Department of Health &Family Welfare in 2014
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.
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.
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