position on the global level for this important

public health measure.

(6) A Committee has been constituted to review and suggest amendments to the

Cigarettes and other Tobacco Products (prohibition of Advertisement and

Regulation of Trade and Commerce, Production, Supply and Distribution)

Act, 2003 (COTPA). The Committee has made a number of

recommendations with regard to, inter alia, prohibition of smoking in public

place, advertisements at point of sale, minimum legal age for sale of tobacco

products, loose sale of tobacco products, depiction of tar and nicotine

contents and the penal provisions etc. A draft note has been prepared for the

Cabinet and circulated for inter- ministerial consultation.

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(7) An Inter-ministerial Committee of Secretaries has been constituted at the

national level under the chairpersonship of the Cabinet Secretary to review

and develop a comprehensive policy on tobacco and tobacco related issues.

6. PradhanMantriSwasthyaSurakshaYojana (PMSSY)

The PradhanMantriSwasthyaSurakshaYojana (PMSSY) has been launched with the

objectives of correcting regional imbalances in the availability of affordable/reliable

tertiary healthcare services and to also augment facilities for quality medical

education in the country. PMSSY has two components – setting up of AIIMS like

institutions and upgradation of State Government Medical Colleges.

In first phase, six AIIMS are being set up, one each at Bhopal, Bhubaneswar,

Jodhpur, Patna, Raipur and Rishikesh. Two more AIIMS, one each in Uttar Pradesh

and West Bengal have been approved. Simultaneously, 19 existing Government

Medical College Institutions have been undertaken for upgradation for creation of

super speciality facilities in the first and second phases of PMSSY. In addition, it has

also been decided to take up upgradation of 39 more medical college in the third

phase of PMSSY, and 12 government medical colleges under fourth phase of PMSSY.

7. Medical education

A total of 17 new Medical Colleges and 8 new Dental Colleges have been

established. There has been an increase in intake capacity: 2750 MBBS seats and 1120

BDS seats. With the intervention of the Minister for Health & Family Welfare, there

has been renewal of 4747 seats restored in case of 73 Government Medical Colleges.

In addition, there has been increase in intake capacity of Postgraduate seats by 1150

seats.

MoUshave been signed with 18 States/UTs under the scheme for ‘Establishment of

new Medical Colleges attached with existing District/ Referral hospitals’. In

addition, 127 ANM and 137 GNM Schools have been approved in 29 States.

8. Ebola surveillance

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Heightened surveillance and tracking systems have been put in p lace at India’s air

and sea ports after World Health Organisation (WHO) put out an international alert

on 8th August 2014 against Ebola Virus Disease. Over 100 samples have been tested

at these two laboratories using RT PCR test. Ten additional laboratories have been

identified by Indian Council of Medical Research (ICMR) for testing Ebola Virus

Disease, and are ready to test samples. Moreover, about 9500 Personal Protective

Equipment (PPE) kits have been provided to the states by the Medical Store

Organization. The Health Ministry has conducted separate trainings for Master

Trainers and the State Rapid Response Teams (RRT) of all states for public health

preparedness and response to Ebola Virus disease. Master Trainers from 25 states

and Rapid Response Teams of all the states/UTs have been trained through four

Regional Training Workshops.

Till date not a single Ebola case has been found in India.

9. Drug resistant survey for 13 TB drugs launched

Biggest ever drug resistant survey in the world for 13 TB drugs launched, results

expected in a year’s time. The nationwide drug resistance survey (DRS) will provide

RNTCP with a better estimate on the burden of Multi-Drug Resistant Tuberculosis in

the community. As part of the survey, the samples will be subjected to susceptibility

testing for 13 anti-TB drugs (5 first line drugs and 8 second line drugs).

10. National Programme for Prevention and Control of Cancer, Diabetes,

Cardiovascular Diseases and Stroke

A total of 364 districts have been taken up for implementation by the end of financial

year 2014- 15.

Functional Status of NCD Cells/ Clinics

State NCD Cell established in 26 states.

District NCD Cell established in 142 districts.

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District NCD Clinic established in 147 districts.

Cardiac Care Unit

Cardiac Care Units have been established in 65 districts

Glucometers

As on 31-03-2014 total of 5,57,39,571persons have been screened for Diabetes

and Hypertension respectively. Of these, 6.15%are suspected to be Diabetes and

5.12% found to be hypertensive or pre hypertensive.

Textbook on health education for schools from IIIrd to Xth standard has been

developed in collaboration with NIHFW.

A consultation meeting in collaboration with WHO for Development of National

Multi-sectoral Action Plan for prevention and control of Non- communicable

diseases was held in Delhi on 23rd and 24th May 2014.

Proposed guidelines are under preparation for utilisation of AYUSH practitioners

for promotion of behaviour and lifestyle changes in relation to LSRDs.

An advisory group of developing a national framework for monitoring the

prevention and control of Non-Communicable Diseases for established to reach an

agreement on the National NCD Monitoring Framework in consonance with the

WHO Global Action Plan and Monitoring Framework

11. Country’s first National Mental Health Policy launched

The Ministry launched the country’s first ever Mental Health Policy in October 2014.

The Policy’s objective is to provide universal access to mental health care by

enhancing understanding of mental health and strengthening leadership in the

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mental health sector at all levels. It clearly spells out the specific roles to be played by

the central government, state governments, local bodies and civil society

organisations.

12. Steps against Japanese Encephalitis (JE) and Acute Encephalitis Syndrome

(AES)

The Ministry of Health launched a 100 percent vaccination drive against JE in

Muzaffarpur district, Bihar through a two-day camp on 22-23 June, 2014. To combat

AES, the Ministry removed all bottlenecks to set up facilities for concentrated care of

patients in the government hospitals of the affected districts.

13. Introduction of new vaccines against preventable diseases

On July 3, the Prime Minister announced expansion of India’s Universal

Immunisation Programme (UIP) to cover four more diseases – Rotavirus, Rubella,

Polio and adult cases of Japanese Encephalitis. This will cover 2.7 crore children and

give momentum to India’s aim of achieving Millennium Development Goal (MDG-

4) targets that include reducing child mortality.

14. Kala Azar elimination drive

On 22August, 2014 a new thrust was adopted for the elimination for Kala Azar, a

disease endemic in Bihar, Jharkand, West Bengal and Uttar Pradesh. The new plan

lists activities, timelines and responsibilities. The Ministry has planned to work

elimination of Kala Azar by 2015.

15. Elimination of Filariasis

The Ministry is geared towards elimination of Lymphatic Filariasis by 2015. Efforts

are targeted to achieve 80% coverage of targeted population during Mass Drug

Administration which has been launched in 250 endemic districts.

16. National Organ Transplant Programme

National Organ and Tissue Transplant Organisation (NOTTO) have been set up at

Safdarjung Hospital, New Delhi.

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A Cadaver Organ Retrieval Operation Theatre has been constructed at Safdarjung

Hospital.

Formats for Donor Pledge, Hospital Registration System, Patient Registration,

Kidney Transplant have been prepared.

17. Trauma and burns

Total of 13 additional Trauma Centres on National/State Highways have been

approved for funding. While, 17 Burn Units in Medical Colleges approved for

support.

18. National Programme for Control of Blindness

The National Programme for Control of Blindness was launched in the year 1976 as a

100% Centrally Sponsored scheme with the goal to reduce the prevalence of

blindness from 1.4% to 0.3% by 2020.

Achievements:

62.63 lakh cataract surgeries conducted during 2013-14 in the States/UTs.

6.25 lakh free spectacles distributed to school children during 2013-14.

Around 50,000 donated eyes collected during 2013-14.

One Regional Institute of Ophthalmology supported for strengthening and

modernisation.

3 district hospitals, 1 sub-district hospital and 25 vision centres supported.

2 Tele-ophthalmic units supported.

19. Central Government Health Scheme (CGHS)

On 1 September, 2013 twenty six CGHS wellness centres in Delhi were opened every

day from 1.30 pm to 3 pm to senior citizens for OPD consultation as a pilot project to

make the service more inclusive.

Details of payments made to empanelled hospitals and diagnostic centres in

preceding month are being placed on CGHS website.

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Notification of new hospitals and diagnostic labs and revised rates completed in

Delhi and NCR on 1.10.2014 and 12.11.2014- 229 hospitals and 59 diagnostic labs

notified.

Notification of new hospitals and diagnostic labs completed in other cities by

17.11.2014 (except Mumbai, Shillong and Lucknow. No e-tender issued in Mumbai;

no bidders in Shillong, no technically qualified bidders in Lucknow-existing facilities

continuing in those ‘3’ cities).

File Tracking System (FTS) implemented up to Zonal offices under CGHS, Delhi.

Online processing of hospital bills started in Delhi.

20. Development of Allied Health Sciences

The Government has taken steps to initiate the process of setting up a Centrally

Sponsored Scheme for establishment of one National Institute of Allied Health

Sciences (NIAHS) and eight Regional Institute of Allied Health Sciences (RIAHS).

The Scheme aims to augment the supply of skilled Allied Health manpower and

promote their training through standardization of such education/ courses across

the country.

This capacity building scheme will also lead to:-

Reduction in regional imbalances in availability of Allied Health

Professionals.

Introduction of courses in New/Cutting Edge Discipline

Augmentation of Capacity for Planning, Monitoring, Evaluation etc.

Provision of Quality assured services through in-services training, action

research, onsite support etc.

The Government has also initiated steps for establishment of the ‘National Board for

Allied Health Sciences’ for standardization of Allied Health education.

In another scheme namely ‘Strengthening/ up-gradation of Pharmacy Institutions

and Continuing Education Programme for faculty and practicing pharmacists’ the

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Government is taking steps to strengthen/ upgrade Pharmacy Institutes along with

faculty development programmes and training for practicing Pharmacists.

21. Food standards and safety

With the objective to consolidate the laws relating to food and for laying down

science based standards for articles of food and to regulate their manufacture,

storage, distribution, sale and import, to ensure availability of safe and wholesome

food for human consumption and for matters connected therewith or incidental

thereto, the Food Safety and Standards Act was enacted, and the Food Safety and

Standards Authority of India (FSSAI) was established in the year 2008.

The following activities were undertaken during this year:

i) Online payment Gateway System for food licensing started from

01/04/2014.

ii) Draft notification dated 2/6/2014 for amending Food Safety and

Standards (Food Products Standards and Food additives) Regulations, 2011

relating to use of Encapsulation Ferrous Fumarate and additives for Double

Fortified Salt, issued for seeking public comments.

iii) Final Notification dated 10.6.2014 of FSS (Licensing and Registration of

Food Businesses) Amendment Regulations, 2014 for extending the time line

upto 04.08.2014 for Food Business Operators seeking conversion/renewal of

existing licence/registration under repealed Act/order

iv) Time for the Food Business Operators seeking conversion/renewal of

existing licence/registration under repealed Act/orders, extended upto

04.02.2015 in August, 2014.

v) Draft notification dated 25/8/2014 for amending Food Safety and

Standards (Food Products Standards and Food additives) Regulations,

2011 relating to use of Aspartame and Acesulfame salt, issued for seeking

public comments.

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vi) Draft notification dated 28/8/2014 for amending Food Safety and

Standards (Food Products Standards and Food additives) Regulations, 2011

regarding use of Glucose Oxidase, Lipase and Xylanase as processing in food

products, issued for seeking public comments.

vii) Draft notification dated 17/10/2014 for amending Food Safety and

Standards (Food Products Standards and Food additives) Regulations, 2011

regarding use of Pullulan as food additives in various food, issued for seeking

public comments.

viii) Draft notification dated 11/11/2014 for amending Food Safety and

Standards (Food Products Standards and Food additives) Regulations, 2011

for bringing down the maximum limit of transfat from 10% to 5% of the food

products, issued for seeking public comments.

ix) Online Food Product Approval System launched on 9/9/2014.

x) A Task Force constituted to draft Regulations for Product Approval in

September, 2014.

xi) A Committee has also been constituted for undertaking comprehensive

review of the Food Safety and Standards Act, Rules and Regulations made

thereunder.

22. Central Drugs Standard Control Organization

a. Strengthening of Drug Regulatory System in the country under 12th Five

Year Plan

In the 12th Five Year Plan, it has been proposed that Drug Regulatory

mechanism in terms of infrastructure, both physical and human resources at

the Centre and the States/ UTs are strengthened.

For strengthening the Central Drug Regulatory system, the revised outlay

provides an outlay of Rs. 1058.68 crores for strengthening of infrastructure of

CDSCO for so as to enable it effectively discharging various functions of the

Central Drug Regulatory System. The Government recommended Rs. 250

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crore for introduction of information technology enabled services at CDSCO

for the purpose of discharging various functions assigned to it.

For strengthening the State Drug Regulatory mechanism, a new centrally

sponsored scheme under National Health Mission (NHM) Umbrella has been

proposed with 75:25 sharing pattern for providing financial and human

resource support to the States / UTs. Under the Scheme there shall be

requirement of Rs. 1079 crores, in which the States share would be of Rs. 229

crores and the Central Government share would be of Rs. 850 crores. The

components of expense heads approved relates to up-gradation of State Labs,

expansion of existing offices, manpower accommodation and creation of new

labs or mobile labs.

b. Prof. Ranjit Roy Chaudhury Expert Committee

An Expert Committee was constituted by the Ministry of Health and Family

Welfare under the Chairmanship of Prof. Ranjit Roy Chaudhury to formulate

policy and guidelines for approval of new drugs, clinical trials and banning of

drugs. The Committee in its report made a number of recommendations in

respect of regulating the conduct of clinical trials in the country in a most

authentic and transparent way. The recommendations included accreditation

of Ethics Committees, investigators and clinical trial sites, procedures to be

followed for review and grant of permissions for clinical trials, use of

information technology to ensure transparency in the system, establishing a

system of reporting of serious adverse events and compensations in case of

injury or death related to clinical trials etc. Majority of the recommendations

have been accepted by the Government and actions initiated. These measures

will ensure that data generated in the clinical trials is authentic while the

rights of human subjects participating in the trial are well protected.

c. National Survey on to assess the prevalence of spurious substandard

drugs

An All India Survey is proposed to be conducted in the country with

methodology prepared by Indian Statistical Institute, Hyderabad to assess the

prevalence of spurious and sub-standard drugs in the country. In the

proposed survey, around 42,000 samples would be drawn from across the

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country which would include 15 therapeutic categories of drugs which is

listed in National List of Essential Medicines (NLEM), 2011.The exact quantity

of drugs to be sampled will be finalized after discussion with Indian

Statistical Institute (ISI), Hyderabad and National Sample Survey Office

(NSSO), Delhi. The proposed survey is to be conducted in the year 2014 and

2015. In order to conduct the survey effectively the State Drug Inspectors,

participating in the survey will be identified, trained by the National Institute

of Biologicals, Noida.

d. Revision of National List of Essential Medicines (NLEM), 2011

The National List of Essential Medicines (NLEM) is one of the key

instruments in balanced healthcare delivery system of a country which inter

alia includes accessible, affordable quality medicine at all the primary,

secondary, tertiary levels of healthcare. NLEM was last revised in 2011.

A core committee has been constituted by the Government under the

Chairmanship of Dr. V. M. Katoch, Secretary, HR & DG, ICMR for updating

the NLEM, 2011. The committee has met three times and has prepared

guidelines for revision of NLEM, 2011. The National consultations are in

progress for the purpose of finalization revision of NLEM.

e. Banning of drugs

Drugs about which reports are received that these are likely to involve risk to

human beings or animals in the present context of the knowledge are

examined for their safety and rationality through the expert committees and

/ or DTAB after due examination of their rationality and safety. Following

drugs were prohibited during the period.

a. ‘Dextropropoxyphene and formulations containing

Dextropropoxyphene for human use’ (G.S.R. 332(E) dated

23.05.2013).

b. ‘Fixed dose combination of flupenthixol + Melitracen for human

use’ (G.S.R. 377(E) dated 18.06.2013) and 498(E) dated 11.07.2014.

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c. Restriction of sale of Oxytocin bulk to licensed manufacturers only

and sale of vet. Oxytocin injection to veterinary hospitals only (GSR

29(E) dated 17.01.2014).

d. Analgin and all formulations containing analgin for human use to

be marketed for restricted indications only (GSR 86(E) dated

13.02.2014).

f. Prohibition of testing of cosmetics on animals

The Drugs and Cosmetics Rules, 1945 has been amended vide Gazette

notification G.S.R. 346(E) dated 21.05.2014 prohibiting the testing of cosmetics

on animals in the country. The rules were further amended to prohibit import

of cosmetics tested on animals vide Gazette notification G.S.R. 718(E) dated

13.10.2014.

g. Clinical Trials

Various initiatives have been taken for further strengthening of clinical trial

regulation to ensure the protection rights, safety and wellbeing of Clinical

Trial subjects and authenticity of bio medical data generated. Some of the

initiatives are given below:-

i. Following amendments have been made under the Drugs and

Cosmetics Rules for strengthening the regulations relating to clinical

trials.

a. Rule 122 DAB was introduced on 30.01.2013 specifying

requirements for providing medical management in case of

injury and payment of compensation in case of trial related

injury or death (G.S.R. 53(E)).

b. Rule 122 DAC was introduced on 01.02.2013 specifying

conditions for conduct of clinical trials (G.S.R. 63(E)).

c. Rule 122 DD was introduced relating to registration of Ethics

Committees by the office of DCG(I) (G.S.R. 72(E)).

ii. A system of supervision of procedure for grant of clinical trial has been

put in place by constituting an Apex Committee under Chairmanship

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of Secretary, Health and Family Welfare and a Technical Committee

under Chairmanship of DGHS in compliance to the Hon’ble Supreme

Court’s order dated 03.01.2013,.

iii. The procedure now followed for review of Clinical trial applications is

a three tier review process. The applications are first evaluated by the

New Drugs Advisory Committees (NDACs)/ Investigational New

Drugs (IND) committee. The recommendations of these committees are

reviewed by the Technical Committee and then approved by the Apex

Committee.

iv. It has been made mandatory with effect from 30.11.2013 that in all

clinical trials, in addition to the requirement of obtaining written

informed consent, audio-visual recording of the informed consent

process of each trial subject, is required to be done as per directions of

the Hon’ble Supreme Court on 21.10.2013,. The Drugs and Cosmetics

Rules, 1945 are also being amended to make audio-video recording

mandatory before enrolling the clinical trial subjects.

v. An Expert Committee has been constituted to examine the reports of

deaths in clinical trials. The committee has prepared a formula for

determining the quantum of compensation in case of clinical trial

related deaths which is available in CDSCO website.

vi. Expert committees have also been constituted for examination of

Serious Adverse Events related to clinical trials.

h. Strengthening of Central Drug Testing Laboratories

For strengthening the testing capacities of the Central Drug Testing

Laboratories, an amount of Rs. 12,84,77,206/- was sanctioned on account of

procurement of various equipments for these laboratories.

i. Quality assurance and patient safety

In the 47th meeting of the Drugs Consultative Committee meeting held in July,

2014 it was decided that inspections of drug manufacturing unites will be

exhaustive and for both Good Manufacturing Practices (GMPs) as well as

Good Laboratory Practices (GLPs) to ensure quality production of Drugs in

the country.

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It was also decided that State Drugs Controllers should focus on patient safety

and rules should be implemented in such a way that it is ensured that safe

and efficacious drugs are made available to the patients.

Further, in the special DCC meeting held on 27.10.2014 it has been resolved

that the States / UTs Drug Regulatory Authorities will also have mission and

vision adopted by the CDSCO earlier.

The mission is: ‘to safeguard and enhance the public health by assuring the safety,

efficacy and quality of drugs, cosmetics and medical devices.’

23. Strengthening nursing services

a. The Centrally Sponsored Scheme is for Strengthening/Upgradation of

Nursing Services with funding pattern of 85% by Central Government and

15% by the State Government for starting new ANM/GNM Nursing Schools

is proposed to be continued during 12th Plan Period. The EFC for the

scheme was held on 2nd April, 2014.

The Government has initiated action for the opening of 132 Auxiliary Nurse

Midwife (ANM) and 137 General Nursing Midwifery (GNM)) schools in

those districts of 23 high focus states the country where there is no such

school. This will create 13500 additional intake capacities of candidates per

year. So far 127 ANM schools and 137 GNM schools have been approved

across the Country.

b. The Central Sector Scheme aims at the Development of Nursing Services by

way of Training of Nurses, upgradation of School of Nursing into College of

Nursing and by giving Florence Nightingale National Awards, is proposed

to be continued during 12th Plan Period. The SFC of the Scheme was held

on 19th September, 2014.

c. A Nursing and Midwifery Portal was launched on June 13. It is an online

resource centre for the state nursing councils and the entire nursing and

midwifery cadre. Such a resource centre makes it possible to being all

stakeholders in the health ecosystem –nurses, midwives, students, state

nursing councils, Indian Nursing Council, the Ministry – on a common

platform.

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24. Capacity Building for developing Trauma Care Facilities on National

Highways

- The pre-hospital trauma technician course curriculum has been revised and

the revised curriculum is being implemented in the three Central Government

Hospitals in Delhi namely Dr. RML Hospital, Safdarjung Hospital and

LHMC, for training of pre-hospital trauma technicians to be posted in

ambulances (ALS/BLS) all over the country.

- National Injury Surveillance Centre has been established at Dr. RMLHospital,

New Delhi.

25. National Health Portal

The National Health Portal (NHP) (http://nhp.gov.in) has been launched on

14.11.2014. NHP will serve as a gateway to authentic health information for all and

for providing authenticated health information for citizens, students, healthcare

professionals and researchers. Now, the NHP is disseminating information in Hindi,

Gujarati, Bangla, Tamil and English.

Department of Health Research

1. Department of Health Research (DHR) has taken following steps to launch the

affordable indigenously developed technologies:

i) Technologies launched:-

Indigenous strips and detection system(s) for diabetes mellitus

(13th Jan,2014)

New test for detection of pathogenic bacteria in food and Technologies for

Vitamin A and Ferritin estimations (20th Feb, 2014)

Novel non-invasive methods for diagnosis of visceral leishmaniasis (Kala-

Azar) by rK39 testing of sputum/ urine samples: launched on 2nd September,

2014. This disease strikes in Bihar, Jharkhand, West Bengal and Uttar Pradesh.

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ii) Technologies which are ready for launch:

Diagnostic kit for lung fluke disease (Paragonimiasis) – developed by

Regional Medical Research Centre (RMRC), Dibrugarh, Assam. Lung Fluke is

often confused with TB.

Diagnostic kits for Leptospirosis developed by RMRC, Port Blair. This disease

is prevalent in Karnataka, Gujarat and Tamil Nadu.

Diagnostic kits developed by NIRRH, Mumbai to detect Chlamydial infection

which is a reproductive tract infection (RTI) prevalent in women.

Kits for Hormone Assays developed by NIRRH Mumbai; useful for

reproductive health problems, with the potential of reducing costs.

Cooling jacket developed by NIOH, Ahmedabad for prevention against

exposure to high temperatures particularly in industrial workforce.

iii) Other important technologies initiated:-

New rapid molecular methods for detection of drug resistance in TB

New test methods for diagnosis of chikunguniya, Crimean-Congo

Haemorrahagic fever, dengue.

An immune-chromatographic dipstick kit for cholera, biocides for mosquito

control, rapid test for assessing osteoporosis, ergonomic cycle rickshaw

developed by ROHC (NIOH), Kolkata , non-invasive test for diabetes, test for

glycosylated haemoglobin, genomic chips for cancer diagnosis and

classification.

2. Research Programme on Environmental and Occupational Health launched to

monitor the effects of pesticides on human and animal health.

3. Decision to establish National Institute for Research on Environmental Health

at Bhopal with focus on robust research in managing health programmes

caused by chemical exposure.

4. DHR has developed a knowledge management policy to use e-connectivity

provided by National Knowledge Network for improving the service,

education and research in health. Model projects have been developed by state

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medical institutions in north India to demonstrate the usefulness of this policy

framework to be launched shortly.

5. ICMR has also developed a conceptual framework for joint research with the

Ministry of Environment and Forests, Indian Council of Agricultural Research

and other institutions to find solutions to water, soil and air pollution. At least

20 projects as Inter-departmental/ inter-ministerial research cum action

programmes are targeted.

6. ICMR has developed a blueprint for research-cum-action on disabilities

prevention and management. An institution framework will be announced

shortly.

7. Legislation:

DHR/ICMR has prepared the following three Bills for introduction in

Parliament during winter session of 2014:

a) The Biomedical and Health Research Regulation Bill, 2014 (to deal with

Ethical Issues pertaining to entire Biomedical Research other than trials on

new drugs/ vaccines/ devices on human subjects)

b) Assisted Reproductive Technology (Regulation) Bill 2014 (to regulate

medical, social, ethical and legal aspects of surrogacy in the country)

c) The Recognition of New Systems of Medicine Bill 2014 (to regulate the

process for recognition of any proposed new systems of medicine)

8. Strengthening of infrastructure and human resource to promote Biomedical

and health research in the country:

7 Model Rural Health Research Units (MRHRUs)approved for Karnataka,

Punjab, Maharashtra,Odisha, Chattisgarh, Madhya Pradesh and Andhra

Pradesh to focus on research on disease specific rural issues and to introduce

new technologies into rural health care.

16 Multi-disciplinary Research Units (MRUs)have been approved in

government medical collegesfocused on NCDs and health of women &

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child.Further seven unitsearlier approved have already become functional

during the year.

29 Virology Diagnostic Research Labs (VDRLs) 3Regional labs + 5 State Level

Labs + 21 Medical College level labs for research on viral diseases in different

States were approved during this period.

Upgradation to Regional Medical Research Centre (RMRC) at Gorakhpur

SFC proposal submitted.For upgradation of NIV Pune at Gorakhpur unit this

centre will carry out research on communicable, non-communicable, maternal

and child health, nutrition, environmental and other aspects relevant to

region.

A Centre for Policy Research on Vaccine Preventable Diseases

AnMoU has been signed with DBT, Deptt of Health & Family Welfare and

Department of Health Research/ICMR. The centre will generate evidence

with regard to vaccines for public health policy as well as play an advisory

role with regard to vaccines that may not be included for use in national

programme but will be available to public.

Samrat Ashok Tropical Disease Research Centre at RMRI, Patna

A 200 bedded hospital for research on tropical diseases is ready for

inauguration soon.

Establishment of Medical/Health Technology Assessment Board for

Technology Choice:

With aim to develop guidelines and provide guidance for introduction of

cost-effective technologies/strategies for public health for reducing expenses

on health care.

Department of AIDS Control

1. Country’s Plasma Policy announced - The National Policy for Access to

Plasma Derived Medicinal Products from Human Plasma for Clinical/

Therapeutic Use was announced on World Blood Donors Day (14 June 2014).

The Policy aims at making available, easily accessible and adequate supply of

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high quality plasma derived proteins for clinical/therapeutic use. It aims to

enable mobilization of excess plasma stocks from blood banks to the plasma

fractionation units in order to obtain higher value products that can be made

available for clinical and therapeutic use.

2. On World AIDS Day, Toll free National AIDS Helpline was launched along

with India HIV/AIDS Resource Centre and Inventory management system and

Prevention of Parent to Child Transmission (PPTCT) campaign.

3. Sexually Transmitted Infection Division at NACO and RMNCH+A division at

NRHM jointly revised and released the National Guidelines on STI/RTI

Control and Prevention in August, 2014.

4. 45 HIV laboratories (National and State Reference Laboratories) attained NABL

accreditation till date.

5. National AIDS Control Organisation has signed 11 MoUs with Ministries/

Departments for mainstreaming HIV/AIDS.

6. 30 new Opioid Substitution Therapy (OST) centres established in Government

health facilities

7. A National Working Committee on HIV/ AIDS and Prison Intervention and

Law enforcement agencies with representatives from the Narcotics Control

Bureau, MSJE, police training academies, etc., has been formed with Secretary

(Health)as the Chairperson to plan and implement HIV/AIDS prevention and

care in prison setting in India.

8. Published National Framework for HIV/TB collaborative activities in India,

PPTCT National -Guidelines & National Strategic Plan of PPTCT and

disseminated to SACS.

9. Integrated Induction Training and refresher training module for counselors

under NACP – Developed

10. National TB/HIV coordination committee meeting and National Joint review

meetings of States & UTs for HIV/ TB held.

11. 677 New ICTCs including F-ICTC’s, PPP & Mobile ICTC’s established during

2014-15

12. Assessment of Prevention of Parent to Child Transmission of HIV(PPTCT)

services implementation in States of Andhra Pradesh, Telangana, Karnataka

and Tamil Nadu.

13. NACO Condom Social Marketing Program implementation was concluded in

11 states (UP,Uttarakhand, AP, MP, Delhi, Bihar, Jharkhand, Chhattisgarh,

Goa, Punjab, Haryana & Chandigarh) covering 224 districts.

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14. NACO Condom Social Marketing Program implementation was rolled out in

12 new states (Karnataka, Rajasthan, Gujarat, Maharashtra, West Bengal,

Odisha, Assam, Nagaland, Manipur, Mizoram, Meghalaya & Tripura) covering

171 districts.

15. Conducted Condom Quality Audit to determine the quality of different

condom brands available at retail outlets across the country. Findings

reiterated that GoI condom brands i.e. Nirodh (free supply) and Deluxe Nirodh

(Socially Marketed) are at par with the best of commercial brands in terms of

quality.

16. Special communication drives for migrants were carried out in program states

during DiwaliandDurga Puja festivals across 18 program states.

17. For care and support, new guidelines adopted as per WHO guidelines. Also,

newer initiatives like pharmacovigilance, early warning indicator and quality

care indicators analysis done to improve quality of care for patients living with

HIV-AIDS.

*****

HQ –322 (31.12.2014)