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) 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 crore to 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 crore have 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.
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 2 lakhs. 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.
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
·
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 up to 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.
·
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:
·
Janani
Suraksha Yojana 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 Janani Suraksha Yojana (JSY), the
number of beneficiaries receiving cash assistance has risen to over 1.06 crores
per year.
·
Building
on JSY, Janani Shishu Suraksha Karyakaram (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.
·
Rashtriya
Bal Swasthya Karyakram (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 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 32 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.
Rashtriya Kishor
Swasthya Karyakram (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, assured health
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)
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.
(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:
ü 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%
ü 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.
(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. Pradhan
Mantri Swasthya Suraksha Yojana (PMSSY)
The Pradhan Mantri
Swasthya Suraksha Yojana (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.
MoUs have 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
Heightened surveillance
and tracking systems have been put in place 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
Ø State NCD
Cell established in 26 states.
Ø District NCD
Cell established in 142 districts.
Ø District NCD
Clinic established in 147 districts.
·
Cardiac
Care Unit
Ø
Cardiac Care Units have been established in 65
districts
·
Glucometers
As on
31-03-2014 total of 5,57,39,571 persons 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 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 22 August, 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.
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.
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 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 up to 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.
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 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 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.
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 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.
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.
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. RML Hospital, 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.
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 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 colleges focused on NCDs and health of women &
child. Further seven units earlier approved have already become
functional during the year.
— 29
Virology Diagnostic Research Labs (VDRLs) 3 Regional 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
An
MoU 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 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.
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
Diwali and Durga 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.