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REPORTS OF THE WORKING GROUP ON
HEALTH
FOR
THE ELEVANTH FIVE YEAR PLAN
(2007 - 2012)
NO. 2-.
GOVERNMENT OF INDIA
PLANNING COMMISSION
2006
I
“rH
i
SI. No. _____________________________Title____________________________
Report and recommendations of subgroup-I on Health Informatics for the XI
1
Five Year Plan
____ ____________________________________
9
Report of the working group on Health Systems Research. Biomedical
Research & Development and Regulation of Drugs & Therapeutics
Report
of the working group on Health Care Financing Including Health
3
Insurance for the 11th Five Year Plan_______________________________
Report of the working group on Clinical Establishements, Professional
4
Services Regulation and Accreditation of Health Care Infrastructure for the
11th Five-year plan______________________________________
I 5
Report of the working group on Population stabilization for the 11th Five
Year Plan
6
I—
7
8
r
Pages
Report and Recommendations
of
SubGroup-I
on Health Informatics
for the XI Five Year Plan
10th FIVE YEAR PLAN (FYP) - FOCUS
INITIATIVES TAKEN DURING 10th FYP
MAJOR THRUST AREAS DURING XI FYP
MANPOWER & FINANCIAL REQUIREMENT
0
18
Sub-Group -II
(TOR 3) To suggest modification in policies, priorities and programmes during
llth Plan period, New initiatives and strategies such as tele-medicines etc., so to
improve quality and coverage of services at affordable cost and also cope with ex isting,
re-emerging and new challenges in diseases, emerging problems of non-communicable
diseases due to increasing longevity, life style changes and environmental degradation.
(TOR 4) To indicate Manpower requirement and financial outlays required for
implementation of these programmes during the 11th Plan period.
1. Ms. Ganga Murthy - Convener,
Economic Adviser,
244(B) A Wing, MOHFW,
New Delhi-110011
Ph: (011)23062744
E-mail: gangamurthy@gmail.com
2. Sh. B.S. Bedi,
Scientist “G” HOD,
Deptt. of Information & Technology
New Delhi-110003
Ph: (011) 24360582, 9868243335
E-mail: bedi@mit.gov.in
3. Prof. K. Ganpathy, Head
Apollo Telemedicine Networking
Foundation, Chennai-600006
Ph: 044-28295447
E-mail: drkganapathy@gmail.com
4. Sh. L.S. Satyamurthy,
Programme Director (Telemedicine)
Deptt. of Space, Hqr. IRSO
Antrix Bhavan, Bangalore-560094
Ph: 080-22172187, 23415459, 098451417905
E-mail: lsaty@antrix.org________________
6. Dr. D. Bachani,
Programme Officer IDSP
NICD, 22, Sham Nath Marg, Delhi-110054
Ph : (011) 23932290, E-mail: idsp-npo@nic.in
5 Dr. K. Satyanarayana
Sr. DDG (P&I Division)
ICMR, Ansari Nagar New Delhi-110011
Ph:(0ll)26589258
E-mail: kanikaram_s@yahoo.com
7. Dr. Sudhir Gupta, CMO, Dte.GHS
Nirman B hawan, New Delhi-110011
Ph: (011)23061980
E-mail: cmoncd@nic.in
drsudhirgupta@gmail.com
8. Dr. (Mrs.) Jagdish Kaur,
Chief Medial Officer (JK),
352, Nirman Bhawan, Dte GHS,
Nirman Bhawan^ New Delhi-110011
Ph: (011)23063120
E:mail: jagk2001@rediffmail.com
9. Sh. M.M. Chanda,
Joint Adviser ( C&I)
Planning Commission, New Delhi-110001
Ph: (011) 23096759
E-mail: iumchanda@nic.in
10. Mr. Rajeev Lochan Director (Health)
Planning Commission,
New Delhi-110001
Ph: (011)23096711
E-mail: rlochan@nic.in
11 Principal Secretary (Health)
Department of Health, Medical & F. W.
Govt, of Andhra Pradesh, A.P. Secretariat
Hyderabad - 500 022Ph: 040-23455824
E-mail: prisecy_hmfw@ap.gov.in
^.Representative of Secretary (Health)
Andaman & Nicobar Is.-744101
Ph: 03192-234880
E-mail: rajendra@and.nic.iri
13. Dr. K. K. Agarwal, Ex-President
Delhi Medical Associaton
S-344, GK-I, New Delhi-110048
Ph: (011) 41620701,41620702
E-mail: drkk@ijcp.com
14. Mr. K.L. Gupta,
Dy. Director (NRHM)
Director of Health Services, Swasthya Sadan
Himachal Pradesh, Kasumpti, Shimla-171005
Ph: 0177-2623429, 09418060164
17
Report & Recommendation of Sub Group -1 for XI Five Year Plan
In its first meeting of the Working Group on Health Informatics held on 5.7.2006
under the Chairmanship of DGHS, the sub-group I was constituted with Dr. Arvind
Pandey, Director, National Institute of Medical Statistics (NIMS), as the Convener and
other members. This sub-group focused on three terms of references (TORs) of the
Working Group viz. (i) to assess the availability and quality of data, their accuracy
and reliability and problems in making estimates. Methods for improvement in XI
FYP (ii) to review the present Health Management Information System (HMIS), its
capability to provide up-to-date information for effective timely response to policy
makers & implementing agencies so as to make HMIS an integral part of National
Rural Health Mission and (iii) to indicate Manpower requirement and financial
outlays required for implementation of these programmes during the XI Plan
period.
The sub-group I in its meting held on 17.7.2006 discussed at length the present scenario
of the health information, its limitations and inadequacies. It was noted by the sub-group
that accurate, relevant and up-to-date information is essential to health service managers
if they are to recognize the weaknesses in health service provision and take actions that will
improve service delivery. Accordingly, the development of effective information systems is a
necessary precursor to managerial improvement. It was observed that a health management
information system is a process whereby health data (input) are recorded, stored,
retrieved and processed for decision-making (output). Decision making broadly includes
managerial aspects such as the planning, organizing and control of health care facilities at the
national, state and sub-state levels and clinical aspects which can be subdivided into (i) providing
optimal patient care (ii) training of medical personnel to generate appropriate human resources,
and (iii) facilitate research and development activities in various fields of medicine.
Subsequently after the second meeting of the working group held on 1st August 2006 the
chairman expressed his satisfaction about the progress made so far.
However, he also
suggested both the sub-groups to design their plan in a more focused manner linking with the
outcome of the plan. He suggested concretizing and finalising their plan with due inclusion of the
manpower and financial requirement for the Eleventh Plan and submit report by 11 August
2006. Accordingly, a meeting of this subgroup was organized on 8.8.06 to review the
recommendations and to finalise the report of subgroup -1.
19
HMIS is an essential management tool for effective functioning of the health
system. During the Eighth Plan the Central Bureau of Health Intelligence and the state
Bureaus of Health Intelligence developed a HMIS system for sending district level
information on morbidity reported by the government primary health care institutions
through National Informatics district computer network. Though some states responded
initially the system was never fully operationalised in any state. The HMIS system did
not take root due to the several inherent deficiencies. The major problems faced in the
implementation of HMIS were:
a) HMIS proforma requires continuous maintenance of detailed Subcentre Registers,
numbering 13, along with the Reporting formats. This involves substantial recurring
expenditure for printing of forms and registers. The States/UTs expressed inability to
meet the recurring expenditure for printing of forms and registers.
b) Lack of hardware, software and trained personnel at the district and lower levels and the
NIC facilities were inadequate to meet computing requirements of HMIS
c) Separate programme wise Information System - required by some users
d) No legal provisions for collecting data from non-govemment sector.
e) No compulsion at State / UT level to implement the system.
As a result there is no system through which reliable data on morbidity in different
districts/states could be collected and analyzed and used for decentralized district based
planning. So far there has not been any effort to use the currently available IT tools to
build up a comprehensive HMIS and use it to improve efficiency and functional status of
the health system.
2. 10TH FIVE-YEAR PLAN (2002-07) - FOCUS
During the Tenth Plan the focus was to ensure that effective two way management
information system is built up throughout the country; all data pertaining to health and
family welfare programmes to be collected, collated and reported from all districts and
utilized to improve functional status and efficiency of the health system. Efforts would
also be made to build up a fully functional, accurate HMIS utilizing currently available
IT tools; this real time communication link requires to send data on births, deaths,
diseases, drugs, diagnostics and equipment and status of ongoing programmes through
service channels within existing infrastructure and manpower and funding. It also
facilitates decentralized district based planning, implementation and monitoring.
20
The Tenth Plan envisaged a comprehensive review of (a) disease surveillance
programmes which was being implemented in different states under different disease control
programmes and under the project on disease surveillance. Private sector provides over 75% of
curative care. However, data from private health providers is not yet included in any disease
surveillance system, (b) laboratory facilities available for investigation of epidemic prone
diseases and (c) also the reporting systems currently in use. However, health and family welfare
issues continued to follow two different pathways which were far from the concept of integration
necessary for a unified health information system. Efforts also need to be made to integrate the
ongoing programmes for disease surveillance and develop a comprehensive disease
surveillance programme at the district level.
Thus tenth five year plan (2002-07) focused on:
•
Building up a fully functional, accurate Health Management Information System
(HMIS) utilizing communication link will send data on births, deaths, diseases, request for drugs,
diagnostics and equipment and status of ongoing programmes through service channels within
existing infrastructure and manpower and funding; it will also facilitate decentralized district
based planning, implementation and monitoring.
•
Building up an effective system of disease surveillance and response at the
district, state and national level as a part of existing health services.
3. INITIATIVES UNDERTAKEN DURING X FIVE YEAR PLAN
3.1 Constitution of National Statistical Commission
The Union Ministry of Statistics & Programme Implementation (MOSPI) during the year 2001
constituted the National Statistical Commission (NSC) under the Chairmanship of Dr. C.
Rangarajan which had articulated the deficiencies observed in the health and family welfare
statistics. It had observed * that as extensive data are being collected by various agencies and
compiled, there exist various problems, deficiencies and gaps. The system was not successful on
account of non-reporting, under-reporting, variable coverage, delays in receipt of reports, data not
being gender-specific and age specific, data not catering to the needs of the general public, etc.
The major problems faced in the implementation of HMIS in the past were lack of
hardware, software and trained personnel at the district and lower levels. The National
Informatics Centre (NIC) facilities were inadequate to meet the computing requirements
* - Report on National Statistical Commission published by M/o SPI2001
21
of HMIS. Further, while the information for various programmes is collected separately
by the peripheral worker and sent upwards from sub-centre, primary health centre and
community health centre to the district and
State levels, there is no coordination between the various health programmes
implemented by the several Departments of Ministry of H&FW. Maintenance of patient
care records is also very poor in most of the Government hospitals. The information from
the private sector is not properly collected and included in the data generated by the
official sources. Most of the States have riot paid attention to implement the programme
due to various reasons including lack of funds and trained manpower resources. As a
result the HMIS has failed to achieve the objectives for which it was set up and has not
functioned satisfactorily.
Due to poor implementation of HMIS by the States, the earlier system of collection of
information by various programme authorities has continued to be in existence along with
HMIS, which has created an undue burden on the peripheral workers as they have to fill up a
number of proforma and maintain a number of records related to various programmes namely,
malaria eradication, goitre, immunisation, MCH, family planning, blindness control, tuberculosis,
AIDS and leprosy.
The Commission observed that a computerised health information system at all treatment
facilities is an essential prerequisite for establishing an effective Health Management
Information System. The HMIS has a good potential to provide a comprehensive database on
working of health programmes at the decentralised level up to the district. The HMIS if properly
implemented would reduce delays in the information flow, provide qualitative information in a
standardised form, avoid duplication and facilitate quick retrieval of information by all agencies
concerned. Some of the key recommendations of the Commission are:
(a) A comprehensive assessment of the Health Management Information System (HMIS)
should be made by a small Committee quickly and HMIS be reintroduced in the country
in a phased manner with necessary modifications. The combined HMIS format should be
separated into programme-wise modules. While revising the programme modules, care
should be taken to meet the data requirements of both the Central and State
Governments. Flexibility should be given to the States and UTs to include
additional items to meet their State specific data requirements.
22
(b) Steps should be taken to rationalise and minimise the number of records and
registers maintained by the peripheral health workers such as ANMs and public
health inspectors to reduce their burden and to improve the quality of data. The
minimum data set on which data from the grass root levels should be regularly
collected along with their periodicity should be clearly identified.
(c) A suitable mechanism to collect the data at the grass roots level and its upward
transmission to the district, State and the National level should be evolved and for
that methods of data collection, transmission, and processing must be modernised.
As NIC facilities are inadequate to meet the requirements of HMIS, adequate
funds need to be provided for necessary hardware, software and connectivity and
training of personnel.
(d) The Central Bureau of Health Intelligence (CBHI), which is at present a part of
Directorate General of Health Services (DGHS) should be separated and
upgraded to a full-fledged Directorate of Health Statistics (DHS) directly under
the Department of Health. An officer from the Indian Statistical Service at the
Additional Secretary level should head this Directorate and act as the Statistical
Adviser to the Ministry. Also required posts of supporting officers should be created.
The DHS should be the nodal agency in matters of health statistics and should advise the
Department in all matters related to the collection of Health Statistics; coordinate with the
National Statistical Office the Central and State Governments as well as international
agencies in matters related to health statistics.
(e) The CBHI upgraded as DHS should be strengthened with adequate Electronic
Data Processing (EDP) personnel and existing personnel should be trained in
EDP operations, to enable the processing, tabulation and presentation of the large
volume of data on health. Adequate funds out of the national health programmes should
be earmarked for development and maintenance of information system as well as for
verification of field level performance data through independent agencies.
(f) In order to facilitate effective implementation of the HMIS in the States and UTs,
the State Department of Health and Family Welfare in every State should have a
Statistical Division headed by a senior level statistical officer. In the districts, a
health statistics cell should be set up in the Office of Chief Medical Officer
(CMO) to implement HMIS and to take care of all health and family welfare
statistical activities of the district.
23
3.2
Constitution of a committee by MOHFW/GOI to review HMIS & its
recommendation
Accordingly, Union M/o Health & Family Welfare constituted a Committee* under the
chairmanship of DGHS with 13 members from MOHFW/GOI, CSO, Planning Commission and
NIC and Director CBHI as the Member Secretary, with the following terms of references:
I. Comprehensive Assessment of HMIS for re-introduction with modifications and
schedule of re-introduction in phased manner.
II. Separation of combined format into programme-wise modules.
III. Flexibility of States/UTs to include additional items to meet States specific data
requirements.
IV. Setting up of detailed action plan with definite milestones and target dates for
implementation of recommendations of National Statistical Commission, keeping in
view result of HMIS assessment.
The committee met twice, on 5.10.2004 and 2.12.2004 and reviewed the HMIS and its
functioning in the country.
Keeping in view of National Health Policy (1983) and to achieve the goal of Health for
AH by 2000 AD through Primary Health Care Approach there was a strong need for efficient
Management Information & Evaluation System in health sector. As a combined effort of
Dte.GHS/MOHFW, State Health Departments, NIC, Planning Commission and WHO (1986-88),
the need based HMIS was developed and field-tested in 1989 in one District each of Gujarat,
Haryana, Maharashtra and Rajasthan. It was only meant to cover rural health services. In a
review meeting during 1989 HMIS found to be satisfactory and merited implementation
throughout the country in phased manner. Also it was decided that the system should be given a
computer compatible format and to operate the same through NICNET in due course.
Accordingly the system was made computer compatible by NIC/ CBHI and PHC/District
Hospital/Private Hospital Formats were developed (HMIS version 2.0) in 1990. During 1992,
under HMIS Ver. 2.0, NIC/CBHI developed thirteen Sub-Centre Registers, three Model
Reporting Formats and Control Charts for PHC & District levels. In all 13 States were included
for HMIS Ver. 2.0 implementation and the States were requested to examine the model formats
and adapt accordingly to specific needs with minimal set of essential information.
In a review meeting held in March 1996 it was observed that only two States (Haryana &
Sikkim) had implemented HMIS 2.0. This review recommended that (i) a task force with
adequate and appropriate representation from various programme and states be constituted which
should inter-alia look into desirability of devising a unified programme by consulting the
existing machinery at sub-centes, PHC, District, State and Central level programme officers to
(*) - Vide Order No. Z - 1802115/2002 - PH(CBHI) dated 31.12.2003
24
'W
come up with suitable recommendations for changes in the existing formats, (ii) since the
district NIC facilities are inadequate to meet the computing requirements of HMIS, this
set up needs to be suitably strengthened in terms of manpower, equipment and
infrastructure, for meeting the HIS requirements, (iii) also to make the HMIS more
comprehensive and effective, the urban health care system should also be studied, (iv) the training
programmes required more funding and manpower to make the implementation rapid and
effective, and (v) the respective State Governments may consider bringing an Act with a view to
formulate guidelines making it obligatory on the part of private sector, Local Self Govt.
Departments (LSGD) to provide information related to various health services being rendered by •
them.
In a subsequent workshop held in December 1997 on HMIS reviewed the extent of
computerization of distt. Chief Medical & Health Officer & their connectivity to NIC'NET.
Following important recommendations emerged:
i)
Computers at NIC district centre are hardly available for entry of HMIS and other
health data. It is, therefore, necessary that the requisite hardware with accessories and
the latest operating softwares are provided to the District Chief Medical Officer and
Directorate of Health Services at State/UT HQrs. with common software.
»)
The trained personnel may be available at district and state level for operation and
maintenance of computer hardware and softwares. Each programme should have a
component of training in “General awareness to computer, data entry, programming
etc.” at district and state level. The requisite fund may be kept at the disposal of
District Chief Medical Officer and Directorate of Health Services/State Bureau of
Health Intelligence at State/UT HQrs. Distt. Programme Manager to ensure data
entry in Distt. CMHO office computer.
Hi)
It was strongly felt that 15% of the total cost of hardware may be earmarked for
annual maintenance and a fixed amount in every district may be provided towards
purchase of computer consumables and other stationery items. There should be a
nodal agency at the national level and also at the state level for all the
programmes responsible for drawing funds from different programmes and
make available the registers and formats.
iv)
HMIS format to be revised to independent programme wise modular formats keeping
in view that the modular formats may be uniform over States/UTs and contain gender
information and also information by specific age groups wherever applicable.
v)
NIC to Centrally Develop Data entry software with flexibility for add on
information.
25
This Committee under the chairmanship of DGHS/GOI after due deliberations
observed that over last two decades an appreciable advancements have taken place in the
development of health information systems in India, especially National Health
Programmes like RNTCP, NVBDCP, NBCP, NLEP, etc. have utilized the modem
information techiiology/software for their information system. The Union Ministry of
Health & Family Welfare after due planning has launched (November 2004) the World
Bank supported Integrated Disease Surveillance Project (IDSP) with cost of more than
Rs.400 Crores and this projects envisages the further strengthened and efficient health
information system from periphery with computer/server facilities at each district and State / UT
and with due flexibility to State / UT to incorporate information in the system.
Under this project, care has been taken to link all the program specific computers
in each district with IDSP server so as to make integration of all health information. With
this advancement and commitment by the MOHFW / GOI, there is a need to integrate
HMIS with IDSP with an appropriately designed information format and indicators at
various levels of health care delivery for an appropriate timely corrective measures.
The final recommendation of this committee was communicated to M/o Statistics
& PI * clearly indicating that “it will be desirable to strengthen this IDSP as a national health
information system with appropriate computer connectivity rather than pursuing the HMIS which
was conceived about two decades back and could not succeed for various reasons. In the present
context, this Union M/o Health & FW is committed to ensure the efficient implementation of
IDSP which is one of the major projects undertaken with World Bank loan. This Ministry is also
tracking the information on financial, logistics, manpower and implementation aspects for
ensuring timely corrective appropriate measures I hope this will suffice fulfilling the need of
aforesaid recommendation of NSC on the subject matter. Your further suggestion will be
appreciated”.
33 Launch of Integrated Disease Surveillance Project (IDSP)
Integrated Disease Surveillance Project (IDSP) is a decentralized, State based
Surveillance Program in the country. It is intended to detect early warning signals of
impending outbreaks and help initiate an effective response in a timely manner. It is also
expected to provide essential data to monitor progress of on-going disease control
programme
and
help
allocate
health
resources
more
efficiently.
D.O. letter no. Z-18021 / 5/ 2002 -CBHI dated 28.1.2005 from Union Secretary MOHFW to
Union Secretary, M/o Statistics & PI.
26
The IDSP was launched by Hon’ble Union Minister of H&FW in November 2004 with
following objectives to:
D
Establish a decentralized district based system of surveillance for communicable
and non-communicable diseases so that timely and effective public health actions
can be initiated in response to health challenges in the urban and rural areas while
establishing Public private Partnership.
iO
Integrate the existing surveillance activities (to the extent possible without having a
negative impact on their activities) so as to avoid duplication and facilitate sharing
of information across all disease control programmes and other stake holders, so
that valid data are available for decision making at district, state and national levels.
A brief on IDSP indicating (a) diseases covered in Regular Surveillance, Sentinel
Surveillance, regular Periodic Surveys, State Specific Diseases, (b) Organization
Structure, (c) Training of District Surveillance Teams, (d) Procurement of Goods (e)
Development of software for diseases surveillance (f) Baseline study on Public Health
Laboratories (g) External Quality Assurance System (h) Participation of Private Sector &
Medical colleges (i) NCD Risk Factor Surveillance (j) budget allocated and utilized, are
enclosed at Aunexure -1.
3.3.2 IDSP Satellite Communication System
IDSP launched Satellite Linkage on 29111 March 2006 with Central studio at National
Institute of Communicable Diseases with a sub-hub in Nirman Bhawan and 800 Satellite
Interactive Terminals (SITs) located throughout the country would be set up connecting all
the State and Districts Units, Medical Colleges and premier state and national public health
institutions. For a fully functional network, it is also being considered of intervention of
network under National Rural Health Missions and various National Health Programmes.
EDUSAT, a dedicated educational satellite launched by ISRO is being utilized to set
up communication and information network throughout the country’.
Proposal has
been submitted to the World Bank for clearance. This network will be utilized for
distance training programmes, teleconferencing and data transmission. Funds have
been sanctioned from IDSP Budget for 2005-06 to ISRO to cover 400 SITs by June
06. Remaining 400 SITs would be covered during 2006-07 and covered by December
2006.
27
3.4 Constitution of National Commission on Macroeconomics and Health
(NCMH) by Govt, of India
The NCMH in its Report* titled “Building a Health System for Improving Health
in India - The Way Forward” recommended:
A National Institute of Health Information & Disease Surveillance needs to be
■
established as an autonomous body consisting of Board members from other
ministries, statisticians, researchers and State-level policy makers. The Institute must
also have a multidisciplinary composition comprising economists, public health
specialists, epidemiologists, and doctors. Disease burden estimations. National Health
Accounts, cost-effectiveness studies of interventions, efficacy of vertically driven
interventions including ICDS in countering the problem of malnutrition in the country,
independent evaluations of programme implementation are examples of the kind of
work that needs to be undertaken.
■
There is a need of reviewing National health information system at various levels Central, State, district and block - by various agencies - different ministries and
departments in the government - method of data flow, gaps in data, utilization of the
data, organizational set up, accessibility of information to various persons at various
levels are aspects to be examined.
■
Alongwith domestic resources, external aid, WHO assistance etc. be fruitfully
utilized for processresearch capacity by earmarking fellowships every year to
institutes of excellence abroad and within India. Of the total 25% must be at the
doctoral level and the rest at the Master’s level. It should be our target to have a pool
of atleast 500 persons with a combination of such critical skills by the end of 2012.
Such fellowships should be open for competition and not be confined to central
government employees of the Ministry of Health. This will help develop capacity and
expertise outside government and be available for policy advise in an objective manner.
3.5 Launch of National Rural Health Mission (NRHM) by Govt, of India
Recognizing the importance of Health in the process of economic and social
development and improving the quality of life of our citizens, the Government of India has
launched the NRHM in April 2005 to carry out necessary architectural correction in the basic
healthcare delivery system. The Mission adopts a synergistic approach by relating Health to
determinants of good health viz. of nutrition, sanitation, hygiene and safe drinking water.
* - Report of National Commission on Macroeconomics and Health - 2005
28
It also aims at mainstreaming the Indian systems of medicine to facilitate health care.
The Plan of Action includes increasing public expenditure on health, reducing regional
imbalance in health infrastructure, pooling resources, integration of organizational
structures, optimization of health manpower, decentralization and district management of
health programmes, community participation and ownership of assets, induction of
management and financial personnel into district health system, and operationalising
Community Health Centres into functional hospitals meeting India Public Health
Standards in each Block of the Country.
The goal of the Mission is to improve the availability of and access to quality health care by
people, especially for those residing in rural areas with specific objectives:
•
Reduction in Infant Mortality Rate (IMR) and Maternal Mortality Ratio (MMR)
•
Universal access to public health services such as Women’s health, child health, water,
sanitation & hygiene, immunization, and Nutrition.
•
Prevention and control of communicable and non-communicable diseases,
including locally endemic diseases
•
Access to integrated comprehensive primary healthcare
•
Population stabilization, gender and demographic balance.
•
Revitalize local health traditions and mainstream AYUSH
•
Promotion of healthy life styles
The NRHM seeks to provide effective healthcare to rural population throughout the
country with special focus on 18 states, which have weak public health indicators and/or weak
infrastructure. These 18 States are Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Himachal
Pradesh, Jharkhand, Jammu & Kashmir, Manipur, Mizoram, Meghalaya, Madhya Pradesh,
Nagaland, Orissa, Rajasthan, Sikkim, Tripura, Uttaranchal and Uttar Pradesh.
3.6 Constitution of Task Force on HMIS by Union Ministry of Health &
FW
A Task Force on HMIS was constituted by the Ministry of Health & Family Welfare during
March, 2006 * under the chairmanship of DGHS with the TOR’s to:
(a) Suggest a format of reporting from Districts and States that could capture health
information required for purposes of planning, monitoring and review.
(b) Suggest the manpower structure at District, State and national levels for a
commonly agreed system of data collection, data entry and data analysis.
29
(c) Agree on the formats of data collection at various levels and its analysis.
(d) Reconfigure the system of statistics and data gathering at the national level to provide for
a more effective and efficient internal organization that meets the requirements of States.
(e) Develop illustrative structures of coordination among various health data interventions
including IDSP at district and State levels.
(f) Weed out unwanted data collection systems and replace them with a consolidated and
comprehensive data system; which can thus satisfied the need.
This task force in its two meetings held till date, viewed the HMIS of different states like Tamil
Nadu, Rajasthan, Gujarat and Chattisgarh through their detailed presentations as well as
through video conferencing. This task force is in the process of deliberation and is expected to
come out with its recommendations on the above TORs by end of August 2006.
3.7 In depth Review with ail the States/UTs for Improving & Strengthening Health
Information System & use of ICO 10 and National Recommendations
In order to ensure electronic data flow and further improve the efficient Health Information
System (HIS), CBHI had held (a) training workshop of States/UTs for sensitizing them on
electronic data transmission, October 2003, and (b) followed by four regional workshops with
the State/UTs for improving and strengthening the Health Information System during 2002-2004.
The Combined Report & Recommendation** (Annexure-II) of the above said workshops
were communicated to all State/UT health authorities for necessary action. This was pursued by
CBHI officers who visited 18 states/UTs upto peripheral level to make an “on the spot”
situation analysis & supportive supervision for efficient HIS.
During 2005, two national
workshops were organized to review the action plan of all the States/UTs to implement the above
said national recommendations.
During 2006-07, CBHI has planned with selected states to concretize their District specific
action plan to improve & strengthen HIS upto peripheral level, while involving Private Public
Partnership and also study for electronic flow of health information from peripheral to
district/state/national level.
CBHI undertook a case study of 20 hospitals belonging to Central Govt, State Govt, Local
Bodies, Private Sector in cities of Delhi and Rohtak, during years 2004 & 2005 with the objective
to identify the status of implementation of ICD 10, the major constraints and their feasible
solutions to improve and strengthen the use of ICD 10 as well as medical record department in
the country. The important recommendations of the case study are (i) Capacity Building
and Trained Manpower development for using ICD 10, (ii) ensuring administrative actions
to ensure and improved use of ICD 10 in all medical & health institutions in the country and
(*) Vide order no. N-23011/13/2006-Policy dated 23.3.2006
(**) Combined Reports & Recommendation published by CBHI in August 2004
30
(iii) establishment of World Health Organisation Collaborating Centre for Family of International
Classifications on Diseases & other Health Related Aspects for South East Asia Region in India,
inCBHI. ,
The Executive summary & major recommendations (Annexure-III) * of this case study
have been communicated to all States/UTs health authorities & others concerned for
prompt implementation.
3.8 Health Sector Policy Reform Options Database (HS-PROD) with website
address www.prod-india.com
HS-PROD is a Health Sector Reforms Database. On request of the Donor Coordination Division,
MOHFW, GOI; CBHI after getting due approval from Director General of Health Services has
allotted a Project of high national importance on “Health Sector Policy Reform Option Database
(PROD) of India” which is being supported by European Commission through its Sector
Investment Plan (SIP) with an estimated budget provision of Rs.84 lakhs (approx.). Already 152
entries have been uploaded in the website prod.india.com and this site is being brought to
MOHFW/GOI through NIC. The brochure detailing on HS-PROD is placed as Annexure IV.
4.
MAJOR THRUST AREAS SUGGESTED/RECOMMENDED DURING
XIFYP
1.
While prioritizing Efficient Health Information System (HIS), to begin the States/UTs
should strengthen the existing State/UT health statistics unit in their respective health &
FW directorates with identified nodal officers, trained personnel and computer so as to
effectively coordinate for validated health data base & capacity building in State/UT &
closely link with CBHI.
Subsequently States/UTs to make efforts for establishing a
dedicated State/UT Health Statistics Division, equipped with adequate infrastructure. This
Division be responsible for efficient HIS, validated health database of the State/UT,
monitoring & evaluation as well as capacity building, while keeping close linkages
with CBHI and various reporting unit within the State/UT.
2.
At district level. Chief Medical & Health Officer is responsible for all health statistical
activities under whom the existing Distt Health Statistics cell be strengthened by the
States/UTs and efforts be initiated to equip this cell with a dedicated trained officer as its
incharge and a Group C staff oriented in computer operation and atleast one computer with
accessories. This Distt. Health Information Unit can then coordinate for efficient health
information system in the district, including on the spot supervision and related capacity
building of PHCs & other Health units in the district.
* - Report & Recommendations Published by CBHI, 2006..
31
3.
At PHC/CHC/Dispensary level, the States/UTs should make efforts to orient & reorient
the medical officers and health supervisors towards health data management through
continued supportive supervision and wherever necessary through in service training
program organized by State/UT, CBHI and other Institutions. A close coordination with all
the existing govt./non govt, health institutions in respective jurisdiction will ensure
maximum coverage of health & medical data with requisite quality & timeliness.
4.
Since ANMs at grass root levels are heavily loaded due to their multitasking operations it
is necessary to reduce their workload by providing two MPW(F) in each sub-centre as per
IPHS requirements. They should be given the responsibility of maintaining registers for all
health and family welfare related database. The acute shortfall of MPWs* (64211 out
of sanctioned strength of 81561) has been a cause of concern not only to provide basic
health services but also to document the quantifiable services as a pivot for health
management information system. Similarly there is an urgent need on part of all the
States/UTs to fill in all the post of MPW (male) at both, Sub-Centre and PHC levels, that
will be responsible for collection of health related information.
5.
There is a acute shortage of CHCs too. To maintain the norm of having one CHC
per 1,00,000 population, the present requirement is at least 7415 CHCs, against only 3043
CHCs. Moreover, in the 3,043 CHCs that we do have, only 440 have a pediatrician, only
704 have a physician, only 780 have a gynecologist and 781 a surgeon. So not only is the
infrastructure inadequate, we don't even have the staff to use the existing infrastructure.
Such a large shortfall in medical and paramedical personnel has got an important bearing
on the low priority of the documentation of the information, which should on priority basis
be attended by all concerned state/UT and central level health authorities.
6.
Central & State/UT Governments may bring an act for compulsory registration of all
private/ non govt, medical institutions and practitioners with the State/UT Government and
mandatory for them to furnish medical/health reports to appropriate Govt. Health Facility in
their vicinity.
7.
For Monitoring of Information & Evaluation System (MIES) an integrated format on
different health indicators is being developed under RCH/NRHM with an aim to ensure
uniformity in the health information collection system. It is expected that this format will
rationalize the information system avoiding the multiplicity of formats, weeding out
redundant information and thus leading to qualitative dissemination with varying
periodicity
♦ Rural Health Bulletin, 2006, MOHFW/GOI
32
8.
In order to maintain data quality which is required to be used as inputs for any decision
making, the exercise of validation at different levels hardly needs any emphasis. Since
NRHM had already initiated the concept of establishing Programme Management Units at
state and sub-state levels, their involvement in the validation process should be ensured. In
addition, possibilities may also be explored to associate and identify a nodal officer in the
district health offices so as to assume the ownership of data being transmitted from the
district to the state.
}
9.
What is most important is to remove any underlying apathy to collect the health
information and document them with greater speed and accuracy. This can. be achieved by
putting the right people at the right place having a data sense and data use. The States have
got a greater visible role to play to ensure this important aspect of HMIS. To improve the
quality of data, the grassroots level functionaries need to understand the importance
and use of data generated at their level so that the recording and reporting of data by them
could be improved. Also, the monitoring system at all levels need to be strengthened and
emphasis should be on monitoring of all programmes/components, strengthening feedback
mechanism and utilization of data at all levels for monitoring and planning purposes.
States/UTs may ensue all measures to fully utilize the in-service training programs of
CBHI on Health Statistics and Medical Coding (ICD-10) as well as Medical Record
Management, being organized for various categories of medical/non-medical staff involved
in handling medical/health data, for which purpose CBHI communicates its annual training
calendar well in advance to all States/UTs. For this purpose, every State/UT should
prepare district wise inventory of such training needs, people trained and remaining to be
trained and utilize this inventory for promptly recommending the names of untrained
personnel to various CBHI in-service training courses. The GIS mapping is an essential
tool now^a-days. NIC has already developed GIS maps up to the village level. The facility
should be availed by all the State/UT authorities for GIS mapping on various health
indicators.
10.
The Birth and Death Registration System in the country is still way behind and there is an
urgent need to improve the system. The Civil Registration System must be improved and
strengthened. For this purpose the ASHA, recruited under NRHM can also be utilized for
recording & reporting the birth and death cases to the appropriate authority with a suitable
honorarium.
11.
The capacity building of the Health manpower starting from grass root level is extremely
essential and allocation of funds for providing the training must be earmarked in this plan
period. The training on the electronic data management system should also be provided in
association with D/o IT and NIC.
33
12.
ICD-10 coding system be implemented throughout the country for comparison at
both, national and international levels and the use of ICD-10 be concurrently
monitored by hospital administration for timely corrective measures at various
levels, including meeting the ICD-10 trained manpower needs.
13.
As already decided by the MOHFW/GOI, it will be desirable to strengthen IDS? as
a national health information system with appropriate computer connectivity rather
than pursuing the HMIS which was conceived about two decades back and could
not succeed for various reasons. In the present context, this Union M/o Health &
FW is committed to ensure the efficient implementation of IDSP which is one of
the major projects undertaken with World Bank loan. Apart from the work on surveillance,
also attempt to collect information on financial, logistics, manpower and implementation
aspects in the health sector.
14.
Like CBHI has developed a central website for health information, the States/UTs may also
initiate efforts to develop similar websites along with district specific health information,
while utilizing the available expertise of state & districts NIC units.
15.
States/UTs may initiate steps towards computerizing the Hospital Information System in
a phased manner to begin with state/regional level hospitals. This will facilitate efficient
hospital database on morbidity & mortality based on ICD-10,
essential for
District/State/National Statistics on morbidity & mortality. Likewise at the grass root level,
on a pilot basis the use of Hand Held Electronic Device can be explored in association with
the Ministry of Information Technology.
16.
A National Institute of Health Infonnation System, as already recommended by NCMH
may be considered, for which purpose, CBHI be properly upgraded with necessary supports
from public health, statistics and national health programmes to play the role effectively.
This institute will also be responsible for Human Resource Development and research
studies. NIMS, ICMR may be involved in taking up evolution studies and operation
research periodically. The recommendation of National Statistical Commission to upgrade
’ the CBHI as a full fledged Directorate of Health Statistics as a nodal agency to provide
sufficient inputs on health statistics should be seriously pursued. The M & E division
of the Department of Family Welfare which is responsible for collecting and collating all
Family Welfare information including RCH should be merged in the proposed National
Institute of Health Information System. Keeping in view the recommendations of NRHM,
the synergy between the Health and Family Welfare Information System need to be
made and this Institute should be responsible for Monitoring and Evaluation of all
health related programme including RCH.
34
Report and Recommendations
of
SubGroup-II
on Telemedicine
for the XI Five Year Plan
Reflector
R^ftgSX-fRl*
1
I?
I
I
PMHtOUl
I
10™ FIVE YEAR PLAN (FYP) - FOCUS
INITIATIVES TAKEN DURING 10™ FYP
MAJOR THRUST AREAS DURING XI FYP
MANPOWER & FINANCIAL REQUIREMENT
36
REPORT OF SUB-GROUP II
The Working Group on Health Informatics including Telemedicine in its first
meeting on 5.7.2006 discussed the terms of reference and time schedule for its
functioning. It was decided in this meeting that the terms of reference would be gone into
in-depth by two sub-groups separately constituted for the purpose. Sub-group-II was
constituted with Mrs Ganga Murthy, Economic Advisor/ MOHFW as Convenor to look
into the following TORs: (i) To suggest modification in policies, priorities and
programmes during 11th Plan period, New initiatives and strategies such as telemedicines etc., so to improve quality and coverage of services at affordable cost and
also cope with existing, reemerging and new challenges in diseases, emerging
problems of non-communicable diseases due to increasing longevity, life style
changes and environmental degradation.(ii) To indicate Manpower requirement
and financial outlays required for implementation of these programmes during the
11th Plan period.
With the area of 32,87,268 Sq km. Population of 1.1 billion, urban-rural divide,
inaccessible hilly regions, islands and many tribal areas, India is an ideal setting for
telemedicine assisted health care delivery. Growing number of medical, paramedical
colleges and schools with lack of adequate infrastructure, learning materials and teachers
needs is a matter of grave concern. E health technology has the potential to create a
national level GRID which can form the backbone to be shared by healthcare providers,
trainers and beneficiaries. A strong fiber backbone and indigenous satellite communication
technology in place with large mass of human potential trained in IT and local presence of
telepathy industry, e health application and implementation should not be a problem technically.
Further a number of pilot projects over last five years with successful outcome stand to its
testimony. A ground work on telemedicine in the country has already been laid with the efforts of
ISRO and Information Technology department partnering with many State Government and
specialty Institutes/hospitals. Policy standardization and infrastructural issues have
already been researched. Professional societies on telemedicine/e health have been active. Print
and electronic media are participating in awareness campaign. However, a country level plan is
long due to steer the Telepathy ship by the Captain (M/o Health & Family Welfare/GOI) with its
crew (technology and healthcare providers/educators) and passengers (citizen) in right direction
(policy, implementation, application, security, social and legal issues) to reach at the
destination (Quality healthcare & wellness).
37
1. Focus & initiatives on telemedicine During 10th Five Year Plan period
The 10th Plan inter-alia had focused on building up a fully functional accurate health
’ management system, utilizing available IT tools, so as to enable the real time
communication link to send data on births, deaths, diseases, requests for drugs,
diagnostics and equipment, facilitate decentralized district planning, implementation and
monitoring.
-
A strong formulation for telemedicine in the country has been laid by ISRO and the
Department of Information & Technology partnering with many State governments,
hospitals and speciality hospitals. Issues of policy, standardization and infrastructure have
been delved into by them. Professional societies on telemedicine/ e-health are actively
engaged in its development.
Information Technology is now one of the major components of the
technological infrastructure for health management. All sub-sectors dealing with the
generation, transmission and utilization of demographic and epidemiological data such as
bio-informatics, bio-statistics, HMIS and the decision support systems (DSS) are finding
increasing use in health planning and management. The nationwide network of NICNET
provides rapid reporting mechanism for health information; MEDLARS Biomedical
Informatics Programmes provides ready access to medical databases to post graduates
and research workers as well as practicing physicians.
Planning Commission has
provided additional central assistance to the UHSs in Karnataka, Andhra Pradesh, Tamil
Nadu, Punjab and Maharashtra for strengthening of libraries and networking them
through IT. This effort has to be augmented and all medical colleges need to be brought
into the network.
1.1 Indian Space Research Organisation (ISRO)
ISRO has been actively engaged in applying space technology for healthcare and
education through specific initiatives which include inter-alia:
(a) Providing telemedicine technology and connectivity between remote/rural
hospitals and super-speciality hospital for tele-consultation, treatment and
training of doctors and para-medics.
38
(b) Providing technology and connectivity for continuing medical education between
medical colleges and post-medical institutions/hospitals.
(c) Providing technology and connectivity for mobile tele-medicine units for rural
health camps in the areas of ophthalmology and community health.
ISRO’s experience goes back to more than 2 decades of SatCom Application
Programmes namely “Training and Developmental Communication Channel” (TDCC)
and “Jhabua Developmental Communication Project” (JDCP) for application of SatCom
for rural development. The Telemedicine initiative developed in selected parts of the
country during the past 4 years has been one such effort to reach the Speciality Health
care to the rural and remote district / trust hospitals. The technology involved the ICT
based system consisting of customized medical software integrated with computer
hardware along with the medical diagnostic instruments and connected through the
telecom medium like ISDN or VSATs at each location. The initial pilot efforts had
adopted point-to-point telemedicine system wherein at a given time one rural end could
have tele-consultation with one specialist end.
The telemedicine software consisted
essentially of store and forward modules for tele-radiology, tele-cardiology and tele
pathology purposes alongwith video-conferencing facility.
With the growing demands of telemedicine facility by various States, “point-tomultipoint” connectivity through Local Area Network (LAN) and finally “multi point” to
“multi point” connectivity with Wide Area Network (WAN) with integration of the
facility for Continuing Medical Education requirement have been evolved and
established. ISRO has constantly been upgrading the technology with a view of bringing
down the cost both for the ICT hardware and sofhyare. Over more than 1,00,000 patients
have been treated in the ISRO network including the Army network, Mobile Tele
Ophthalmology for rural eye camps, telemedicine services for special situations catering
to the large pilgrim population etc. The aspects of development of business model and
also the involvement of medical insurance scheme is getting evolved gradually.
1.2 Department of IT, Ministry of Information and Technology
As with ISRO, the DIT has also started tele-medicine projects in different parts of the
country. DIT by acting as facilitator has taken initiatives for development of technology,
launching of pilot schemes and standardization of tele-medicine in the country.
the achievements of DIT in this regard include:
39
}
Some of
(a)
Development of tele-medicine software systems. Under the ongoing C-DAC
project, technology developed has been used for connecting 3 premier
institutions namely SGPGI, Lucknow, ADMS, New Delhi and PGIMER,
Chandigarh using ISDM connectivity.
(b)
Tele-medicine for diagnosis and monitoring of tropical diseases has been
implemented in West Bengal.
(c) An oncology network for providing tele-medicine services in cancer detection,
treatment, pain relief, patient follow-up and continuity of care in peripheral
hospitals of RCCs has been established.
(d) Development
of State-wise telemedicine network based on terrestrial
communication in the State of Himachal Pradesh.
1.3 Private Sector
A number of initiatives in tele-medicine have been made in the private sector, SGPIMS,
Apollo Hospitals, Asia Heart Foundation, Escorts and others are presently engaged in
extending consultations through tele-medicine and are conducting regular tele-education,
tele-consultation and tele follow-up sessions with patients.
1
1.4 Initiatives by State Governments
State-wise location & progress of telemedicine projects is at Annexure-III. Several
States have also come up with their own initiatives with the usage of information
technology.
A drug inventory monitoring and control system has been evolved in
Haryana. The med-centre of Haryana is an integrated software project to capture
utilization of medicine inventory data and analysis consumption pattern of various
medicines location-wise to monitor disease occurrence pattern, pilferages and any other
deviation in the functioning of the health institutions. The initiative of personal digital assistant
provided to auxiliary mid-wife in Nalgonda district of Andhra Pradesh is another illustration in
point. Through this device, ANMs could record patient information directly on the PBAs which
enable them to follow up cases, whether of pregnant women for ante-natal care or of children for
immunization.
In electronic format, this data can be also transmitted to higher
administrative levels. (Advantages of better targeting the beneficiaries for ante-natal care
and immunization and identification of high risk population in terms of illness). The tele
doc initiative of the JIVA Institute provides for field health representatives in villages
transmitting health information on mobile phones to doctors who then diagnose and
prescribe treatments according to which medicines are supplied.
40
2. Need for strengthening telemedicine / e-health initiatives in India
Despite the massive public health infrastructure, healthcare in rural areas remains a
critical challenge. The magnitude of healthcare services required in the context of the
existing shortage of medical officers and trained para-medics clearly demonstrate the
need for strengthening tele-medicine and other e-health initiatives over the next Plan.
The National Rural Health Mission provides an opportunity for taking tele-medicine to
the healthcare facilities at the primary, secondary and tertiary levels of care.
Computerization of health related data would be an essential first step.
With the establishment of about 300 Telemedicine nodes by Govt. I Private / Trust
agencies of which 175 nodes by ISRO all over the country and the experiences gained by
each of the implementation agencies have brought to bear some of the important issues
that needs to be addressed for future implementation strategies for the development of
telemedicine and e-health for augmenting the present healthcare delivery system in the
country.
Internet and mobile communication can enormously enhance connectivity between
grass-root health worker and medical specialists as well as translation and storage of data
from the field through the Centralized units.
Telemedicine aims at equal access to medical expertise irrespective of the geographical location
of the person in need. Recent developments in Information and Communication Technologies
(ICT) have enabled the transmission of medical images in sufficiently high quality that allows for
a reliable diagnosis to be determined by the expert at the receiving site.
Access to many different sources of medical data, usually geographically distributed, and the
availability of computer based tools that can extract the knowledge from that data are key
requirements for providing a standard healthcare provision of high quality.
Developments in the integration of bio-medical knowledge, advances in imaging, new
computational tools and the use of these technologies in diagnosis and treatment suggest that
Grid-based systems can make a significant contribution to this goal. In addition to enhancement
of improved access by integration of information, the benefits are raised to a new level, over a
Grid because of multi dimensional access to the information.
Medical informatics is often called healthcare informatics or biomedical informatics,
and forms part of the wider domain of e-Health. Medical informatics optimises the
computer analysis, storage, retrieval and transfer of patient and other health care data.
41
:■
3. Lessons Learnt during X Five year Plan:
•
Lack of IT infrastructure in the state governments health administration and the
district/taluk hospital.
•
Non- acceptability of telemedicine/e governance by doctors, patients and the
associated staff due to certain “fear of the unknown” and “fear of loss of opportunity”
which has retarded the speed with which the facility could be established.
•
X
The administrative and financial constraints by the State Health Administration for
supporting the implementation of telemedicine at the District Hospitals.
•
Lack of requisite infrastructure and financial support for establishment of the facility.
•
The cost of the equipments though progressively brought down considerably, is still
expensive for most of the hospitals and the Government establishments.
•
The communication bandwidth cost, presently provided by ISRO’s satellites free of
charge whereas others like BSNL and Private Agencies are charged which is
expensive for most of the Hospitals, Health Centre and even Super Specialty
Hospitals.
•
Need for enhanced public awareness of the advantages of Telemedicine / Tele-health
for medical consultations, treatment and postoperative follow-up.
I
•
The present Healthcare delivery system in each state has detailed procedures
established long time ago in terms of Medical Administration and practice covering
diagnosis, treatment, drug prescription and distribution, surgery and follow-up.
Continuing Medical Education and Training of Doctors and Paramedics etc., and they
have certain policy and operational guidelines. This requires to be extended or
additionally enunciated for appropriate implementing the technology based healthcare
delivery system of telemedicine / tele-health.
•
The policy aspects related to availability and utilization of information which
constitute medical Information and Communication Technologies (ICT) which
constitute the connectivity need to be integrated with the healthcare delivery system
effectively.
4. MOHFW/GOI has constituted task force vide order no. T 2105/1/2004-NCD in
September 2005 on Tele-Medicine in India for formulation of strategies regarding its
42
applications in Health Sector under the chairmanship of Secretary, Health & Family
Welfare with the following TORs:
1. To work on interoperability - Standards for data transmission; software, hardware,
training etc.
2. To define a National telemedicine Grid and consider its standards and operational
-'i
aspects. (The task force needs to consider connectivities to be provided in the next
two-three years, as currently there is certain ad-hocism in this process. Available
bandwidth etc. has to be most efficiently used for obtaining priority connectivites).
3. To identify all players and projects currently involved in telemedicine in India and
evaluate their performance, capacity and replicabilty.
4. To prepare pilot projects for connection of super speciality hospitals/ medical
colleges with district hospitals and /or CHCs / PHCs specially keeping in the mind to
provide access to remote areas. (The focus would be North-East, J&K, three new
States, other tribal areas and Lakshdeep).
5. To prepare National Cancer Telemedicine Network.
6. To examine possibility of utilization of stand alone centers of the depth Of
communication in rural areas.
7. To define standards and structures of electronic medical records and patient data base
which could be accessed on a National telemedicine Grid. For this purpose, the
national task force may constitute sub committees for developing electronic medical
records in various fields.
8. To enable the telemedicine centers in teaching institutions to impart training to all
govt. medical/Dental/Nursing Colleges in 3 years time (as there is a huge shortage of
teaching faculty).
9. To prepare curriculum and projects for CMEs through telemedicine.
10. To draft a National Policy on ‘Telemedicine and Telemedical Education and to
prepare a central scheme for the 11th plan.
Five subgroups have been formed to look into different matters:
Subgroup I: On Telemedicine Standards.
Subgroup II: For formation of National Telemedicine Grid.
43
Subgroup III-A: To identify players and framing evaluation framework for projects
involved in Telemedicine in India, prepare pilot projects (pending proposals, mobile
services, national medical Colleges network etc.) (TOR 3&4).
Subgroup III-B: For ONCONET INDIA (TOR 5).
Subgroup IV: For utilization of existing tele linkage facility in rural areas by
Department of Communication, Standardisation of e-records, training
and CMEs in telemedicine, human resources- medical informatics.
Subgroup V: For preparation of National Policy on Telemedicine and to prepare central
scheme for 1 llh FYP.
5. Initiatives Needed on telemedicine During XI Five Year Plan:
All these aspects will need to be carefully addressed in the XI Plan. The action plan
would need to take into account the following:
•
A massive awareness programme to the public, doctors and the hospitals staff about the benefits of telemedicine & e-health and its efficacy.
•
A proper inter-departmental coordination and cooperation to ensure adequate
support to the doctors and hospitals for commissioning, operation and maintenance of
the facility.
•
A cost effective business model by which the system can be made self sustainable
over a period of time.
•
Effort by the concerned Industries to ensure availability of the equipments and
facilities at reasonable and affordable costs.
•
Aspects of drugs distribution at the remote hospitals when provided with
teleconsultation/treatment by speciality hospitals.
•
Social aspects of telemedicine covering the licensing aspects of medical practitioners
I agencies including the legal aspects.
•
Aspects of private, public partnership for delivery of health care to the rural and
semi-urban population.
j
•
An appropriate policy by Government of India to provide bandwidth at affordable
cost.
•
Aspects of Continuing Medical Education & Training for Doctors, Paramedics and
Health care workers in the form of separate network.
44
/
•
Referral hierarchy for medical treatment, disease prevention and health promotion aspects.
♦
Introduction of academic courses on all aspects of Telemedicine / Medical information in
various Engineering and Medical Institutions.
5.1 The National Task Force is recommending a national telemedicine grid which will contain
the following major functions / constituents. The Task Force is already looking into the
connectivity, hardware, software requirements for projection under the IIth Five Year Plan
which could be incorporated in the Report of the Health Informatics Working Group.
Essentially the following is already under consideration of the Task Force:
a.
A health portal at the M/o H&FW providing all information related to health
informatics, telemedicine, disease surveillance data, medical care details and other
educational material or information related to specific Indian healthcare system not
available in the internet or hyper link to the internet data repository. This portal will be a
constituent of the national grid for repository of information and guidance.
b. An All India Medical Institution network connecting the various recognised medical
institution, national institutes like PGMER, AIIMS, JIPMER, SGPGI etc., and major
super speciality hospitals (Govt. & Private) in the country for medical education,
- ;»
exchange of knowledge, CME etc.
c.
An All India Network connecting the various selected district hospitals in the country to
be connected to major super speciality hospitals (Govt. /Trust/ Private) for specialist
referrals for consultation and treatment and also medical informatics, disease
information and health promotion aspects from different states of the country, (super
speciality hospital network).
d. A national network for medical training connecting various agencies in the country and
also establish/integrate similar networks at state levels. (National Medical Training
Network).
5.2 State Telemedicine/e-Health Grids (STG)
As a part of e-health program and digitalisation of health records some of the states have been
operating Telemedicine Networks initiated by ISRO and other agencies like Department of
Information Technology (DIT) under Closed Usage Group (CUG) concept e.g. Chhattisgarh,
Karnataka, and Kerala. Many more states are planning to implement such state level networks.
There is a need to formalise the state Telemedicine networks into standard State Grids for
specific purposes of application and usage like; providing State Health Information,
Monitoring and Surveillance of Disease/Epidemic outbreak, identification and mapping
susceptible areas and population etc., as mandated by MoH&FW for health governance.
45
5.3 National Medical Education Institutions Network (NMEIN)
A National Medical Education Institutions Network if created would act as a useful
resource base for knowledge sharing for Medical Education, Research and training including
CME. The teaching and practical sessions can be configured in live or recorded video, audio and
information data broadcast, accessed on the grid, for an effective learning experience.
5.4 Association / Society / Health portals Network (ASHPN)
Several associations/agencies are hosting and maintaining diverse health portals like
DOCTORYANYWHERE.COM in health care services.
It
is
necessary
to
pool
the
resources
available
with
the
various
autonomous/govemment/trust medical associations like Indian Medical Association (EMA),
Cardiology Society of India (CSI), Neurological Society of India (NSI), Federation of
Gynaecological and Obstetrics Society of India (FoGSI) etc and form an Association/society
/health portals Network.
■
5.5 Digital Library & Medical Informatics Network (DLMIN)
It is required to establish a Digital Library & Medical Informatics Network, that will be a
network of pooled information in the form of digital library of data bases and Medical/Health
Information that can be accessed through Internet / Intranet and used for administrative/research
and / or clinical purposes.
Some of databases of immediate value would include, but not limited to:
1.
Manuals of illness, diseases, symptoms, and diagnostic tools.
2.
National registry of speciality hospitals and specialists: names, contact
information.
3.
Health education programs and curricular materials.
4.
Medicines: description, side effects, location, costs.
Online journals, abstracts, preprints.
6.
Environmental profiles by state/region
(a)
Locations of safe water supplies.
(b)
Location of polluted sources (symptoms and treatment).
(c)
Location of emergency food supplies.
(d)
Location and description of health services.
(e)
Location of disease outbreaks.
(0
Changing environments.
46
5.6 Disaster Management Support Network (DMSN)
It is required that the health care services in times of disaster can be effectively provided
'J
through establishment of Disaster Management Support (DMS) Network. This network is
required to integrate identified disaster Monitoring Stations (current and proposed) across
the country and provide periodic and timely information both statistical and remedial to
the central station for necessary advice/action through the power of medical informatics
and digital connectivity.
Capacity building:
Thrust of health informatics education should be use of health
information standards, storage of health information in electronic health records and
research and extra collation of health information for better healthcare. Clinicians,
healthcare managers, technologists, researchers would all need to specialize in various
aspects of healthcare technologies. The course for skill development to include,
certificate course in computer application, education framework for general, para-medical
and nursing staff. These course would need to be certified by Medical Council of India.
6. Major thrust areas for 11th Five Year Plan
Focus in the XI Plan should be on:
•
Establishment of e-Health department in M/o H&FW in states D/o H&FW with
support of state IT Department.
•
Computerisation of health care delivery system and health records at state,
institutions, district and taluk / block level for the flow of information over the
network.
•
Computerisation of three tier healthcare system: CHC/PHC & SC.
•
To acquire and implement IT equipments like servers and client systems, multicast
video conferencing facilities, data storage and archival facilities in all the speciality
hospitals, medical institutions and other centres of excellence who will be providing
teaching and training facility.
•
To identify agencies within the medical institutions / speciality hospitals / research
institutions to develop content for medical education / CME / training modules.
•
To acquire and implement terrestrial / wireless / satcom technologies required for
various connectivities from taluk / block to district to the state capital.
47
• To plan for one dedicated medium weight class Communication satellite
(HEALTHSAT) for satcom based connectivity which will have the capability to meet
the broadband connectivity requirements for various applications of the National
Grid.
•
The cost of HEALTHSAT with launch, operations and maintenance of the satellite is
around Rs.400 crores. Apart from this, the various connectivity charges by other
technologies have to be incorporated. The present cost of a standard telemedicine
node including computer hardware/software and video conferencing system is around
Rs.4.0 lakhs at the district hospital level. Whereas at the CHC / PHC level the cost
will be around Rs. I to 1.5 lakhs. . Hence number of nodes which will come up during
the 11th Five Year Plan upto the block level may have to be worked out.
•
All tele-medicine network should evolve around a National tele-medicine grid.
Ultimately, every individual would need to have a unique ID.
•
Formal specific training programmes in tele-health for all levels (grass-root to policy
makers depending on requirements) and facilitate a support system to provide current
information to doctors in the management of patients through new data bases,
software packages etc.
•
Medical Council of India to include Information Technology in healthcare in the
curriculum of all medical and para-medical degree courses. Information Technology
•>
to be also included in all FT and MBA courses.
•
Introduce at least one mobile van in each district.
•
Trauma care, ambulance on National Highways to be provided with technology for
transmitting audio-video images using EDGE, GPRS, MMS etc. Pilot studies using tele
medicine and ambulances would be required.
•
Setting up of a Tele -health Corporation of India. Given the highly specialized and technical
nature of tele-medicine, a Tele-medicine Board of India needs to be established under the
aegis of the Ministry, which will include a set of technical experts with representatives from
major healthcare organizations and NGOs working for tele-medicine. The basic objective of
this Board would be to oversee the growth of tele-medicine, develop R&D tools, provide
software, manage the National tele-medicine grid and interact with international
organizations.
•
E prescriptions at all levels by the end of XII Plan but to cover atleast PHCs and
above during the XI Plan. This will necessitate availability of computers and net
facility at all healthcare facility.
48
•
Minimum standards of treatment to be documented and made available on the
Ministry of Health website. Details should be available regarding new drugs, banned
drugs, new indications, list of essential drugs, adverse effects, standard treatment
protocol, drugs of choice etc. Skill, knowledge and care should be the comer stone of
what we strive for.
.•
Magnitude of care may vary at different levels but the standard of care to remain the
same. This will be possible once the standard treatment protocols are available and
will help in identifying the kind and nature of drugs to be placed at each level and the
financial requirements for making available these drugs at different health facilities.
•
Synergy amongst all existing initiatives and programmes between different
Departments/Ministries in the area of health:
TCI network being created under Department of IT.
North-Eastern Council initiatives with support from ISRO.
E-govemance initiatives like common service centres under Department of
IT.
Integration of existing infrastructure like CBHI, IDSP, NICD etc. in the
Ministry of Health & F.W. to have proper synergy between them and avoid
duplicacy in data collection, compilation and transmission.
Proposed Tele-medicine project by Delhi Government.
Any other State initiative/Central project which will cater to health needs
and requirements.
Tele-medicine would require minimum bandwidth connectivity which facilitates video
conferencing, image, x-ray, medical transcription etc.
7. Financial and Manpower requirements
Tele-medicine/Health Information Unit upto the District level
The objectives of this would be to facilitate proper data collection, compilation, storage
and facilitate analysis and flow of information. The end objective would be to create the
basic foundation structure and build in future the Tele-medicine grid and take on egovemance activities.
49
7.1 Total number of units to be covered under telemedicine programme
SI.
TMd
ITEMS
No.
1
District Hospitals
604 (As per NIC website)
2
Government Medical Colleges
115 (Only Govt. Medical College excluding
Trusts, Societies, Pvt.)
36
State Headquarters
3
(Jammu
&
Kashmir
has
twoseparate
Division).
4
755
Total
7.2. Manpower required and financial Implication
Items
SI. No.
Expenditure
Total cost in a yea
1
I Supervisor
Rs. 10, 000 per month
9.06 Crore
2
1 Data Entry Operator
Rs.6500 per month
5.90 Crore
3
Total for the annual Plan
Rs.16, 500 per month
15 Crores
4.
Provision for Xlth five year plan:
80 Cn
(a) Equipments
•A
Total Cost
ITEMS
SI. No.
Financial assistance for equipments @ Rs. 10 lakh each unit f Rs. 75.5 Crs.
1
units
Maintenance @Rs. 2 lakh per annum/unit X 5 years for 755 un Rs.75.5 Crs.
2
Rs. 151 Crs.
Total
This can be provided in a phased manner (in three years) with a provision of Rs.
50 Crores in annual plan 2007-08,2008-09 and Rs. 51 Crore in 2009-10
(b) Cost of Computerization at PHC level:
SI. No.
1.
Total Cost
ITEMS
Computer with 5 years on-site maintenance with spares & trainir Rs. 80.90 crores
@ Rs.35,000 per PHC per annum X 23109 (PHC).
This also can be provided in a phased manner (in two years) with a provision of
Rs. 40 Crores in annual plan 2007-08 and Rs. 41 Crore in 2008-09.
50
(c) Health Channel
There should be one dedicated Health Channel from Doordarshan. It should cover the
areas like Education to UG, PG and Post PG Courses; Education to medical practitioners;
Consultations; News at certain intervals; National programmes, disease forecast, helpline
one hour a day, live OPD etc. It should be made mandatory to all cable operators to
beam this channel.
.
30 minutes programme
•
12 hours per day
.
30 days every month
•
30 X 24 = 720 programmes per month
.
Total cost per month = 720 X 2 lakhs = Rs. 14.40 crores
.
Total cost per year = Rs. 14.40 X 12 = Rs. 172 crores
.
Software development of programme can be for Rs. 100 crores instead of Rs. 172 cores
•
Also equipments = 25 Crores
.
Total cost in the entire plan period = 125 Crores (Entire expenditure to be taken
during the first year of the Plan period)
7.3 Other Expenditure
7.3.1 Digital ECG Machine at District hospitals Rs. 20,000 X 604 Hospitals = 1.2 Crore
7.3.2 Web-site and Content Development = Rs. 5 crores
There should be a national health website covering various aspects like Standard
Treatment Protocols, links to various health related website etc.
7.4 GRAND TOTAL: Rs. 443.2 Crores - for the entire Five Year Plan
I
Year wise Annual Plan requirement
Year
Amount
2007-08
2008-09
2009-10
2010-11
2011-12
Total
236.2
108.0
67.0
16.0
16.0
443.2
Rs.in Crores
****:****
SI
WG:
REPORT OF THE
WORKING GROUP ON
HEALTH SYSTEMS RESEARCH,
BIOMEDICAL RESEARCH & DEVELOPMENT
AND
REGULATION OF DRUGS & THERAPEUTICS
i
11th FIVE YEAR PLAN
(2007-2012)
I
GOVERNMENT OF INDIA
PLANNING COMMISSION
September-2006
CONTENTS
Preface
i
Executive Summary
ii
1. Introduction
2. Biomedical Research : Current scenario
and future projections
J
>
j
11
3. Product Development and Evaluation
32
4. Inter-agency Collaboration and Translating
Research into action
50
5. Human Resources Development for Health
and Biomedical Research
54
6. Biomedical Research Information Technology
58
Bibliography
3
1
Annexure
68
69
Preface
The Planning Commission had constituted a Working Group on Health
Systems Research, Biomedical Research and Development and Regulation of
Drugs and Therapeutics for the 11,h Five Year Plan vide its order
No.2(11)/2006-H&FW of 25th May, 2006 (copy placed as Annexure). The
Director-General of the Indian Council of Medical Research was named the
Chairman with 21 other members.
The membership included representatives of various Departments (CSIR,
Health & Family Welfare, Science & Technology, Biotechnology, and AYUSH)
Directors of relevant Institutes (Central Drug Research Institute and Industrial
Toxicology Research Centre, Lucknow; Indian Institute of Health Systems,
Hyderabad, Indian Institute of Technology, Chennai, Indian Institute of Science,
Bangalore) Drugs Controller General of India, eminent scientists (Dr. Ranjit Roy
Choudhary, Dr. Somnath Roy, Dr. Y. Atal), representative NGOs (Voluntary
Health Association of India, Centre for Equity into Health & Allied Themes) and
officials from Planning Commission and Ministry of Finance.
Dr.Gerald Keusch, Director, Global Health Initiative, Boston University, who
was a member of the Performance Appraisal Board (PAB) of the ICMR, was in
New Delhi during one of the meetings of the Working Group. He was also
invited to interact with the members.
The Chairman had co-opted Prof. Indira Chakroborty, Director, All India
Institute of Hygiene and Public Health, Kolkata and scientists/officials from the
ICMR for their inputs in view of their experience and expertise (Dr. A. Pandey,
Director, National Institute of Medical Statistics; Dr. Bela Shah, Sr. Dy. Director
General, Division of Non-Communicable Diseases; Dr. V. Muthuswamy, Sr. Dy.
Director General, Division of Basic Medical Sciences; Dr. D. Mukherjee, Chief,
Division of Epidemiology; Dr. K.K. Singh, Chief, Manpower Development and
Dr. Malabika Roy, Coordinator, Division of Reproductive Health and Nutrition).
The Working Group met twice. In the first meeting, the members deliberated
on the modus operandi and offered suggestions. They agreed to provide their
own and/or their parent organization’s inputs on each Term of Reference.
Based on these, a draft report was prepared and circulated to the members.
The second meeting was taken by the Chairman to finalize the report.
This report is the outcome of invaluable contributions provided by the
members.E
r•
9
Executive Summary
Health of a country depends to a large extent on the quality and reach of the
health system as well as the support provided by the health research system to
respond to the health challenges. With the development and use of
sophisticated tools of modern biology, a better understanding of complex
interplay between the host, agent and environment is emerging. This is
resulting in the generation of new knowledge. One of the greatest challenges
that the health community faces today is to find means of bridging this know-do
gap. This scientific knowledge is to be used to develop drugs, diagnostics,
devices, and vaccines which should find a place in the health systems of the
country. A vibrant inter-phase between the research community, the industry
and the health systems is the only way to facilitate this.
In order to make meaningful suggestions and recommendations for the 11th
Plan period on the areas identified in the Terms of Reference, it is prudent to
look at the existing scenario, the lacunae therein, and the future challenges.
From this would emerge the areas that need strengthening as well as the new
initiatives required. The Reports of the National Commission on Health and
Macroeconomics, the Performance Appraisal Board of the ICMR, and several
other national and international publications were reviewed.
As a result of the advances made by the country in various fields, the health of
the common man has improved but it could have been better. It is not only the
technological advances in public health and medicine that influence health of
the population. The epidemiology of disease extends beyond biology. A
sociological perspective is important to understand the occurrence, persistence
and cure of a disease. The diseases are not rooted in biological causes above,
but are multifactorial. This calls for an inter-disciplinary approach to health
research. The 11,h Plan, therefore, should mark a departure in its orientation.
No amount of pure bio-medical research will be able to find solutions to health
issues unless it addresses upfront the social determinants of health.
1. The absence of a national health research policy, weak health research
system, neglect of health systems research, inadequate capacity to plan
and implement, lax monitoring and evaluation system, priority setting not
done on accepted scientific principles, inadequate budget for health and in
turn for health research, narrow research base in medical colleges and
other institutes, lack of policy, plan or management of human resource
development for health research, neglect of translational research, and notso-strong inter-agency collaborations all have contributed to the current
state. Many of these factors have been repeatedly highlighted in reports of
various committees the. latest one being that of the National Commission for
. Health and Macroeconomics.
<
ii
Several of these factors would be addressed once the decision of the
Ministry of Health & Family Welfare to create a new Department of Health
Research within the Ministry is implemented. This decision has been hailed
as one of the most significant steps the Government is taking to elevate
health research to centre stage of health promotion and care. It is hoped
that with this initiative health research would be able to contribute effectively
towards country’s economic and human development.
Each agency involved in health research has worked out a detailed plan of
activities for the 11th Plan period which they would submit to their respective
Ministries. Some important cross-cutting generic issues which need
attention are:
• enunciate National Health Research Policy
• develop a National Health Research System
• formulate a National Health Research Plan
• attach high priority to Health Systems Research
• inculcate a culture of research in medical colleges and other
institutes by providing opportunities to participate in capacity building
and infrastructure development programmes
• promote good governance of health research
• Strengthen partnerships at all levels-local, regional, national and
international among all the stakeholders.
• identify current and future needs of human resources
• enhance allocation for health and health research
• facilitate translational research
New Institutes have been recommended to address some of the important
areas. For example, Schools of Public Health, Clinical Trial Centre, Centre
for Cardiovascular Disease, Diabetes and Stroke, Animal Resource Facility,
Institute for Research on Ageing etc.
2. In order to address the issues surrounding development, testing and quality
control of drugs and devices, the Government had set up several
committees. Most prominent among them was Mashelkar Committee which
was mandated to undertake a comprehensive examination of drug
regulating issues including the problem of spurious drugs. This Committee
has recommended creation of a well equipped and professionally managed
CDSCO which could be given the status of Central Drug Authority of India.
It also calls for strengthening of the State level regulatory apparatus, use of
scientifically and statistical valid methods for quality checks, and
amendment of Drugs and Cosmetics Act to check manufacture and sale of
sub-standard drugs.
Specific recommendations have been made on ethical and IPR issues;
regulation of recombinant pharmaceuticals, food including nutritional
supplements, genetically modified foods; biologies,, biobanks, stem cell
iii
research and devices. The need for establishing clinical trial centers and a
registry has been emphasized.
The AYUSH component has negligible visibility in terms of Drug Controllers,
Drug Inspectors, Drug Analysts and other manpower required to regulate
quality of formulations of indigenous systems of medicine. Though the
Department of AYUSH has launched a scheme to develop Standard
Operating Procedures of manufacturing process to enable maintaining of
quality of these products, still lots of work needs to be done for
standardization and quality control.
During the 11th Plan period
strengthening/upgrading of various drugs, testing laboratories, ensuring of
availability of genuine raw materials, strengthening of drugs control
department of states and at central level, development of herb
garden/museum/herbarium are other priority areas that need to be
addressed.
3. The human resources capacity for health research is a measure of country’s
capacity and capability to effectively address the existing and future
research agenda. Though the ICMR and other agencies and Institute offer
some very high quality training, but such opportunities are few and only a
small number of scientists get trained. It is therefore, important to assess
the current and future needs of scientific manpower in various disciplines
using appropriate analytical methods. There should be an organized and
focused effort towards formulation of a long term comprehensive human
resource development policy and plan to address wide range of related
issues. The career opportunities should be made more attractive for
scientists. The compensation package being offered to scientists should be
made generous to retain and attract bright brains.
4. Each agency engaged in health research has an elaborate peer review
system of its research activities to address and monitor research in priorities
areas. In addition, there are strategies to facilitate better utilization of
results of research by the health systems. During the 10th Plan period, new
initiatives to enhance inter-agency collaborations have been taken like the
Golden Triangle (AYUSH-CSIR-ICMR) and DBT-ICMR MOU to work
together on areas of mutual interest. There is significant scope of further
improvement in inter-agency collaborations for addressing priority areas and
to avoid duplication of efforts. An overarching National Health Research
Management Forum is suggested. In this, all key stakeholders would be
represented and it would advise on and evolve national health research
policies and priorities and suggest mechanisms and action plan for their
implementation; facilitate utilization of research results and review research
management and recommend strategies to overcome problems in
implementation of polices.
. iv
5. Access and utilization of health research information is critical for research.
There are thousands of journals, reports, status papers and other
documents that are produced every year. Many of these do not come in the
realm of formal literature. Their availability is limited in the existing system
of information and communication. To effectively search and retrieve the
most relevant information the availability and use of appropriate technology
like computers, computer readable data-bases, CD-ROM technology, and
satellite based tools etc. is necessary to meet the requirement. ICMR and
other agencies have taken very concrete initiatives to improve the access to
national and international health information.
MEDLARS Biomedical
Informatics Programmes provides ready access to medical databases to
researches. Ground work on telemedicine in the country has already been
laid with efforts of ISRO and Information Technology Department. The
NCMH has already recommended setting up of a National Institute of Health
Information System. A National Medical Education Institutions Network is
also suggested for the country. This would act as a useful resource base
for knowledge sharing for Medical Education, and Research. The country
should also have a Digital Library and Medical Informatics Network. This
would be a network of pooled information in the form of digital library of
data bases and health information that can be accessed through
internet/intranet and used for research purposes also. The libraries of
medical colleges and other institutes should be modernized to bring them to
a certain minimum benchmark in term of infrastructure, databases and
services offered. Steps toward national resource sharing and networking of
the libraries should be taken. This would also help to improve the
accessibility of health information. S
10598 r0^
V
CHAPTER - 1
Introduction —
A sort of revolution in health research is underway. New insights have been
gained into the human body. Humans are understood as social beings
whose health is influenced by an intricate interplay amongst the biological,
genetic, social, economic and environmental determinants of health.
Outcomes of this revolution in health research are transforming the way
diseases are diagnosed, treated, and prevented as also the methods for
promotion of health.
Significant advances in better understanding of human health and disease
are also being boosted by new ways of thinking, new technologies, new
partnerships, and new industries. The complexity and scale of today's health
research challenges increasingly require that researchers reach out beyond
their own areas of expertise and establish partnerships that bring people
who share a common vision and interests together.
Health challenges and disease know no boundaries. Public safety and
security requires a health system and a research community that can
respond quickly and appropriately to rapidly emerging health concerns.
While health research has made appreciable progress there remains an
unacceptable lag time in translating the research outcomes into tangible
health products or in application of the knowledge generated through
research. Thus, the task is of how best to mobilize research to bridge the
gap between what is known and what is done - the 'know-do' gap. Equally
important is to ensure that the products of health research reach and are
used for and by the people who need it most. Health research should be
directed to provide ways and means of bringing about equity and improving
access to health technologies.
The health of the population would not only be influenced by the
technological advances in medicine and public health but also by the
changes in structure of the society. Some of these changes are bound to
happen like the demographic transition, (increasing in age-segment of more
than 60 years), modification of life styles (increased consumption of alcohol
and tobacco and consequent effects on health) and the changing
environment (urbanization, occupational diseases, injuries and accidents).
The 11th Plan should aim to create a healthy environment which can
decrease the admissions to hospitals. This cannot be achieved by actions of
health sector alone. Health.is an outcome of interplay between various
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'
variables like clean environment, potable and safe drinking water, sanitation,
housing, infrastructure facilities, education and income. An inter-sectoral
and inter-disciplinary approach would be critical.
The crude birth rate has decreased from 41.7 in 1951-61 to 24.8 in 2002-03,
and crude death rate has fallen from 25 to 8 in the same period. Maternal
mortality ratio has decreased from more than 5 to less than 2 and infant
mortality rate has decline from 146 to 60. The total fertility rate has declined
from 6 (1970-71) to 3 (2002-03). Small pox and guinea worm have been
eradicated. Leprosy has been eliminated as a public health problem.
Significant progress has been made in fight for polio eradication. It is
believed that since the introduction of Directly Observed Treatment Strategy
(DOTS) in the country over 500,000 deaths have been averted due to
tuberculosis. The number of malaria cases have been contained at about 2
m a year.
The country is burdened with infectious diseases alongside the emergence
of non-communicable diseases. Management of some of these is quite
costly for example diabetes, vascular diseases, hypertension, mental health,
cancers, injuries, respiratory infections etc. Contrary to popular belief, these
lifestyle diseases do not spare the poor. The investment in public health is
low and the state of health systems is unsatisfactory. Coping with these set
of new diseases along with existing diseases calls for reforms in India's
health system.
The Report of the National Commission on Macroeconomics and Health
(NCMH) builds a strong case for investing in indigenous research and
encouraging Indian companies and universities in partnership to engage in
R&D for drugs, medical devices and vaccines relevant to the needs of India’s
poor. For developing a culture for research, the Report suggests that the
Government should initiate steps to debureaucratize procedures, introduce
greater transparency, provide incentives and adequate flexibilities to enable
engaging and retaining the best minds to undertake research - both in public
and private universities and research institutions. There is also a compelling
need to build multidisciplinary research blending physical, medical and social
sciences. Besides, there is also an equal urgency to establish regulations,
strict ethical norms and transparency, standardize methodology and
international standards of research. Such capacity is necessary for
undertaking operational research as also large-scale trials of drugs of both
modern and traditional systems of medicine.
Report of WG on HSR, Blomed R & 0, Regulation of Drugs and Therapeutics... 2
The Planning Commission’s Approach Paper to the 11th Plan provides the
general directions, and the recommendations of the National Commission on
Macroeconomics and Health the road-map to develop a blue print for health
systems research, biomedical research and development, and regulation of
drugs and therapeutics.
Future Challenges
Report of the National Commission on Macroeconomics and Health has
provided a glimpse of the future challenges that the country is likely to face
by the year 2015. This would provide the basis of development of research
agenda.
Demographic Changes
At present, the elderly population in India constitutes approximately 7% of
the total population. This is likely to increase to about 20% by 2050. India
will have a population of 137 million of older persons in year 2020. Chronic
diseases disabilities, mental illnesses, visual, locomotors and hearing
impairment are major health challenges in this age group. It is important to
ensure that living longer should mean living healthily. The focus of research
should be on how to prepare for this change in demographic structure. It
should not be adding years to life but life to years - how to ensure that years
added to life are not the years of ill health and disease. In addition to
equipping medical facilities to handle the disease profile of the aged, a
healthy environment has to be created so that old age does not become a
victim of surrounding million and become a resident of hospices and
hospitals. With growing number of senior citizens, there would be substantial
increase in health care needs. Increasing availability and awareness about
technological advances for better understanding of these problems raise the
expectation of the population for acceptable, affordable and sustainable
interventions. Health research will have to gear up to make available
necessary preventive, promotive, curative and rehabilitative strategies for
growing population of senior citizens.
Disease Burden
I. Communicable Disease
1. HIV
Based on the surveillance data, it is estimated that there are 5.1 million
adults with HIV infection between 15 and 49 years. An estimated
additional 50 million people are likely to become HIV positive by the year
2025; and some 15-18 million by 2015. Women have a two-fold higher
incidence, largely due to female sex workers as well as higher biological
susceptibility of women to HIV-1 infection. What is worrying is the
projection of an increasing number of HIV infected women from among
the low-risk category.
2. Tuberculosis
According to ICMR’s Tuberculosis Research Centre, an estimated 3.8
million bacillary cases and 3.9 million abacillary cases, (totaling to 7.7
million) were suffering from TB in 2000. In this estimation the possible
association of HIV and multi-drug resistant (MDR)-TB are not included.
An estimated 400,000 die of the disease each year. This makes TB the
single most important cause of death in India. While no future projections
for TB in India are currently available, it is expected that an expanded
HIV epidemic will greatly increase the numbers with active TB weakening
the affected individuals' immune system in a population with high rates of
M.tuberculosis infection.
3. Malaria
Malaria, dengue and some other conditions fall in the category of ‘malaria
and vector-borne diseases'. In 1998, these were estimated to account for
1.6°Zo of India's total disease burden. This is likely to be an underestimate
of the true disease burden of these conditions.Data show that the
prevalence of reported cases of malaria (per 1000 population) declined in
India during the period 1995 to 2003 but the proportion of Plasmodium
falciparum cases, a serious form of malaria that is also expensive to
treat, increased during the same period at the all-lndia level-from 38.8%
in 1995 to 47.5% in 2003. With increasing resistance of the malarial
parasite to available drugs, and without effective interventions, one may
even see an increase in the disease burden from malaria in the future.
4. Emerging Re-emerging infections
During the last three decades, 30 new infections have been reported
globally. India too had some experience of BARS and later of avian flu.
Outbreak of encephalitis due tp Chandipura virus was reported in Andhra
Pradesh and Gujarat. Nipah virus outbreak happed in Siliguri, a new
strain of V.cholerae 0139 emerged, diarrhea due to Group B adult rota
virus was detected in Kolkata so was V.parahaemolyticus 03:K6. The
threat is also posed by terrorist groups using natural or genetically
engineered strains of microorganism with evil intent. Stepping up
specialized disease surveillance is corner stone to emerging infectious
disease threat. Laboratories with adequate biosafety levels would be
needed and trained staff to work in them. Repositories of important
microorganism would be needed to compare and study genetic changes.
Animal facilities would be required to under take animal studies and
development of diagnostics and other tools. Japanese encephalitis is
spreading from rural to urban areas and dengue from urban to rural
Report of WG on HSR, Biomed R & O, Regulatlon'of Drugs and Therapeutics... 4
areas. The annual number of cases are increasing and so is the number
of deaths. And now Chikungunya is reported to be spreading.
•"5
II. Non-communicable Diseases
1. Cardiovascular Diseases
Starting from a level of about 38 million cases in the year 2005, there
may be as many as 641 million cases of cardiovascular disease (CVD)
in 2015; and the number of deaths from CVD will also more than double
mostly on account of coronary heart disease - a mix of conditions that
includes acute myocardial infarction, angina pectoris, congestive heart
failure and inflammatory heart disease, although these are not
necessarily mutually exclusive terms. The rates of prevalence of CVD in
rural populations will be lower than in urban populations, but will continue
to increase, reaching roughly 13.5% of the rural population in the age
group of 60-69 years by 2015. The prevalence rates among younger
adults and women (in the age group of 40 years and above) are also
likely to increase.
2. Diabetes
Diabetes, also associated with an increased risk for CVD, is emerging as
a serious health challenge in India, even though it accounted for only
about 0.7% of India’s disease burden in 1998. It is estimated that there
may be a significant load of diabetes cases in India-rising from 31 million
in 2005 to approximately 46 million by 2015, and particularly
concentrated in the urban population.
3. Cancers
In India, cancers account for about of 3.3% of the disease burden and
about 9% of all deaths. These estimates will, however, surely change as
many of the common risk factors for cancers, such as tobacco and
alcohol consumption, continue to become more prevalent in India. It is
estimated that the number of people living with cancera will rise by nearly
one-quarter between 2001 and 2016.- Nearly one million new cases of
cancers will be diagnosed in 2015 compared to about 807,000 in 2004,
and nearly 670,000 people are expected to die.
4. Mental Health
Nearly 65-70 million people in India are in need of care for various
mental disorders in all age groups. This estimate excludes a large group
of common mental disorders like phobia, anxiety, disassociative
disorders, panic states, mild depression and substance abuse (varying
spectrum of associated hazardous use). It is difficult to establish the true
burden of all these disorders but has been estimated to be nearly 20.5
• million people.. Alcohol related problems are increasing in India nearly 62
million people predominantly men - are likely to be current alcohol users
with nearly 10.2 million being alcohol dependants and about 30 million
alcohol users.
5. Chronic and Obstructive pulmonary diseases and asthma
It is estimated that there were roughly 15 million chronic cases of COPD
in the age group of 30 years and above, and 25 million cases of asthma
in 2001 in India. These numbers are projected to increase by nearly 50%
by the year 2016, including ‘severe’ cases, some of whom may require
greater levels of care, including hospitalization.
6. Accidents and injuries
Data from Survey of Causes of Death and Medical Certification of
Causes of Deaths reveals that 10-11% of total deaths in India were due
to injuries. It is estimated that nearly 8,50,000 persons die due to direct
injury related causes every year in India during 2005, with 17 million
hospitalizations and 50 million requiring hospital care for minor injuries.
By 2015, the toll is expected to rise to 1.1 million deaths and 22 million
hospitalization and 53.0 million minor injuries in the absence of any
positive intervention. While official reports capture majority of these
deaths, domestic and occupational injuries, falls, drowning, animal bites
and injuries in disaster go unreported.
7. Oral Health
The number of cases of the various oral health conditions is expected to
increase by 25% over the next decade.
8. Suicide
Suicide is major public health problem and is among the top ten causes
of death in most countries. In India, total numbers of suicides were
38829 in year 1967, which has increased to 110851 in the year 2003
(National Crimes Records Bureau). The numbers of suicides (during
decade 1993-2003) have increased at an annual compound growth rate
of 3.11 per cent as against the corresponding population growth rate of
only 1.9 per cent.
Recently, suicides by students (pressures of
examinations) and farmers (economic pressures) have brought into
sharp focus the need for research in this neglected though important
area. With increasing urbination, the stress factor is likely to also
increase and may prove to be a trap for larger number of suicides among
the vulnerable population.
9. Strokes and Neurological Disorders
The estimates for the burden of NCD by ICMR indicated the prevalence
rate of stroke to be 1.54/1000 in age group 20 years and more with a
death rate of 0.6/1000 (2004). The number of cases of stroke in India
increased from 0.79 million in 1998 to 0.93 million cases in year 2004,
Report of WG on HSR. Biomed R.&D, Regulation of Drugs and Therapeutics... 6 -
whereas DALYs attributable to stroke increased from 5.8 million in year
1998 to 6.4 million in year 2004.
III. Problems of Urban Health
India’s urban population is 285 million which amounts to nearly 30% of
the total population. The urban growth will account for over two thirds of
the total population increase in the first quarter of this century. Slum
population growth will continue to outpace growth rates of India, urban
India and mega cities. Demographers refer to this as the 2-3-4-5
syndrome; in the last decade, India grew at an average growth rate of
2%, urban India grew at 3%, mega cities at 4% and slum population
increased by 5%. By 2030, the urban population is expected to reach
297 million. Official estimates do not account for unrecognized squatter
settlement and other populations. Population projections postulate that
slum growth is expected to surpass the capacities of civic authorities to
respond to the health and infrastructure needs of the urban population.
Lack of water and sanitation and the high population density in slums
facilitates rapid spread of infections. Poor housing conditions, exposure
to heat or cold, air and water pollution and occupational hazards add to
the environmental risks for the urban poor. The urban health is also
vulnerable, as they do not have back up savings, food stocks or social
support systems to help them during illness. Thus, even though there is
a concentration of health care facilities in urban areas, the urban poor
lack access to health care. Urban health initiatives in the country to date
have been limited and fragmented.
The challenge of increasing
urbanization with growth of slums and low-income families in cities has
made access to health care for the urban poor a matter of priority. It may
be necessary to create a separate unit with multi-discipline expertise to
address this issue.
IV. Nutritional Problems
The incidence of nutritionally poor population, particularly the rural poor,
is the quite high in Orissa, Bihar, Madhya Pradesh, Uttar Pradesh and
Andhra Pradesh. Another related issue is the problem of hidden hunger as the problem of micronutrient deficiency. While estimates suggest that
800 million people are undernourished, the number of people suffering
from micronutrient deficiency is as high as 3.5 billion globally; a very high
percentage of these are in India. In India, the magnitude of iron
deficiency is perhaps the greatest. Thus, for example, 70% of pregnant
women in India suffer from iron deficiency anaemia (IDA); and the figure
for young children is also high. Between 10 and 20 million children in
India suffer from vitamin A deficiency (VAD) and 60,000 annually go blind
because of VAD. The consequences of these deficiencies, in terms of
impaired physical and cognitive development, disability and mortality are
correspondingly staggering. There is a need to develop appropriate
vehicles for these micronutrients. With the increase in the availability of
processed food and development of food industry, food safety has
emerged as an important issue. High levels of certain chemicals in
ground water (like arsenic) and use of unacceptably large amounts of
pesticides in agriculture, find their way in food stuffs consumed by
people. There is an urgent need to develop technology to deal with such
toxic agents in the food chain. Energy requirements for special groups
like women who have to walk several kilometers to draw potable water or
collect wood for fuel needs to be addressed by development of low cost
technology.
V. Reproductive and Child Health (RCH)
According to the NRHM maternal, perinatal and childhood conditions
account for a significant percentage of the disease burden. The IMR is
about 66 per 1000 live-births, a substantial improvement over the levels
nearly 30 years ago. The under-five mortality rate (U5MR) was estimated
at 95 per 1000 live-births in 1998-99, and is declining at a rate similar to
that of the IMR. Two-thirds of deaths occur within the first week of birth.
About 35 babies of every 1000 childbirths die within one month; 30
before one year and 26 between 1 and 5 years of age. In India, the ratio
of the neonatal death rate to the 1-5 year death rate is 1.3, against 10 in
developed countries. Therefore, any strategy to reduce child deaths must
focus on all three age periods, as focusing on any one may result in
merely shifting the burden to the other. There is a reported decline of the
maternal mortality rate (MMR) from about 580 per 100,000 live-births
during 1982-86 to 540 per 100,000 live-births in 1998-99(NFHS-II).
Significant improvement has taken place in reproductive health of the
population. The couple protection rate has increased from 1.4% in 197071 to 50-52% in 2002-03 and total fertility rate has declines from 6 to 3.
However, there are problem areas which need to be tackled. Maternal
mortality, infant and neonatal mortality are still very high. Main causes of
maternal mortality are unattended delivery, obstructed labour, post
partum complications and unsafe abortions. Use of spacing method
(about 6%) and male participation (7-8%) are very low. Unmet need for
contraception is very, high, particularly among young women below 20
years. (27%) resulting in'high-rate of unplanned and undesirable
pregnancy, compelling them to resort to unsafe abortions.
Report of WG on HSR; Biomed R & O, Regulation of Drugs and Therapeutics... 8
In addition to the unset need for reproductive health care, there are my
idle of sociological factors which have contributed to the continued
reproductive ill health.
Research would, therefore, be needed to, for example, how to alter
gender perceptions, strategies to build rational and healthy sexual
attitude and behaviour amongst adolescents and youths, approaches to
ending discrimination and injustice, better understanding of barriers to
girls education, empowerment and development, improve men’s
participation in reproductive health care, needs of under-privileged
sections of population like the tribal, inequities related to poverty and
access to health care.
Need for a different orientation to 11th Plan
Conventional response to persisting and new emerging health challenges
would be to step up research in control method and improving the health
systems research, epidemiology of the disease goes beyond biology.
Sociological perspective is important to understand the occurrence of a
disease and its cure so that the patient returns and normalcy and contributes
to functioning of society.
■"I
It is now increasingly realized that this is not enough. No amount of pure
bio-med research would be complete unless it is extended to social
determinants of health. Many of them are embedded in the circumstances in
which people live and work. AH forms and shades of poverty, inequity, food
insecurity, social discrimination, poor conditions of housing, unsafe working
conditions, poor access and/or utilization of health services are some of the
important social factors influencing disease burden.
The 11th Plan,
therefore, should mark a departure in its orientation to health research.
Health care does not end once the fever is down and stitches are out.
Disease are persisting, and/or emerging because of sociological changes,
life-style changes, and social disruptions (riots, violence etc.). Diseases are
not solely rooted in biological causes, but are multifactorial. This calls for a
multi and inter disciplinary approach to health research.
Central to health systems research and biomedical research and
development is improvement in public health and making available to then
the ‘goods’ required for attaining positive health. This requires partnerships
with various stakeholders' viz. donors, pharmaceutical industry, IT industry,
engineering sciences, science and technology and biotechnology, social
sciences, town planners, architects. It requires strengthening research
capacity of medical schools, colleges, universities and institutions,
development of skills and infrastructure. Human resource development,
creating an enabling environment for researchers, setting up new
infrastructure to address gap areas and creating effective networks are also
priority areas. Undertaking these activities would translate into allocation of
more funds for health and to health research. Underpinning all these
principles are the attainment of targets laid down Millennium Development
Goals (MDGs) meeting the objectives of the National Rural Health Mission,
addressing the Government’s Common Minimum Needs Programme.
Report of WG on HSR, Biomed R&D, Regulation of Drugs and Therapeutics.
10
Biomedical Research: Current
scenario and future projections
CHAPTER - 2
Terms of Reference
• To review the position/progress/problems in basic, clinical, applied and
operational studies during the 10th Plan period and to suggest priority
areas for research in these areas, and mechanism to avoid
duplication/overlapping and to bring about transparency and social
control in research work including ethical issues during the 11th Plan
To review the current investment in bio-medical research and health
systems research by various agencies and project requirements to
address the identified priorities during the Eleventh Plan period.
•
Introduction
The group reviewed the present position, progress and problems in basic,
clinical, applied and operational studies in biomedical research during the
10th Plan period. The major achievements in areas of health research of the
ICMR, CSIR, DBT and Deptt. of Science & Technology were reviewed in the
backdrop of the Planning Commission thrust areas of the 10th Plan period.
The thrust areas identified during the 10th Plan covered basic, applied and
operational research in the area of health, family welfare, nutrition and the
indigenous systems of medicine. During the 10th Plan period, based on
these identified thrust areas, the different agencies involved in biomedical
research have carried out significant work that has contributed towards
achieving many of the objectives. These have been reviewed in detail in the
11th Plan document submitted by ICMR, DBT, DST and CSIR respectively.
The Group deliberated on the reasons for tardy improvement in the health
indices for the country. Some of the major concerns include:
National Priority Setting
New policy initiatives in the health system are at times taken on inadequate
evidence-base due to lack of adequate research in evaluating the policy
experimentation. The work initiated by many state governments on PublicPrivate Partnership point to the fact that successes are announced and
attempts made v/ithout undertaking rigorous research on such initiatives.
At present while one may talk about the dominance of the private health .
research funding upsetting the national health priorities, but the fact is that
[.
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the country has no transparent evidence based mechanism for priority
setting in health research. Unless such a mechanism is set up, the
institutions and researchers, and the ethics committees as local/institutional
regulatory bodies, will not be in a position to resist the research proposals
pushed by the multinational and Indian corporate firms looking for the
markets abroad using the Indian biomedical research data. Therefore, it is
imperative that the Government of India set up an expert group to make
recommendations on the priority setting for the health research - particularly
the clinical trials in biomedical research. This work of priority setting must be
reviewed periodically say every three years so that the national health
research priorities are updated on a regular basis. Due to lack of clear
national priorities and committed resources for the health research, there
has been an increasing influx of the foreign governmental, private foundation
and corporate sponsored health research. There is a great danger that such
research could distort the health priorities of the country.
Insufficient thrust on Health Systems Research
Even as India needs to contain and reduce prevalence of existing diseases,
it is burdened with a growing emergence of non-communicable diseases
(such as diabetes, cardio-vascular diseases, hypertension, mental health,
cancers, injuries, respiratory infections etc) which are very expensive to
treat. There is also increasing evidence that these ‘lifestyle’ diseases affect
the poor due to low resilience to infections, poverty induced malnutrition and
stress. Coping with these double burden diseases calls for reforms in India's
health system. Health systems research is likely to provide feasible
solutions.
The Group recognized the neglect of the health system research by
institutions. The problem in health systems research in India is not that
research on new topics is not conducted, but that there are system blocks in
improving the health of people using the research outcomes. Thus, unless
the health systems research is provided a prime place it deserves and its
findings are used in shaping policies to remove system blocks in improving
people’s health, the expensive biomedical research would remain on paper
or would be useful only to the health systems in developed world. Another
worrying trend relates to the hiring of the for-profit market research and
consultancy firms - Indian as well as from abroad or multinational, at times
of questionable credentials to undertake health system research at very high
cost. This has gradually led to financial and scientific undermining of the
public and NGO research institutions undertaking health system research.
Report of WG on HSR,-8)ome"d R & 0, Regulation of Drugs and Therapeutics... - 12
Need for Performance-based monitoring
No method is currently available within the health system to measure or
assess on a concurrent basis the efficacy or utility of an intervention to
identify critical problems and suggest corrective action. In the past, for every
corrective system that was put in place, a more ingenious system of
statistical manipulations evolved. Correcting this implies setting up a system
of monitoring and review which are transparent and frequent such as, for
example: (i) statistical sampling every quarter, and (ii) social audit.
Inadequate Capacity to plan and implement
According to the NCHM, there is an acute shortage of epidemiologists,
biostatisticians and other personnel trained in public health. Specialists in
certain disciplines often work as generalists in public health, which is an
inefficient use of a scarce resource. Even generalist bureaucrats who serve
as Project Officers for special programmes often lack the technical capacity
to provide the desired level of comprehension and quality of leadership,
proving to be a serious handicap. Lack of relevant technical expertise and
non-availability of even the critical minimum at the Central and State levels
are reasons for public health programmes lacking in focused design, non
development of national treatment protocols and standards, non-integration
with other related sectors/programmes such as TB with HIV, HIV with
maternal health, maternal health with malaria, health with nutrition or water,
etc. The inability to provide required technical leadership to States and
districts on the operationalization of interventions based on technical norms
or the inability to assess and build the technical skills and human resources
required by the programme is yet another reflection of the lack of technical
leadership. More important is not utilising operational research for designing
better targeted programmes in keeping with the wide social and
geographical disparities that characterize this country has been a serious
shortcoming.
Need for Regulation of quality of drugs and devices
The quality of drugs sold in the market has been a major concern. The
common man often ends up buying spurious or sub-standard drugs. The
Supreme Court of India, the National Humans Rights Commission and MPs
have time and again expressed concern about this and have urged the
Government to improve the drug regulatory system. In the past, several
committees have been constituted to examine the issue and have made
many recommendations. Some of these have been implemented, but the
core issue has remained unresolved. The NCMH’s report has too flagged
the need for strengthening of regulatory mechanism of not only drugs but
also of devices. According to this report, there is no effective quality
regulation also on the sale of high-technology medical devices, with the
existing BIS (Bureau of Indian Standards) mark norm limited to a small
subset of low-cost medical equipment. Consequently, substandard second
hand medical devices are currently flowing into and floating around the
country. The only regulation that currently exists is the protection relating to
radiation. However, there is little or no control on what the equipment does
relative to its claimed effects, its technical specifications, etc. Availability of
good quality spare parts is also a serious problem faced by both public and
private health service providers in India. While the problem is especially
acute for older equipment, spare parts for which are no longer made by the
original manufacturer, there are a lot of equipment suppliers who simply do
not deliver follow-up services, making the search for alternative providers a
costly exercise. There is severe shortage of technical experts for repairing
medical equipment.
Narrow Research Base
Presently there are about 170 MCI recognized and 65 permitted medical
colleges. About 20,000 to 25,000 students graduate every year. Medical
schools are the cradle of health researchers of tomorrow. About 8000 of
these do post-graduation in various specialties (38 PG degree courses, 32
PG diploma, 37 discipline for Ph.Ds and 24 super specialties). The quality of
research in these medical colleges is low. Less than 10% are active in
research, most of the papers resulting from research are published in non
indexed journals with low impact factor. More than half of the medical
colleges (53%) had published less than 10 research papers in an indexed
journal during 1990-94, and only 10% have 100 or more papers during that
period. It is essential to inculcate a culture of research in medical colleges if
the quality and quantity of health research is to be improved in the country.
Limited Human Resource
There have not been any organized and focused efforts towards human
resource estimation for research or its development. It is not only an issue
of numbers and skills, but also giving attention to generate a demand for
research among policy makers. There has also been a ban on creation of
new positions. This has further hampered human resource development.
The only new blood that has been inducted has been against vacant posts.
Rapid progress is being made in biomedical sciences. Fresh technologies
are opening new vistas. But the country is unable to exploit them to the full
in absence of adequate human resource. Cutting edge areas are being
neglected.
Report of WG on
Blomed ft & o; Regulation of Drugs and Therapeutics.^ 14
Neglect of Translational Research
Translation of research to action involves using scientific knowledge to
develop drugs, vaccines, diagnostics, devices and other interventions. There
is a gap in using knowledge to inform policy and practice in health systems
countries. Some challenges faced are limited access to technology and
scientific information leading to scientific isolation, limited scientific career
opportunities and the inability to synthesize existing knowledge towards
improving interventions and performance of health systems. There is thus
an urgent need for a health research system that would not only generate
research outputs but also utilize scientific knowledge to inform policy and to
promote knowledge based change in health system.
Recommendations
Setting up a Department of Health Research
The Group welcomed the decision of the Government of India to set up a
Department of Health research within the Ministry of Health & Family
Welfare. This Department would have the responsibility to address the
shortcomings in the present system, and improve health research within the
country.
National Health Research Policy
A clearly defined National Health Research Policy on the lines of Science &
Technology Policy is the basis for maximising the return on investment in
health research. The Government should therefore, enunciate a National
Health Research Policy. The draft policy which has already been prepared
by the ICMR should be quickly finalized and adopted.
This policy should aim to generate the evidence-base for Health Systems
and Services, so that they will be significant promoters of equity and
contribute to National Development; establish linkages between health
research and national health programs to facilitate the operationalisation of
evidence based programs and to obtain feedback for the optimisation of
Health Research; encourage the development of fundamental research in
areas relevant to health to ensure that a national critical mass of scientists
who can contribute the benefits of modern technology to health research is
developed. The proposed Policy would also ensure that the optimum
benefits of modern technology are harnessed to promote national health;
build and integrate capacity for research in National Health Programs,
research institutions and in the private sector (profit and non-profit
organisations) utilising as far as possible areas of excellence already
available in the country. The Policy would facilitate optimal use of
information, communication and networking technology to ensure that the
global knowledge base is available for national programs, and that research
is channelled in relevant directions without unnecessary duplication; manage
global resources and transactional collaborations optimally to ensure that
collaborative health research primarily facilitates the development of national
health systems and services. It would also ensure that health research is
truly intersectoral and can harness the resources in areas such as social
sciences, economics and traditional systems of medicine; optimum
harmonisation of National Policies is essential to facilitate intersectoral
collaboration and partnership, so that maximum developmental returns can
occur from health research.
National Health Research System
Health Research in the country should be developed into a National Health
Research System (NHRS) wherein all research agencies, cutting across
ministries and sectors identify priority areas of research and coordinate with
each other to avoid duplication, fragmentation, redundancy and gaps in
knowledge, in order to enable the results of research to transform health as
a major driving force for development. The NHRS would generate and
communicate knowledge that helps to form the national health plan and
guides its implementation, and thus contributes, directly or indirectly, to
equitable health development in the country; adapt and apply knowledge
generated elsewhere to national health development; and contribute to the
global knowledge base on issues relevant to the country.
National Health Research Plan
A National Health Research Plan would be developed based on a
transparent priority setting exercise involving all stakeholders. It shall be a
rolling Biennial plan, to be reviewed and updated annually in the framework
of a 5-year projection. A medium term (5 years) and a long-term (10 years)
vision for health research would be developed for the entire country in
consultation with all governmental agencies and others who provide funds
for health research.
National Health Systems Research
A high priority should be accorded to support health systems research to
generate the evidence for health policy to enable informed decisions for
improved health service delivery. This would include assessing health needs
of the country, the availability, acceptability and accessibility of health
interventions, health technology assessments such as cost effectiveness of
interventions, the tracking of resources for health (including for health
research) as part of the National Health Accounts, the availability and means
of financing of health interventions. An interdisciplinary team would be set up
to identify priorities for health systems research.
Recent studies of the economic impact of health research suggest that the
health and wealth dividends from investment in research far outweigh the
costs of the research. In partnership with other organizations, new concepts
of both financial and non-fmancial benefits should be applied in the Indian
context, to help build the evidence base and give a clear picture of the
broad-ranging impact of health research.
Research which focuses on improving the health status of vulnerable
populations, particularly Indians living in poverty; residents of rural areas;
tribal
populations; immigrants and refugees; people facing gender
inequities; the homeless; children; seniors; the disabled and chronically ill;
and victims of violence; and to support research on improving access to
effective delivery of health services for these same vulnerable populations.
Research that emphasizes the following should be encouraged:
•
access to and equity in health services for vulnerable populations;
•
biological, social, economic, cultural, and structural/environmental
factors that influence vulnerability and disparities;
•
identification, description and analyses of health disparities at the
population level;
Intervention research that informs the development of responsive
programs, policies, and practices.
•
Research should also be supported on how social disadvantage is mediated
by and interacts with other determinants of inequality, including poverty,
social cohesion, gender and ethnicity, and how such factors influence health.
There should be a continued need for research that will help to develop and
evaluate ways to reduce social and health inequalities and to inform public
health and social policy. A particular priority should be the impact of
inequalities on women and children, rural populations, those belonging to
underprivileged sections of society (like the SC, ST, and the OBC) their
development and their long-term health.
The health system research is a multi-disciplinary social science, public
health and policy research. There is a need to recognize (a) contribution of
the social scientists and public health specialists in the research; (b) involve
health system researchers before undertaking biomedical research and
Report of WG on HSR, Biomed R&D, Regulation of Drugs and Therapeutrcs...
17
clinical trials to ensure that there would be possibility of such research
reaching to the people of the country and would not become only preserve of
few; (c)sponsor multi-disciplinary intervention research to understand how
the system can be improved and the new biomedical research could be
disseminated.
Several priority areas for the health system research can be identified:
•
Encouraging intervention research for seeking evidence useful for
policy making: A wide range of intervention research projects may be
financed in order to understand what works and what does not, and
the reasons for the same.
•
Many state governments have embarked upon the public-private
partnership without creating good evidence based on its impact on the
public health services, on the state finances, and whether they really
bring about the equity in health access.
•
Studies on health insurance: Increasingly, social health insurance is
emerging as one of the major instrument for financing health care,
and the private health insurance is also increasing. In both areas,
major studies are needed.
•
Urban health: Issues of health care access in urban areas despite
high availability of private health care are not adequately studied.
Besides, the health problems of urban poor, the migrants etc. need
more attention.
•
Research on violence and health care in conflict situations: This is a
grossly under-researched area of health care despite increasing
violence in the society.
•
Health care in disaster situation: More work is needed in this area.
•
Gender and health: The gender issues in disease prevalence, access
to health care, and medical education, etc. must be paid priority
attention.
•
Studies on the use and misuse of medical technologies: While more
and more health care technologies are being introduced in health care
services, particularly in private sector, there is very little research on
their relevance or appropriateness, misuse and irrational use, the
additional financial burden on the users due to misuse etc. Such
studies should cover prescription practices to the new medical
technologies such as genetics, assisted reproduction, life prolonging
technologies, organ donation and transplantations etc. etc.
Medical audit and audit, of research: Through research, we need to
establish various ways of undertaking medical audit of health services
at different levels.
•
I
•
Research on nursing practices: The nursing is a much-neglected area
of research in India. It is high time to encourage more nursing
research by the nursing as well as social science and bioethics
institutions in India.
Strengthening health research in medical colleges and other Institutes
The ICMR as a major funding agency of health research, should commit
itself to strengthen India's health research communities by broadening,
deepening and sustaining health research excellence. A skillful cadre of
researchers working in state-of-the-art facilities with adequate and
appropriate equipments and committed trainees, is the best strategy to
ensure that India has the capacity and expertise to mobilize in order to
address important health issues.
The best ideas of the researchers across the full spectrum of health research
should get funded allowing them to pursue their own creative ideas for novel
and significant research projects. At the same time, build on this foundation
of research excellence through targeted research investments focused on
emerging opportunities and challenges. Health research agencies should
invest in strategic research initiatives designed to take advantage of new
knowledge flowing from scientific progress, and to respond to the challenge
of the health research priorities.
The convergence of disciplines should be encouraged that underlie the most
exciting and important discoveries in health research, and to resolve ever
more complex health problems. Thus, the support for multidisciplinary and
multi-sectoral teams of researchers as well as individual researchers working
in medical colleges, universities and research institutes should be increased.
The right balance and mix of health researchers should be supported to
realize its mandate and strategic objectives. It should continue to reach out
through its extramural research programs and activities to those research
communities that can contribute to health research. New investigators bring
new ideas and ways of thinking and the energy of youth to health research.
The ICMR should explore mechanisms to attract and encourage new
investigators to establish themselves in health research.
Finally, attracting and mentoring the young to the exciting, relevant and
important career in health research is key to ensuring the strength and
vitality of India’s health.research system in the coming decades. This would
■ involve creating a critical number of health researcher and positions in
Report of WG on HSR, Biomed R & D, Regulation of Drugs and Therapeutics...
19
4
9
medical colleges. The health research agencies should develop, in
partnership with relevant stakeholders, a national initiative that reaches out
to young students. Progress in research requires that the best researchers
should be supported, work in stimulating and supportive environments. It
may be necessary to set-up new departments like that of molecular medicine
in medical institutes. Research would be given top priority in medical
education. A formal programme of medical research should be incorporated
in undergraduate and postgraduate level curriculum. Research should be
make a core requirement for career advancement. Researchers should be
should be suitable rewarded and appropriate infrastructure should be put in
place. The ICMR should take up this challenge. This would require a
substantial allocation of funds. The Working Group agrees with the
recommendation of PAB of ICMR that the allocation for extramural research
programmes should be about 50% of its budget.
Good governance of health research
The agencies, like the ICMR, should promote and provide guidelines on
research governance issues, including good research practice, ethics and
scientific probity. Thinking has to be reviewed within a continuously
developing social and legislative context, and must respond to the moral and
ethical questions that new scientific developments sometimes rise. One of
the important tenants of good governance of health research is to promote
the use of best available scientific evidence and results of research. The
knowledge must be leveraged effectively to achieve better health. The
generation, sharing and management of knowledge are necessary for its
effective application. The agencies should give high priority to knowledge
management. Consensus should be achieved through a continuing dialogue
with the general public, users of health research, government, industry, the
funding agencies, scientists and health service professionals. It may be
necessary to accreditate certain facilities like the IVF clinics, research
centres and clinics, stem cell research and therapy, clinical trial centres etc.
Partnerships
Partnerships are integral to the health research. As the challenges facing
health sciences have become more complex and multi-disciplinary, the need
for organizations to pool resources and expertise becomes increasingly
important. Partnerships should be designed to meet the needs of a jointly
agreed initiative whilst respecting the autonomy of individual participants.
Partnerships are about shared vision, common objectives and alignment of
priorities and programs.
By building partnerships amongst its stakeholders - those that have an
interest and stake in health, the health system, and health research - India
will be better positioned to support stronger research initiatives that produce
quality results more quickly for the benefit of Indians.
Partnerships are critical in setting research agenda, share best practices in
research, build research capacity, make more effective use of resources for
research and eliminate redundancy in research activities and funding.
Finally, partnerships are key to any successful knowledge translation
strategy.
International collaborations
In recent years there has been an increasing number of new international
partnerships in health research as organisations have come together to
tackle some of the main scientific and medical issues of modern time.
Initiatives would include partnerships with international research funders.
National and international partnerships should be facilitated and nurtured in
a variety of ways; through scientific workshops and meetings, bilateral
interactions at agency level, and participation in consortia and other
collaborations. Efforts should be made to:
• encourage and foster International collaborations based on equal
partnerships, with mutual technology transfer, wherever appropriate
•
Steer international collaborative health research to ensure that the
country derives maximum benefit and the global goals are attained.
•
Consider the possibility of extending resources and expertise to help
other developing countries in their research efforts.
•
Generate more financial resources as additionality to core funding to
be used in research from various international agencies like BMGF,
global fund for its TB and Malaria IAVI, GAVI and others.
Set up North-South and South-South Global partnership by enhancing
India’s role in international health and by becoming and innovator and
motivator for neighboring countries. South-South interactions should
be made seamless and sufficient funds should be allocated for the
purpose.
•
Translational research
Development of evidence-based medicine and healthcare by translating
basic research outcomes into clinical evaluation is essential for their ultimate
use into health policy and practice in the national health systems. A new
initiative in clinical research should .be developed in partnership with other
research funders,, industry and healthcare providers to. This will enable a
Reportof WG on HSR, Blomed R & D, Regulation of Drugs and Therapeutics...
21
better assessments of the impact of research and the outcomes for patients.
Such considerations will become integral to the research from the outset,
and will ensure timely and effective implementation of new policy and
practice.
An initiative should be launched to create greater opportunity to catalyze the
development of a new discipline of clinical and translational science.
Promising ideas for novel therapeutic interventions may encounter
roadblocks in bench-to-bedside testing. While translation is sometimes
facilitated by public-private partnerships, high-risk ideas or therapies for
uncommon disorders frequently do not attract private sector investment.
Where private sector capacity is limited or not available the public sector
should step in to bridge the gap between discovery and clinical testing so
that more efficient translation of promising discoveries may take place.
To make further progress in controlling major human diseases, initiatives
should be launched to cultivate and train a cadre of clinical researchers with
skills that match the increasing complexity and needs of the research
enterprise.
Investing in interventions with high cost-benefit ratio cost-effective
interventions
In a developing country like India, where a significant proportion of
population is poor, a conscious decision has to be taken on the areas of
investments in health research. It is important to keep in mind that key
interventions that would yield the maximum improvements in population
health outcomes should have the highest cost benefit ratio. According to a
study, a worldwide demographic epidemiological advance between 1990
and 2020 would result in substantial decline in communicable diseases in
importance among the poor and in relative terms, the significance of noncommunicable disease would increase.
Modelling exercises have compared the impacts of interventions aimed at
accelerated decline in communicable diseases with those targeting faster
reduction in death and disability from non-communicable diseases. Such
calculations indicate that an acceleration in overall progress against
communicable diseases world bring about a significantly larger gain for the
poor than would an acceleration of comparable magnitude achieved against
non-communicable conditions. The additional 4.1 years of life expectancy
that faster progress against communicable ailments would generate.
D'^l
BBS
(compared to the base-line scenario) is almost 3 times as great as 1.4 year
increase that faster decline in non-communicable diseases would produce.
Balanced Research portfolio for the 11th Plan
The potential to improve human health in areas where the burden of disease
is most significant should be encouraged. Health needs influence the
decisions about what research to support. However, the right balance has to
be struck between short-term 'pay-offs' and promoting the longer-term
development of fundamental science that will in time lead to improvements in
health.
A number of health priorities have been identified in which new research is
especially needed and where India can expect to make an impact, both
socially and economically, in the years ahead. These range from well-known
and long-standing causes of death and debilitation such as tuberculosis,
malaria, HIV, cancer and heart disease, to problems that are on the
increase, such as obesity, diabetes and respiratory problems including
asthma. Infectious diseases continue to be a challenge, for example with the
emergence of problems such as severe acute respiratory syndrome (SARS)
and the ability of well-known viruses such as influenza to emerge in newly
dangerous forms.
The research to be undertaken and supported should have an increasing
relevance to health and disease, with equal emphasis on translational
approaches at the basic/clinical interface.
The health research agencies, especially the ICMR should be committed to
a research agenda that recognizes that future improvements in health and
well-being will depend on research that:
• increases understanding of both the molecular and biological
mechanisms underlying diseases as well as the psychosocial,
economic and environmental determinants of health;
supports efforts to develop new vaccines, diagnostic tools and costeffective therapies;
• allows to understand and prevent the underlying social and behavioral
causes of injuries and lifestyle diseases;
• links health with Science & Technology, engineering and related
disciplines; and
• promotes healthy living and reduces risk behaviours.
•
Report of WG on HSR, Biomed R & 0, Regulation of Drugs and Therapeutics... 23
There is a need to encourage harnessing of new knowledge of gene and
gene functions, expand capacity for structural biology (structures of proteins
and now different proteins interact). The complexity of the systems would
demand development of bio-informatics. as a major discipline. While
fundamental and strategic research is critical, clinical research and
translation of results of results of research into action should also be
promoted. Clinical research capacity should be strengthened through
training programme. To promote evidence-based decision making, the
linkages with other health research agencies, academia and the industry
should be strengthened.
The health research domains would be in accordance with the national
health priorities, and address to known and emerging causes of morbidity
and mortality:
•
Communicable diseases
•
Non-communicable diseases
•
Maternal and child health
•
Reproductive health
•
Nutritional problems
•
Environment and health
•
Health issues of under privileged sections of society
To tackle problems in these priority areas, research approaches at many
levels are needed: molecules, cells and tissues, animal models, whole
organs and systems, individuals and populations.
The current level of knowledge provides exciting opportunities for
multidisciplinary approaches. Many diseases have complex causes involving
the interaction between genes and environmental factors, including, for
example, exposure to chemicals, physical effects such as ultra-violet
radiation, socio-economic status and lifestyle factors including diet, smoking
and use of alcohol.
Development and use of modern biology tools (for example the micro-array,
cryo-electron microscope, X-ray crystallography, magnetic resonance
spectroscope etc) and disciplines (like structural biology, stem cell research,
computational biology, nanotechnology, nano-medicine, bio-informatics,
genomics and gene therapy) should be facilitated for a better understanding
of the biology of health and disease and devise interventions. The wealth of
knowledge in traditional systems of medicine should be tapped.
r,
•
-
oo
Comparative therapeutic trials of traditional medicines with allopathic drugs
should be undertaken.
A better understanding of the processes and mechanisms involved in
disease causation and progression at molecular level holds the key to
development of more effective tools for prevention and cure. The Working
Group supports the priority areas identified by Department of Biotechnology.
Some of these include:
i.
Molecular characterization of mechanisms of pathogen invasion to
provide clues for identification of drug targets. Under this purview,
infectious diseases like tuberculosis, HIV/AIDS, diarrhoeal diseases,
encephalitis, and hepatitis, and malaria, tropical diseases like
Leishmaniasis, Filariasis, Leprosy, and Dengue will be included.
Pathogen virulence, disease progression and pathogenesis are governed
by multiple factors that include the host genes, the genetic make up of
the pathogen and immunological factors besides many others. Research
into exploring the mechanisms used by the immune system to respond to
bacterial, viral and parasitic diseases that will provide guiding principle for
preventive, diagnostic and curative strategies should be encouraged.
Research into host pathogen interactions should form a priority area
within the infectious diseases research programme. For example, the
interactions of HIV with host cells are an important issue as the course of
the disease varies considerably among infected individuals. In this
context, identification and elucidation of function of relevant host and
pathogen genes are important. With the onset of AIDS, scenario for
some other diseases has changed due to co-infections and increase in
infection rates due to compromised immune status. In this scenario, co
infections of mycobacteria and HIV or HIV and Leishmania are a major
problem. Studies on cells of the innate immune system that harbors the
pathogens would be essential to provide clues to prevention of
occurrence of such co-infections.
ii. Identification of new lead molecules of potential therapeutic interest
through a combination of approaches integrating traditional knowledge,
recent advances and futuristic genomics-based predictions for infectious
diseases would be an area of interest. The increasing emergence of
drug resistance in pathogens is a relevant area of address. For this,
research-encompassing basic mechanistic like how drug resistance is
acquired and activated should be encouraged. One of the interesting
areas under this is the design of novel inhibitors for decimating the
pathogen.
Many metabolic processes. within the pathogens could
possibly be inhibited by small-molecule inhibitors for which drugs are not
available.. Research into design of small molecule inhibitors and devising
Report of WGi on HSR, Blomed R-& 0, Regulation of Drugs andI Therapeutics...' 25:
of means to increase the potency of these would form an area of interest.
Development in the area of design of the inhibitors.
iii. Vaccine development against viral, bacterial and parasitic diseases
should be a priority area. Research initiative into the design,
development, administration and efficacy studies in vaccines for a variety
of diseases should be followed. Development of microbicides against HIV
proteins relevant to HIV replication would be an important areas where
research into developing bio-conjugates inhibiting replication proteins
and assessment of their efficacy would be encouraged.
iv. Research to develop kits and reagents for diagnostic purposes should be
supported for infections chikunguniya.
v. Developing systems for intracellular delivery of drugs or
pharmacologically active agents selectively to specific cell types is an
area which needs fortification in the context of infectious and other
diseases and research in this area should be encouraged.
vi. Analysis of developmental cues that control the process of reproduction
and development so as to provide clues for understanding genetic as well
as environmental factors that lead to developmental defects in the
systems.
vii. Autoimmune endocrine diseases, including those involving the thyroid
(Graves' disease, Hashimoto’s thyroiditis), insulin dependent diabetes
mellitus (IDDM), and Addison's disease are among the most prevalent or
common endocrine disorders. For autoimmune endocrine diseases
considerable questions exist regarding the etiology, pathogenesis, and
potential treatments directed at the autoimmune basis of these diseases.
For IDDM, factors associated with autoimmune diseases including T-cell,
and HLA markers have been implicated in disease initiation and
progression. Putative role(s) played by various factors in eliciting and/or
contributing to IDDM is not known. Clearly, a fuller understanding of the
autoimmune basis of endocrine disorders is necessary to open the way
for more effective immune (and other) system approaches to disease
treatment and/or prevention. Research topics that should be considered
relevant to this area would include the etiology, pathogenesis and
treatment of endocrine diseases, including IDDM and autoimmune
thyroid disease, the cellular and molecular basis of autoimmune
endocrine diseases, the molecular basis for the increased prevalence of
autoimmune endocrine diseases in women, the role of cytokines and
growth factors in the etiology and/or path physiology of autoimmune
endocrine diseases and potential therapeutic approaches to autoimmune
endocrine diseases.
viii. Dissecting the specific molecular anatomy of a tumor is likely to be critical
for the development of more specific, effective and safe treatments.
^eport:of,^onHSRJ.Biot
D
Research on understanding the cause and mechanisms of cancer,
improving early detection and diagnosis, developing effective and
efficient treatments should be addressed. Identifying and using specific
targets for diagnosis and intervention would be critical.
ix. Because of the potential of stem cells to alleviate many disease
conditions, stem cell research would be an area of interest. Research on
basic biology of mammalian stem cells, culture conditions for maximal
growth and their potential to be used for disease treatments should be an
encouraged.
x. Research on molecular and cellular aspects of nervous system function
in health and disease should be fostered. The research will illuminate the
understanding of how nerve cells function and communicate in the brain,
especially as they relate to the development of novel therapeutic
approaches to neurodegenerative diseases.
Proposed New Institutes
Centre for Policy Research for Non Communicable Diseases
This Centre will target to systematically synthesize information relevant to
comprehensive health care models and apply this knowledge in the Indian
context. It would provide leadership in development and integration of
policies and programs for prevention and control of non communicable
diseases through partnership with relevant stakeholders at national level".
The Centre for Policy Research for Non Communicable Disease will use
innovative processes to obtain authoritative, objective and scientifically
balanced answers to unique problems in NCDs in India and translate this
knowledge effectively into products of healthcare system so as to improve
the health of Indians. The Centre would inter alia identify the NCD research
needs of the country and obtain new knowledge, knowledge translation into
products and action, supporting and developing measures for integrated
surveillance of NCDs, developing a mechanism for incorporating NCD
prevention in health care system, building research capacity manpower in
the country establish centers for molecular medicine and creating
partnership between medical institutes and universities.
National Centre for Cardiovascular Diseases, Diabetes and Stroke
This center will work out multi-pronged strategies to bring down the morbidity
and mortality due the cardiovascular diseases, diabetes and stroke, thus
making a significant dent in the emerging epidemic in the region. The Centre
will support research efforts to promote new discoveries and enhance
scientific progress through support of cutting edge basic and clinical
■
■
.
-
research related to cardiovascular diseases, diabetes and stroke, with a goal
of rapidly translating research findings into novel strategies for prevention,
treatment and cure of these diseases.
The Centre would among other objectives help to generate new knowledge
by stimulating and sustaining interdisciplinary research for resolving complex
issues in CVDs, diabetes and stroke, to undertake research activities which
accelerate the translation of health research into action develop national
clinical guidelines for prevention, management and control of CVDs,
diabetes and stroke, create database of information on cardiovascular
diseases, diabetes and stroke so as to act as national referral centre for
these diseases. The Centre would be located at Chandigarh.
National Center for Disease Informatics and Research
This Centre would be set-up by upgrading the existing Coordinating Urjit of
the National Cancer Registry Programme at Bangalore. The proposed center
besides working on collection and analysis of data on cancer would also
work on establishment and running of registries related to diabetes,
cardiovascular diseases and stroke. The data thus collected is expected to
help in evaluation of control activities in the concerned areas. This would
also provide a base for undertaking multi-disciplinary and multi-centric
research projects. Surveillance programmes would also be supported by the
activities of the Centre.
ICMR Schools of Public Health
For decision making in public health reliable data and information is often not
available. Even if data and information is available, to use these effectively
would require analytical skills which may not be readily available within the
health system. There is an urgent need to enhance this very limited capacity
in India for strengthening research and policy development in public health.
To meet this demand trained human resources in the precept and practice of
public health will have to be developed. The Government of India plans to
raise public health specialists through establishing, initially two Schools of
Public Health through the aegis of the Public Health Foundation of India.
The ICMR plans to supplement this effort by setting up a chain of Schools of
Public Health.
The National Institute of Epidemiology, Chennai would provide the core
support to the regional institutions to be developed at National Institute of
Cholera & Enteric Diseases, Kolkata, Post-Graduate Institute of Medical
Education & Research, Chandgiarh and the National .Institute of Virology and
t
National AIDS Research Institute, Pune. These would offer specialized
training facilities in partnership with other medical colleges and research
institutes. Several international schools of public health have also agreed to
partner in this effort (like School of Public Health, Boston, Swiss Institute of
Tropical Diseases, Minnesota School of Public Health, and Aberdeen
University).
National Animal Resource Facility for Biomedical Research
For combating the health challenges posed by persisting and emerging
diseases, intervention tools like drugs and vaccine would be needed. It is
essential that they are evaluated for their safety, efficacy and toxicity in
animal studies. Such studies it is required by law to use animals of defined
quality, of genetic and disease free status in order to obtain reliable and
reproducible results. Currently there is neither a private centre nor any large
breeding facility in the country which can supply quality animals. It is
proposed to fill this gap by setting up National Animal Resource Facility for
Biomedical Research at Genome Valley, Hyderabad. This would be a major
central animal facilities for large, small, transgenic animals within the health
systems. There is hence, a great demand of such animals and facilities in
the country.
Institute for Research on Ageing
India will have a population of 137 million older persons in year 2020 as per
estimates by the Registrar General of India (SRS-1991). The older persons
face physical, psychological, social and economic difficulties due to various
factors. They develop degenerative disorders such as those related to joint
and cario-vascular systems, suffer from mental health problems, visual and
hearing impairments etc. This has direct implications for the health and
social service sectors, which need to be augmented to take care of these
health concerns as the population ages.
India has a National Policy on Older Persons, not though much headway ha
been made. Concentrated efforts have not been made to study the process
of ageing, as well as the various health, psychological and other related
issues. This needs institutional set-up with proper infrastructure.
Therefore, an Institute for Research on Ageing (IRA) is required to undertake
multi-disciplinary studies. This multi-specialty centre should address to
various research areas like epidemiology, morbidity profile, health care
management, nutritional assessment, drug metabolism, molecular biology,
neurobiofogy, socio-psychology and studies on health systems research
Report of WG on HSR, Biomed R & D, Regulation of Drugs and Therapeutics... 29
4
would be addressed. The Institute should encompass health, sociobehavioural, and rehabilitation areas.
Budget Requirement
The Working Group agrees with the observations of the ICMR’s PAB that the
funding for medical research in the country continues to be abysmal and is
ridiculously low. India should be spending a great deal more on medical
research if it hopes to even touch the fringes of medical problems which face
the country. As prescribed in the National Health Policy, the Government
must keep its commitment of increasing the funds for medical research to
1% of its health expenditure by 2005 and 2% by 2010.
Medical research is an interdisciplinary, multi-agency effort involving the
government, academic institutions, and the private sector, and requiring
progress in many diverse fields of science to succeed. Medical research
competes annually with other worthy domestic spending priorities for its
share of our national budget. Medical research is the responsibility of the
national government, and one in which the government is uniquely
positioned to take the lead. The health research is to a large extent funded
by the Govt, of India through Ministry of health, the funding for health
research depends on health budget, which itself is meager in the national
budget. The current level of funding for health research is grossly
inadequate. Ideally, spending on health research should be at least 2% of
the total spending. Currently it is less than 1%. The ICMR has been able to
increase its funding in last 4-5 years and utilized the same fruitfully.
However, the funds available are about one third of the demand (allocation
of Rs.970 crores as against requirement of Rs.25000 million for the 10,h Plan
period). The ICMR and its institutes have demonstrated ability to attract
funds from the Government and other funding agencies both in India and
abroad. In addition, the Council has demonstrated abilities to expend the
allocated finances in a timely fashion reflective of good project management
practices. However, the Council needs large infusions of funds to undertake
large scale expansion and embark on mission mode projects.
The Working Group reviewed carefully the budget submitted for the 11th Plan
by the Council and other agencies along with their proposed strategies of
action. The Group endorsed the plan of action of the Council and
departments and recommended that their budget provisions are appropriate
for the activities that are envisaged.
________________ ICMR
Total Budget Required
Rs. in crores
Intramural
3504
Extramural
1496
ICMR Hqrs
TOTAL
New Posts Required
5000
Numbers
500
Scientific
0
Technical
___
Administrative
TOTAL
500
The Working Group approved the new activities suggested by the ICMR for
the 11th Plan period.
In addition, special and ear-marked funds should be made available for:
i. addressing neglected diseases and disorders; and
ii. health systems to interact with industry to develop products that the
health systems need.
The budgets of CSIR, DST and DBT have presented to the appropriate
controlling authorities by the respective agencies.
Report of WG on HSR, Biomed R & p,.Regulation of Drugs and Therapeutics... 31
’
....... ' -.................. •».,........................ ■ -
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CHAPTER - 3
Product Development & Evaluation
Terms of Reference
•
To review the current situation regarding development, testing and
quality control of drugs and devices, both in the modem system of
medicine and AYUSH and suggest priority areas for research and
institutional strengthening during the 11th Plan period.
Introduction
With the introduction of product patent laws in India, there is a compelling
need for investing in indigenous research and quality control for drugs,
medical devices and vaccines relevant to the needs of India’s poor. The
development of new drugs from the knowledge and information possessed
by a community must ensure that part of the financial benefits from the use
of these drugs flows back to the community that initially owned the
knowledge. The NCMH has recommended that an R&D policy needs to be
formulated for assuring drug, medical technology and vaccine security and
investing funds for upgrading public sector research institutions at Kasauli,
Conoor and research institutions of the ICMR, DST, CSIR, DRDO, DBT,
Universities etc.
Besides stepping up health systems research, there is also an equal urgency
to establish regulations, strict ethical norms and transparency, standardize
methodology and international standards of research for tapping the global
market for clinical research. India has the possibility of becoming the
international hub of clinical trials. With its quantum of well-trained physicians,
pharmacologists and clinical pharmacologists, the availability of a large
untreated naive population providing numbers, the relatively low cost of
conducting trials, and the recent patent regulations. India has a huge
comparative advantage that gives it an opportunity to be at the forefront of
drug discovery, besides earning valuable foreign exchange and providing
employment to many.
Among the limitations plaguing new drug discovery are lack of GMP
compliant facilities, few centres for undertaking pharmacokinetic studies and
poor quality study of animals. An area in which India could make significant
contribution is drugs for chronic diseases. Significant knowledge is available
on traditional systems of medicine. This could be taken as a mission-project.
The research has to be innovative which can only be done by encouraging
basic research in cutting edge areas. Good quality clinical trials are .not
Report of WG on HSR, (Siomed R&D, Regulation of Drugs and Therapeutics... 3Z.
being undertaken. This is so primarily because of lack of trained personnel.
Training courses in clinical epidemiology, clinical pharmacology, GCP, GLP,
Quality control, toxicology, pharmacokinetics etc. would need to be
expanded. Simultaneously a mechanism of accreditation of clinical trial
centres should be put in place. The action of drugs at molecular levels would
have to be studied along with pharmacokinetic studies (using biomarkers).
Monitoring quality of these drugs would also be an important aspect which
needs to be addressed.
During the 10th Plan period, the Government had set up various Committees
to address several of the issues listed in this Term of Reference. The Group
reviewed these Reports and recommendations made therein. The members
supported these recommendations and hoped that they would be soon
implemented.
The Central Drugs Standard Control Organization (CDSCO), under Drugs
Controller General (India), DGHS, Ministry of Health is responsible for
ensuring the safety, efficacy and quality of drugs and therapeutics as per the
provision under Drugs & Cosmetics Act, 1940 and Rules 1945. The
regulatory requirements pertaining to safety efficacy and quality is currently
effectively implemented through:
• The State and Central Drug Regulatory Authorities
•
•
States and the Central Drug Testing Laboratories with infrastructure
and facilities to ensure speedy analysis of drug samples.
Good Manufacturing Practices (GMP) mandatory for all
pharmaceuticals production houses.
•
Stringent quality regulatory process for import of drugs Le Import
Registration process.
•
•
Publication of Essential Medicine List.
National Pharmacovigilance Programme to ensure self sustaining and
viable adverse drug reaction monitoring programme.
Regulation in respect of licensing of import as well as manufacture of
10 sterile medical devices in place since October 2005. Subsequently,
guidelines have been issued for import and manufacture of medical
devices.
At present, there is an indirect control like licensing for the products
exclusively for export giving for NOG for the export drugs to regularize
the same in addition to manufacture, sale and distribution in India.
•
•
1
Regulation of Drugs and Pharmaceuticals
There has been a wide-ranging national concern about spurious/
counterfeit/substandard drugs. The Drugs and Cosmetics Act has not been
reviewed in a comprehensive manner since its inception although the Rules
have been amended from time to time. The Report of the Expert Committee
under the chairmanship of Dr. R.A. Mashelkar
on a comprehensive
examination of drug regulatory issues, including the problem of spurious
drugs has submitted its report in November 2003.
The Committee concluded that the problems in the regulatory system in the
country were primarily due to inadequate or weak drug control infrastructure
at the State and Central level, inadequate testing facilities, shortage of drug
inspectors, non-uniformity of enforcement, lack of specially trained cadres for
specific regulatory areas, non-existence of data bank and non-availability of
accurate information.
The report of the Committee deals comprehensively with the issue of
implementation of all the rules and regulations, which guide, monitor and
control the activities of the providers of the healthcare system in the country
and the way to bring them up to international standards. It provides the
design of Central Drug Administration (CDA), its size, functions and the
sharing of the responsibilities vis-S-vis the States including directions for
licensing of manufacturing units by a central authority. It also deals with the
regulatory health food/dietary supplements/therapeutic foods, Indian system
of medicines and herbal products, over the counter drugs, medicines &
diagnostics. It addresses the issue of drug development and clinical
research in India with special reference to the drug regulatory agency
including modern biotechnology.
Major recommendation of Mashelkar Committee include:
•
Create a well equipped and professionally managed CDSCO, which
could be given the status of Central Drug Administration (CDA) and
strengthen the State level regulatory apparatus with complementary
roles of the Centre and the States, while at the same time ensuring
uniform and effective implementation,
• A scientifically and statistically valid methodology should be used to
evaluate and quantify the extent of the problem of spurious drugs at
various levels in the supply chain at the Regional and National levels.
ReporterWG on.HSR, Biomed R & D, Regulation of Drugs and Therapeutics... 34
The Drugs and Cosmetics Act should be suitably amended and the
maximum penalty for sale and manufacture of spurious drugs causing
grievous hurt or death should be enhanced from life imprisonment to
death.
•
During the 11lh Plan, it is proposed to establish a Central Drug Authority of
India as per recommendations of the Mashelkar Committee.
Regulation of Recombinant Pharmaceuticals
A Task Force on Recombinant Pharma, was appointed by Ministry of
Environmental & Forestry in 2004 to suggest a new regulatory framework for
recombinant pharma products. Headed by Dr R A Mashelkar, DirectorGeneral, Council of Scientific and Industrial Research (CSIR), the Task
Force has submitted its report.
The Task Force has laid down the Procedure for Regulation of Recombinant
Pharma Products derived from Living Modified Organisms (LMOs). Taking
into consideration the regulatory objective of GEAC, which, is confined to
regulation of LMOs, two protocols have been recommended: (i) products
derived from LMOs but the end product is not a LMO and (ii) product derived
from LMO where the end product is a LMO.
•
•
Where the end product is a LMO (which has the potential for
propagating/replicating in the environment), a higher level of
regulation is needed as compared to end products which are not
LMO.
The magnitude and probability of environmental risk depends on the
extent of use of LMOs within the R&D and production units. In case of
imports of finished products. The risk is not there, especially in cases
of therapeutic proteins in finished form.
The Task Force has also recommended that the regulatory procedure need
to be rationalized for the various scenarios regarding LMOs and other linked
issues. It has proposed establishing of an Independent Institutional
Mechanism National Biotechnology Regulatory Authority/ Commission. This
is a complex issue and it has been recommended that an inter-ministerial
group be established to examine the model proposed by Secretary DBT
among various others administrative Departments/ Ministries, for functioning
of the proposed authority and make specific proposals with respect to the
implementation including the budgetary requirements.
AYUSH Formulations
AYUSH systems are based on experience and interaction with nature and
natural resources. Scientific evidence to prove the rationale of using these
formulations in health care is essential not only to develop and preserve the
cultural heritage but also to make them acceptable at large.
Even though Research Councils under the Deptt. of AYUSH have
undertaken clinical and health care research programmes, the multi
institutional support with AYUSH based approach in research at other
centres was evidently lacking. Active participation of AYUSH in service
oriented surveys, surveillance programme, and community health care
research programme is yet to be achieved in R&D sector.
Though a number of pre-clinical and clinical studies are carried out on
medicinal plants used in ISM including isolation and purification of active
principles, scientific evaluation of Ayurvedic therapies and medicines based
on Ayurvedic pharmacological principles and clinical parameters deserves
to be carried out. The scientific evaluation of Ayurvedic drugs through
placebo controlled clinical trials have to be reviewed for its appropriateness
in Ayurvedic system. The comparison should be done with standard care
available in modem medicine. It is, therefore, proposed to re-analyze the
clinical drug trial data base incorporating Ayurvedic parameters and
evaluate the hypothesis for Ayurveda driven drug studies for proving their
‘equivalent efficacy and comparative safety'.
In the research front multiple agencies like CCRAS, CCRUM, CCRYN,
CCRH, ICMR, S&T, CSIR and its units, various University Departments,
AYUSH teaching institutions etc. are attempting to solve the same problems
and creating same kind of data over the years. Such duplication should be
avoided. There should be a well co-ordinated programme for execution at
different institutions in accordance with their mandate. Similarly, the
documentation and validation of traditional therapies being practiced in
various parts of the country is required to be taken up on priority. It is
desirable that ICMR in collaboration with AYUSH research councils should
take up R&D on ASU drugs that could be included in the National Disease
Control and health programmes
Quality Control Regulation of Drugs in AYUSH
One of the priority tasks of the Department of AYUSH is to publish
pharmacopoeial standards for Ayurveda, Siddha and Unani and
Homoeopathy (ASU&H) medicines, both for single and compound drugs.
Pharmacopoeial standards are important and are mandatory for the
ReportofWG on HSR.Biomed R & D, Regulation of Drugsand Therapeutics...
36
I
implementations of the drug testing provisions under the Drugs and
Cosmetics Act, 1940 and Rules there under. These standards are also
essential to check samples of drugs available in the market for their safety
and efficacy. The Department of AYUSH launched a Central Scheme to
develop Standard Operating Procedure of manufacturing processes, to
develop pharmacopoeia! standards and shelf life studies of Ayurveda,
Siddha & Unani Compound drugs under 10th Five Year Plan and achieved
significant results, but still lots of work have to be done in the field of
standardization and quality control. For this strengthening / upgrading of
various drugs testing laboratories (Government /autonomous / states/other
accredited laboratories), ensuring of availability of genuine raw materials of
commonly available drugs as well as rare and endangered drugs of
plants/animals/minerals origin, substitutes of similar species have to taken
up in the 11th Plan to handle the task of drugs quality control. New area
relating to drugs e.g. strengthening of Drugs Control department of States
and Central, Developing Herb garden/Museum/herbarium are essential
requirement for quality medicines.
It is necessary to develop the Quality Standards along with their Safety
Profile for the extracts of the most common drugs used in ASU system. It is
also necessary to develop pharmacopoeial and quality standards for Indian
medicinal plants used for the purpose of food and cosmetics and official
substitutes of non-availab)e drugs/ plants/animals. This work should be give
priority in the 11th Plan.
Other priorities for the 11th Plan are :
i)
ii)
iii)
iv)
v)
To publish SOPs and Quality standards, shelf life monographs for at
least 100 compound formulations per year to complete the work on 500
ASU drugs.
Revise and update the various volumes of pharmacopoeias and
Formularies.
Capacity Building : The new GMP provisions require regular testing
during the process of manufacturing as well as for the products.
Therefore, there is a need of developing and supporting large number
of DTLs for ASU&H systems.
Centre for Safety Evaluation/Toxicity studies for AYUSH Drugs:
However, there is a felt need to establish the safety of various single
drugs as well as formulations containing poisonous ingredients in
various dosage forms.
National Herbarium, Museum, Herbal Garden for ASU Drugs: There is
a need to establish/strengthen a couple of medicinal plant garden
vi)
vii)
containing all the medicine plant species used in ASU&H system.
These gardens will act as Demonstration Garden as well as source of
authentic raw drug samples.
Training and provisions of Scholarships/Fellowship in ASU&H
Pharmaceuticals, Quality Control and standardization : Degree, Post
Graduate and Post Doctorate training is required in ASU&H drug sector.
There is lot of scope and urgent need to work on different aspects of
preparation, standardization, safety, efficacy, doses forms and
pharmacology of metal based Bhasmas and Ras Aushadhis.
viii) ASU drug industry is a green industry, cause minimum pollution, make
use of all indigenous material and giving job opportunities for needy
people.
ix)
Support the R&D based production of classical and P&P drugs, there is
a need to allocate ASU&H “Pharma Industries Support Corpus” fund of
Rs. 100 crores to meet the bank interest (amount of interest difference
between the bank rate and soft loan rate of interest) which will be
recoverable in 10 year period. Similar scheme was implemented by
DST earlier.
x)
Scheme to supply authentic raw material for ASU&H Drug industry
xi)
Strengthening of Drug Control Division in Centre and States : There is
utter lack of infrastructure, human resource expertise and other
requirements to regulate the provision of Drug & Cosmetics Act at
Centre and State. The AYUSH component has negligible visibility in
terms of Drug Controller, Drug Inspectors, Drug Analysts and other
manpower required to regulate the provision of Drugs and Cosmetics
Act. There is an urgent need to strengthen Centre and State Licensing
and Regulatory Authorities. There is a need for comprehensive review
of regulatory provisions of AYUSH products. To begin with, regulatory
changes can be started by implementing a system of registration on
AYUSH products on the basis of proper product dossier with State
licensing authority on the basis of proper guidelines developed by the
Central Government. There is an urgent need to support technical
experts in Drug Control section of AYUSH along with supporting staff.
xii)
Repository for plants used in Traditional Medicine: A national well
stocked repository of drugs from the traditional medicine source in
order to house crude drug samples of authenticated parts of the plants,
used as medicine is highly essential. This referral facility could be
accessible to pharmaceutical industry, traders, medicinal practitioners,
natural product chemists, students and academics. This may provides
an accessible repository of quick overviews of particular herbs and
pointers for further research , describes methods for studying specific
activities of plants in vitro and in animal models as well as in humans,
. •!*??****
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Repprt of-WG oniHSR, Biomed B & Dj Regulation of Drugs and Therapeutics... ;; 38
includes regional reviews from an international group of contributors ,
allows to compare and contrast information specific to geographical
areas and between geographical areas and also may contains an upto-date summary of available knowledge on plants tested for specific
disease activity. The increasing prevalence of various metabolic
disorders world-wide is an issue of major socio-economic concern.
Scientific interest in plant-derived medicine is steadily rising, yet there is
often a wide disparity in the caliber of information available. A detailed
compilation of scientific information on traditional medicines plants may
highlight the potential role of dietary and medicinal plant materials in the
prevention, treatment, and control of various diseases and its
complications.
Regulation of Food Including Nutrition Supplements
There is increasing evidence that many food based materials have potential
health or medicinal benefits. Such products fall into a grey area between
foods and medicines and have been described as “functional foods" or
“nutraceuticals”. It needs to be verified whether these so-called “health
foods” really are safe for human consumption and offer the purported health
benefits.
Some nutraceuticals are already in the U.S. supermarkets - eggs with fishderived fatty acids to lower the risk of heart disease orange juice fortified
with calcium to fight osteoporosis, herbal teas with anti-oxidants that may
lower cancer risks : and margarine laced with a wood pulp ingredient that
lowers cholesterol by 10%.
Several products are in the pipelines, Investigators are now busy using a
combination of traditional plant breeding, genetic engineering, and just plain
chemistry to produce foods enhanced with compounds they hope will lower
the risk of many diseases. Those focusing on cancer are looking at
compounds such as lycopene in tomatoes, beta carotene in carrots
glucosinolates in broccoli, and isoflavones in soy. Soy protein extracts,
sweeter carrots with greater concentrations of beta carotene and higher
lycopene containing tomatoes, besides mushrooms, garlic are potential
candidates for this food based medicine approach.
A major challenge for those involved in the research and development of
functional foods is the scientific validation and substantiation of a claim in the
eyes of the law. It is already clear that in some areas, manufacturers will
need better clinical evidence of the overall relationship between diet and
disease, and they may need to carry out specific clinical trials on their
products. The issue of substantiation of claim covers not only the safety and
efficacy of the food component(s) themselves, but also the finished food as it
would be used by people. In future, nutritional assessments of novel foods
will need to be carried out against a background of rapidly advancing
knowledge on the role of diet in the causation and prevention of many
diseases, from classical nutrient deficiencies to illnesses that are major
causes of morbidity and mortality, such as coronary heart disease and some
types of cancer. For parts of the food industry, this is a move toward greater
use of biomedical sciences, more akin to the pharmaceutical industries.
The evidence and commercial criteria for a growing inter-face between the
two industries are under constant review. Whatever happens in the
commercial environment the use of specific nutrients and ingredients or
combinations thereof that are claimed or perceived to be beneficial to health
will stimulate the reformulation and repositioning of existing products as well
as product and process innovation. Key areas of interest include antioxidant
substances (e.g. beta-carotene, vitamins C and E), minerals (e.g. calcium,
magnesium, zinc, selenium), phytochemicals (e.g. flavonoids), probiotics
(e.g. bifidus and lactobacillus), fatty acids and lipids (e.g. bifidus and
lactobacillus) fatty acids and lipids (e.g. fish oils), and a range of
macromolecules (e.g. dietary fibers and oligosacharides).
The Indian Food Safety and Standards Bill 2005, introduced recently is
aimed to consolidate the laws relating to food and to establish the Food
Safety and Standards Authority of India 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. The new
rule is expected to boost the level of science behind products, as it will
define the scope of acceptable health and nutrition claims. Such claims will
need to be based on clinical trials, protocols, or scientific studies conducted
as part of their R&D and product development. All of these need
strengthened during 11th Plan.
Regulation of Genetically Modified Foods
Current issues are:
• Whether testing of GM foods is necessary as regulatory exercise
once, the product has been cleared for use (from the point of view of
food safety) and labelling provisions are in place to advise the
consumers.
•
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Beportpf WQ.ori^HSR, Biomed R &. D, R^iifeti0n of Drugs
•
If testing is necessary then the nature of the protocols to be
developed for testing both imported and domestically produced foods.
•
Whether capacity needs to be built up in, Central Food Laboratories
(CFLs) or specialized laboratories need to be identified where
capacity is being developed and there can be networking of these
laboratories, given the large resources needed.
•
The development of protocols for risk assessment and generating
data under the existing regulatory framework, to facilitate the
manufacturers/importers
to
easily
comply
with
regulatory
requirements without delay or duplication of efforts
•
To address the labelling concerns at the earliest and identification of
an institution under concerned Ministry which could be resource
centre for collection and documentation of information on GM foods.
Currently, there is no appropriate
regulatory mechanism for monitoring
marketed imported GM Foods and also for sale of GM Food produced in the
country. The Ministry of Health and Family Welfare is responsible for making
regulations for sale of safe foods including GM Foods under PFA Rules
1955. Thus, there is a need to incorporate regulatory provisions for GM
Foods:
•
Labelling of GM food, may however be one of the practical option for
regulating post-marketing of GM Foods on one hand and on the other
it would provide information to consumers who have the right to
choose whether or not to consume GM food based on the information
provided on the label.
•
Keeping in view the current scenario, it may not be feasible to decide
on the threshold level of GM foods, therefore, the Ministry of Health
should consider incorporating the labeling provisions under the PFA
Rules.
Based on these recommendations, notifications on labeling of GM Foods
were issued in May 2006.
Regulation of Biologies
The term "Biologies" generally refers to any biological product that can only
be made using a living system or organism, usually DNA, proteins, bacteria
or other microorganisms. Biologies are inherently different from chemical
drugs, which are synthesized from raw chemicals using more predictable
and replicable processes. Since the production of Biologies occurs in a living
cell, the process is subject to considerable variability. The 21st century
heralds the “biotech revolution" where biologic medicinals promise cures for
fdj
some of the most complex diseases. Currently, over 370 innovative biologic
products are being tested, targeting more than 200 diseases, including
cancers, neurological disorders, heart disease, diabetes, multiple sclerosis,
AIDS and arthritis. The biophamnaceutical industry represents one of the
fastest growing segments of U.S. healthcare. The regulation of follow-on
Biologies is a rising concern for the biotech industry since many Biologies
are approaching the end of their patent life, and as a result, will open the
market for more affordable generics. Due to the complex processes that are
used to produce Biologies, creating an exact copy of the original, pioneer
biologic is often very difficult. The many sources of variability in the process,
from bio-environmental factors such as gene splicing and culture media to
physical factors such as temperature and chemical make-up of petri dishes,
can lead to variability in the product as well. Biotechnology is used when
the desired drug product is a large molecule that is difficult to produce
through chemical synthesis. Because of simpler, more straightforward
processes used in the production of chemical drugs, exact copies of the
original drugs can be produced and marketed as “generics”. Brand
manufacturers argue that science is not capable of detecting changes in
protein structure between the brand biologic and the generic. Furthermore,
the brand industry contends that biologies are impossible for generics
manufacturers to successfully reverse-engineer without the proprietary good
manufacturing practice (GMP) and good laboratory practice (GLP) protocols
of the innovator company. The policy issues surrounding the approval of
Biologies must consider the need to balance the rights of innovator
companies with the economic needs of healthcare consumers, while
ensuring high quality healthcare. Promoting innovation requires the right
combination of incentives, safeguards, and effective regulation to secure
maximum benefit from new medical technologies, while assuring
mechanisms for equitable access to the treatments.
With the recent developments in clinical research and business process
outsourcing it is proposed to develop strategies to regulate the import and
export of biological material at this juncture for the social benefit and
economic development of our country.
Biobanks
Human tissue is critical for new areas of research that promise to
revolutionize medicine like genomics and proteomics. The samples are
important for various types of studies like population genetics, human
diversity studies, and even in forensic medicine. The samples reveal the
types of genetic changes or protein "signatures" associated with a particular
. disease and experiments on human tissue are there is enough scope for the
findings to be translated into new diagnostic and prognostic tests. Human
Report of WG on HSR, Biomed R & D, Regulation of Drugs and Therapeutics... 42
tissue has its greatest potential benefit when there is associated clinical data
for analysis because genomic and proteomic research may then reveal
associations between genetic or protein patterns and response to therapy, or
toxicity. Biobank sample collections are used for various purposes, namely
for clinical, research, and industrial uses. Council has already prepared a
draft guideline on ethical, legal and social issues for National repository of
genetic resources and database in the year 2006.
Regulation of Stem Cell Research
The stem ceh research hold s great promise of improving human health by
control of degenerative diseases and restoration of damage to organs by
various injuries; but at the same time it also raises several ethical and social
issues such as destruction of human embryos to create human embryonic
stem (hES) cell lines, potential for introducing commoditization in human
tissues and organs with inherent barriers of access to socio-economically
deprived and possible iise of technology for germ-line engineering and
reproductive cloning. The research in this field, therefore, needs to be
regulated to strike a balance. The Council has prepared draft Guidelines for
Stem Cell Research and Therapy in collaboration with DBT.
These
guidelines emphasis a separate mechanism of Review and Monitoring is
proposed for Research and Therapy in the field of human stem cells, one at
the National level called as National Apex Committee for Stem Cell
Research and Therapy (NAC-SCRT) and the other at the institutional level
called Institutional Committee for Stem Cell Research and Therapy (ICSCRT). These guidelines will be debated in different parts of the country
before finalization.
Regulation of Devices
India has stunting growth of medical devices industry due to inadequate
regulation. Only low technology devices (thermometers, weighing machines
etc) are being made because these do not require a pre market certification,
and optional QC is provided by agencies like Bureau of Indian Standards.
The Drugs and Cosmetics Act was not covering the critical medical devices(
pace makers, implants, internal catheters or other critical in vitro testing
devices) resulting in near zero indigenous production. Absence of such a
regulatory body has resulted in India becoming dumping ground of outdated
or third rate western devices which have actually been discarded in the west
due to information about their harmful effects. That information is withheld
from Indian users who have no other way of knowing the harmful effects
because of lack of a regulatory and surveillance body. Formation of such a
governing body having regulatory and surveillance responsibility pertaining
to the medical devices is, therefore, very essential.-
The wide range and huge number of medical devices that are being
constantly introduced in comparison to the few drugs every year make the
traditional pre market approval approach impossible to implement. As
devices are based on a number of advanced technologies having a great
diversity in mechanism of their action, they can also fail because of a myriad
of mechanical faults, electrical component failure, or biocompatibility
problems. An implantable device may fail after many years of its use at an
unpredictable time period. Hence, besides product regulation, its correct use
must also be ensured to assure safety of device.
There is no doubt about this out country definitely needs a system to ensure
that our public is not exposed to poor quality products, especially in this
rapidly growing market segment. Also, the advantages of having a device
regulation to the various segments of the developmental chain - the R&D
groups, the manufacturer, the clinicians and finally the patients have to be
clearly elucidated. This medical device regulation will be advantageous to
one and all, provided that it is well implemented and administered like in
Europe and other developed countries
Recently, the Ministry of Health and FW under Gazette notification S.O.
1468 (E) dated 6.10.05 declared the following sterile devices to be
considered as drugs under Section 3 (b) (iv) of the Act: Cardiac stents; Drug
Eluting Stents; Catheters; Intra Ocular Lenses; I.V. Cannulae; Bone
Cements; Heart Valves; Scalp Vein set; Orthopedic Implants; Internal
Prosthetic replacements;
These guidelines have become effective from 1st March 2006. These cover
purpose, procedures for Import of Medical Devices, Registration of Medical
Devices for Import, Manufacture of Medical Devices in the country and sale
of Medical devices in the country
Ethical Issues in Animal Experimentation
The Ministry of Environment and Forests has notified, the Breeding of and
Experiments on Animals (Control and Supervision) Amendment Rules, 2005
in Jan 2006 in continuation of the Breeding of and Experiments on Animals
(Control and Supervision) Rules, 1998 and its amendment in 2001. This
amendment emphasizes:
i) personnel using experimental animals shall be responsible for the
welfare of animal during their use in experiments;
■
I:;...;::::::::::::::.:.:::::.-::.
,
Report of WG on HSR, BiomedR&D, Regulation of Drugs andTherapeutics... 44
ii) investigators shall be responsible for the aftercare and rehabilitation of
animal after experimentation, and shall not euthanise animals except in
defined situation;
iii) costs of aftercare and rehabilitation of animal after experimentation
shall be made part of research costs and shall be scaled in positive
correlation with the level of costs involved in such aftercare and
rehabilitation of the animals;
iv) rehabilitation treatment of animals after experimentation shall extend till
the point the animal is able to resume a normal existence by providing
a lump-sum amount as costs for rehabilitation and care of such animal
to cover its entire statistical expected life span; and
v) the establishment undertaking experiments or duly licensed and
authorised animal welfare organization under the control of the
Committee may, on payment of lump-sum amount,
undertake
rehabilitation of animals.
These draft rules if approved will result in extra costing of the research
projects aiming at New Drug Developments for which provisions have to be
made by all the funding agencies. There is also need for establishing
Centres which can develop alternatives to animal experimentation.
Ethical Issues in Drug Development Involving Human Subjects
The Ethical Guidelines For Biomedical Research On Human Subjects,
released by ICMR in 2000 have been drafted for Legislation and were
forwarded to the Ministry of Health and Family Welfare, and Ministry of Law
and suggestions have been incorporated. The Bill entitled "The Biomedical
Research on Human Subjects (Promotion and Regulation) Bill, 2006 is now
ready to be placed before the Parliament for notification.
There is a need at the present time for a strong centralized regulatory regime
which can guide high quality development of ethical capacity with extra
vigilance with an informed understanding of acceptable risk.
Clinical Trial Registry
A number of clinical trials are carried out for which results are not published
either because the company decides not to market its product, or because
the results are negative or neutral or because the trial was terminated.
Information about a drug that does not demonstrate efficacy in a controlled
trial or that demonstrates significant hazards that are important for making
health care decisions. Failure to publish results of such studies could
compromise patient safety. To ensure that systematic reviews are unbiased,
the need for an international trial register of all controlled clinical trials has
been highlighted in many scientific fora.
Recognizing the importance of a clinical trial registry, the ICMR is piloting the
establishment of a Clinical Trial Register that is web based and designed to
be compatible with international clinical trial registry. Once established, a full
fledged National Clinical Trial Registry should be established during the
Eleventh Plan period.
Research and Development
The India Pharmaceutical industry in the last six decades has grown
substantially and has the capabilities to manufacture APIs through different
technology like Chemistry, Biotechnology, Biology and also has developed
technologies to manufacture various doses forms like parenterals, oral,
aerosols etc. This also includes capacity to manufacture immunobiologicals
like vaccines for prophylactic and therapeutic use in human and animals.
Industry's focus is on Chemistry based, R & D and in the last decades
substantial effort are being made for their presence in drug discovery
research.
Potential growth in Pharma Sector
Process development still will be a focus area for growth and research in
APIs. India has been recognized as a single source for carrying out research
in existing molecules as well as molecules under patent. This has huge
potentials to encase the opportunity in the 11th Plan. Another important
emerging area is to prepare dossiers for submission of R & D application
concerning the approval of generic drugs in USA, EU, Japan etc. India has a
huge potential of highly qualified post graduates in pharmaceutical
chemistry, analytical chemistry, instrumentation etc. This needs support from
Government during the 11th Plan to capture the growth opportunities
Pharmaceutical Formulations
In the field of biotechnology, there is a need to focus on the Research &
Development, of all cell lines for existing as well as newer vaccine for selfsufficiency. In this area, already a lot of work has been done at the
International level for developing therapeutic drug and biotech products for
treatment of Cancer, Infectious disease, Heart diseases, inflammatory
disorder, allergies etc. India has become a choice for research and clinical
trials as the country has all the requirements for carrying out the same. The
government should explore the possibilities to support the R & D work that
can help local CROs and attract the global pharmaceutical industry. Also
Report of WG on HSR, Biomed R & D, Regulation of Drugs and Therapeutics... 46
V.
potential scope to create R & D facilities for producing drug products for
clinical trials.
Human Resource Development
There is a need to produce highly qualified Doctors/Scientist in this field of
science to meet the growing demand in R & D. Institutes of excellence which
can liaison with the industry and government must be developed. Focus
should also be on continuation of education through training programmes by
a well defined training module and also infrastructure.
Indian pharmaceutical companies have been competing for their share in
global generic market by creating state of the art manufacturing facilities. It is
therefore, imperative to capture the opportunities in contract manufacturing
by building large number of units with global standard this would encourage
the local industry to manufacture the product as per cGMP norms in order to
boost export of their products. This would also generate employment
opportunities of technically skilled and unskilled personnel.
In order to meet the global standards, R & D efforts needs to be focused on
the various ancillary requirements i.e. primary packaging material,
automation in equipments.
Integration of information technology in the field of Pharma and Biotech
industry, self-sufficiency in manufacturing of analytical and other ancillary
equipments for manufacturing of quality drugs is also an important
requirement of the industry.
Intellectual Property Rights (IPR) and Technology Transfer
Closely linked to development of drugs, diagnostics, devices and vaccines
are issues of IPR and technology transfer.
Improving public health is one of the most effective means to reduce poverty
in developing countries and access to safe, effective and affordable drugs
and vaccines is essential to achieving improved health. This has been
demonstrated in the battle against such illnesses as tuberculosis, AIDS,
malaria and life-threatening diarrhea etc.. Programmes addressing
reproductive health and non-communicable diseases also are dependent on
modern drugs, too. There is a widening gulf between developed and
developing countries with respect to access to advanced health
technologies. Primarily either due to inability of developing countries to
■
generate enough intellectual property for the development of new drugs or
there is just not enough money even to buy the generic drugs available.
Also, not many pharma companies are willing to invest on R&D on drugs
afflicting the poor countries and it is for us to address these issues. There
are several strategies being adapted to address this issues both at the
global and at the national levels through several mechanisms and public
private partnerships etc.
Besides sufficient and sustained support for research and development
(R&D) for the creation of candidate products for the poor, there is also a
need to establish policies and systems for improved management of IP to
help bring candidate products for the poor to reality, especially since the
public sector's experience with handling IP is limited. There is enough
evidence to show that better management of IP can be quite powerful in
enhancing product development and availability for the poor.
IP is a complex subject which vary by product type, by country, by
proposed partner, by the nature of the further development work needed,
efc. But the following are a few high-priority, highly feasible and
complementary tasks.
•
Training scientists and officials at universities and research institutes to
manage IP.
•
Identification and implementation of best practices of IP management
to help public sector develop new IP management norms.
• Advising developing and developed country groups concerned with
research and product development.
•
Promoting coordination and synergy in public sector product R&D
through partnerships with the private sector.
•
Research on the quantitative relationship between IP and health
product availability and cost.
•
Collaborate with other countries and other stake holders on issues of
TRIPS and other international treaties to facilitate formulation of national
policies and strategies for India and other developing countries.
New initiatives
• Centre for Clinical Research including clinical trials research: A Clinical
Trial Centre is needed to provide leadership in this field. It should be a
facility for human resource development using internationally
recognized curriculum related to clinical trials, management of data,
designing clinical data base, quality control and assurance. The Centre
should help to train clinicians in the concept of scientific and evidence
based medicine. It could also undertake large single or multi centre
clinical trial and take part in national and international collaborative trial
group and contribute expertise to trials run by others. It could offer
advice on trial design or operation, randomize patients or analyze data
for groups wanting to run their own trials. The Centre should be
committed to promoting the quality and efficiency of clinical trials
through ethical considerations, scientific expertise, quality assurance
and education.
•
•
Centres for carrying out pharmacokinetic studies in India.
Toxicology Centre for carrying out regulatory toxicity studies on Lead
compounds.
Report of WG on HSR, Biomed R & 0. Regulation of Drugs and Therapeutics.- t49
Inter agency collaboration and
Translating Research into Action
CHAPTER - 4
Terms of Reference
•
To review current status of inter-agency, inter-ministry collaboration in
priority areas of research and to suggest mechanism of improvement
during the 11th Plan period.
•
To review the situation regarding research agencies addressing
priority areas of research identified by service providers and
implementation of major suggestions emerging from resea'rch studies
and to suggest mechanism for improvement of these during 11th Plan
period.
Present status
The Committee reviewed the existing mechanisms and strategies in each of
major organizations.
The ICMR has an elaborate peer review system to oversee its research
activities. Its Scientific Advisory Board (the highest technical body of the
ICMR) includes eminent scientists from different disciplines and
Agency/Departmental representatives from DGHS, DBT and DGAFMS.
Each Technical Division has its Scientific Advisory Group. Each of the 26
ICMR Institutes has its Scientific Advisory Committee, on which the
Programme Managers of Central/State Health Department / Directorates,
Representatives of other ICMR Institutes, and non-ICMR scientists are
involved. These are intended to provide the ICMR with the directions for
research to be pursued without unnecessary duplication, in clearly identified
priority areas. Likewise, ICMR is represented in the Scientific Committees of
other agencies such as DST, DBT, DS1R, CS1R, Research Councils of CSIR
Institutes working in areas related to biomedicine, DGHS, State Councils for
S&T, NIHFW etc. The ICMR has been using the following strategies for
better utilization of the results of research:
• Involvement of officials of MOH&W, DGHS, National Programme
Advisors from the planning stage till the final review meeting.
•
Involvement of officials of Government of India in the high-level policy
making committees like the SAC/SAG/SAB of ICMR.
•
Dissemination of research results to all concerned in MOH&FW and
DGHS.
Holding workshops, symposia, and conferences for dissemination of
research results.
•
•
Participation of ICMR officials in the meetings of Health Ministry and
DHGS in order to focus its research on the problems and priorities
and help the national policies and programmes.
At present, inter-scientific-agency dialogue exists, sometimes on formal
basis but mostly on informal basis. For example, ICMR has linkages with the
CSIR laboratories and DBT is increasingly trying to forge collaboration with
ICMR for efficacy evaluation of products developed by the investigations
through the support of DBT, in human subjects. Thus, it was noted a
mechanism at informal level exists, through which exchange of information
between agencies occurs. However, it was felt that the persons who
participate in inter Agency / Institution meetings may very often give personal
views and not institutional ‘considered opinions'. This result in a lack of true
representation in each other’s Committees, and the inputs provided by them
do not really reflect the Agency's perspective. Therefore such informal
’collaboration' leaves much to be desired, in terms of policy directions,
identification of research priorities and ensuring the avoidance of duplication
of health.
New Initiatives taken in the 10th Plan
Ministry of Health
A Joint Monitoring Group has been set up under the Chairmanship of DGHS
to monitor situation of avian flu in the country. This Group meets every
fortnight, but in case of an outbreak meets daily. The members of the group
include representatives for Animal Husbandry, the NICD, ICMR and WHO
country office.
A high level Task Force chaired by Secretary (Health) also meets on avian
flu every fortnight. It includes representatives of Department of Animal
Husbandry also.
CSIR
The Department of AYUSH, CSIR and ICMR have entered into the Golden
Triangle collaboration for research on traditional systems of treatment. The
Bhasmas and Rasayanas would be systematically and scientifically studied
for their role in management of identified conditions like joint disorders,
bronchial allergy, fertility and infertility, cardiac disorders, irritable formal
syndrome, diabetes, malaria, filarial and kala azar. The CSIR would the QC
and predinical studies which the ICMR would assist in clinical evaluation.
Report Of WG on HSR. Biomed R & D, Regulation of Drugs and Therapeutics...
$1-
DBT
The DBT and ICMR have signed a Memorandum of Understanding to work
together on areas of mutual concern. HIV/AIDS and Microbides are
examples of two areas where a 'call for proposals' for joint funding has been
issued. A Centre for Translational Research is coming up.
Recommendations
Realizing the importance of sociological studies, it is recommended that the
ICMR-1CSSR (Indian Council for Social Sciences Research) Joint-Panel be
revived. Links with other Institutes like the Indian Institute for Philosophical
Research should be established.
It is important to understand the varied type of social phenomenon in
medicine, if the health care services are to function better. For example,
study the different attitudes and values which various segments of
population have towards health, illness, and medical care, social
organization of health personnel; social structure and functioning of
hospitals; social rates played by patients and health personnel as they
interact in different settings; social processes through which health
personnel acquire the outlook, standards, and competence for providing
satisfactory professional service; social and psychological factors concerning
different kinds of disease; studies are also needed on medal students,
nurses and doctors; what medical personnel expect of patients, and on types
of behaviours that patients expect of medical personnel.
As suggested by PAB of ICMR an overarching National Health Research
Management Forum should be put in place wherein all existing and the
prospective players in health research will have a space of their own. In this
representation of all key stakeholders will be ensured. The ICMR would act
as its Secretariat, and would have the following functions:
•
To advise on and evolve national health research policies and
priorities and to evolve mechanisms and action plans for their
implementation;
•
To review the output from the National Health research System
annually and provide suggestions;
•
To promote the development of health research activities in the
country;
To review biomedical & health research management, and suggest
strategies to overcome problems in implementation of policies;
•
♦
To suggest mechanisms to nurture a scientific environment to attract
talent, and to develop human resources for biomedical and health
research; and
•
To facilitate utilisation of research results.
The National Health Research Management Forum would be chaired by the
Minister of Health, Secretary-DG ICMR with Secretaries of Health, DST,
DBT, CSIR, AYUSH, DG-DGHS one representative each of private sector
and industry, and about three eminent health scientists of the country.
Create a coordination structure with other Ministries, S&T agencies and
other partners (like ICSSR) where technologies developed by other
organizations are assessed and if found suitable are moved into the system.
Create several public-private platforms analogues to some of the existing
ones in other departments (like NIMITLI) in down stream health technologies
which are not being addressed currently.
r=--------------- :
.......................
I Reportof WGon HSR^jomedR^D^Regulation^ofDrugs andTherapeutics...
53
Human Resources Development
for Health and Biomedical Research
CHAPTER - 5
Terms of Reference
•
To review the manpower position and infrastructure available for
research in research institutions, universities, medical college and
service institutions and to suggest mechanisms for optimal utilization
of these human resources and facilities during the 11th Plan.
Introduction
The human resources capacity for health research is a measure of country’s
capacity and capability to effectively address to existing and emerging health
concerns of the country. Further strengthening of efforts is required to
bridge the existing gap in the availability of trained human resource in health
research not only within India but also for the South Asia region and beyond.
It is important to select appropriate analytical method that would best identify
current and future needs. The policy goals should be laid down clearly in the
order of priority. The strategies that will support their realizations should be
identified.
Human Resource Development
The ICMR should formulate a HRD development plan which should focus on
developing policies, procedures, and partnerships to ensure the
competitiveness of Indian science in health research. Skilled and talented
people are undoubtedly the most important resource for the delivery of high
quality science and its translation for the public’s health. Current recruitment
policies preclude staffing changes that will be conducive to the conduct of
research at the cutting edge of science. There should be a recruitment policy
to attract and retain the right calibre of staff to meet the country's evolving
needs. The aim should be to employ highly qualified staff to deliver
outstanding results. While primarily considering qualifications, knowledge,
skills and personal qualities it should also evaluate the capacity to adapt and
evolve over the longer term. The career opportunities should be made more
attractive not only for current employees but also for scientists abroad. It
may be necessary to restructure the compensation package offered to
scientists to very generous levels by adopting an aggressive approach. At
the minimum the pay structure would be on par with those of other S&T
organizations in the country such as the CSIR and DBT, including
introduction of appropriate number of positions at Scientist G and H levels.
All efforts should be taken to retain distinguished scientists and should
consider offering a Rs. 26,000 scale also. Similarly the career opportunities
and compensation packages of technical staff should also be reexamined.
There should be an organized and focused effort towards formulation of a
long term comprehensive human resource development policy and plan to
address wide range of related issues. For almost twenty years, many
Institutes/Organizations in social sector like the ICMR have had a ban on
creation of new positions which is continuing. Only openings available have
been on superannuation or resignation of staff. It has not been possible to
address cutting-edge areas of modern science adequately. Retraining and
re-deployment has helped but not much. Consequently several Institutes of
ICMR are sub-critically staffed. There is thus an urgent need for assessing
the requirements and creation of adequate number of new positions. For
example, the Performance Appraisal Board of ICMR has recommended
creations of 500 new scientific positions.
The objective of the Policy should be to ensure the conduct of quality and
relevant health research by recruiting, training, managing and retaining a
sufficient number of health research personnel based on identified priority
areas of research needs and within sustainable resources.
Development of research capacity
The human resource and skills required for meeting the current demands
and future challenges is abysmally low. In a billion.populations, In a billion
populations only a very small number is engaged in health research. The
ICMR should liberalize its policy of institutional fellowships like SRFs and
RAs. These Fellows could be mentored by senior scientists. As happens in
other international research agencies, like the NIH, those who do good work
could compete for regular positions as and when advertised.
Examples of some of the ICMR schemes which are currently in operation:
•
ICMR Fellowship Programme for Sr.Research Fellow and Research
Associate.
•
Jr. Research Fellowship Programme in collaboration with PGIMER,
Chandigarh.
•
MD, Ph.D. programme in collaboration with Sanjay Gandhi Institute of
Post-Graduate Institute, Lucknow.
•
It provides support for MD thesis in priority area.
•
Supports Indian scientists (Jr. and Senior) for training abroad, as well
as scientists from developing countries to come to India.
The ICMR also offers some regular training courses:
i mport of WGLffl
Biorrieid R & p; Regiilatlbn of Ordgs and Therapeutics... 55
•
Super-Specialization (DM in Haematology)
•
Post Graduate Courses
► Masters in Applied Epidemiology
► M.Sc.
-
Applied nutrition
-
Virology
-
Entomology
► Diploma
-
Occupational Health
► Certificate course
-
Nutrition
In addition, the ICMR provides short term training courses in nutrition,
virology, animal sciences, epidemiologic technique, outbreak response,
transfusion medicine, vector control, occupational health, genetics, ethics
etc.
The NCHM has recommended that along with domestic resources, external
aid, WHO assistance etc. be fruitfully utilized for developing such capacity by
earmarking fellowships every year to institutes of excellence abroad and
within India. Of the total 25% must be at the doctoral level and the rest at the
Master's level. It should be our target to have a pool of at least 500 persons
with a combination of such critical skills by the end of 2012. Such fellowships
should be open for competition and not be confined to central government
employees of the Ministry of Health. This will help develop capacity and
expertise outside government and be available for policy advice in an
objective manner. The working Group supports this recommendations.
Specific disciplines for human resource development
One of the important areas in which there is an acute shortage of human
resource is social scientists to work on social determinants of health. Social
scientist can bring a social science perspective to practice of medicine,
making doctors socially responsible, sensitize them about the role of culture
and social relationship in causing and treating disease. Well trained social
scientists are needed who can undertake researches in an interdisciplinary
perspective to contribute to the social science of medicine and health and
assist in improving health people of the community. Very little research has
been done in India on sociology of sickness and on medical anthropology,
encouragement should be provided for development of human resource in
Hp'/X-O
the field by creating opportunities for training and teaching. A special effort
should be made to develop and nurture this expertise.
Some of the other areas in which human resource is needed include:
•
Epidemiology, Public Health
•
•
Clinical trials
Toxicology, animal technologies
•
•
GCP, GLP
Quality control and Quality assurance
•
Genomics and gene therapy
•
Bioinfonmatics
•
Health information technology
•
Geriatrics
•
Health economics
•
Socio-behavioural sciences
•
Bio-ethics
•
Biotechnology
•
Molecular Biology
•
Stem Cells research and stem cell therapy
•
Genetics
Report of WG on-HSR, Bionted R & D, Regulation of Drugs and Therapeutics.
57
Biomedical Research
Information Technology
CHAPTER - 6
Terms of Reference
• To study the current status of access to research information from
India and abroad to researchers in India, suggest mechanism for
research information dissemination and central clearing house for
facilities for research information.
Introduction
Information is central to the growth and development of medicine - the
practice, teaching or research. In the present times, when new information
is growing at an exponential rate, professionals are finding it difficult to cope
with the deluge of information. Informatics is also playing a vital role in
discovery research. The different kind of data that are required in managing
a drug discovery is enormous. The challenge is to make different sets of
knowledge bases to complement each other. In the post-genomic era, the
research paradigm has shifted towards more rational models. Added to this
are the ever growing genomic, proteomic, and transcriptomic databases.
Even to find and read the meaningful and relevant content from myriad
publications today. There is need for computational text mining. Suitable
information tools to churn and extricate useful information need to be
developed to complement the explosion of data. The entire spectrum of
information ranging from three dimensional protein structures to clinical data
is now available. There is an urgent need for an integrated informatics
platform which fosters various facets of drug discovery research. With the
rapid generation of information, new journals are being started to cater to
such needs. The number of scientific journals is growing at a steady 5-7
percent per annum. Despite an occasional discontinuation, the number of
journals doubles every ten years. There are an estimated 50,000 in
biomedical sciences.
In addition, numerous of reports, status papers and other documents are
produced. There are also documents, which give data relating to various
parameters such as population, health indicators, mortality and morbidity
statistics etc., which are equally important for researchers, policy makers
and other decision makers. Availability of such information is also very
limited in the existing system of information and communication.
This growth of the literature has made virtually impossible for information
seekers access literature from primary sources such as the printed journals.
Secondary information sources such as abstracting/indexing journals have
come into existence to provide ready and rapid access to the content of
journals. But to effectively search and retrieve the most relevant information,
the use of appropriate technology is essential. This is where the information
technology such as computers, computer-readable databases, CD-ROM
technology, satellite-based communication systems etc. provides the
necessary tools to fulfill the requirement.
IT based Information services have thus become an essential infrastructural
requirement for supporting medical community whether they are practicing
physicians, teachers of health care providers at the community level or
researchers in medical colleges. Unfortunately, the existing health science
information infrastructure is rather inadequate to meet the complex needs of
the health professionals. In order to make health science libraries more
responsive to the growing demands of the health team and to meet the
challenging needs of information and documentation, it is imperative that the
existing resources and services for health science libraries are strengthened.
The new electronic technologies have also come to be regarded as powerful
agents for helping the libraries to achieve speedier access to information.
They have, in fact, revolutionised every function of the library and
information science to the benefit of both the library profession and the users
especially in the West. And the advent of computerised databases has
largely helped researchers to now easily update their knowledge fast with a
variety of tools and technologies of information retrieval. Information
highway, info- routes, cyberspace- all of these terms point to the same
future: the “information revolution" - a result of progress made in
telecommunications and computing, along with the expansion of mass
media. More and more medical researchers are now beginning to rely on the
World Wide Web and the Internet.
While the new technologies have made the access of information faster and
easier, this has benefited only those scientists located in the metropolitan
cities and/or those working in well funded Government laboratories.
Information
access
to
scientists/teachers
in
most
Medical
Colleges/Universities/Research Institutes etc. is still poor as they are deprive
of these very basic facilities; this may be one of the reasons why quality of
science/research from these areas is not really up to the expected standard.
Information Technology is now one of the major components of the
technological infrastructure for health management. All sub-sectors dealing
. with the generation, transmission and utilization of demographic and
Report of WG on-’HSR, BiotnedR& D, Regulation of Drugs and Therapeutics...
59
epidemiological data such as bio-informatics, bio-statistics, HMIS and the
decision support systems (DSS) are finding increasingJ use in health planning
and management. The nationwide network of NICNET
---------’ provides rapid
reporting mechanism for health information, MEDLARS Biomedical
Informatics Programmes provides ready access to medical databases to
post graduates and research workers as well as practicing physicians.
Planning Commission has provided additional central assistance to the
UHSs in Karnataka, Andhra Pradesh, Tamil Nadu, Punjab and Maharashtra
for strengthening of libraries and networking them through IT. This effort has
to be augmented and all medical colleges need to be brought into the
network.
Following are the major initiatives taken by of ICMR
•
The Indian Journal of Medical Research (IJMR) was made available full
text free on the website www.icmr.nic.in from 2004. New sections such
as Editorials, Commentaries, Letter to the Editor have been introduced
from January 2004.
•
A series of four Lancet-ICMR Workshops on Medical Paper Writing for
Publication conducted in February 2005 at Vellore, Kolkata, Mumbai and
New Delhi. Junior and middle level scientists from medical colleges
participated in these workshops. Received very encouraging feed back.
•
ProQuest full text electronic database which contains about 550 + full text
medical journals subscribed. The Council has installed only two sites of
ProQuest for NICED, Kolkata and NIN, Hyderabad during the year 200203 and later, due to increase in demand, four sites more were installed at
NJIL & and Other Mycobacterial Diseases, Agra; RMRC, Dibrugarh;
ICMR Hqrs, New Delhi; NIMR, Delhi.
•
JCCC@ICMR subscribed. JCCC is customized e-journal gateway-cumdatabase service.
•
The ICMR-NIC Centre for Biomedical Information’s website has been
ranked the top Indian health website by Google since November 2003
and has won several awards for the content as well design. The webpage
provides links to the Centre’s services in addition it also acts as a portal
to National Library of Medicine’s (NLM) databases as well as other
resources available over the Net. A Meta search tool, MetaMED, was
designed to search NLM’s PubMED and the Centre’s IndMED database
in one click.
medIND database (a full-text version of IndMEd journals) was launched
in August 2003 at www.medind.nic.in.(extramural)
•
■ Ml
.
A prototype Open Archive, OpenMED@NIC, was launched for Medical
and Allied Sciences where authors/owners can self-archive their scientific
and technical documents.
Recommended initiatives for the 11th Plan
The 10th Plan inter-alia had focused on building up a fully functional accurate
health management system, utilizing available IT tools, so as to enable the
real time communication link to send data on births, deaths, diseases
requests for drugs, diagnostics and equipment, facilitate decentralized
“A
district planning, implementation and monitoring.
A web based, one point interactive health research information system
should be developed which would provide information about the health and
biomedical research projects carried out in medical colleges, research
institutes, universities, government departments, NGOs, private sector etc.
This information could be used by policy makers, planners, programme
managers, researchers etc. This would provide access to national and
international biomedical databases and health research websites. The
system would act as an information portal for published and un-published
work. The Health Research Information System would need to be linked with
policy and decision-making
A National Institute of Health Information System, as already recommended
by NCMH, should be established. For this purpose, CBHI should be properly
upgraded with necessary supports from public health, statistics and national
health programmes to play the role effectively. This institute will also be
responsible for Human Resource Development and research studies. NIMS,
ICMR may be involved in taking up evaluation studies and operation
research periodically. The recommendation of National Statistical
Commission to upgrade the CBHI as a full fledged Directorate of Health
Statistics as a nodal agency to provide sufficient inputs on health statistics
should be seriously pursued. The Monitoring and Evaluation division of the
Department of Family Welfare which is responsible for collecting and
collating all Family Welfare information including RCH should be merged in
the proposed National Institute of Health Information System. Keeping in
view the recommendations of NRHM, the synergy between the Health and
Family Welfare Information System need to be made and this Institute
should be responsible for Monitoring and Evaluation of all health related
programme including RCH.
RgpdrtofWQ on HSR, &iomfedR&OJ Regulation of Drugsand Therapeutics...
Telemedicine
With the area of 3.3 million sq km, population of 1.1 billion, urban-rural
divide, inaccessible hilly regions, islands and many tribal areas, India is an
ideal setting for telemedicine assisted health care delivery. Growing number
of medical, paramedical colleges and schools with lack of adequate
infrastructure, learning materials and teachers needs is a matter of grave
concern. E health technology has the potential to create a national level
GRID which can form the backbone to be shared by healthcare providers
tramers and beneficiaries. A strong fiber backbone and indigenous satellite
communication technology in place with large mass of human potential
trained in IT and local presence of telepathy industry, e-health application
and implementation should not be a problem technically. Further, a number
of pilot projects over last five years with successful outcome stand to its
testimony. A ground work on telemedicine in the country has already been
laid with the efforts of ISRO and Information Technology department
partnering with many State Government and specialty Institutes/hospitals.
Policy standardization and infrastructural issues have already been
researched.
A strong formulation for telemedicine in the country has been laid by ISRO
and the Department of Information & Technology partnering with many State
governments, hospitals and specialty hospitals. Issues of policy,
standardization and infrastructure have been delved into by them.'
Professional societies on telemedicine/ e-health are actively engaged in its
development.
Telemedicine aims at equal access to medical expertise irrespective of the
geographical location of the person in need. Recent developments in
Information and Communication Technologies (ICT) have enabled the
transmission of medical images in sufficiently high quality that allows for a
reliable diagnosis to be determined by the expert at the receiving site.
Access too many different sources of medical data, usually geographically
distributed, and the availability of computer based tools that can extract the
knowledge from that data are key requirements for providing a standard
healthcare provision of high quality.
Developments in the integration of bio-medical knowledge, advances in
imaging, new computational tools and the use of these technologies in
diagnosis and treatment suggest that Grid-based systems can make a
significant contribution to this goal. In addition to enhancement of improved
access by integration of information, the benefits are raised to a new level,
over a Grid because of multi dimensional access to the information.
It is understood that the National Task Force has recommended a Nationa
Telemedicine Grid which will contain the following major functions I
constituents. The Task Force is already looking into the connectivity,
hardware, software requirements for projection under the 11 Five Year P an
which could be incorporated in the Report of the Health lnformat.cs Workmg
Group. Essentially the following is already under consideration of the Task
Force;
„
. A health portal at the Ministry of Health & Family Welfare providing all
information related to health informatics, telemedicine, disease
surveillance data, medical care details and other educational material
or information related to specific Indian healthcare system not
available in the internet or hyper link to the internet data repository^
This portal will be a constituent of the national grid for reposrtory of
•
information and guidance.
An All India Medical Institution network connecting the various
recognised medical institution, national institutes like PGMER, AllMS,
JIPMER SGPGI etc., and major super specialty hospitals
(Government and Private) in the country for medical education,
exchange of knowledge, CME etc.
• An All India Network connecting the various selected district hospitals
in the country to be connected to major super specialty hospitals
(Govt. .Trust/ Private) for specialist referrals for consultation and
treatment and also medical informatics, disease information and
health promotion aspects from different states of the country, (super
specialty hospital network).
• A national network for medical training connecting various agencies in
the country and also establish/integrate similar networks at state
levels. (National Medical Training Network).
State Telemedicine/e-Health Grids (STG)
As a part of e-health program and digitalisation of health records, some of
the states have been operating Telemedicine Networks initiated by ISRO
and other agencies like Department of Information Technology (DIT) under
Closed Usage Group (CUG) concept e.g. Chhattisgarh, Karnataka, and
Kerala. Many more states are planning to implement such state level
networks. There is a need to formalise the state Telemedicine networks into
standard State Grids for specific purposes of application and usage like;
providing State Health Information, Monitoring and Surveillance of
Report of WG on HSR, Biomed R & 0, Regulation of Drugs and Therapeutics... 63
J
Disease/Epidemic outbreak, identification and mapping susceptible areas
and population etc., as mandated by MoH&FW for health governance.
National Medical Education Institutions Network (NMEIN)
A National Medical Education Institutions Network if created would act as a
useful resource base for knowledge sharing for Medical Education,
Research and training including CME. The teaching and practical sessions
can be configured in live or recorded video, audio and information data
broadcast, accessed on the grid, for an effective learning experience.
Association / Society / Health portals Network (ASHPN)
Several associations/agencies are hosting and maintaining diverse health
portals like DOCTORYANYWHERE.COM in health care services.
It is necessary to pool the resources available with the various
autonomous/government/trust medical associations like Indian Medical
Association (IMA), Cardiology Society of India (CSI), Neurological Society of
India (NSI), Federation of Gynaecological and Obstetrics Society of India
(FoGSI) etc and form an Association/society /health portals Network.
Digital Library & Medical Informatics Network (DLMIN)
It is required to establish a Digital Library & Medical Informatics Network,
that will be a network of pooled information in the form of digital library of
data bases and Medical/Health Information that can be accessed through
Internet I Intranet and used for administrative/research and I or clinical
purposes.
Some of databases of immediate value would include, but not limited to:
•
Manuals of illness, diseases, symptoms, and diagnostic tools.
•
National registry of specialty hospitals and specialists: names, contact
information.
•
Health education programs and curricular materials.
•
Medicines: description, side effects, location, costs.
•
Online journals, abstracts, preprints.
•
Environmental profiles by state/region
- Locations of safe water supplies.
- Location of polluted sources (symptoms and treatment).
- . Location of.emergency food supplies.
- Location and description of health services.
on HSRi:BipiTi^d R&p^^^egglatlon qf^^Dfugs^^Thyapeutics;.;^^- ■
■
)
Location of disease outbreaks.
Changing environments.
Disaster Management Support Network (DMSN)
It is required that the health care services in times of disaster can be
effectively provided through establishment of Disaster Management Support
(DMS) Network. This network is required to integrate identified disaster
Monitoring Stations (current and proposed) across the country and provide
periodic and timely information both statistical and remedial to the central
station for necessary advice/action through the power of medical informatics
and digital connectivity.
Capacity building: Thrust of health informatics education should be use of
health information standards, storage of health information in electronic
health records and research and extra collation of health information for
better healthcare. Clinicians, healthcare managers, technologists,
researchers would all need to specialize in various aspects of healthcare
technologies. The course for skill development to include, certificate course
in computer application, education framework for general, para-medical and
nursing staff. These courses would need to be certified by Medical Council
of India.
System of statistical data and collection
In India, health information exists at various levels, forms and systems.
There is a wide variety of data that are collected by several agencies, mainly
government, both at the Central and the State levels through routine data
collection and periodic sample surveys. There is a plethora of information
concerning the health sector but in a highly fragmented manner. The health
management information system at the ground level especially tends to be
duplicated by various agencies.
A major problem of health information is the reliability of data and
consequent utilization for decision-making. In some respects, the reliability,
relevance, timeliness and quality of the data are questionable. There is
therefore a need to review national health information systems at various
levels — Central, State, district and block— by various agencies — different
ministries and departments in the government — method of data flow, gaps
in data, utilization of the data, organisational set up, accessibility of
information to various persons at various levels are aspects to be examined.
Such a review would help in improving data collection techniques and
quality, selectively expanding and examining the data load at various levels,
I
different types of information sources, biases in data management, reporting
of data transmission, vertical, horizontal, utility and use of information,
protocols for monitoring and evaluation of health information systems on a
routine basis.
These shortcomings are known and have been spelt out by the Statistical
Commission of India. It is recommended that action be taken to implement
the recommendations made therein with regard to the particular needs of the
health sector. Non availability of good quality data and reliable baseline
estimations are responsible for lack of clarity in policy design and strategies
being adopted.
Other steps to improve information access and flow include i) commitment
for sharing information and using electronic media; and ii) standardizing
formats for information exchange.
Action Plan for Research Information Dissemination
The current state of library and information network in medical colleges
continued to be poor. There is thus a great need to upgrade these facilities
to bring them, at least to a level at par with other libraries in sister disciplines
using IT. Students and teachers in these disciplines get adequate exposure
to the new information technology and are quite comfortable using these
new facilities in these libraries some of which are near global level. There is
no reason why the same cannot be done in medical colleges.
Policy makers have also shown inclination towards a comprehensive and
wholesale upgradation of such facilities and the recognition that without
modern information technology there cannot be any real progress in the
quality of medical education. It is important to motivate the library personnel
to take up the new challenge, as new IT would help them provide better
services to their user. A systematic approach is called for to chalk out a
strategy for the revamping exercise. As a starter an in depth, evaluation is
required to know the existing facilities of these libraries in terms of existing
availability of hardware and software and plan means of strengthening the
libraries. In fact, the ICMR has just started steps to modernize its network of
libraries and upgrade them to modern information centres. In view of the
massive exercise involved, it has been proposed to take up this in a phased
manner to enable both the information providers and users come to grips
with the new developments. A similar exercise is needed for the revamping
of these libraries, especially those in medical colleges.
L
Report of WG on HSR. BIomed R & D, Regulation of Drugs and Therapeutics... 66
9
Some Suggested Strategies/recommendations
Some of the action points to help the overall improvement of the medical
college libraries including the use of IT in these exercises to provide easy
and speedier access to relevant information for all health personnel and
other users are given below. Some of these have been suggested in the 10th
Plan but could not be implemented.
• As seen, the present IT infrastructure of the medical colleges/
biomedical institutions libraries in terms of user needs and the
potential for growth. Undertake this modernization in a phased
manner to bring all the libraries of the medical colleges / biomedical
institutions to a certain minimum benchmark in terms of infrastructure,
databases and services offered in the first phase.
•
Create computer-readable indexes of the holdings of these libraries.
Automate in a phased manner routine library operations like indexing,
issue and return of books, reminder system, inventory control of
purchases etc. through computerization.
•
Switch over as far as possible from printed versions of
alerting/journals/reference sources like Current Contents, Index
Medicus, Tropical Diseases Bulletin, and some core medical journals,
to the electronic form as CD.-ROMs, to improve the accessibility of
literature, save reader's time and save shelf space in the library.
Train users to access these facilities themselves.
•
Train the library staff on a continuing basis to get familiar with the
rapidly changing technological developments in the area of computerbased communications to access/provide these new facilities to
users. Involve IT professionals in library activities.
•
Plan steps towards national resource sharing and networking of the
libraries.
To begin with, libraries can network with
institutes/universities, which are closer in terms of proximity. They
should also be encouraged to join networks of other libraries with the
current IT infrastructure in India thus should be possible.
■I
BIBLIOGRAPHY
1. Burden of Diseases in India, National Commission on
Macroeconomics and Health, Ministry of Health & Family Welfare,
Sept 2005.
2. Ethical Guidelines for Biomedical Research on Human Subjects
Indian Council of Medical Research, New Delhi, 2000.
3. India Health Report. Rajiv Misra, Rachel Chatterjee, Sujatha Rao,
Oxford University Press, New Delhi, 2003.
4. Macroeconomics and Health: Investing in Health for Economic
Development. Report of the Commission on Macroeconomics and
Health, WHO Geneva, 2001.
5. National Family Health Survey (NFHS-3) 2005-2006.
International
Institute for Population Sciences, Mumbai.
6. National Health Policy 2002. Ministry of Health and Family Welfare.
7. National Rural Health Mission (2005-2012).
Ministry of Health and Family Welfare.
Mission Document,
8. RCH Phase II. National Programme Implementation Plan, Ministry of
Health and Family Welfare, Government of India.
9. Report of the National Commission on Macroeconomics and Health,
Ministry of Health and Family Welfare, Government of India, 2005.
10. World Health Report on Knowledge for Better Health. Strengthening
Health Systems. World Health Organization, Geneva, 2004.
11. World Health Report, 2005.
World Health Organization.
Make every mother and Child Count,
12. World Health Report, 2006.
Health Organization.
Working together for Health.
World
13. World Bank, The Burden of Disease among the Global Poor Davidson
R Gwatkin and Michel Guillot, 2000.
Report of WG on HSR, Biomed R & 0, Regulation of Drugs and Therapeutics... 68-
I
ANNEXURE
WG3
No.2(ll)/2006-H.&F.W.
Government of India
Planning Commission
(Health, Family Welfare & Nutrition)
Yojana Bhawan
Sansad Marg
New Delhi
25'1’ May, 2006
ORDER
Subject: Working Group on Health Systems Research, Biomedical Research &
Development and Regulation of Drugs and Therapeutics for the
Eleventh Five-Year Plan (2007-2012)
In the context of formulation of the Eleventh Five Year Plan (2007-12), it
has been decided to set up a Working Group on Health Systems Research.
Biomedical Research & Development and Regulation of Drugs & Therapeutics
under the Chairmanship of Director General, ICMR, New Delhi. The composition of
the Working Group will be as follows:___________________
2. Director General, Indian Council of Medical Research, New Delhi Chairman
2. Representative, Deptt. of AYUSH, Ministry of Health & Family Member
Welfare, New Delhi._______
Member
Representative, Deptt. of Health and Family Welfare, New Delhi
4. Representative, Deptt. of Science & Technology, New Delhi._____ Member
5. Representative, Deptt. of Bio-technology, New Delhi___________ Member
6. Representative, Directorate General of Health Services, New Delhi Member
7. Representative, Council of Scientific and Industrial Research, New Member
Delhi. _____________________________________________
8. Drugs Controller of India, DGHS, Ministry of Health & Family Member
Welfare, New Delhi____________________________________
9. Director, Central Drugs Research Institute, Lucknow___________ Member
10. Director, Industrial Toxicology Research Centre, Lucknow______ Member
11. Dr. C.K. George, Director, Institute of Health Systems, Member
Hyderabad.___________________________________________
12. Dr. Y.K. Gupta, Professor of Pharmacology, All India Institute of Member
Medical Sciences, New Delhi_____________________________
13. Prof. V.R. Muraleedharan, Indian Institute of Technology, Member
Chennai_____________________________________________
14. Director, Indian Institute of Science, Bangalore _____________ Member
1-5. Shri Rajeev Lochan, Director, (Health), Planning Commission, Member
New Delhi
Shri K.M. Gupta, Director, Ministry of Finance, New Delhi______
Dr. Ranjit Roy Choudhary, New Delhi______________________
Dr. Somnath Roy, Emeritus Professor, New Delhi_____________
Dr. Y. Atal, Ex-Principal Director, UNESCO, Gurgaon_________
Dr. Mira Shiva, Voluntary Health Association of India, New Delhi
Dr. Amar Jessani, Centre for Enquiry into Health & Allied
Themes, Mumbai______________________________________
22. Deputy Director-General, Indian Council of Medical Research,
New Delhi
16.
17.
18.
19.
20.
21.
2.
Member
Member
Member
Member
Member
Member
MemberSecretary
The terms of reference of the Working Group will be as under:
To review the position/progress/problems in basic, clinical, applied
(i)
and operational studies during the 10lh Plan period and to suggest
priority areas for research in these areas, and mechanism to avoid
duplication/overlapping and to bring about transparency and social
control in research work including ethical issues during the 1 llh Plan.
To review the current situation regarding development, testing and
(ii)
quality control of drugs and devices, both in the modem system of
medicine and AYUSH and suggest priority areas for research and
institutional strengthening during the 1 llh Plan period.
To
review the manpower position and infrastructure available for
(iii)
research in research institutions, universities, medical college and
service institutions and to suggest mechanisms for optimal utilization
of these human resources and facilities during the 11” Plan.
To review current status of inter-agency, inter-ministry collaboration
(iv)
in priority areas of research and to suggest mechanism of
improvement during the 1 l,h Plan period.
To review the situation regarding research agencies addressing
(v)
priority areas of research identified by service providers and
implementation of major suggestions emerging from research studies
and to suggest mechanism for improvement of these during 11th Plan
period.
To study the current status of access to research information from
(Vi)
India and abroad to researchers in India, suggest mechanism for
research information dissemination and central clearing house for
facilities for research information.
(vii) To review the current investment in bio-medical research and health
systems research by various agencies and project requirements to
address the identified priorities during the Eleventh Plan period.
(viii) To deliberate and give recommendations on any other matter relevant
to the topic.
The Chairman may form sub-groups and co-opt official or non-offical
3.
members as needed. The Working Group will submit its report by 31sl August,
2006.
^p<^;d^^^6n^^^j^mied’K^;l3<R^ulatiori^P^uaS;an^Th^peuUcs...:<70:;
i
)
)
4.
Shri Rajeev Lochan, Director (Health), Room No.463, Planning
Commission, Yojana Bhawan, New Delhi will be the Nodal Officer for all further
communications.
The expenditure on TA/DA in connection with the meetings of the Working
Group in respect of the official members will be borne by the parent
Department/Ministry to which the official belongs as per the rules of entitlement
applicable to them, the non-official members of the Working Group will be entitled
to TA/DA as permissible to Grade-1 officers of the Government of India under SR
190 (a) and this expenditure will be borne by the Planning Commission.
5.
(Rajeev Lochan)
Director (Health)
Tel.No.23096711
rlochan@,nic.in
To : The Chairman and all Members of the Working Group.
Copy to:
1.
2.
3.
4.
5.
J
6.
PS to Deputy Chairman/MOS
(Planning)/Members(KP)/(AS)/(VCL)/(BLM)/(BNY)/(AH)/(SH)/Memeb
r-Secretary, Planning Commission, Yojana Bhawan, New Delhi
All Pr. Advisers/Advisers/HODs in Planning Commission
Prime Minister’s Office, South, Block, New Delhi
Cabinet Secretariat, Rashtrapati Bhawan, New Delhi
US (Admin.I) / Pay & Accounts Officer/Accounts-I Section, Planning
Commission/DDO, Planning Commission
Information Officer, Planning Commission
(Rajeev Lochan)
Director (Health)
•\
i
nxiW
List of persons who attended the meeting of Working Group on 23rd Sept,
2006
Prof. N.K.Ganguly, Chairman
Director General,
Indian Council of Medical Research,
Ansari Nagar,
New Delhi - 110029.
Dr. M.K. Bhan.
Secretary,
Department of Biotechnology,
Block-2, 7th Floor, CGO Complex, Lodi
Road,
New Delhi- 110 003
mkbhan@dbt.nic.in
Dr. S.K. Sharma,
Dy. Director
Ministry of Health & Family Welfare,
Department of Ayurveda, Yoga & Naturopathy, Dr. S.K. Gupta,
Research Officer,
Unani, Siddha and Homoeopathy (AYUSH)
(Health & Family Welfare & Division),
Room No. 207, Red Cross Building,
Planning Commission,
New Delhi - 110 001
Yojana Bhawan, Sansad Marg,
Email: adv avurveda@vahoo.com
New Delhi
Email: rlochan@nic in
Dr. Laxman Prasad,
Department of Science
Dr. Mira Shiva,
& Technology,
Voluntary Health Association of India,
Technology Bhawan,
40 Institutional Area Near Qutab Hotel,
New Mehrauli Road,
New Delhi - 110 016
New Delhi-110 016
Email: mirashiva@vahoo.com
Email: laxman@nic.in
Dr.Lalita Goyal,
Scientist,
Council of Scientific &
Industrial Research, Anusandhan Bhavan,
2, Rafi Marg, New Delhi -110 001
Email: goyal l@csir.res.in
Dr. Amar Jesani,
Coordinator,
Centre for Enquiry into Health & Allied
Themes, Aaram Society Road, Vakola,
Mumbai-400 055
Email: amar.iesani@qmail.com
Dr. M. Venkateswarlu,
Drugs Controller General of India,
Directorate General of Health Services,
Nirman Bhawan,
New Delhi-110 011
Email: dci@nb.nic.in
Dr. R.K. Shrivastava,
Director General of Health Services,
Directorate General of Health Services,
Nirman Bhwavan,
New Delhi - 110 011
Email: dqhs@nb.nic.in
Dr. C.M. Gupta,
Director,
Central Drugs Research Institute,
Chattar Manzil Palace,
Post Box No. 173,
Lucknow - 226 001
Email: drcmq@sify.com
Prof. V.R, Muraleedharan,
Associate Professor,
Indian Institute of Technology,
l.l.T. Post Office,
Chennai - 600 036
Email: vrm@jitm.acJn
Dr. C.K. George,
Director,
Institute of Health Systems,
HACA Bhavan,
Hyderabad - 500 004
Email: ckqeorqe@ihsnet.org.in
Dr. Y.K. Gupta,
Professor of Pharmacology,
All India Institute of Medical Sciences,
New Delhi - 110 029
Email: ykq@hotmail.com
\
Dr. P. Balaram,
Director,
Indian Institute of Sciences,
Bangalore -560 012
Email: diroff@admin.iisc.ernet.in
Shri Govind Mohan,
Director,
Ministry of Finance,
Room No.167-C, North Block, .
New Delhi-110 001
qovindmohan@yahoo.com
c
72-•.
Ms. Bhavani Tnyagarajan,
Joint Secretary,
Ministry of Health & F.W.,
Nirman Bhawan,
New Delhi - 110 011
Email: jsbt@nb.nic.in
)
Dr. V. Muthuswamy,
Sr.DDG (BMS),
ICMR,
Email: muthuswamvv@icmr.orq.in
Dr. K. Satyanaryana,
Sr.DDG (P&l),
ICMR,
Email: kanikaram@icmr.orq.in
Dr. Ranjit Roy Choudhary,
Chair INCLEN Trust,
161-L, Hans Mansion,
1S1 Floor, Left Wing,
Gautam Nagar.
New Delhi - 110 049
Email: chairinclen@sifY.com
Prof. Somnath Roy,
410, Niligiri Apartment,
Alaknanda Pocket-A,
New Delhi-110 019
Email: drsornnathroY@yahoo.co.in
Dr. Deepali Mukherjee,
Chief, (ECD),
ICMR,
Email: mukherieed@icmr.orq.in
Prof. Yogesh A:al,
D-224 Seema Sadan,
Sushant Lok Phase One,
Gurgaon-122 009
Dr. Malabika Roy,
Coordinator (RHN)
ICMR,
Email: roym@icmr.org.in
Email: vogatal@Yahoo.com
Dr.Lalit Kant, Member Secretary
Sr.Deputy Director General(Hqrs.),
Indian Council of Medical Research,
Ansari Nagar,
New Delhi-110029.
Co-opted members
Dr. Indira Chakroborty
Director
All India Institute of Hygiene & Public Health,
Kolkata
Dr. Arvind Pandey,
Director,
National Institute of Medical Statistics,
Ansari Nagar,
New Delhi-110 029
Email: arvindpandev@icmr.org.in
Shri P.D. Seth,
Financial Adviser,
ICMR,
Email: sethpd@icmr.org.in
Shri Mohinder Singh,
Sr. DDG (Admn.)
ICMR,
Email: msinqh@icmr.org.in
Dr. Bela Shah,
Sr.DDG (NCD),
ICMR,
Email: shahb@icmr.orq.in
T.
Dr K K Singh
Chief, Manpower development Unit,
ICMR,
Email: singhkk@icmr.org.in
3
Dr. Ambujam Nair Kapoor,
DDG (ECD)
ICMR,
Email: ambujam@icmr.org.in
October 2006
Report of the
Working Group on
Health Care Financing including
Health Insurance
for the 11th Five Year Plan
JTT.n rn
Ministry of Health & Family Welfare
Nirman Bhawan, New Delhi - 110011
1
Ministry of Health & Family Welfare
Subject:
Report of the Working Group on Health Care Financing
including Health Insurance for the 11th Five Year Plan
*****
The Planning Commission constituted a Working Group on the above
mentioned subject with the following Terms of Reference:
(i)
To review the present position of health financing at state, centre and
individual levels. Keeping in view identified problems and constraints of
existing system, make suggestions for improvement in quality and
efficiency with reduction in the cost of health care to the poor in the
Eleventh Plan;
(ii)
To suggest management strategies for community based health insurance
as well as process and impact assessment parameters for these initiatives
during the Eleventh Plan;
(iii)
To assess disease burden and cost of ill health in the country and project
figures for 2012 and 2017;
(iv)
To give cost estimates for health care-public, NGO and private-current
and for the Eleventh Plan period;
(v)
To suggest alternative sources / strategies for health financing during the
11th Plan to meet the cost of health care;
(vi)
To deliberate and give recommendations on any other matter relevant to
the topic.
2
The membership of the Committee was as follows:
1
2
3
4
5
6
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
Secretary (Health & FW)
Ministry of Health & Family Welfare, GOI______________________
Joint Secretary (In-charge of Insurance), Ministry of Finance_______
Joint Secretary, Ministry of Finance
_________________________
Director General, NSSO, New Delhi
Director General, NCAER, New Delhi__________________________
Secretary (Health), Government of Andhra Pradesh______________
Secretary (Health), Government of Madhya Pradesh______________
Secretary (Health), Government of Karnataka____________________
Secretary (Health), Government of Gujarat______________________
Shri A. Kumar, Director (H&FW), Planning Commission, New
Delhi
Shri K.M. Gupta, Director, Ministry of Finance, New Delhi________
Director, Centre for Development Studies, Thiruvananthapuram
President, IMA, New Delhi____________________________________
Shri Ashok Sahni, Hon. Executive Director, Indian Society for
Health Administrators, Bangalore_________________________
Dr. Ravi Duggal, CEHAT, Mumbai_____________________________
Shri B.B.L. Sharma, Health Economist, New Delhi________________
Prof. Ramtesh Bhatt, IIM, Ahmedabad__________________________
Dr. A.S. Dua, Former Member, Sub-Commission, NCMH, New
Delhi
Dr. Moneer Alam, Health Economist, IEG, New Delhi_____________
Dr. K.S. Nair, Faculty, NIHFW, New Delhi_______________________
Dr. P. Mohapatra, Ex-Director, Institute of Health Systems,
Hyderabad_________________________________________
Joint Secretary, Ministry of Health & Family Welfare
Chairman
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Secretary
The Secretary (H&FW) authorized Ms. K. Sujatha Rao, AS & DG (NACO)
to be the Chairperson on his behalf and Shri Amarjeet Sinha, Joint Secretary,
Ministry of Health and Family Welfare, to be the Member Secretary. The group
met on 18th July, 2006. The minutes of the meeting are placed at Annex - I.
3
Introduction : The context
India is one of the few countries that has a public health spending of less
than 1% of GDP resulting in nearly three quarters of the money being met from
out of pocket by households. Of the Rs. 148727 crores spent on health during the
year 2004 - 2005 accounting to 5.2% - of 5DP at the factor cost Government spent
is about 22% (Annexure II) Almost 73% was met by households making it a very
regressive system of health financing. Of this, about 50% was spent on primary
care. Estimates show that Government in 2004-2005 met barely 50% of the total
required to implement the six National Health Programs aimed at controlling
communicable diseases such as malaria, TB, leprosy, HIV/ AIDS and RCH.
Besides, data also shows that over time, revenue outlays for health in proportion
to total budgets have been steadily falling in almost all states. Annexure II, III,
IV. Data also showed that besides chronic underfunding, the sector was plagued
with instances of inefficiencies at several levels resulting in waste, duplication
and suboptimal use of scarce resources. All these factors combined have had an
adverse impact on the functioning of the public health sector's ability to provide
health care services to the people, resulting in an estimated 3.3 % of the
population getting impoverished on account of high health expenditures
incurred in private sector hospitals. Health spending averaged 11% of non food
expenditures and almost 5% of the total annual expenditures of households.
Almost 40% were reported to have taken loans to incur such expenditures and
nearly 10% sold assets resulting in intergenerational poverty.
It is in the above context that the Working Group on Health Financing
deliberated the specific TOR's in two meetings as under :
4
Terms of Reference - I
To review the present position of health financing at state, centre and
individual levels. Keeping in view identified problems and constraints of
existing system, make suggestions for improvement in quality and efficiency
with reduction in the cost of health care to the poor in the Eleventh Plan;
The Working Group on Health Financing initiated the deliberations
keeping in mind the need to ensure an equitable and efficient health system
through the rational use of resources. In reviewing the present position of health
financing and the existing system of health financing in the country, note was
taken of the recently published report of the National Commission on Macro
Economics and Health (NCMH August 2005) which had undertaken a detailed
exercise on financing of health care. The Report had made certain projections of
investments required to be made in the health sector for reducing inequities and
inefficiencies that characterize the health sector. The WG also reviewed the
health spending estimates as provided under the National Health Accounts
framework for the year 2001-02 and later reiterated by the Ministry of Health-
Annexure V. It also noted three subsequent developments having implications
for health financing:
a) The NSSO 60th Round Report (January - June 2004) on Morbidity Health Care
and the condition of the aged (March 2006) showing two worrying developments
: an increase by nearly 50% in health expenditures in urban and rural areas as
compared to the last survey conducted in 1994-5;and a near stagnation in the
utilization of public facilities with a sharp fall in Bihar - Annexure VI.
5
b) The Report of the Task Force on Innovative Health Financing Mechanisms
under the NRHM (December 2005). The Report recommended the need to
develop systems for risk pooling for obtaining access to medical services from
the public and private facilities in accordance with commonly agreed standards
and prices. Based on this the Ministry of Health & Family Welfare has developed
a framework for Community Health Insurance advocating a policy of different
approaches being adopted as far as risk pooling and community health insurance
is concerned.
c) Approval of the detailed Framework for Implementation of the National Rural
Health Mission (July 2006). The approval includes in principle agreement on
financial resources for the NRHM 2005-2012 in line with the commitment made
in the Common Minimum Programme and the recommendations of the NCMH,
providing for an annual increase of 30-40% Central Government allocation and
10% by States'.
Apart from the NSSO surveys that have shown the steady decline in the
utilization of public facilities except in a few states, evidence from several other
reports have also conclusively brought out the increasing dependence of the
private households on the private sector, often paying huge amounts often for
substandard quality of care. While at the periphery, primary health care facilities
lack drugs, well trained personnel, diagnostic facilities, poor access due to
inconvenient location and mismanagement, the higher level facilities provide
low quality of care due to patient overload and exhausted staff. It is clear that
with the mere correction of these shortcomings and by bringing in better
management, utilization of the existing facilities can be improved. This alone will
substantially reduce out of pocket expenditures, particularly among the poor,
and also get better returns on the investments made in the establishment of the
public health infrastructure.
6
The dysfunctional nature of the health was also perceived to be the result
of a centralized disease control approach that provided little scope for inclusive
strategies where the beneficiaries of the system also had a role to play; inflexible
financial systems and procedures; and poor human resource management. The
financing system is equally dysfunctional as funds are released in five years
cycles, divided under different and complex budget heads- revenue, capital etc
providing for little flexibility to respond to any health emergency. To address
such technical and allocative inefficiencies in resource utilization. Government
has in the last one year initiated several interventions under the National Rural
Health Mission (NRHM) in 5 key areas that when implemented will have a
significant impact on reducing current inequities in health care financing and
access.
•
Decentralized planning under which every district is expected to prepare
a perspective and an Annual District Health Action Plan 2005-2012,
projecting the basic health care needs of local communities, integrating
also the wider determinants of health and combining promotive,
preventive and curative care in a common referral link that operates from
the village to the District Hospital. This process is based on the principle
of decentralization of funds and functions to Panchayat Raj institutions
and locally elected bodies, hospital committees in partnership with
community organizations and Village Health and Sanitation Committees
and broader civil society. This measure will bring in both accountability
and generate demand for services as well;
•
Strengthening of management capacity at all levels, with equal emphasis
on skill development and development of the required human resources
for coping future health challenges;
7
•
Improved financial management by providing flexibility and making it
performance and outcome based;
•
Improved delivery of services based on the recognition of the need to
guarantee a minimum package of services to every citizen at all the levels
of care; and
•
Close monitoring based on baseline surveys and a list of critical health
indicators.
The practice, constrains and action needed to overcome taken may be seen at
Annexure- VII.
It is believed that the implementation of the above initiatives will increase
utilization of the health facilities and provide the poor a measure of protection
from risk and reduce out of pocket expenditures. The implementation of the
policy framework indicated above will however require a quantum increase in
resources. Such an increase is expected to be provided under the NRHM during
the Xlth Plan period as per norms described below :
Norms and broad financial framework of the NRHM:
The NRHM derives its cost norms from three sources: (i) existing norms of
schemes brought under the umbrella of NRHM; (ii) norms and (iii) standards
developed by the National Commission on Macro Economics and Health; norms
suggested in the EFC. A diverse set of norms are expected to provide flexibility
to States in planning and to accommodate interventions/innovations as required
for meeting local needs.
For achieving program efficiencies ,the National Disease Control
Programmes related to control of TB, Malaria, Blindness , Iodine Deficiency,
Kalazar. the
Integrated Disease Surveillance Programme, and all the Family
8
Welfare Programmes of the Ministry of Health and Family Welfare have been
integrated under the NRHM. Financial integration is proposed by creating a
single Budget head for NRHM, while other disease control programs such as
Cancer, non - communicable diseases, HIV/AIDS prevention etc. will converge
their programs with the NRHM interventions. Such integration is expected to
bring down duplication of services and make better use of existing resources.
Optimizing existing resources and infrastructure will alone release an estimated
30% of existing budgetary outlays for alternative use.
13.
The National Commission on Macro Economics and Health has provided
the cost of a package of services to be provided at the primary and secondary
levels of health care facilities. The core and basic package include childhood
diseases/health conditions, maternal diseases/health conditions, blindness,
leprosy, TB, Vector borne diseases, RTI/STI, preventive and promotive activities,
minor injuries, other minor ailments, and snake bite. The NCMH also provides
standard costs for non-recurring and recurring costs of Sub Health Centres,
PHCs, CHCs. The Ministry of Health and Family Welfare has developed IPHS
for SHC/PHC/CHC and is in the process of developing IPHS for Sub Divisional
and District Hospitals. The NCMH assessments, read with the IPHS and the
actual Facility Survey of each health facility, will determine the actual resource
need. The over all resource envelope for NRHM has been projected as per
assessment of NCMH, which is in line with the CMP promise of raising public
expenditure on health to 2-3 % of the GDP.
Specific norms have been proposed for untied grants at al levels of health
action. These include - (i) grants to Panchayats/Rogi Kalyan Samitis; (ii) capacity
building in community organizations; (iii) skill needs of doctors/para
medics/educated RMPs; (iv) local criteria and need based selection of resident
health workers/Nurses/Doctors/Specialists as per IPHS; (v) partnerships with
9
the Non Governmental sector; (vi) nurturing and development of ASH As; (vii)
strengthening of Block and district level management; (viii) improving physical
infrastructure for health; (ix) MIS/monitoring-evaluation of programme; (x)
behaviour change and communication/IEC; (xi) support to mobile medical units
in each district of the country; (xii) grants to Rogi Kalyan Samitis at PHC, CHC,
Sub Divisional, District Hospital in all States and to Government Medical College
Hospitals in special focus States; (xiii) grants - in-aid to NGOs at district, state
and national levels; (xiv) support for school health programmes/ ICDS health
component, nutrition and health education programmes for women, resources
for surveys, public reports on health, etc.; (xv) Social health insurance as per local
models with subsidies only for Below Poverty Line Families at par with the
current limits under the Universal Health Insurance Scheme; (xvi) strengthening
nursing
institutions/Medical
Colleges
in
capacity
development;
(xvii)
Ambulances and phones at al levels; (xviii) National and State level Health
System Resource Centres and District and Block level resource Groups; (xix)
strengthening procurement and logistics in States; (xx) meeting diversity of
northeastern States.
Resource assessment and Centre - State sharing
As regards costing of additional resource needs, the National Commission
on Macro Economics and Health has made a detailed assessment of investment
requirements, based on disease burden estimations, bare minimum standards
and treatment protocols, and unit cost estimations of providing such services at
government prices that are 30-50% lower than the private sector. The
Commission has recommended additional non-recurring investment of Rs.
33,811 crores and a recurring investment of Rs. 41,006 crores for health
promotion, regulatory systems, enforcement of regulations, human resources for
10
health, training, research and development, delivery of health care services, and
social health insurance as under :
Table 1: Estimated Additional Resources as Estimated by NCMH
Activity
Non
recurring
additional investment
1. Health Promotion
including
publicity and dissemination and
community
involvement
for
preventive activities.
Recurring
investment
additional
Rupees 4000 crores
2. Training - of Village Health
Committees, unqualified RMPs, village
level workers, in service health
personnel, fellowships, rural allowance
for health personnel, etc.
Rs. 853 crores
Rs. 765 crores
3. Delivery of health care services (Bare
minimum requirements)
Rs. 23968.92 crores
Rs. 20,958.86 crores
4.Social Healt insurance including
premium - subsidy for BPL families.
Rs. 9000 crores
5. Human resource for health opening, upgrading and strengthening
Nursing Colleges
Rs. 3923 crores
Rs. 526.50 crores
TOTAL
Rs. 28744.92 crores
Rs. 35250.26 crores
The resource projections indicated above have been found to be realistic
and adopted for purpose of estimating additional allocations under NRHM for
the Xlth Plan period. However, there is need to bear in mind two caveats: 1. The
cost of construction and other unit costs in the North Eastern States, the hilly
regions, need to be estimated by 1.5 times; and 2. Given the current absorptive
capacities in the States and weak management structures at various levels, it is
likely that the demand for resources may be lower than anticipated. Therefore,
while adopting the resource envelope suggested by NCMH in principle, the
actual need year on year requirement of resources will depend on the pace at
11
which States push reforms in order to remove the clogs that are currently
constraining their e ability to absorb and effectively utilize additional resources.
A substantial share of the additionality indicated above will have to come
from Central funds. It is proposed that NRHM provide 100% grants to States on
a 75-25 sharing basis between the Center and States during the Xlth Plan. The
long term additional funding by the Central Government will significantly
improve the central share in overall public expenditure on health. While doing
so, the Central Government will constantly monitor the state expenditures on
health to ensure that they increase in proportion to central spending in real
terms.
Given the absorptive capacity in the States and the time it may take to
improve the implementation capacity, it should be fair to assume an annual 30%
increase in health sector allocations up to 2007-08 and an annual increase of 40%
from 2009-201O to 2011-12. Following this broad assessment, the Central
Government resource needs are likely to be as follows:
Table 2 : Projected Resource need for NRHM 2005-2012
Rupees in crores
Year
Central
Government
NRHM
allocation
Recurring
NonRecurring
State
Contribution
Total
6500
2005-06
6500
2006-07
9500
9000
500
2007-08
12350
11000
1350
2179
14529
2008-09
17290
13000
4290
3051
20341
2009-10
24206
16206
8000
4272
28478
2010-11
33884
23884
10000
5980
39864
9500
12
47439
2011-12
42439
5000
8372
55811
The resources indicated above relate to communicable disease control
programmes, RCH, Family Planning, IDSP, etc. programs that come under the
NRHM.
There is need to, however, also provide an estimate of resources
required for the non-communicable disease control programmes (mental health,
vascular diseases, cancer, etc.), HIV/AIDS, medical education, etc.
Since the
non-communicable diseases do not entail any externalities, normally public
funding is not provided in a significant manner.
However, with evidence
suggesting increasing prevalence of hypertension, mental health, accidents &
injuries affecting a large number of poor and the treatment under all these
conditions being exorbitant, public health financing has to take into account
provisioning of free treatment in all public health facilities for these
diseases/conditions. It is accordingly recommended that 20 per cent of the total
amount projected in the table 2 above may be provided additionally for tertiary
care which may also include medical education and research.
Regarding HIV/AIDS, the importance of containing this disease needs to
be under-scored since treatment of AIDS is extremely expensive besides the fact
that this infectious disease has the capacity to devastate the socio-economic fabric
as witnessed in South Africa. Adequate resources have to be provided to stabilize
and reverse the epidemic.
For the Phase-Ill of the National AIDS Control
Programme to be implemented during the 11th Five Year Plan, an estimated
amount of Rs. 11,285 crores has been projected. Of this an amount of Rs. 8,000
crores is required to be provided in the budget. 25 per cent of this is under
domestic budget (NRHM) and 75 per cent under the EAP component.
Therefore, the additional budgetary provision over and above Rs. 55,811 crores
projected in Table-2 above is Rs. 5,814 crores for the HIV/AIDS programme.
13
Thus the additional total resource requirement for health during the 11th Plan is
estimated to be Rs. 72,788 crores.
Terms of Reference - II
To suggest management strategies for community based health insurance as
well as process and impact assessment parameters for these initiatives during
the Eleventh Plan;
Need for new avenues of health financing
The Group expressed its desire to explore new health financing
mechanisms in order to reduce the burden of health expenditures among the
poor households. The National Commission on Macroeconomics & Health has
pointed out that 3.3% of India's population is impoverished every year on
account of health distress. There is also evidence to suggest that the poorest 10%
of the population rely on sale of assets to meet their health care needs. A study
in some of the poorest districts by Jha & Jhingran 2002 had revealed that illness
of a family member is the most common reason among poor households leading
to a financial crisis and causing a sense of insecurity. Nearly 40% of the Below
Poverty Line families reported having faced a financial crisis during the last two
years and about 69% of these was on account of illness and 11% on account of a
death of a family member.
Clearly poor people in rural areas are spending
significant amounts on health care leading to their impoverishment.
Vulnerability and risk among informal sector workers
Work and social security are the central concerns of the poor in our
country. Most of our nation's poor or almost 400 million workers are engaged in
14
the informal economy, also called the informal or unorganized sector. There are a
large number of agricultural labour who fall in the below poverty line category.
Among these workers, women are the poorest and most vulnerable of all facing
varied risks. Risk pooling could be one way of reducing such risk.
The poor have devised their own systems to cope with the many risks in
their lives. The most well-known of these is savings for a variety of purposes,
including coping with risk - paying for medical expenses, funeral costs, or a
leaking roof. The system of "Vishi", or contributing to a central pool of money
which is then drawn upon by a few of the contributors in times of need, is thus a
kind of risk management. The several examples of micro credit organizations
and the
Self- Help Group movement
are based upon and built on these
practices.
Current Status of Health Insurance in India:
The ESIS and CGHS are the oldest schemes for social health insurance in
India. ESI Hospitals provide services to an estimated 35 million beneficiary
across the country, while the CGHS serves an estimated 4 million cardholdres.
CGHS uses a subscription but the actual expenditure incurred is many times
more than the premium collected. The experience with health insurance so far
has been mixed. Some policies like Mediclaim covers more than 75 lakh persons
with a range of premium varying from Rs. 175 to Rs. 5770 per annum, the claims
ratio being 84%. The Yeshasvini Cooperative Farmers Health Care System, the
work of Karuna Trust, the Vimo SEW A, etc. are some recent examples of
community health insurance providing protection against catastrophic health
expenditure. Similarly, State Governments and some central ministeries have
also been exploring the possibilities of risk pooling for Health Care. Government
of Assam started a Health Insurance Scheme which covers major surgeries but
15
excludes essential maternity care etc.
Government of Jharkhand is trying to
design a Health Financing Product without exclusions in one block of each
District with the partnership of industrial houses and Insurance Management
Organization.
Government of Kerala has recently initiated a programme of
health insurance for 25 lakh below poverty line families called Kudumbshree
Scheme which tries to rectify some of the exclusions in the earlier UHIS Scheme.
The National Commission on Enterprises in the unorganized sector has also been
examining the feasibility of Health Insurance for informal sector workers. The
Ministry of Textiles has started a Health Insurance Scheme for co-operatives of
weavers.
One of the impressive models of CBHI aimed at the poor is SEW A in
Gujarat. SEWA's experience over 14 years based on insuring over 140,000
workers and their families suggests that for health insurance to be viable, it has
to be controlled and run by the users themselves - negotiating fees, treatment
regimens etc. with providers, both public and private. Those providers that
adopt poor quality of care or fraudulent practices are black-listed. This has
already had the effect of providers improving the quality of their care and
revising some of their prices.
It has also resulted in the public health system
gearing itself up to provide the care required, with the public charitable trust
hospitals serving as a back-up or alternative to the public and private-for-profit
health providers. Finally, the experience of SEW A with health insurance has
encouraged the development of a "cashless" system with providers, both public
and private, enabling women and their families to seek quality care of their
choice without having to pay upfront immediately. This new system is being
tested out in eight talukas in Gujarat, as well as two working class
neighbourhoods of Ahmedabad city.
16
SEW A experience points to the need for a comprehensive insurance
package covering both life and non-life risks. This is advisable both because a
holistic approach to risks and shocks faced by the poor is required, and also
because this will lead to overall viability of insurance for the poor.
The Government of India's Universal Health Insurance Scheme (UHIS)
was launched in the Budget of 2003-04 and is the first broad-based health
security scheme having an element of financial contribution from the State. In
2004-05 budget the UHIS was revised to restrict it to Below Poverty Line families;
increase the subsidy element to Rs.200 against the Rs.365 annual premium paid
for individual coverage; Rs.300 for the Rs.547.50 premium for a family of five and
Rs.400 for those paying a premium of Rs.730 for covering a family of seven
persons. The coverage under UHIS is unsatisfactory (barely 1.3 lakh persons till
31 July 2005). Maternity benefit is not covered under UHIS. Exclusion of essential
health care needs are likely to make any policy unattractive. Perhaps a range of
health insurance products developed as per local needs, improved social
marketing of such products, simpler procedures for claims, and accredited
facilities for hospitalization in rural areas could have helped a larger coverage
under UHIS.
The perception of Insurance Companies about UHIS
The General Insurers' (Public Sector) Association of India (GIPSA) have
identified the following constraints in the UHIS programme: inability of BPL
families to pay even the subsidized premium; low premium structure being cost
prohibitive for effective canvassing and service; perception of government
sponsored scheme as a free scheme; health insurance for poor as state
responsibility and not commercially viable; and inadequate public health
facilities, standards and system of Third Party Administrators.
17
The perspective for improving coverage for Risk Pooling
The experiences from across the world show that health insurance is
neither a substitute for a well - functioning, effective and efficient public health
care system, nor, an argument for undermining higher public investments as the
success of risk pooling is dependent on the provision of health care services in
the public and private sectors. Health insurance is an effective mechanism for
reducing risk against lumpy and unpredictable expenditures that characterize
health spending. Given the inability of households, more particularly the poor to
raise such resources in a short time, cashless and simple procedures for claim
settlement seem to be the ideal ways of ensuring access to health services to the
poor and creating confidence among them regarding the system of health
insurance as a way of health financing.
NRHM - An opportunity
The National Rural Health Mission (NRHM) aims to bring about
fundamental reforms in the system of health care delivery as well as exploring
new health care financing mechanisms and developing credible community
based health insurance schemes. The NRHM envisages an empowered District
Health Mission with adequate technical, managerial and accounting support in
managing risk pooling and health security. With schemes to have Accredited
Social Health Activists (ASHAs) for every 1000 population; strengthened 3222
Community Health Centres and a 24 hour round the clock hospital facilities in
every Block; subsidizing indirect costs under the Janani Suraksha Yojana for
promoting institutional deliveries among Below Poverty Line pregnant woman.
18
All these initiatives will contribute to providing opportunities to improve risk
pooling through community based health insurance.
Need for diversity of approaches - letting a hundred flowers bloom
A critical issue in the context of India's health insurance is the rapid
growth of an unregulated private health sector following no standards and with
no control on the prices to be charged or use of technology. The 60th Round of
NSSO shows a doubling of the costs of inpatient hospitalization in urban areas
since the past decade. Combined with long waits and poor quality of care in the
public health facilities, this escalation is leading to the greater indebtedness of
people.
In the above context and in order to provide choice and expand access,
international experience shows that insurance coverage for the poor is indeed
possible, if certain critical issues are taken into account. The most important of
these issues is developing a mechanism of implementation that is specially
tailored to the reality of the poor, and organized according to their convenience.
Need for participation of government funded public health institutions
The Group deliberated on the participation of Government Health Care
facilities in any innovative risk pooling arrangement. The Group felt that the
participation of Government Hospitals and Health Centres was very critical for
any risk pooling arrangement as otherwise it becomes a system of subsidizing
private health care. It was also felt that the challenge of risk pooling for remote
rural households can only be met when public health systems are also a part of
such innovative health financing mechanisms. The example of Karuna Trust's
work in Karnataka showed how by compensating poor households for loss of
19
wages and other indirect expenses and reimbursing hospitals a certain amount
for drugs and medicines in every case of hospitalization, result in increasing
access to medical care, optimal utilization of the public facilities and reduction in
households expenditures.
One possibility therefore is to have a number of
pilots undertaken on risk pooling for poor households through NGOs, Self Help
Groups, other community organizations covering the indirect expenditures that
are incurred in seeking health care.
Any kind of Health Insurance Scheme, which does not involve the public
medical facilities, would not succeed because, in majority of states, these are the
only facilities available in rural areas. The involvement of the States could be
worked out by designing a Plan Scheme by the Ministry of Health and Family
Welfare with subsidy being passed on to the hospitals through the State
Governments.
In such a situation, the State Governments can invite bids on
'premium to the charged' at their level from all the insurance companies, both
public and private. For availing of the subsidy from the Central Government, the
minimum features of the Scheme could be decided a priori and informed to the
State Governments. The State Government may add some more features to the
scheme and may also provide financial assistance to the policyholders by
contributing whole or part of the premium. In this scenario, the modalities of
administering the scheme at different levels may be described in detail by the
Central Government or may be left to the State Governments.
Innovative financing for efficiency
Innovative mechanisms of health financing
can be used to improve
accountability of the health system, be it in the public or private sector. For
example if a CHC were to receive resources directly on the basis of their case
load, it would contribute to a more effective service delivery. Similar would be
20
the case of the private sector. For involving the private sector as a provider of
care paid for by a public financing system, there is need to establish effective
standards, capacity to monitor their enforcement, and a regulatory framework
for ensuring that providers did not exploit the market imperfections so inherent
in the health sector. The work of the National Commission on Macroeconomics
and Health on unit costs for core, basic and secondary health care package
alongside the facility survey of the public and private sectors in 8 districts could
be a useful starting point for developing standard costs and treatment protocols
and a basis for public private partnerships in health service delivery.
Difficulty with formal insurance organizations
There was an apprehension feeling that the formal organization of Health
Insurance Companies do not have the capacity to address the needs of the poor
on account of the complex procedures involved in reimbursing the amounts and
setting claims.
Even
the
current arrangement of a
few Third
Party
Administrators [TPA] to facilitate health care reimbursements does not seem to
be effective in enabling the poor participate in health insurance. The Group felt
that there was a need for a district level body to play the role of TPA. The Group
felt that the District Level Board for Innovative Health Financing could mobilize
finances from a varied set of sources such as user fees from those with ability to
pay, household contributions, government subsidy etc. In such a system the role
of the NGOs, Community Based Organizations is vital for articulating peoples
needs, ensuring access without hassles and motivating communities to
contribute and save for health care. For discharging these functions, the District
Health Financing Boards as well as the NGO's need capacity building in
management and financing. In this context it was noted with satisfaction the
IRDA notification issued on 10th November, 2005 on micro-insurance.
21
formalizing the involvement of NGOs, cooperatives and other community based
organizations in health insurance.
Role of Panchayati Raj Institutions
Panchayati Raj Institutions have the mandate to manage the Primary
Health system. The various tiers of Panchayati Raj Institutions ought to exercise
control and supervision over health facilities, functionaries and functions.
Communitization through ownership by Panchyati Raj Institutions adequately
prepared to undertake the management role is necessary for an efficient and
effective health system. The experience with Hospital Development Committees
in Kerala and Rogi Kalyan Samitis in Madhya Pradesh has prompted the Central
Government to mandatorily seek the establishment of such community
organizations in health institutions. Innovative health financing would require
active ownership of the public health system by Panchayati Raj Institutions.
Amendments needed in the regulations on health insurance
The single most important determinant for the success of any health
insurance scheme is the confidence and trust that it generates among the
contributory households, as in this case, they are sanctioning current use for a
future benefit, year after year. While the regulations for insurance are enforced
by the Insurance Regulatory and Development Authority (IRDA), a structure
and rules framed for their operations, licenses for Third Party Administrators
systematized etc.for addressing the concerns of the model of financing proposed,
two major changes would be required: (i) allowing NGOs and local district
health financing boards to manage health insurance; and (ii) widen the network
of the Third Party Administrators in order to provide such scope and possibility
22
at the district level, so as to allow entry to NGOs and district health financing
boards. Monopolies of the few insurance companies and a handful of Third
Party Administrators will have to give way to several players at the local level
district based organizations working through an equally large network of Third
Party Administrators. For effectively regulating such diverse systems of health
financing models and to cope with the complexities of the health sector it would
be adviseable to establish a Health Insurance Regulatory Authority as an
independent authority or under the aegis of the existing IRDA.
In conclusion, it is recommended that to initiate establishing risk pools for the
poor based on the concepts of community based health insurance the following
steps may be considered:
•
Appoint a body that will take the responsibility of organising the health
insurance programme - could be an independent Health Insurance
Corporation, or a cell in the Dept, of H & FW, a separate trust, or a NGO.
•
Examine the feasibility of organizing large risk pools by combining the
organized sector with the organized elements in the informal sector such
as cooperatives, self help groups etc. This is essential as size of risk pools
determine the extent to which the cross subsidization between the rich
and poor, the old and the young and the sick and healthy can take place.
Such cross subsidization is essential for long term sustainability of the
insurance scheme.
•
Arrive at a basic package that would address the medical, surgical and
other health needs of the poor to be provided as inpatient or outpatient.
For the BPL families, transport and wage loss compensation need to also
be factored.
23
•
The premium for a reasonable package of basic services is estimated to
cost about Rs 250 for a family of five. The proportionate share between
the three key stake holders will need to be finalized : the Central
Governemnt, the State Governemtn and the individual households. It is
necessary to note that the poor cannot sustain contributing to a scheme
which is not subsidized.
•
An independent body should be appointed to administer the scheme
having the requisite technical and managerial capacity.
•
A cell should be established to closely monitor specific indicators to
ensure that the programme is on track.
Terms of Reference - HI
To assess disease burden and cost of ill health in the country and project
figures for 2012 and 2017;
The NCMH recently carried out disease burden estimations based on an
exhaustive review of available research and data and extrapolated to 2015. These
estimations were also peer reviewed by experts. For each disease/ health
condition, experts also provided a minimum standard and treatment protocol.
Costs of treating a condition as per the given protocol was then computed using
market prices for drugs, medicines and other goods. For services and the capital
infrastructure required, government rates were adopted and unit costs derived
by arriving at average utilization rates currently observed. It is for this reason
stated that the cost of delivering a similar service in a private facility would be
30-50 % more. As there is no new research or evidence emerging, the WG felt
24
that there was no purpose served in undertaking a review of these estimations.
Accordingly, the disease burden for 2015 and the cost of treatment as arrived at
by the NCMH is adopted.
Terms of Reference - IV
To give cost estimates for health care-public, NGO and private-current and for
the Eleventh Plan period;
The only source of data available for providing an estimate of the proportional
share of health expenditures by NGO's, the public and the private sector and for
the Xlth. Plan period is the 60th. Round NSSO which is a large household survey
recently conducted. As per this survey, the average medical expenditures
incurred at different health facilities for inpatient care is given below. As can be
seen from the table, there has been an overall increase in the expenditures
incurred in all facilities, in rural as well as urban areas. Most worrying is the near
doubling of expenses incurred in the private hospitals located in urban areas. It is
recommended that to get better insights into how adverse has been the impact of
these increases, an analysis fractile goup wise needs to be undertaken.
Table -3 :Average Medical Expenditure (Rs.) per Hospitalization Case
Type of Hospital ______
__________ Rural
2004
1995-96
Government
3,238
2,080
Hospitals
Private Hospitals
7,408
4,300
Any Hospital
5,695
3,202
Source : 60th Round NSSO 2004
Urban
^004
3,877
1995-96
2,195
11,553
8,851
5,344
3,921
Terms of Reference - V
25
To suggest alternative sources / strategies for health financing during the 11th
Plan to meet the cost of health care;
Currently India's health financing mechanism as mentioned earlier is
largely
out-of-pocket and
a
declining trend
in public
finance.
Some
recommendations for resource mobilization to meet the enhanced investment
levels for health care are given below:
First, within the existing public finance of healthcare, macro policy
changes in the way funds are allocated can bring about substantial equity in
reducing geographical inequities between rural and urban areas. Presently, the
central and state governments together spend Rs.250 per capita at the national
level, but this is inequitably allocated between urban and rural areas. The rural
healthcare system gets only Rs.120 per capita and urban areas get Rs.560 per
capita, a difference of over 4 V2 times.
If allocations are made using the
mechanism of global budgeting, as is done in Canada for instance, that is on a
per capita basis then rural and urban areas will both get Rs.250 per capita. This
will be a major gain, over two times, for rural healthcare and this can help fill
gaps in both human and material resources in the rural healthcare system. The
urban areas in addition have municipal resources, and of course will have to
generate more resources to maintain their health care systems which at least in
terms of numbers (like hospital bed : population ratios and doctor : population
ratios) are adequately provided for. Global budgeting also means autonomy in
how resources are used at the local level. The highly centralized planning and
programming in the public health sector will have to be done away with and
greater faith will have to be placed in local capacities.
26
Second, shortage of human resources and skills is a major constraint for
the public health system to realize its goal of universal access to health services.
In this context it is pertinent to consider the fact that since the public exchequer
contributes substantially to medical education, to the extent that nearly 80% of
medical graduates are from public medical schools, there is need to utilize this
resource for public good. Since medical education is virtually free in public
medical schools the state must demand compulsory public service for at least
three years from those who graduate from public medical schools as a return for
the social investment.
Today only about 15% of such medical graduates are
absorbed in the public health system. In fact, public service should be made
mandatory also for those who want to do post-graduate studies (as many as 55%
of MDBS doctors opt for post-graduate studies). Such a measure will be the least
costly way of assuring availability of the required medical skills a the point of
delivery in the public health system. Such assured availability of quality care is
necessary for enforcing the concept of guaranteed care, a cornerstone of the
NRHM policy.
Third, the governments can raise additional resources through levying
"sin taxes" - compulsory
cesses and levies on products such as
cigarettes,
beedis, alcohol, pann masalas and guthka, personal vehicles etc. that directly
contribute to enhancing health risks, that are also extremely expensive to treat.
For instance tobacco, which kills 670,000 people in India each year, is a Rs.350
billion industry and a 2% health cess would generate Rs.7 billion annually for the
public health budget. Similarly alcohol, which presently generates Rs.250 billion
in revenues, can also bring in substantial resources if a 2% health cess is levied.
With 10% of morbidity and mortality, particularly among the young is on
account of accidents and injuries, the same logic can be applied to personal
transportation vehicles both at point of purchase as well as each year through a
27
health cess on road tax and insurance paid owners. Land revenues and property
taxes can also attract a health cess which is earmarked for public health.
Fourth, social insurance can be strengthened by making contributions
similar to ESIS compulsory across the entire organized sector and integrating
ESIS, CGHS etc. with the general public health system. Also social insurance
must be gradually extended to the other employment sectors using models from
a number of experiments in collective financing like sugar-cane farmers in south
Maharashtra paid Re 1 per tonne of cane as a health cess and their entire family
was assured healthcare through the sugar cooperative. There are many NGO
experiments in using micro-credit as a tool to factor in health financing for the
members and their family. Large collectives, whether self-help groups facilitated
by NGOs, or self-employed groups like headload workers in Kerala, can buy
insurance cover as a collective and provide health protection to its members. At
least 60% of the workforce in India has the potential to contribute to a social
insurance programme.
Fifth, other options to raise additional resources could be various forms of
innovative direct taxes like a health tax similar to profession tax (which funds
employment guarantee) deducted at source of income for employed and in
trading transactions for self-employed. Using the Tobin tax route is a highly
progressive form of taxation which in an increasingly service sector based
economy can generate huge resources without being taxing on the individual as
it is a very small amount of deduction at the point of transaction. What this
basically means is that for every financial transaction, whether cheque, credit
card, cash, stock market, forex etc. a very small proportion is deducted as tax and
transferred to a fund earmarked for social sector. For example if 0.025% is the
transaction tax then for every Rs.100,000 the transaction tax would be a mere
Rs.25 or one paise per Rs.40 transacted. This would not hurt anyone if it were
28
made clear that it would be used for social sectors like health, education, public
housing, social welfare etc.
The Group felt that over time, attention should shift from incremental change to
a structural overhaul of the health system in order to assure universal access
based on a rights-based approach. This requires a multi-pronged strategy of
building awareness and consensus in civil society, advocating right to healthcare
at the political level, demanding legislative and constitutional changes, and
regulating and reorganizing the entire healthcare system, especially the private
health sector, alongside making the required level of problem investment in
health care.
Likewise to reduce out - of-pocket financing of the healthcare system,
policies need to be quickly put in place for a system of health financing that will
be a combination of public finance and private contribution by establishing
various
collective
financing
options
such
as
social
insurance,
collectives/common interest groups etc. At another level the healthcare system
needs to be organized into a regulated system that is ethical and accountable and
is governed by a statutory mandate, which pools together the various sources of
financing and manages it for ensuring all the members access to comprehensive
healthcare. This will happen only if the entire healthcare system, public and
private, is organized under a common umbrella, ideally through a single-payer
mechanism that operates in a decentralized way.
29
Terms of Reference - VI
To deliberate and give recommendations on any other matter relevant to the
topic.
Strategies for health financing during the 11th plan
Hospital Development Committees/Rogi Kalyan Samitis
Hospital Committees should be established in every public health
facilities with elected representatives, health care providers, representatives of
consumer groups etc. For instance, in Rajasthan Medical Relief Societies, RKS in
Madhya Pradesh and SKS in Haryana have been set up in all the government
hospitals at district sub- division and below levels for the purpose of better
maintenance and improvement of hospital services.
Availability of Drugs through PPPs
In order to provide cheaper medicines to the common man, MRS in
Rajasthan has established outlets known as life-line fluid stores opened within
the hospital premises, providing medicines free of cost to BPL families. PPP
initiatives can be started in collaboration with pharmaceutical companies, private
pharmacies and govt, hospitals
Through these initiatives several critical medicines, injections, antibiotics,
IV Fluids etc. can be purchased in bulk through open tender from the
manufacturing companies and sold through the outlets in the hospital premises.
This will result in to reduction of prices considerably
30
All states may be advised to replicate similar models which would help
make available critical drugs at affordable prices to the common man and to
provide medicines free of cost to BPL families.
Levying of User charges
A nominal user charges may be levied for all outpatient services provided
in public health facilities. Available studies show that there is a willingness to
pay for services provided in government hospitals. The poorest of the poor may
be exempted from paying for services. For in-patient care, a modest user charges
may be levied (based on cost of recurrent items). The funds collected should be
kept at the disposal of hospital committee and should be utilized for the
improvement of service delivery. Government may provide matching grants
linked to user charges collected to those facilities located in rural remote areas.
More over the exemption mechanism needs to be properly implemented. Graded
user charges can be levied. Awareness should be generated among the segment
of the population who are exempted from paying user charges (as the poor in
some cases do not know that they have been exempted from paying charges).
Facilities should hold periodic and timely Audit and regular utilization
reviews to identify whether user fee policy has had an adverse impact.
Community may be given responsibility to identify the families, which have no
means to pay (eg. Tanzania). Issuing card should be made less bureaucratic.
Encourage maternal health insurance scheme
Encourage maternity health insurance scheme under the NRHM (pooling
JSY incentives), to increase institutional deliveries, achieve reductions in
maternal and infant mortality, stimulate the development of accreditation
31
systems across rural and urban India, institutionalize multiple partnerships and
contribute to the development of sound, inclusive referral systems.
Encourage Small risk pools
The cost of hospitalization (both direct & indirect costs) is huge among the
poor in rural areas. Currently, there is no financial protection available to this
vast majority of the population. Initially, small risk pools led by a consortium of
self-help groups, may be encouraged to administer financial help to needy
households at village levels, in the event of hospitalization and death.
Government can encourage consortium of such self -help groups by proving an
initial grant for its operation.
Encourage Co-operative health insurance
Promote health insurance schemes by Involving network of co-operatives
as in Karnataka. Constitute risk pools around professional or occupational
groups like self help groups or micro credit groups, weavers, fishermen, farmers,
agricultural laborers and other informal groups (as in Kozhikod, Kerala)
Creation of separate budget head for all donor grants
In India, foreign grant is received for combating specific diseases like
HIV/AIDS, TB, leprosy, malaria etc. Such grants are disease specific which often
do not take into account the disease burden or the priority of the Government.
The funds from donor agencies should therefore be pooled under a single budget
head so that government may prioritize the spending according to the disease
burden of the population. This may well make all the difference.
32
Other Recommendations
•
Govt should enable need based bottom up programme planning and budget
should be in consonance with the extent of the disease burden
•
A separate provision should be made in the budget for meeting all
emergencies. Certain discretion should be allowed to reallocate available
funds in meeting emergencies at least up to the District level
•
Institute an internal audit system at state and district level (as done in
srilanka)
33
Annex- I
MINUTES OF THE MEETING OF WORKING GROUP ON HEALTH CARE
FINANCING INCLUDING HEALTH INSURANCE FOR THE ELEVENTH
PLAN HELD ON 18th JULY, 2006 AT NIRMAN BHAVAN, NEW DELHI.
Following were present:
1. Ms. Sujata Rao, Additional Secretary (NACO), MOH&FW, GOI. Chairperson
2. Shri I. V. Subba Rao, Pr. Secretary (Health), Govt, of AP
3. Ms. Usha Ganesh, Pr. Secretary (Health) Govt, of Karnataka
4. Shri M.M. Upadhyay, Pr. Secretary (Health) Govt, of MP
5. Dr. Amarjit Singh, Commissioner (Health) Govt, of Gujarat
6. Sh. GC Chaturvedi, Joint Secretary, Insurance Division, Ministry of
Finance, GOI
7. Dr. D. Narayana, Fellow, CDS, Trivendrum
8. Dr. Ravi Duggal, CEHAT, MUMBAI
9. Dr. Moneer Alam, Health Economist, Professor, IEG, New Delhi
10. Dr. N. Devadasan, Institute of Public Health, Bangalore
11. Dr. Ravendra Singh, Director(Policy),MOHFW, GOI
12. Dr. S.P. Goswamy, National Consultant (Health Insurance), MOHFW,
GOI
13. Ms. Radha Ashrit, SRO(Health), Planning Commission, New Delhi
14. Sh. Amarjeet Sinha, Joint Secretary, MOHFW, GOI- Member Secretary
The Planning Commission, New Delhi, vide their letter No. 2(15) /06H&FW Dated 25-05-06 constituted a Working Group on Health Care Financing
including Health Insurance for the Eleventh Plan, defining the Terms of
Reference for deliberations. The first meeting of the Group was held on 18/07/06
under the Chairpersonship of Ms Sujata Rao, Additional Secretary (NACO),
MOH&FW, GOI, New Delhi. In her welcome address, Ms. Rao requested the
members to provide suggestions for low cost health care to the poor people.
Shri Amarjeet Sinha, Joint Secretary, MOHFW explained the various
aspects of NRHM 2007-2012 to the participants. He also highlighted various
points relating to Health Financing and Health Insurance which are under active
consideration of MOHFW, GOI. He further deliberated on the factors increasing
high out of pocket health expenditure and ways of reducing health expenditure.
He also highlighted the various health insurance schemes being run by NGOs in
various States. He gave a broad framework of Terms of References which were as
follows:
34
i.
To review the present position of health financing at state, centre and
individual levels. Keeping in view, identified problems and
constraints of existing system, make suggestions for improvement in
quahty and efficiency with reduction in the cost of health care to the
poor in the Eleventh plan.
ii.
To suggest management strategies for community based health
insurance as well as process and impact assessment parameters for
these initiatives during the 11th plan.
iii.
To assess disease burden and cost of ill health in the country and
project figures for 2012 and 2017.
iv.
To give cost estimates for health care public, NGO and private current and for the 11th Plan period.
v.
To suggest alternative sources/strategies for health financing during
the 11th Plan to meet the cost of health care.
vi.
To deliberate and give recommendations on any other matter relevant
to the topic.
Dr. Amarjeet Singh, Commissioner (Health), Gujarat, explained the
success story of Chiranjeevee Scheme launched by the Gujarat in 5 selected
districts with the help of Public-Private Partnership, providing Maternity benefit
to the women. Out of 215 Gynecologists in the State, 163 got themselves
empanelled under the scheme and earning substantial amount. Based on the
success of the scheme. State Government would be considering introducing this
scheme in whole of the State.
Shri Upadhaya, Pr. Secretary (Health), MP, explained the insurance
scheme launched by the State to provide the Maternity benefit to 45 lacs BPL
women. He informed that due to this scheme, the number of institutional
deliveries has doubled in just 5 months. District Committee are processing the
claim and releasing the money to the beneficiaries and taking the re
imbursement from the Insurance Company.
Dr. Narayana, CDS, Trivendrum mentioned that the utilisation of public
services had been going down while the use of private sector health care facilities
had increased. Dr. Ravi Duggal, CHEHAT, Mumbai highlighted the need for
improving the utilisation of existing Government health facilities. He advocated
that the funds should be provided to PHCs, CHCs etc. on the basis of utilisation
of these facilities like beds, OPD, Indoor patients, deliveries etc.
Shri Chaturvedi, Joint Secretary (Insurance) suggested that private sector
should be provided more funds for making available health services in the rural
areas. He also advocated more public-private partnership in this regard.
35
Ms. Usha Ganesh, Pr. Secretary (Health) mentioned that there should be
incentive for Government hospital staff also. They should be allowed to get 30%
of the funds generated through the health insurance.
Some of the participants have mentioned the issues about the availability
of specialist doctors for posting at rural areas, management of hospitals and the
payment system to the doctors. The need for more utilisation of private health
facilities was also mentioned as and where the government health facilities could
not able to function properly. There was also a suggestion for taxing health
hazardous items, which could be utilized for provision of health care to poor
patients.
As the representative from NSSO was not present in the meeting, Ms. Rao
asked Shri Amarjeet Sinha, Joint Secretary, MOHFW to request NSSO to send a
representative during the next meeting apart from making a presentation on the
findings from various NSSO surveys about the cost of treatment at rural areas as
well as on utilisation of Government health facilities in availing various health
services.
Summing up the discussions, Ms. Rao requested all the participants to
send their suggestions/material on various items of Terms of Reference to Shri
Amarjeet Sinha (email: amarjeet_sinha@hotmail.com ) latest by 31/07/06, which
shall be exchanged amongst the members for their final views. The next meeting
would be held in the 2nd week of August 06 after the receipt of the suggestion
from the members.
The meeting was ended with vote of thanks.
36
I
Annexure II
Household, public and total health expenditure in India (2004-2005)
9
c
t
c
£
c
c
Central Govt.
A.P.
Arun. Pradesh
Atiam
Bihar
Delhi
Goa
Gujarat
Haryana
HP.
J&K
Karnataka
:■ 8373..
M.P.
6432
FWiharaihtra . . ■ 11703
Manipur
420
Maflhalaya
58
Mlxoram
38
Nagaland
1024
Orlaaa
2999
Punjab
3493
Rajasthan
3399
Sikkim
72
Tamil Nadu
3624
Tripura
253
Uttar PradoHh
17158
West Bengal
7782
U.Tb.
3160
State Totals
109308
GTjGOHState]
'109308
c
r
14819
1696
67
672
1091
721
116
996
421
306
471
1267
1048
1051
3527.
89
94
58
84
684
827
1190
55
1590
100
2650
1715
325
17965
32784
SB - W
730
—
15549
640
8777
0
497
52
3778
202
13147
55
1780
22
662
6313
424
J75
3981
40
2472
47
2277
353
5467
.281
49702
7711
228
15957
726
8
517
8
160
0
96
7
1116
111
3795
273
4593
267
4855
0
127
760
5974
13
366
550
20359
433
9929
227
3712
5906
133178
6636 . ■148727
0
820
3776
1089
1021
664
3613
920
1518
3377
1609
702
2548
746
1156
1680
242
405
4897
786
1379
565
1274
566
760
924
931
11168
1012
1012
137
216
589
239
124
476
798
187
7
82
0
19
23
37
153
80
189
79
486
431
231
319
164
348
356
388
64
43
64
86;
35
72
32
34
0
37
29
108
44
0
119
40
31
52
37
54
61
623
404
179
326
198
965
248
301
150
205
52
167
’■304
144
1118
4365
1347
1497
1177
4564
1187
1786
0
95.3
73.38 19.39
86.51 13.49
80.84 17.78
90.17
8.3
56.41 40.48
79.17 17.48
____ 15.78
____
77.51
85.03
3927 85.99
2082 77.26
997 70.36
2952
86.3
1200 83.41
1576 '73.34
2068 81.24
664 36.45
1027
5338
39.39
91.74
TO&j1
4.7
7.29
0
1.38
1.53
3.11
3.53
6.71
10.56
4.4
12.38
1.63
20.69
2.05
23.18
6.46
10j8<
2.9
13.63
2.96
22.1
4.55
17.2
1.56
58.37
5.18
60.61
0
7.57
0.7
995 79.04 18.02
2.93
1813 76.05
18 5.95
808
70 24.5
5.5
2240 56.89 43.11
0
933 60.67 26.61 12.72
1101 68.99 27.35
3.66
1152 84.28 13.02
2.7
1188 78.38 17.27
4.36
598 85.13
8.74
6.12
1233
1377
73.5 7
22- 4.46
Notes;
i) Household Expenditure Based on NHA for the year 2001-02 and extrapolated for 2004-05
ii) Central Govt, expenditure includes transfer to states, other central ministries and central PSUs; and data obtained from Demand
for Grants (Provisional), Govt, of India
iii) Govt. Expenditure Includes Central, States, Local Govt, and PSUs: data obtained from States Finances (Provisional) RBI
Various issues
iv) Other include foreign agencies, private firms and NGOs; data relates to 2001-02, which is subsequently extrapolated for 2004-05
v) PC HH Exp. - Per Capita Household Expenditure; PC G Exp. - Per Capita Govt. Expenditure; PC Other Exp. - Per Capita Other
Expenditure; HH as % of THE - Household as % of Total Health Expenditure; PE as % THE - Public Expenditure as % of Total
Health Expenditure; OE as % of THE - Other Expenditure as % of Total Health Expenditure; C. Govt - Central Govt’ U Ts Union Territories.
Source:
i
0
6441
430
3054
11854
1004
524
4893
3385
2126
1759
3847
Report of the National Commission on Macro Economics & Health. 2005
I
Annexure III
Trends in Health Expenditure in India
'W^Per^apifa Public
Revenue
:; (Rs4.
1950-51
1955-56
1960-61
1965-66
1970-71
1975-76
1980-81
1985-86
1990-91
1995-96
2000- 01
2001- 02
2002- 03
2003- 04
0.22
0.49
0.63
0.61
0.74
0.73
0.83
0.96
0.89
0.82
0.86
0.79
0.82
0.86
NA
NA
NA
NA
NA
0.08
0.09
0.09
0.06
0.06
0.04
0.04
0.04
0.06
0.22
0.49
0.63
0.61
0.74
0.81
0.91
1.05
0.96
0.88
0.90
0.83
0.86
0.91
"•
0.61
1.36
2.48
3.47
6.22
11.15
19.37
38.63
64.83
112.21
184.56
183.56
202.22
214.62
•l
1
I
Note:
i)
ii)
GDP is at market price, with 1993-94 as the base year
Includes only Central and State government expenditure
Source: Report of the National Commission on Macro Economics & Health, 2005
I
1
c
e
e
c
I
9
Annexure IV
9
Share of Health in Revenue Budget of Major States (in %)
'4
Assam
Bihar
Gujarat
Haryana
Karnataka
Kerala
Maharashtra
Madhya Pradesh
Orissa
.-iRuinlfilfei ■
Rajasthan
Tafri'IWadu
Uttar Pradesh
West Bengal
All States
■ W-
6.75
5.68
7.45
6.24
6.55
7.69
6.05
6.63
7.38
7,19
8.1
7.47
7.67
8.9
7.02
6.61
6.08
5.65
7.8
5.42
5.34
4.19
2.99
5.94
5.85
6.92
6.81
5.25
5.18
5.66
5.07
5.94
5.42
4.32
4.56
6.85
6.18
4.82 << 6.4
6
5.73
7.31
7.16
5.72
5.7
5.25
6.3
5.2T
4.08
5.7
5.95
4.59
5.18
5.03
5;34
6.39
5.51
4.42
6.3
5.48
Source : Report of the National Commission on Macro Economics & Health, 2005.
c
c
r
ri
I
r
4.39
4.84
3.68
3.63
4.85
5.42
4.39
4.47
<4.27
5.75
5.26
5.13
5.23
4.97
4.36
6.47
3.76
3.35
4.18
5.2
3.89
■ .W'?5:08
4.58
< 4.05
5.73
4:91
5.75
5.04
4.71
!
Annexure V
Statement on Funds for Health Care in India, 2001-02
Exp. In Rs.OOOS
% Distribution
1. Central Government
67,185,399
6.4
2. State Government
132,709,065
12.6
Urban Local Bodies and
3.
Institutions #
14,496,554
1.3
214,391,018
20.3
1. Households
760,939,107
72.0
2. Firms $
55,365,142
5.3
799,783
0.1
818,104,032
77.4
16.483,158
1.5
825,937
0.1
3. Grants to State Government
2,389,555
0.2
4. To NGOs
5,147,996
0.5
Total (c)
24.846,646
2.3
Total funds
1,057,341,696
100.0
Source of funds
(a) Public funds
Panchayat Raj
Total (a)
IK-'
(b) Private funds
3.
Non Governments
Households (NGOs) *
Institutions
Total (b)
Serving
(c) External Support
1. Grants to Central Government
2. Material Aid to Central Government
F
F
F
Source : National Health Accounts, India 2001-02-, -Mrnistry of Health & Family Welfare
c
c.
o
Annexure VI
% of Treated Ailments Receiving Non-Hospitalized Treatment from
Government Sources
i
t
Major State
Andhra Pradesh
Assam
Bihar
Chhattisgarh
Delhi
Gujarat
Haryana
Himachal
Pradesh
Jammu
KaaHfiilr,
Jharkhand
Kamataka
I
l
i
t
t
!
3
*
2004
60th Rd
21
27
5
15
@
21
12
68
Karala
Madhya Pradesh
Maharashtra
Orissa
Punjab
Rajasthan
Tamil Nadu
Uttaranchal
Uttar Pradesh
West Bonflal
India
&
Rural
1995-96
_52na Rd
22
29
13
1986-87
42nd Rd
12
40
14
25
13
28
15
2004
60th Rd
20
24
11
20
23
18
20
86
52
51
13
34
37
23
16
51
16
44
29
18
10
19_____
22
24
16
22
23
11
54
18
53
22
35
13
20
19
Urban
1995-96
52nd Rd
19
22
33
22
11
?.
'■
1986^7
42nd Rd
16
26
17
18
19
■
32
26
28
23
16
38
7
36
25
32
24
21
37
12
46
28
8
15
19
16
21
17
28
19
17
34
6
41
28
30
33
28
15
43
11
52
31
9
19
20
14
20
24
Note: 1. The estimates of the 52nd round are based only on the treatments with reported source of
treatment
2. * denotes estimate not available and @ denotes estimate not presented
Source : Morbidity, Health Care and the condition of the aged NSS 60,h Round, Ministry of Statistics &
Programme Implementation, 2006.
Report on the
Working Group on
Clinical Establishments,
Professional Services Regulation
and Accreditation of Health Care
Infrastructure
For
the 11th Five-Year Plan
Government of India
Planning Commission
i
Report on the Working Group on Clinical Establishments,
Professional Services Regulation and Accreditation of Health
Care Infrastructure For the 11"' Five-Year Plan
Composition of the Working Group
1.
The Planning Commission constituted a Working Group on Clinical
Establishments, Professional Services Regulation and Accreditation of Health Care
Infrastructure for the Eleventh Five -Year Plan (2007-2012) under the Chairmanship of
Secretary, Department of Health & Family Welfare, Government of India with the
following members:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
Secretary, Department of Health & Family Welfare, New Delhi____
Secretary (Health), Govt, of Assam___________________________
Secretary (Health), Govt, of Rajasthan_________________________
Secretary (Health), Govt, of Uttar Pradesh______________________
Secretary (Health), Govt, of Kerala___________________________
Secretary (Health), Govt, of Tamil Nadu_______________________
Director General of Health Services, Directorate General of Health
Services, New Delhi________________________________________
Chief, Bureau of Indian Standards, New Delhi___________________
Shri Rajeev Lochan, Director (Health), Planning Commission, New
Delhi____________________________________________________
Shri K.M. Gupta, Director, Ministry of Finance, New Delhi________
Dr Antia, Foundation for Research in Community Health, Pune
Dr. Naresh Trehan, Escorts Hospital, New Delhi
Dr. Akhil Sangal, Chief Executive Officer, Indian Confederation for
Health Care Accreditation___________________________________
Dr. Shakti Gupta, Medical Superintendent, All India Institute of
Medical Sciences, New Delhi________________________________
Head, Medical Care & Hospital Administration, National Institute of
Health & Family Welfare, New Delhi_________________________
Dr. l.H. David, Health Management Consultant, Hyderabad________
Dr. Prakasamma, Director, School of Nurses, Hyderabad__________
Joint Secretary, Ministry of Health & Family Welfare, New Delhi
2
Chairman
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Member
Secretary
Terms of Reference:
2.
The Terms of reference of the Working Group were as under:
i)
To review the existing system of Clinical Establishments, Professional
Services Regulation and Accreditation of Health Care Infrastructure (Public,
Private, NGO) in urban and rural areas with a view to provide universal access
to equitable, affordable and quality health care which is accountable at the
same time responsive to the needs of the people, reduction of child and
maternal deaths as well as population stabilization, and also achieve goals set
under the National Health Policy and the Millennium Development Goals.
ii)
To identify the potential areas/infrastructure/ institutions involved in
providing accreditation with a view to ensure cost effective and standardized
delivery of health services to people in rural & urban areas.
iii)
To suggest a practical and cost efficient system of Accreditation of Health
Care Infrastructure.
iv)
To deliberate and give recommendations on any other matter relevant to the
topic.
It was decided by Secretary (Health & FW) that Dr R.K. Srivastava, Director General of
Health Services will chair the meetings of the Working Group and Shri Vineet
Chawdhry, Joint Secretary would function as Secretary.
Setting up of a Core Group
3.
Director General Health Services set up a core group comprising of the following
to prepare the background material as per the TORs: 1.
Shri Vineet Chawdhry, Joint Secretary, Ministry of Health &
Family Welfare, Nirman Bhavan, New Delhi.
2.
Shri Giridhar Gyani, Secretary General, Quality Council of
India, New Delhi.
3.
Shri Sunil Nandraj, WR Office, WHO, Nirman Bhavan, New
Delhi.
4.
Dr. A.N. Sinha, CMO, Dte. General of Health Services,
Nirman Bhavan, New Delhi.
3
Meetings of the Core Group & Working Group
4.
Two meetings of the Core Group were held on 24.7.2006 and 18.9.2006 to
finalise the background papers on Clinical Establishment Registration & Regulation
Legislation and Accreditation of Clinical Establishment and the same were circulated to
all the members of the Working Group.
A meeting of the Working Group was held on 25.9.06 in Nirman Bhawan, New
5.
Delhi. List of participants is enclosed (Annexure- I).
Regulation of Clinical Establishments
Introduction and background
In majority of the countries, quality of care provided by the health care delivery
6.
system has come into sharp focus. Since quality is a crucial factor in health care,
initiatives to address quality of health care have become worldwide phenomena. Many
countries are exploring various means and methods to improve the quality of health care
services. In India the quality of services provided to the population by both public and
private sectors remains largely an unaddressed issue. The current structure of the health
care delivery system does not provide enough incentives for improvement in efficiency.
Mechanisms used in other countries to produce grater efficiency, accountability, and
more responsible governance in hospitals are not yet deployed in India. The for-profit
private sector accounts for a substantial proportion of health care in India (50% of
inpatient care and 60-70% of outpatient care), but has received relatively less attention
from the policy makers as compared to the public sector. Thus the private sector health
care delivery system in India has remained largely fragmented and uncontrolled, and
there is a clear evidence of serious quality of care deficiencies in many practices.
Problems range from inadequate and inappropriate treatments, excessive use of higher
technologies, and wasting of scarce resources, to serious problems of medical malpractice
and negligence. Current policies and processes for health care are inadequate or not
responsive to ensure health care services of acceptable quality and prevent negligence.
In the present situation there is a need to establish bodies and systems to monitor
7.
clinical and non-clinical effectiveness of the services offered in the public and private
facilities. In India concerns about how to improve health care quality have been
frequently raised by the general public and a wide variety of stakeholders, including
government, professional associations, private providers and agencies financing health
care. There also have been attempts to establish systems and process that would ensure
quality of care by the health providers.
4
Defining Regulation
8.
Regulation can be thought of as occurring when a Government/State exerts
control over the activities of individuals and firms (Roemer, 1993). More specifically,
regulation has been defined as government “ action to manipulate prices, quantities (and
distribution), and quality of products” (Maynard, 1982). Regulation seeks to ensure
quality, accountability, protect the consumers and control costs as well as the distortions
created by market forces.
Regulation of Clinical Establishments
9.
There are several actors involved in the regulatory process namely, the health care
professionals, managers, ministry of health, commercial interests, NGOs, community and
consumer groups amongst others.
Global Experience
10.
Review of global experiences show that regulatory frameworks in the health
sector assume a variety of forms. One of the first challenges countries have faced in
planning for regulation and accreditation systems is to gain consensus on the definitions
of various forms of regulation and evaluation. Licensure, certification and accreditation
of healthcare organizations have been used in many countries as tools for defining the
required characteristics of acceptable healthcare services. Their voluntary or mandatory
nature varies as a function of system objectives-. The following definitions are based on
technical support experiences in a variety of countries:
> Licensure
a government administered mandatory process that requires
healthcare institutions to meet established minimum standards in
order to operate.
> Certification
a voluntary governmental or non-governmental process that grants
recognition to healthcare institutions that meet certain standards
and qualifies them to advertise services or to receive payment or
funding for services provided.
> Accreditation a process by which a government or non-government agency
grants recognition to healthcare institutions that meet certain
standards that require continuous improvement in structures,
procedures or outcomes. It is usually voluntary, time-limited and
based on periodic assessments by the accrediting body, and may,
like certification, be used to achieve other desirable ends such as
payment or funding.
5
Determination of the meehanism(s) a country will adopt is essential in order to
differentiate the evaluation functions to be used, the purposes of each and the entity (ies)
that will employ each mechanism.
Broad concept of Regulation of Clinical Establishments
11.
The foremost amongst these mechanisms is legislation or imposition of legal
restrictions or controls where participants must conform to legislated requirements. In
addition to these formal rules, more informal codes of conduct, standards, guidelines or
recommendations may exist. Essentially, the elements of any regulatory process include
establishment of rules, its application to specific cases, detection or monitoring violations
and imposition of penalties on violators.
The scenario in India
Constitutional Provisions
12.
The preamble to the Constitution of India coupled with the Directive Principles of
State Policy strives to provide a welfare State with socialist patterns of society. It enjoins
the State to make the “improvement of public health” a primary responsibility.
Furthermore, Articles 38,42,43 and 47 of the Constitution provide for promotion of
health of individuals as well as health care. The Constitution of India also enumerates the
separate and shared legislative powers of Parliament and State Legislatures in three
separate lists: the Union List, the State List and the Concurrent List. The Parliament and
State legislatures share authority over matters on the Concurrent List, which include
criminal law and procedure; marriage, divorce and all other personal law matters;
economic and social planning; population control and family planning; social security
and social insurance; employment; education; legal and medical professions; and
prevention of transmission of infectious or contagious diseases. Laws passed by
Parliament with respect to matters on the Concurrent List supersede laws passed by state
legislatures. The Parliament generally has no power to legislate on items from the State
List, including public health, hospitals and sanitation. However, two-thirds of the Rajya
Sabha may vote to allow parliament to pass binding legislation on any state issue if
“necessary or expedient in the national interest”. In addition, two or more States may ask
parliament to legislate on an issue that is otherwise reserved for the state. Other states
may them choose to adopt the resulting legislation.
Issues in regulation of Health matters in India
Health regulation in India encompasses a variety of actors and issues. These
13.
include promulgation of legislation for health facilities & services, disease control &
medical care, human power (Education, Licensing & Professional Responsibility), Ethics
& Patients Rights, Pharmaceuticals & Medical Devices, Radiation Protection, Poisons &
Hazardous Substances, Occupational Health and Accident Prevention, Elderly, Disabled
& Rehabilitation Family, Women & child Health, Mental Health, Smoking/Tobacco
Control, Social Security & Health Insurance, Environmental Protection, Nutrition &
6
Food Safety, Health Information & Statistics and Custody, Civil & Human Rights to
enumerate a few.
Regulation relating to the Medical Profession
14.
There exists legislation with respect to licensing of medical professionals such as
doctors, nurses, dentists and pharmacists with a view to control their entry into the
market. Statutory regulatory councils have been established to monitor the standards of
medical education, promote medical training and research activities, and oversee the
qualifications, registration, and professional conduct of doctors, dentists, nurses,
pharmacists, and practitioners of other systems of Medicine such as Ayurveda, Yoga,
Unani, Siddha and Homeopathy. Important of these laws are: the Indian Medical
Council Act, 1956, the Indian Nursing Council Act, 1947; the Indian Medicine Central
Council Act, 1970; the Homeopathy Central Council Act, 1973; and the Pharmacy Act,
1948. Almost all of these laws establish councils that set forth uniform educational and
qualification standards. In addition, each statute establishes a central registry for
individuals certified to practice the field of medicine regulated. Finally, councils often
prescribe standards of professional conduct and determine which actions amount to
professional misconduct.
15.
There also exist few institution specific regulations such as the All India Institute
of Medical Sciences Act 1956, the Post Graduate Institute of Medical Education and
Research, Chandigarh Act, 1966, the National Institute of Pharmaceutical Education &
Research Act, 1998 and the Sree Chitra Tirunal Institute for Medical Sciences and
Technology, Trivandrum Act, 1980 enables the establishment of institutes of national
importance. The Bureau of Indian Standards Act, 1986 made possible the establishment
of a Bureau for the harmonious development of activities of standardization, marketing
and quality certification of goods.
Regulations relating to Disease Control & Medical Care
16.
Under the realm of disease control and medical care, various laws were enacted.
The oldest laws pre-date to the days of the British Rule. Some of these include, the
Epidemic Disease Act of 1897, which provides for prevention of dangerous epidemic
diseases, the Lepers Act of 1898 and the Indian Aircraft Act of 1934. Thereafter, various
other legislations such as the Medical Termination of Pregnancy Act, 1971 and its
subsequent amendment. Which permits MTP by a registered medical practitioner in a
variety of specified circumstances. Similarly, the use of pre-natal diagnostic techniques
is also regulated through the Pre-natal Diagnostic Techniques (Regulation and Prevention
of Misuse) Act, 1994 and its subsequent amendment in 2002. This Act prohibits the use
of prenatal diagnostic tests for the purpose of determining fetal sex and the practice of
“sex selection”. Such tests may only be conducted at registered facilities and for limited
purposes, including the detection of chromosomal abnormalities, genetic metabolic
diseases, sex-linked genetic disorders, and congenital anomalies. There also exists
separate legislation, namely, the Transplantation of Human Organs Act, 1994 that
7
provides for the regulation of removal, storage and transplantation of human organs and
for the prevention of commercial dealings in human organs.
Regulations relating to Drugs & Pharmaceuticals
17.
The key central statute governing the import, manufacture, distribution and sale of
drugs and cosmetics is the Drugs and Cosmetics Act, 1940. In empowering the Central
Government to regulate the import, manufacture, distribution, and sale of drugs in India,
the Drugs Act establishes institutions - such as the Drugs Technical Advisory Board and
the Central Drugs Laboratory - to execute certain provisions of the Act. The Ministry of
Health and Family Welfare mainly administers the provisions in this Act through the
Central Drugs Standard Control Organization. This organization performs a variety of
functions such as approving new drugs and establishing uniform drug standards. In
addition to the elaborate rules formulated under this Act, the various lists of schedules
regulate various aspects related to vaccines (Schedule G), prescription drugs (Schedule
H), standards of disinfectant fluids (Schedule O), life period of drugs (Schedule P),
standards of condoms (Schedule R), standards of cosmetics (Schedule S), GMP for
Ayurvedic drugs (Schedule T) and requirement and guidelines on clinical trials for import
and manufacture of new drugs (Schedule Y) to enumerate a few.
18.
There also exist several legal standards that address blood safety and transfusion
services. In 1993, amendments to the Drugs and Cosmetics Act and accompanying rules
required the screening of blood for five transmissible infections, including HIV/AIDS.
Blood banks are required to obtain a licensefrom the relevant authority, and these
licenses must berenewed at regular intervals. A 1996 Supreme Court decision also
generated key changes in the regulation of the country’s blood supply. In Common
Cause v. Union of India and others, the courtset forth mandatory licensing of blood
banks, a ban on professional blood donations and strict guidelines for holding blood
donation camps.
Regulations of the private institutional providers of health care
Studies on utilization and household health expenditures reveal that 50 percent of
19.
people seeking indoor care and around 60 to 70 per cent of those seeking ambulatory care
(or out-patient care) go to private health facilities in the country. The private health
sector comprises of the ‘not-for-profit’ and the ‘for-profif health sectors. Despite their
considerable presence in the country, information about the number, role, nature,
structure, functioning, type and quality of care in private hospitals remains grossly
inadequate. Quality of care provided by the private health care services in India has also
come under scrutiny. This exists in a set up where there exist few systems for quality
assurance, with majority of the population utilizing the services of the formal health
sector but having no control on the quality of care.
20.
Furthermore, regulations and accountability mechanisms for private
establishments are far and few in between. In vast majority of the States in India, clinical
8
establishments are not regulated or monitored. Only few States have requirements for
registration of private facilities such as hospitals and nursing homes.
Regulation of Clinical Establishments in India
As ‘ health’ is a state subject, some State legislation had been brought out by
21.
UTs/States quite early such as:
The Bombay Nursing Homes Registration Act, 1949;
i.
Delhi Nursing Homes Registration Act, 1953;
ii.
Tamilnadu Private Clinical Establishments Act, 1997.
iii.
A comparison of the various provisions of the three above named Acts is at Annexure II.
While the Tamilnadu Act did not perhaps get implemented, the other two statutes named
above were also felt to have become outdated. The general impression derived is that
these laws have never been implemented in the right spirit. Even in these States/UTs,
there has been haphazard growth of private clinical establishments. The High Courts of
Delhi and Mumbai have also intervened through their various orders for effective
implementation of these statutes.
Directive from the National Human Rights Commission - 1996
22.
Much later, in 1996 the death of one Ina Raja in a private hospital due to medical
negligence was reported to the NHRC. The Commission directed the Govt, of India, MCI
and the Delhi Govt, to examine:
Registration of private hospitals after ensuring availability of minimum facilities
Monitoring to ensure availability of facilities,
Framing of regulations.
Violation to be made a cognizable offence,
Shifting of non-conforming hospitals that are health hazards from non
conforming areas.
Resolutions of the Central Council of Health & Family Welfare
The Central Council of Health and Family Welfare in its 5th Conference held in
23.
January 1997 had resolved that: (a)
States may enact laws to provide for registration of only those private
hospitals that have minimum facilities for different forms of treatment.
9
(b)
Monitoring mechanisms should be developed by the State to ensure that
the facilities and services created in private and voluntary sector hospitals
continue to be available and are maintained at the desired level; and
(c)
Private Hospitals in non-confirming areas that are posing health hazards
may be considered for shifting to other areas.
(d)
The accreditation system would however, require to be studied.
Consequently, the National Institute of Health & Family Welfare was assigned the
responsibility of drafting model legislation. The same was circulated to all State
governments in February 1999. (Annexure-III).
24.
Again the Council in its 6th Conference held in 1998 examined the matter afresh
and resolved that the Central Government may frame norms and standards for ensuring
proper health care for different categories of institutions in consultation with the State
Governments for private hospital/Nursing Homes/Clinical Establishments to be followed
by all the State Governments. These norms shall prescribe the minimum standards of
staff and infrastructure for all such institutions. The Council further resolved that the
State Government may enact laws to provide for compulsory registration of private
hospitals, nursing homes and clinical establishments in order to ensure minimum
facilities for different forms of treatment. It would also be necessary to regulate fees
charged by the private health institutions. The laws could provide for compulsory
exhibitions of fees, qualification of doctors, equipment available, etc.
25.
To carry out the above mandate a National Workshop was organized by the
Government of India, with assistance of WHO and the Medical Council of India on 18lh
and 19th August, 1999 at New Delhi to provide for a discussion among the service
providers of nursing homes and hospitals for the purpose of presenting the minimum
standards for registration of nursing homes and hospitals. A copy of the proceedings of
this workshop is enclosed (Annexure- IV).
26.
It was however felt that uniform enforcement of minimum standards would
require a central legislation. Therefore, to vest in Parliament the authority to legislate on
this subject. Ministry of Health & Family Welfare wrote to all States for getting
appropriate resolutions passed from the State Legislatures. Only three states viz.
Himachal Pradesh, Mizoram and Arunachal Pradesh have passed such resolutions.
However, this does vests in Parliament to legislate on regulation of Clinical
Establishments. Therefore, in the year 2000, another draft Bill under the nomenclature
Clinical Establishments Regulation and Accreditation Bill was prepared.
10
Legislation by States
27.
During this entire period, various states have also enacted their own legislations
for regulating Clinical Establishments. As per available information the following States
have enacted laws for regulation of clinical establishments:
i.
Bombay Nursing Homes Registration Act, 1949 (Annexure V)
11.
The AP Private Medical Care Establishments Act, (Annexure VI)
iii.
Delhi Nursing Homes Registration Act, 1953 (Annexure VII)
iv.
Orissa Clinical Establishment (Control and Regulation) Act, 1991
(Annexure VIII)
v.
Punjab State Nursing Home Registration Act, 1991 (Annexure IX)
vi.
Manipur Nursing Home and Clinics Registration Act. 1992 (Annexure X)
vn.
Sikkim Clinical Establishments, Act 1995 (Annexure XI)
viii.
Nagaland Health Care Establishments Act, 1997 (Annexure XII)
ix.
MP Clinical Establishments Regulation Act. (Annexure XI1-A)
It is also gathered that some more States such as Rajasthan, Karnataka and Haryana have
drafted the regulatory legislations but have not been able to get them tabled and
considered by their respective legislative assemblies.
Issues relating to enforcement, effectiveness and implementation
28.
Despite the plethora of legislation for regulating clinical establishments, the
common perception continues to be that such establishments are by and large not subject
to any regulation and are, therefore, not accountable. A critical analysis of existing
clinical establishment Acts suggests the following deficiencies and weaknesses:
Out datedness of existing legislations:
29.
Until recently, there are only few examples of regulations promulgated by the
State sat local government levels e.g., Nursing Home Acts of Delhi and Bombay.
Furthermore, most of the legislations affecting the health sector are old, inherited from
pre independence days, cumbersome and irrelevant to the concerns of today’s health
sector. Many regulations have not been updated and, therefore, have lost their relevance.
11
Ineffective implementation:
30.
Despite the existence of basic legislation, the degree to which regulations are
enforced and effective is low. It has been found that the enforcement of regulatory
controls is often weak or lacking. A PIE had to be filed in Maharashtra to force the state
to implement the BNHRA 1949. States have limited capacity and resources to effectively
implement the existing regulations.
Absence of rules:
Even in States that have enacted the clinical establishment Act, rules have not
31.
been framed for its implementation.
Ineffective content of rules:
32.
Even in case the local governments have promulgated the rules, these merely
cover registration of nursing homes/private hospitals. Minimum standards have not been
developed, nor are issues relating to accountability of quality and price been addressed.
Non-coverage of other private institutional providers:
33.
There is absence of legislation to regulate functioning of laboratories and
diagnostic centers private service providers, despite the emergence of a considerable
number of such facilities in India.
No uniformity in standards:
34.Standards framed by different States have nothing in common. Thus what may be a
minimum standard in one State might be considered too harsh in another. While it has to
be acknowledged that State specific variations would certainly exist, the need of the hour
is for uniform standards.
Options for future action
35.
From the preceding discussion, it is evident that despite enactment of legislations
by various States, health care providers in India continue to be fairly unregulated. Some
factors responsible for the wishy-washy implementation of existing laws have been
enumerated in the preceding paragraph. Protracted discussions have been held in this
Ministry with various stakeholders for almost a decade now, with no concrete results. On
account of this, however, there is an increased awareness about the general mistrust and
apprehension on the part of various service providers that such regulatory laws are prone
to be mis-used and would unleash licensing and Inspector Raj into a sector that has
hitherto remained by and large self-regulating. Hence, there is resistance to the
implementation of the laws already enacted.
12
36.
The fact that most of these State laws keep the government clinical establishments
out of the requirements of registration and adherence to minimum norms further fuels this
suspicion. Private sector players are quick to accuse the govt, of observing double
standards in prescribing minimum standards for private establishments and doing nothing
to improve the pathetic conditions in public health institutions. This issue would need to
be addressed in the right spirit by the government. No exemptions have been provided for
government institutions in laws framed for management of bio medical waste, setting up
of blood banks and pre-natal diagnostic tests etc. All these laws have had salutary impact
on their specific areas. All the more reason that government establishments should also
be required to register and comply with prescribed standards. As a matter of fact
MOH&FW has already started developing the Indian Public Health Standards (Annexure
XIII) and compliance to these ought to be made mandatory especially when funds are
also being provided out of the National Rural Health Mission for up gradation of public
Health Institutes.
37.
Another roadblock is the lack of clarity about standards. The variety of health
service provides is so vast that it would be well neigh impossible to have uniform
minimum standards to cover each and very possible clinical establishment. It is the
understanding of this Group that this is one significant reason that has held back most
States from formulating any minimum standards to regulate clinical establishments.
Most States particularly the Health Departments are so bogged down with multifarious
responsibilities that they have hardly any free time for innovative thinking. A lead role
is, therefore, necessary for the Central Government in this area.
Centre to enact Central legislation
38.
Historically, all laws pertaining to registration of medical professional have been
central statutes as the Indian Medical Council Act, The Dentists Act and the Nursing
Council Act. No similar central legislation exists for paramedics and paramedical
education and practice continues to be unregulated despite enactment of laws by States
for regulating para medical education. Moreover, experience suggests that as the private
sector develops or as resources become available, it is much harder to implement
regulatory legislation. Second, the existence of central legislation also means that as the
judicial system is strengthened, or consumers become more aware of their rights, there is
legal recourse through which to pursue the implementation of regulations. In the context
of the NRHM, when the Centre is exploring options for public private partnerships,
regulation of private institutional providers of health assumes greater significance.
Implementation at the district level
39.
In terms of implementation, two aspects are of prime importance - firstly there is
a need to empower Panchayti Raj Institutions to undertake registration and monitor the
minimum standards for clinical establishments. This is already mandated by the 73rd and
74th amendments to the Constitution of India. Secondly there exists a need for provision
of resources and developing capacities to undertake the task of implementing standards
that may get to be prescribed.
13
1
STEPS INVOLVED
In the light of the above discussion, the following steps are recommended for
40.
implementation: -
(i)
The Central Government should enact legislation for registration and
regulation of clinical establishments.
(ii)
Registration should be compulsory for all clinical establishments including
diagnostic centres etc. under any recognized system of medicines.
(iii)
Public Health Clinical Establishments (government owned) should also be
brought under the purview of such legislation.
(iv)
Even if the clinical establishment is already registered under any State
Act, it should be required to re-register under the Central Act. This is
necessary to have a reliable database of functional clinical establishments
in the country. This would also help inventorize availability of manpower
and infrastructure in clinical establishments, which could form the basis
for developing uniform minimum standards. To instill confidence in these
service providers, the Central Law should be simple and client friendly.
(v)
It should encourage use of IT and web based technology so that data
mining and updating of records become completely digitalize.
(vi)
As far as possible, registration should be done on the basis of documents
certified by licensed professionals such as Chartered Accountants,
approved valuators, assessors etc. The setting up of administrative
paraphernalia for inspection is to be discouraged.
(vii)
To the maximum extent possible, the responsibility of actual registration
should be entrusted to Panchayati Raj Institutions (PRIs). There is already
a multiplicity of licensing/inspector authorities under various health
related legislations. These are. therefore, required to be consolidated.
(viii)
There need not be any direct role of the Central Government in the
registration process except for maintaining a National Register of Clinical
Establishments and for determining uniform minimum standards. Such a
pattern already exists in the registration of medical, dental and nursing
professional.
(ix)
A corpus should be set up for supporting research in the development of
standards. It would be necessary to engage specialists and experts to
suggest justifiable standards.
14
r
(X)
Minimum standards should be determined through a consultative process
that would foster greater responsibility. The National Advisory Board
should be set up for overseeing this exercise. Such Boards could draw
upon various professional bodies and individuals for assistance in
development of standards. It has to be encouraged that this will be a long
drawn process and in all probability would have to be preceded by
classification and categorization of various clinical establishments. It is
for this reason that it is not proposed to link registration with
determination of minimum standards.
(Xi)
Due care would have to be taken to avoid over emphasis on standards for
infrastructure. Otherwise investments required to comply with standards
might have a spiraling effect on service costs in the health sector. Greater
focus would, therefore, be required on standards for service delivery.
41.
It is understood that the Ministry of Health and Family Welfare has already
prepared draft legislation on the above lines. A copy of the same is placed at Annexure
XIV. The Group has examined the draft and recommends that the Ministry should carry
this forward.
Regulation of Professionals
42.
In so far as medical professionals are concerned, legislative framework for their
registration and regulation already exist in forms of the Indian Medical Council Act, the
Dentist Act and the Nursing Councils Act. All these legislations set up regulatory
councils at the National and State levels. While the National Councils prescribe norms
and standards of education, the State Councils primarily deal with registration and
enforcement of standards. Despite this, not much data is available at the national level
about the availability and quality of medical and para-medical personnel. The
registration of an individual is currently a one-time exercise in most States. Acquisition
of additional and higher qualifications by the individuals is not required to be registered.
Similarly, the shifting out from a particular State, change of address or the demise of the
registered professional does not necessarily gets updated. All State Councils must,
therefore, shift to a system of periodical renewal of registration, say every three to five
years. Acquisition of qualification of a specialist or a super specialist must also be
required to be registered. These details should also get transferred to a National Register
to be maintained and updated by each apex council. When such data is available, proper
planning of human resource requirement could be possible. There is also need to move
forward towards a system of accreditation of various courses offered by Medical, Dental
and Nursing educational institutions. The Human Resource Ministry has already
established system for accreditation and rating of universities. Such a system is also
needed in the sector of medical education. The proposed Medical Education Grants
Commission could have appropriately handled this task. Till such by time a Commission
15
is set up, this task could be entrusted to premier institutions like the AIIMS, New Delhi,
PGIMER, Chandigarh.
In the field of Para Medical Education, the situation is not comfortable. This sub
43.
sector continues to be primary unregulated.
Few States have set up Para Medical
Councils. However, lack of uniformity of norms and standards has not given any
creditability to set up councils outside the States these have been set up in. The need,
therefore, is to set up National Para Medical Council as an apex body to determine
standards for para medical education, and to ensure uniform enforcement throughout the
country.
Accreditation
Intel national Scenario on Accreditation in Healthcare Services
A critical issue facing the health sector today is quality, with growing urgency
44.
amongst health care providers as well as consumers. Among the various approaches
gaining momentum, ‘accreditation of health facilities’ has gained acceptance and
prominence globally.
Introduction:
45.
Accreditation is defined as public recognition of achievement of accreditation
standards by a healthcare organization, demonstrated through an independent external
assessment of that organization’s level of performance in relation to the standard.
Accreditation assessment relies on establishing technical competence of an organization
in terms of accreditation standards in delivering services with respect to its scope. It goes
beyond compliance. It calls for excellence on continued basis. It is this feature which
makes it market driven involving all stakeholders; be it consumers, empanelling agencies,
regulators and other third parties. Accreditation is also one of the established mechanism
world over, as means to promote acceptance conformity assessment results, nationally as
well as internationally.
46.
In other words, the basis for accreditation is the existence or absence of such
standards measured through qualitative indicators (evidence of performance) observed by
a body of experts.
Accreditation is voluntary. It focuses on learning, self-development, improved
47.
performance and reducing risk. Accreditation is based on optimum standards,
professional accountability and encourages healthcare organization to pursue continual
excellence.
The concept of Hospital Accreditation
Accreditation in healthcare services refer to the evaluation process in which an
48.
accrediting body examines a healthcare organization to ensure that it is meeting certain
16
standards established by experts in the field. Accreditation is usually performed by a
multidisciplinary team of health professionals and is assessed against the published
standards for the environment in which clinical care is delivered. The standards adopted
nationally usually derive from an amalgamation of national statutes, governmental
guidance, independent reports, overseas accreditation standards and biomedical and
health services research.
49.
The process of quality assessment through accreditation features the need of
establishing standards for all services of a general hospital for example according to
universally/nationally accepted quality standards. The best country specific approach is
however, dependant upon the desired outcomes of the accreditation system. The basic
expectations for an accreditation system are that it provides for:
an independent, objective evaluation process;
be highly credible and unbiased;
represent the broadest possible consensus among users and stake holders;
encourage improvement in the delivery of healthcare;
and be relied upon by key users and stakeholders.
50.
Cardinal principles of accreditation evaluation are;
i)
ii)
iii)
iv)
Hospital operation are based on sound principles of system based
organization; transparent and objective.
Accreditation standards are implemented and institutionalized into
hospital functioning.
Patient safety and quality of core, as core values are established
and owned by management and staff in all functions and at all
levels.
There is structured quality improvement program based on
continuous monitoring including feedback on patient care services.
The evaluation process incorporates interview with patients, residents and staff. It
51.
calls for on-site visit to patient care areas and to departments, addressing issues related to
physical assessment of infrastructure, medical equipment, security, infection control etc.,
as required in the accreditation standards. In short accreditation is comprehensive review
of not only facility but also of clinical competence of hospital to deliver services within
its scope.
52.
With rapid growth of state of art private sector in the healthcare, the accreditation
program in moving closer to regulatory agenda. In most developed economies there are
very strong financial incentives to seek accreditation. Governments acknowledge that
independent assessment program by way of accreditation should be encouraged with
17
incentives, more so for secondary/tertiary level of hospitals to bring in thee best in terms
of Patient Safety and Quality of Care.
53.
The accreditation body, while operating in regulatory areas i.e. Healthcare, Food
Safety, will have some kind of linkages, may be with the regulator. For example,
regulation may provide that a healthcare organization will automatically be deemed to
have been registered, if accredited by the recognized national accreditation body.
Similarly accreditation body will take cognizance of applicable regulatory requirements
at the time of granting accreditation.
Global Scenario
54.
The accreditation of health services originated in the U.S. during the early
ninety’s and today is the main instrument used by the U.S. Government for the
distribution of financial resources to health institutions. The Government only contracts
those health institutions that have been accredited. Other regions have also applied this
method, such as Canada. Australia and the Province of Catalonia, in Spain. In the
Australian system, a star rating is given to hospitals like the star ratings of hotels. The
rating is given according to the facilities provided. The form of accreditation, however,
would vary from country to country. The United Kingdom has self-accreditation
program. In Latin America, after the II Accreditation Conference (1992), the process
began to be implemented through national meetings in practically all countries. In
Argentina, Chile and Uruguay initiatives have been observed at the central or state levels.
In the Andean sub-region the success in Bolivia, Colombia and Peru has been significant.
Guatemala stands out the most in Central America; and in the Caribbean, the Dominican
Republic has fully embarked on the process of accrediting its private hospitals. Cuba,
until the end of 1997, intended to have 60 hospitals accredited. In Southeast Asia
significant progress in accreditation has been accomplished in Indonesia and Thailand.
Country specific status of hospital accreditation
USA:
The accreditation of hospitals began way back in 1910 in the United States, when Ernest
Codman, M.D., proposed the “end result system of hospital standardization”. The
proposal became the stated objective of American College of Surgeons (ACS) that
developed the first minimum standards for the hospitals in the year 1917. In the year
1951, the American College of Physicians (ACP), and the Canadian Medical Association
(CMA) joined with the ACS to create the Joint Commission on Accreditation of
Hospitals (JCAHO) and independent, not-for-profit organization whose primary purpose
is to provide voluntary accreditation. It has accredited about 15000 healthcare
organizations.
Australia:
The Australian Council on Healthcare Standards (ACHS) is the pioneer in accreditation
in Australia. It had accredited around 700 healthcare organizations by 15th October 2001.
It began as collaboration between doctors and administrators in adjacent states, based on
18
Canadian model. It an independent, not for profit organization, dedicated to improving
the quality of healthcare in Australia through continually reviewing of performance,
assessment and accreditation.
The organization is governed by a board of Directors elected by council members
and supported by a corporate management structure, which oversees the process of
evaluation and assessment by professionally qualified surveyors. The body has formal
links with the government through representation on council and governing board. The
programme focuses on the primary, secondary and tertiary care service providers. ACHS
was accredited by ISO against their international standards for national healthcare
accreditation bodies in the year 2001.
Canada:
The Canadian Council on Health Services Accreditation (CCHSA) is a national, non
profit, independent organization whose role is to help health services organization, across
Canada and internationally examine and improve the quality of care and service they
provide to their clients. It has accredited around 3500-4000 healthcare organization in the
country and around 5-6 healthcare organizations internationally. It was setup following
the separation of the United States and Canadian accrediting bodies in 1958. It is the
second longest established programme in the world. It is totally independent of
government, but in some provinces the government gives a financial incentive for
accreditation and is sole accrediting body in Canada. The programme focuses on the
primary, secondary and tertiary care service providers. CCHSA underwent accreditation
survey by ISQua in the year 2002.
Ireland:
The Irish Health Services Accreditation Board (IHSAB) is an independent organization
established under a statutory instrument (SI), whose prime purpose is to continuously
review and operate an accreditation scheme for the Irish health system within a quality
improvement framework using an approach of self-assessment and peer review survey.
The board mainly focuses on acute health services. It is on the process of getting ISQua
accreditation. The process of accreditation is voluntary. The board has accredited around
35 hospitals to date.
Malaysia:
The Malaysian Society for Quality in Health (MSQH) was formed through the initiatives
of both the Ministry of Health Malaysia and the Association of Private Hospitals of
Malaysia. The society is an independent, not profit organization working actively in
participation with healthcare professionals to ensure continuous quality improvement in
health in the services provided by healthcare services and facilities in the country. It is
strongly supported by the Ministry of Health. The accreditation process in the country is
voluntary. The society has accredited 66 hospitals as of 6th May 2006.
New Zealand:
Quality Health New Zealand is an independent non-profit organization and is constituted
as an incorporated society. It was set up as the New Zealand Council on Healthcare
19
Standards (NZCHS) to provide a voluntary accreditation programme for hospitals and
other health services with the technical support of ACHS. The government, the Health
Boards Association and the private Hospitals Association, initially funded it. Today it is
financially independent mainly funded from the fees paid by participants in its
Accreditation Programme and clients of its other assessment services.
It mainly focused on aged care facilities and private and public acute hospitals and
services but also have programmes for primary care, hospices, disability support and nofor-profit voluntary organizations. Since 1990 Quality Health New Zealand has worked
with a wide range of health and disability services thought New Zealand, undertaking
well over 500 surveys and numerous audits.
South Africa:
The Council on Health Service Accreditation for South Africa (COHSASA) is structured
as a national collaborative effort between the state, private sector consumers and health
professionals. In terms of the memorandum and articles of association, the structure of
the council includes a board of directors, an executive team and several member
organizations. It is a total independent programme and focuses on all the primary,
secondary and tertiary care. It includes hospital based and district base services and was
developed with technical support from the HAP United Kingdom.
COHSASA is the only body in this country recognized as an impartial accreditation
agency for healthcare facilities and is the only healthcare accrediting organization in
South Africa accredited by ISQua. Since the start of the operation, 400 healthcare
facilities have entered the COHSASA programme and some of the facilities are in the
process of accreditation.
United Kingdom:
The Health Quality Services (HQS) is the longest established health accreditation service
in the UK and the rest of Europe. It was launched by the King’s fund; a London based
charity and developed into HQS providing accreditation across the spectrum of public
and private services.
HQS is accredited by the ISQua. Around 114 organizations were accredited by the HQS
as on 811' March 2006.
From the above scenario of accreditation of different countries, it can be said that the
accreditation systems over a period of time have shifted from a single system focusing on
entire hospital to a more complex pattern with specialized agencies undertaking for
several compartments of the health delivery system.
Hospital Accreditation in India
55.
In the Indian context it can be said that the rising demand for quality care, the
limited healthcare investment by the government, the growing number of private players
in healthcare and insurance sector, the opening-up of the health sector to global patients
makes the search for quality an imminent reality.
20
56.
The demand for Hospital accreditation in India was raised in the early nineties.
The extension of the Consumer Protection Act to medical practitioners stimulated the
demand for Hospital Accreditation. It was viewed as a device to protect medical
practitioners by fixing standards of subordinate and ancillary services that could largely
affect a doctor’s performance and also to eliminate substandard establishments. Many
Non resident Indian doctors sent in suggestions for the establishment of an Autonomous
Council to lay down standards for Hospitals. This Council could also be responsible for
classification of Hospitals/Nursing Homes/ Laboratories/ Clinics and would include
representatives from:
> Hospital Association of India
> Voluntary Health Association of India
> Indian Medical Association
> Medical Council of India
> Dental Council of India
> Nursing Council of India
> National Academy of Medical Sciences
> Director General of Health Services or his Nominee
> Association of Surgeons of India
> Association of Physicians of India
> Association of Obstt. And Gynaecology
> Four Independent Medical Experts
> The model of the Australian Council for Hospital Standards was also
suggested for the Indian Context.
Initiatives taken by the Ministry of Health & Family Welfare
57.
An initiative at the national level, undertaken by the MOHFW, GOI in the year
2001 was the development of a draft organizational framework for developing a hospital
accreditation system in India. This document provides organizational options for
envisioned national and state accrediting organizations and considers important issues in
operational sing the proposed system.
58.
Another initiatives was a workshop, organized by the WTO cell, MOHFW on 9th
February 2005 under the GOI-WHO biennium (2004-2005) to bring together
stakeholders to discuss issues related to accreditation of health facilities.
21
59.
The World Health Organization, India country office organized a one and half day
workshop, ‘Accreditation of Health Facilities in India- A Way Forward’ on October 7-8,
2005 at Taj Malabar, Kochi, Kerala. Other development partners who supported this
initiative included the World Bank amongst others. The Workshop sought to:
• Share key concepts & experiences relating to accreditation of Health care
facilities and review the current scenario in India & draw lessons.
• Engage in a constructive dialogue with key stakeholders to explore options to
develop an accreditation system that would have multiple benefits, including
notably the improvement in quality of care in both public and private sectors in
India.
• Develop a roadmap for establishing an accreditation system in the participating
States.
60.
This workshop brought together representatives from the States of Andhra
Pradesh, Karanataka, Kerala, Maharashtra and Tamil Nadu. The participants included
policy makers from the Central and State Governments, representatives from the private
medical sector as well as civil society from the State of Andhra Pradesh, Karnataka,
Kerala, Maharashtra and Tamil Nadu. Development partners including the World Bank,
USAID, ECTA, DFID and GTZ also participated in the workshop.
Possible Options
61. Option 1
MOHFW Role: Confined to overall policy decisions and development of standards for
health care facilities.
Role of States: Design, operationalization and implementation of an accreditation system
Option 2
MOHFW Role: Preparation of blueprint for states to implement an accreditation system.
including development of standards.
States: To operationalize and implement an accreditation system
Option 3
MOHFW Role
• Policy making in consultation with stakeholders
• The national quality framework and accreditation process, in consultation with
stakeholders
• Development of standards across types and level of services
• Training, information dissemination, conducting relevant, problem based research
• Developing implementation plans and monitoring
• Co-ordination and supervision of regional offices
• Facilitate sharing of experiences and skills transfer.
• Mobilizing the human, physical and financial resources to strengthen state
implementation plans.
• Making recommendations to the GOI concerning quality aspects and related.
22
Role of States
• Implementation of Accreditation as designed by the national body.
• Support services to participants at regional level including training
• Regional monitoring of implementation of accreditation
• Review of the decisions and reports generated by the body to determine their
robustness and
• Usefulness to the providers and consumers
• Redress: participating hospitals, consumer
Progress made so far
National Accreditation Board for Hospitals and Healthcare Providers
62.
National Accreditation Board for Hospitals and Healthcare Providers (NABH) has
come up with a uniform standard for the hospitals throughout the country. NABH is a
constituent Board of Quality Council of India (QCI). It has reportedly adopted its
standards and accreditation process in line with worldwide accreditation practices. The
formal launch of accreditation was announced in February 2006. About 20 major
hospitals were reported to be undergoing accreditation evaluation. It is institutional
member of ISQua.
63.
Other organizations like Indian Confederation for Health Care Accreditation
(ICHA) have also starting the process of accreditation of health institutions. Financial
rating organizations like ICRA have also started rating hospitals.
Empanelment by CGHS
64.
For the empanelment of hospitals and diagnostic centres by the Central
Government health Scheme, it has now been made mandatory that all diagnostic labs
must be certified by the National Accreditation Board for Testing and Calibration
Laboratories (NABL). Similarly, physical inspections of hospital that have applied for
empanelment have been entrusted by Ministry of Health and Family Welfare to the
Quality Council of India. Similar procedures could be adopted by the Employees State
Insurance Corporation of the Labour Ministry and Ex-Servicemen’s Contributory Health
Scheme of the Ministry of Defence for empanelment of hospitals and diagnostic centres.
It is expected that such demands/requirements shall generate further demand for
accreditation and for accrediting agencies. MOHFW has, therefore, taken the position
that no legislation may be necessary for accreditation of health institutions per se. This
would be purely a voluntary exercise. There should therefore be an independent body
that should oversee the functioning of accrediting agency to ensure that institutions of
doubtful competence are not allowed to take the advantage of the lack of well-established
accreditation frame.
This body would also liaise with regulatory of clinical
establishments for ensuring that only such establishments get accreditation that have
complied with the minimum standards. It is, however, to be encouraged that setting up of
such a body would be a complex and contentious exercise. It would therefore not be
prudent to make the establishment of such a Supervisory of Body as a pre-condition for
23
introduction of accreditation in the health sector. The process of setting up a Supervisory
Body can be initiated in the 1 llh Plan period and the financial provision should be made
for facilitating the functioning of such a Body as and when it comes into being.
Recommendations
65.
i)
Accreditation would be purely voluntary
ii.)
There can be several accrediting agencies like NABH under the Quality
Council of India, Indian Confederation for Health Care Accreditation and
even the Bureau of Indian Standards can take up this task.
iii.)
There would be no funding from Central Government. All the
organizations will have work on a self-sustaining process. However,
Government of Indian would promote accreditation.
iv.)
Accrediting agencies will have to take into consideration the requirements
of Medical Tourism for which international standards will recognized by
developed countries need to be adopted for accreditation.
v.)
Accrediting agencies will also have to take into view the requirements of
Insurance Companies.
vi.)
Accreditation standards should be based not only on physical
infrastructure, but also on standard operating procedures (SOPs) for
various kinds of identifiable medical Instruments.
vii)
The focus of accreditation should be on continuous improvement in the
organizational and clinical performance of health services, not just the
achievement of a certificate or award or merely assuring compliance with
minimum acceptable standards.
Taken as a whole, the process will assess the extent to which health care
66.
organizations are delivering safe health care effectively. It would indicate areas of
strength and weakness, including aspects requiring attention; involve an evaluation of the
validity and reliability of an institution’s internal review procedures, and provide
reassurance that each institution has in place effective arrangements for assuring optimal
standards in the organisation and has procedures securely in place that will enable it to
continue to do so.
24
SUMMING UP
67.
i.)
There is need for a central legislation for registration of clinical
establishments in the country. The draft legislation prepared by
Ministry of Health and Family Welfare needs to be carried
forward.
ii.)
Registration of clinical establishments should not be linked to
compliance of standards in the initial years.
iii.)
Uniform standards need to be developed for the entire country.
These standards should not focus on infrastructure alone, but also
on service delivery.
iv.)
The registration of medical professionals needs to be periodically
updated. Additionally acquisition of higher qualifications should
require re-registration. National Registers of all medical and para
medical personnel need to be created.
v.)
National Paramedical Council should be set up for regulating
paramedical education and service delivery.
vi.)
Accreditation of health institutions should be voluntary, but
encouraged by the Central and State governments.
vii.)
There is a need for setting up of National level body to oversee the
functioning of various accreditation agencies that might come into
being.
viii.)
Provisions need to be made in the lllh Plan for facilitating
development of minimum standards and also for setting up an
oversight body for accrediting agencies in the health sector.
25
REPORT OF THE WORKING GROUP ON
POPULATION STABILIZATION
FOR THE
ELEVENTH FIVE YEAR PLAN
(2007-2012)
m
GOVERNMENT OF INDIA
PLANNING COMMISSION
NEW DELHI
Chapter 1
Introduction
India’s successive five-year plans have provided the policy framework and
funding for the development of nationwide health care infrastructure and manpower. In
1951, India became the first country in the world to launch a family planning
programme to check the population growth. Since then, the family planning programme
in India has undergone variety of forms. The passive, clinic-based approach of the
1950s, gave way to a more proactive, extension approach in the early 1960s. The late
1960s saw the emergence of a "time-bound", “target-oriented" approach with a
massive effort to promote the use of IUDs and condoms. This was followed by even
more forceful "camp approach" to promote male sterilization in the 1970s. The
excesses of these campaigns lead to a severe backlash from which it took years for the
programme to recover. After re-christened as Family Welfare Programme in 1978,
maternal and child health services began to receive greater attention under the
programme’s plan of action. The centrally funded programme has been providing the
states additional infrastructure, manpower and consumables needed for the delivery of
services.
In the 1990s, Government of India began to reorient the programme in the light
of recommendations made by a subcommittee of the National Development Council,
an expert group headed by Dr. M. 8. Swaminathan, and more specifically to address
the concerns expressed at the International Conference on Population and
Development held at Cairo in 1994. Following a major review undertaken with the
support of the World Bank and other agencies in 1994-95, method-specific
contraceptives targets were abolished and the emphasis shifted to decentralized
planning at district level based on community needs assessment, and implementation
of programmes aimed at fulfilling unmet needs. The first phase of the Reproductive and
Child Health Programme was launched in 1997 as a flagship programme that covered
the entire gamut of safe motherhood, child health and RTI/STI diagnosis and care. The
National Population Policy (NPP) articulated the new broad-based approach towards
population stabilization, and set long-term policy goals. A National Population
Commission was also set up under the chairmanship of the Prime Minster of India to
review, monitor and give directions for the implementation of the NPP, and to promote
inter-sectoral coordination.
Goals under National Population Policy, 2000
The two important demographic goals of the National Population Policy (2000)
are: achieving the population replacement level (TFR 2.1) by 2010 and a stable
population by 2045. The National Population Policy envisages the following socio
demographic goals to be achieved by 2010.
1. Address the unmet needs for basic reproductive and child health services,
supplies and infrastructure.
2. Make school education up to age 14 free and compulsory, and reduce
dropouts at primary and secondary school levels to below 20 percent for both
boys and girls.
2
3. Reduce infant mortality rate to below 30 per 1000 live births.
4. Reduce maternal mortality ratio to below 100 per 100,000 live births.
5. Achieve universal immunization of children against all vaccine preventable
diseases.
6. Promote delayed marriage for girls, not earlier than age 18 and preferably
after 20 years of age.
7. Achieve 80 percent institutional deliveries and 100 percent deliveries by
trained persons.
8. Achieve universal access to information/counseling, and services for fertility
regulation and contraception with a wide basket of choices.
9. Achieve 100 percent registration of births, deaths, marriage and pregnancy.
10. Contain the spread of Acquired Immunodeficiency Syndrome (AIDS), and
promote greater integration between the management of reproductive tract
infections (RTIs) and sexually transmitted infections (STIs) and the National
AIDS Control Organization.
11. Prevent and control communicable diseases.
12. Integrate Indian Systems of Medicine (ISM) in the provision of reproductive
and child health services, and in reaching out to households.
13. Promote vigorously the small family norm to achieve replacement levels of
TFR.
14. Bring about convergence in implementation of related social sector
programmes so that family welfare becomes a people-centered programme.
Working Group on Population Stabilization
In this context, the Working Group on Population Stabilization for the Eleventh
Plan (2007-2012) was constituted by Planning Commission with the following terms of
reference (TORs) under the chairmanship of Secretary (Health & FW) (Annexure 1A).
The meeting of the Working Group was chaired by Smt. S. Jalaja, Additional Secretary
(Health & FW)
a) Review the current demographic projections for the 11th Plan and beyond: the
time by which the country’s population is likely to stabilize; and to review the
goals indicated in the National Population Policy (NPP), 2000.
b) Suggest strategy for achieving population stabilization as early as possible
keeping in view the current mortality, fertility & couple protection rates in
different states; fixation of state wise goals for the 11th Plan & individual years
for birth rate, IMR, couple protection rates, immunization, antenatal, intra
partum, neonatal & child health care, etc.
c) Assess the current status and future requirements (short, medium & long-term)
of demographic, bio-medical, social and behavioural research aimed at meeting
the felt needs for health care of women and children, adolescents and aged
during the 11th Plan.
d) Project financial implications for implementation of family welfare programme
during 11th Plan including the plan and non-plan requirements; and the CentreState participation in the funding.
e) To deliberate and give recommendations on any other matter relevant to the
topic.
As part of this Working Group, two sub-groups were formed. One sub-group
would prepare the report keeping in view the terms of references while the second
3
sub-group would provide inputs based on the suggestions of various expert
committees constituted under the National Commission for Population.
4
Chapter 2
Demographic Scenario and Projections for Eleventh Plan
Period
Current Demographic Scenario
India, currently the second most populous country in the world, has 17
percent of world’s population in less than three percent of earth’s land area. India
began the 20th century with the population about 238 million and by 2000 it ended up
with 1 billion. According to estimates, India added another 100 million by 2006 when
its population reached 1.1 billion. The country added 16 million people annually in
the1980s and 18 million annually in the 1990s until the present. While the global
population has increased threefold during the last century, from 2 billion to 6 billion,
India has increased its population nearly five times during the same period (Table-1).
India’s population is expected exceed that of China before 2030 to become the most
populous country in the world.
India is in the middle of demographic transition. Both fertility and mortality
have started declining throughout the country, though the pace and magnitude of the
decline varies considerably across the states. Like many countries of the world, the
onset of mortality decline preceded the onset of fertility decline by few decades. The
country has witnessed significant improvements in demographic and health
indicators since Independence. But an accurate assessment of India's demographic
achievements is hampered by data deficiencies, particularly for the period before the
1970s. The official estimates of fertility and mortality levels at the time of independence
are believed to be gross underestimates. Nonetheless, even they suggest significant
achievements in this field. The crude birth rate, which was officially put at 42 per 1,000
in 1951-61, has declined to 24 in 2004, as per the estimates available from the sample
registration system (SRS). The life expectancy at birth, which was about 32 years at
the time of independence, has doubled. Infant mortality rate has come down from
about 150 in 1951 to 58 by 2004.
Considering the size and diversity of India’s population, the decline in both
fertility and mortality is a significant achievement. Nearly one-third of India’s
population has lowered its fertility to replacement level. Fertility in India has come
down under a wide range of socio-economic and cultural conditions. Despite this
achievement, many are concerned with the pace of fertility decline, particularly in the
large, north Indian states. To overcome this, the northern region of India will need
much more focused programmes and more investment not only in the provision of
family welfare services but also for the overall socio-economic development.
5
Table 1: Population Size and Growth, India, 1901-2001
Multiple of
1901
population
1901
238,396
1.0
1911
252,093
1,3697
5.7
1.1
251,321
-772
-0.3
1.1
1921
27,656
1.2
1931
278,977
11.0
14.2
318,661
39,683
1.3
1941
13.3
1.5
361,088
42,428
1951
21.6
1.8
439,235
78,147
1961
24.8
2.3
548,160
108,925
1971
24.7
2.9
683,329
135,169
1981
23.9
3.6
846,421
163,092
1991
21.5
4.3
2001
1,028,737
182,316
Source: Registrar General and Census Commissioner, India, Census of India 2001:
Series-1: India, General Population Tables (2006).
Census year
Growth over decade
Number
Percent
(000s)
Population
(000s)
Achievements of Family Welfare Programme
Although India's success in fertility reduction is not comparable to that of some
other Asian countries (See Annexure A), its achievements are by no means modest.
The total fertility rate (TFR), which used to be over 6 births per woman at the beginning
of 1960s, has declined to 3.0 in 2003, as per the data from the Sample Registration
System. Thus essentially, India has crossed two-thirds of the way towards its goal of
replacement-level fertility of 2.1. Several states in the south, with populations as large
as some other Asian countries, have either already reached replacement fertility or
about to reach it in a few years (see Table 2).
Table 2. Total Fertility Rate around 2000 and the Expected Number of Years It
Would Take to Reach Replacement-Level Fertility, Major Indian states
TFR
2000
Andhra Pradesh
2.5
Assam
3.2
Bihar *
4.3
Gujarat
3.0
Haryana
3.3
2.4
Himachal Pradesh
2.4
Karnataka
Kerala
1.9
Madhya Pradesh *
3.9
Maharashtra
2.7
2.9
Orissa *
2.6
Punjab
Rajasthan *
4.1
Tamil Nadu
2.0
Uttar Pradesh *
4.6
Year
Mean fall Years
Expected
During last required forTFR
10 years® TFR=2.1
2010
0.81
4
1.8
0.61
18
2.6
20
3.2
1.08
22
0.41
2.6
14
2.4
0.86
1.35
2
1.8
1.03
3
1.8
0.17
1.8
0
0.86
. 20
3.0
0.79
7
1.9
9
0.89
2.0
1.8
0.82
6
3.7
0.45
45
0
1.8
0.49
34
3.9
0.75
6
1
West Bengal
All India
2.4
3.3
1.02
0.74
4.2
Mean for EAG
* EAG states.
** State-weighted average.
@ As per the SRS data.
0.82
3
16
(18)**
26
1.8
2.5
(2.6) **
3.4
The percentage of married women using contraception has increased from a
level just over 10 percent in the early 1970s to 48 percent in 1998-99, and to 53
percent by 2004 (Table 3). Considering the logistical problems of supplying information
and services to more than 250 million women of reproductive age, this increase is a
remarkable achievement. Surveys have repeatedly shown that women’s knowledge
about contraception is nearly universal. Female sterilization remains the most common
method of family planning. For the first time in recent decades, the 2001 Census has
registered a fall in the growth rate of population below two percent, indicating that the
decline in the birth rate has begun to overtake the decline in the death rate.
Table 3: Use of Contraceptive Methods in India, 1992-93 to 2002-04
Any method________
Any modern method
Pill_______________
IUD_______________
Condom___________
Female sterilization
Male sterilization
Any traditional method
Periodic abstinence
Withdrawal________
Other_____________
Not using a method
Percent of married women ages
15-49 using contraception
2002-04
1992-93
1998-99
48.2
40.6
53.0
45.7
36.3
42.8
2.1
1.2
3.5
1.6
1.9
1.9
2.4
3.1
4.8
34.2
34.3
27.3
3.4
1.9
0.9
5.0
7.3
4.3
4.1
3.0
2.6
2.7
1.4
2.0
0.4
0.5
0.2
51.8
47.0
59.4
Sources: International Institute for Population Sciences (UPS), National Family
Health Survey 1992-93 (1995); UPS and ORC Macro, National Family Health Survey
(NFHS-2) (2000); and UPS, Reproductive and Child Health; District Level Household
Survey 2002-04 (2006).
In the early 1970s, less than 15 percent of the deliveries were occurring in
institutions. It has increased to 34 percent in 1998-99 and to 41 percent by 2002-04.
Thirty percent of women had institutional delivery in rural areas as against 70 percent
for their urban counterparts. Before the expanded programme of immunization was
lunched in 1978, the percentage of children immunized against the six preventable
diseases was negligible. As per DLHS, the percentage of fully immunised children has
reached 48 percent in 2002-04 at the all-lndia level. The same source shows that
nearly three-forth of pregnant women receive antenatal check-up.
However, there are also indications of slackening in the progress towards
better health. During the 1990s, the SRS data suggest deceleration in the decline of
7
infant mortality rate. In particular, neonatal mortality rate has hardly shown any sign
of fall. The level of child immunization is also not increasing at the rate observed in
the 1980s. During the six-year interval between NFHS-1 and NFHS-2, the proportion
of fully immunized children increased by only one percentage point per annum. At
this rate, India could hope to reach the goal of universal immunization only after 50
years! The surveys also indicate that the decline in maternal mortality rate may have
also been stalled. The decline in the birth rate is yet to pick up speed in some
northern states.
Regional Variations
The five Empowered Action Group states of Bihar, Madhya Pradesh, Orissa,
Rajasthan and Uttar Pradesh (together with the three new states formed in this region,
Jharkhand, Chhattisgarh and Uttaranchal) had a combined TFR of 4.2 around 2000.
For this region as whole it would take another 26 years to reach replacement fertility
under the current rate of decline (see Table 2). Thus, without acceleration of fertility
decline in EAG states, India cannot hope to achieve replacement fertility by 2010.
Assuming the prevalence of below-replacement fertility in some southern states, at
best, India could hope to achieve a TFR of 2.6 by this date.
What are the hopes for a faster reduction in fertility in the EAG states? Table 4
shows the position of EAG states with respect to some important determinants of
fertility around 2000, the average change in the determinants during the last 10 years,
and the number of years it may take the region as whole to reach the levels required to
attain a TFR of 2.1. The current levels of the indicators in some southern states that
have achieved, or close to achieve the mark have been taken as the required levels to
reach replacement-level fertility. Under the current trends, it would take the EAG states
at least 25 years for the use of contraception, female age at marriage, unmet need for
contraception, ideal family size and regular exposure to mass media to reach their
respective levels required to attain replacement-level fertility. Only the trends in infant
mortality and female literacy suggest that they would be reaching the required levels
earlier. But an important caveat with respect to their trends must be noted. Although the
average decline in I MR during the last 10-years has been quite rapid, there has been
substantial deceleration in the decline in recent years, and further decline could be
more difficult. With respect to female literacy, the 2001 Census has recorded a
substantial increase probably because of adult literacy campaigns. It is doubtful
whether an increase in literacy by such means would have the same effect on fertility
as through formal channels. Thus the prospects for India achieving replacement fertility
by 2010 seem bleak, considering the demographic challenges posed by EAG states.
The demographic key indicators for states, based on DLHS (2002-04) and Facility
Survey (2003) of Reproductive and Child Health Project, have been presented in
Annexure B. The time lag between Kerala and other states in selected demographic
parameters is presented in Annexure C.
8
1
Table 4: Levels of Some Important Determinants of Fertility in EAG States and
the Numbers of Years it May Take for Them to Reach the Level
Required for Replacement-Level Fertility
Level
around
Indicators
2000
Percent using contraception
34
15
Median age at marriage
Unmet need for contraception
21
Ideal family size
3
Female literacy rate, age 7+
45
Infant mortality rate
85
Low
Empowerment of women
41
Exposure to mass media
5
Home visit by ANM (%)
Change Required Required
during last level for no. of
10-years TFR = 2.1 Years
10
65
31
18
60
0.5
5
5
32
0.3
2
33
15
80
23
28
40
16
?
?
High
12
75
28
?
?
20
Population Projection
The Technical Group on Population Projections set up by the National
Commission on Population has recently come out with population projections for
India and states. As per this report, India’s population is expected to reach 1.2 billion
by 2011 and 1.4 billion by 2006 (see Table 5). According to this projection,
population would grow by 1.4 percent during the Eleventh Five-Year Plan period
(more precisely during 2006-11). Even by 2021-26, the population is expected to
have a growth rate of 0.9 percent (see Table 6). An important assumption underlying
this projection is that the total fertility rate would reach replacement level
(approximately 2.1) only by 2021. The reason behind this gloomy expectation is the
slow pace of fertility transition in several large, north Indian states. In fact, according
the Technical Group, TFR would not reach the replacement level in some of these
states even by 2031. Although the Technical Group did not carry forward the
projection till the date of stabilization, the projected delay in reaching the
replacement-level fertility would imply that India’s population would not stabilize
before 2060, and until population size nears 1.7 billion.
Table 5. Projected Population of India (in millions) by Broad Age Groups, 20012026
Year
Under Age
15_______
15-59
60+
Total
2001
365
2006
357
2011
347
2016
340
2021
337
2026
327
593
71
1029
672
84
1112
747
98
1193
811
118
1269
860
143
1340
900
173
1400
Source : Office of Registrar General, India
One of the most chilling results of this exercise is the wide geographical
disparity in the projected population growth. If the total population of the country is
expected to grow by 36 percent between 2001 and 2026, in southern states, the
growth is expected to be around 15-25 percent only, whereas in northern parts of the
country, the growth is expected to be in the range of 40-50 percent (see Table 7). Of
the expected addition of 370 million to India’s population during 2001-26, Uttar
9
r
i
Pradesh alone would account for a whopping 22 percent, and the other three
northern states - Bihar, Madhya Pradesh and Rajasthan - would account for another
22 percent. The population growth in these regions is also expected to cause
population pressure in major migration destinations, chiefly Delhi and Maharashtra.
Clearly, something urgent needs to be done to check population growth in these
states.
Table 6. Projected Levels of Some Key Demographic Indicators, India, 2001-26
Indicator
2001-06
Population growth rate (%)
Crude birth rate
Crude death rate
Infant mortality rate
Total fertility rate
Life expectancy at birth for males
Life expectancy at birth for females
Source : Office of Registrar General, India
1.6
23.2
7.5
61
2.9
63.8
66.1
200611
1.4
21.3
7.3
54
2.6
65.8
68.1
201116
1.3
19.6
7.2
49
2.3
67.3
69.6
201621
1.1
18.0
7.1
44
2.2
68.8
71.1
Table 7. Some Key Results of Population Projection for States, 2001-26
Projected Projected population growth
growth rate
2001-26
2006-11 (%) % growth (OOP's) % share
4.8
17,863
23.4
1.0
Andhra Pradesh
2.4
8,946
33.6
1.3
Assam
30,848
8.3
37.2
1.5
Bihar
2.1
7,757
37.2
1.4
Chhattisgarh
3.8
14,131
102.0
2.8
Delhi
18,587
5.0
36.7
1.4
Gujarat
9,942
2.7
47.0
1.7
Haryana
1,497
0.4
24.6
1.0
Himachal Pradesh
3,290
0.9
32.4
1.4
Jammu & Kashmir
2.8
10,410
1.4
38.6
Jharkhand
14,082
3.8
26.6
1.1
Karnataka
1.5
5,413
17.0
0.8
Kerala
7.4
45.4
27,381
1.7
Madhya Pradesh
36,454
9.8
1.4
37.6
Maharashtra
8,519
2.3
23.1
0.9
Orissa
6,986
1.9
28.7
1.2
Punjab
6.7
24,994
44.2
1.7
Rajasthan
9,451
2.5
0.7
15.1
Tamil Nadu
22.2
82,565
49.7
1.8
Uttar Pradesh
0.9
3,257
38.4
1.5
Uttaranchal
5.5
20,358
25.4
1.0
West Bengal
3,782
1.0
31.0
1.2
North-eastern states
100.0
371,228
1.4
36.1
India
State
10
Total fertility rate
2021
2011
1.8
1.9
2.5
2.1
3.0
2.2
2.8
2.2
1.8
1.8
1.9
2.2
1.9
2.3
1.9
1.8
1.9
2.3
2.1
2.7
2.0
1.8
1.8
1.8
2.4
3.0
2.1
1.9
2.1
1.9
1.8
2.0
2.9
2.2
1.8
1.8
3.7
2.8
2.2
2.7
1.9
1.8
____ Z0
1.8
2.1
2.5
202126
0.9
16.0
7.2
40
2.0
69.8
72.3
Chapter 3
Strategies to Achieve Population Stabilization
Fertility decline in India has been the effect of various socio-economic
developments as well as government sponsored family welfare programme. Rising
levels of education, increase in female age at marriage, influence of mass media,
economic development, gender empowerment and measures for equality, continuing
urbanization, diffusion of new idea, and declines in infant and child mortality have all
contributed in lowering the levels of fertility. These factors, along with strong health
infrastructure and focused family welfare programme, will continue to be driving the
fertility transition. Even at the national level, the views regarding the ideal number of
children are fast approaching the two child norm. But at the same time, preference
for sons is clearly evident in many parts of India. The regional difference in fertility
level is also likely to continue for many more years. Given this context, what are the
strategies that can be adopted to achieve the population stabilization within a
reasonable time period?
National Rural Health Mission (NRHM)
Recognizing the importance of health for social and economic development
and for improving the quality of life, the Govt, of India launched the National Rural
Health Mission (NRHM) in 2005 to carry out the necessary correction and
strengthening of basic health care delivery system. The Plan of Action of NRHM
envisages increasing public expenditure on health, reducing regional imbalances in
health infrastructure, pooling resources, integration of organizational structures,
optimization of health manpower, decentralization and district management of health
programmes, community participation and ownership of assets and providing public
private partnership. The goal of the mission is to improve the availability of and
access to quality health care of the people, especially for those residing in rural
areas, the poor, woman and children.
The expected outcomes from the Mission as reflected in statistical data are:
•
•
•
•
•
•
•
•
•
•
IMR reduced to 30/1000 live births by 2012.
Maternal Mortality reduced to 100/100,000 live births by 2012.
TFR reduced to 2.1 by 2012.
Malaria Mortality Reduction Rate - 50% up to 2010, additional 10% by 2012.
Kala Azar Mortality Reduction Rate - 100% by 2010 and sustaining elimination
until 2012.
Filarial/Microfilaria Reduction Rate - 70% by 2010, 80% by 2012 and elimination
by 2015.
Dengue Mortality Reduction Rate - 50% by 2010 and sustaining at that level until
2012.
Cataract operations-increasing to 46 lakhs until 2012.
Leprosy Prevalence Rate - reduce from 1.8 per 10,000 in 2005 to less than 1 per
10,000 thereafter.
Tuberculosis DOTS series - maintain 85% cure rate through entire Mission
Period and also sustain planned case detection rate.
•
•
•
Upgrading all Community Health Centers to Indian Public Health Standards.
Increase utilization of First Referral Units from bed occupancy by referred cases
of less than 20% to over 75%.
Engaging 4,00,000 female Accredited Social Health Activists (ASHAs).
The NRHM (2005-12) seeks to provide effective health care to rural
population throughout the country with specific focus on 18 states that have weak
public health indicators and poor health infrastructure.
Meeting the unmet demand for contraception
The NPP document lays great stress on meeting the unmet need for
contraception as an instrument to achieve population stabilization. The presence of
high level of unmet need for contraception in EAG states is not a myth, as it is
supported by data from both NFHS and DLHS. But it would be a mistake to assume
that inadequate access to services should be the dominant, or even a major,
explanatory factor for its presence. As a carefully conducted in depth investigation in
the Philippines had shown, unmet need for contraception could arise from several
reasons, such as weak motivation, low female autonomy, perceived health risks, and
moral objection to the use of contraception. The elimination of these factors, and thus
the unmet need, could prove to be as difficult as generating fresh demand for
contraception.
According to the DLHS Round 2 (2002-2004) 21 percent of women in India
have an unmet need for family planning. The unmet need for limiting is higher (13
percent) as compared to unmet need for spacing (9 percent). Total unmet need is
highest among the younger women and women of lower parity, particularly for
spacing. If all the women who say that they want to space or limit their births were to
use family planning, the contraceptive prevalence rate could increase from 53
percent to 74 percent. It is important to address the unmet need for contraception,
particularly for spacing by providing access to safe, effective and reversible methods.
To do so it may be necessary to expand the basket of contraceptive choices. Social
marketing of contraceptives and availability of the range of methods would help to
meet the needs of couples who are not ready to accept sterilization. In their annual
surveys of eligible couples, ANMs should be asked to identify women with unmet
need for contraception and address their concerns so that unwanted pregnancies
could be avoided. Even if unmet need cannot be entirely eliminated, elimination of
about half the unmet need would be sufficient to have the desired effect on birth rate.
Expanding the Basket of Contraceptive Choices
Female sterilization has been the mainstay of Indian family planning
programme. The users of reversible methods form less than 15 percent of the users of
all methods. A high level of infant and child mortality, and strong preference for sons,
deter women from accepting a terminal method of contraception early. The data from
the NFHS show that about half of the unmet need for contraception is for spacing. The
Hindu-Muslim difference in fertility and use of contraception has become major political
issue in India. Partly the difference stems from the religious objections for the use of
sterilization among Muslims. Under these circumstances, there is an urgent need to
expand the basket of reversible methods of contraception offered under the
12
programme. Research indicates that addition of a method to the basket of choices has
an independent effect on the overall use. Injectibles and implants, which are not
currently offered under the programme, must be introduced as early as possible by
taking necessary safe guards. Female condoms would also be a welcome addition to
the programme.
Increasing Male involvement
Male methods account for only 6 percent of current contraceptive use.
Vasectomy, which used to be a popular method, went out of favour after the excesses
committed in the 1970s. Vasectomy is safer and easier to perform in primary health
centres than tubectomy. In recent years, the introduction of no scalpel vasectomy
(NSV) has shown some signs of success in some states. Vigorous efforts should be
made to promote this method, and train more doctors in performing this task. As males
are the main decision makers in Indian households, IEC activities also need to focus on
men for imparting knowledge on reproductive health of both men and women and
about the advantages of small family.
Diffusion through Satisfied Users
It has become increasingly clear that fertility decline in India is the result of
horizontal and vertical diffusion of a new reproductive idea and information about
various methods of contraception. Strong spatial patterns in fertility decline, and
systematic changes in fertility differentials by socio-economic status, support the
innovation-diffusion hypothesis. The satisfied adopters of the method play a key role in
this ideational change. By recruiting such couples for working in liaison with grassroots
health workers, it may be possible to increase the rate of diffusion.
Research has shown that contraceptive use increases in closely-knit
communities through diffusion of information and the idea of small family norm. Inter
personal communication plays a key role in the ideational change. Thus satisfied
users can serve as active agent in this process. The Janmangal programme in
Rajasthan is based on this idea. Janani also uses "Women Health Partners" for IEC.
As the family planning programme has been there for half a century, there are
already some users of contraception in every community. The scheme intends to use
them to rapid transmission of small family norm.
ANMs would identify a ‘satisfied’ acceptor couple (SAC) of each method from
caste and communities among whom the acceptance of the method is low. They would
be requested to spread information about the method, and motivate others in their
community. They would work in coordination with health workers at grassroots such
ASHA, ANM and Anganwadi worker. For their services, a fixed honorarium could be
provided. The performance of these SACs would be reviewed each year by the ANM to
decide whether they could be retained for this work in the following year.
The Role of Mass Media
An instrument that has become increasingly important these days is the use of
mass media in promotion of small family norm and providing information on
reproductive and child health services. The rapidly increasing exposure to electronic
media has made this an important channel of behavioural change communication. The
13
analyses of NFHS data have shown that the exposure to mass media, and family
planning messages through these sources have strong independent effects on the
current use of contraception, and future intention to use among non-users. It used to be
contended that interpersonal communication is a more effective agent of behavioural
change than the mass media. But recent research shows that messages though media
stimulate discussion between husband and wife, among friends and neighbours and
with health workers. Thus mass media and inter-personal channels should be seen as
complementary rather than substitutes in the process of developmental
communication.
Research shows that exposure to mass media has a strong independent effect
on the use of family planning methods. Mass media has a wide reach, and would help
to raise curiosity and create grounds for interpersonal communication to occur.
However, surveys show that in EAG states, regular exposure to mass media has not
yet reached desirable levels to have a wider impact. It is therefore required to raise
exposure to mass media in EAG states by providing DVD/CD player and Television set
to PHCs, FRUs and Mahila Mandals. As a part of this scheme, imaginatively produced
DVD/CDs on reproductive and child health, including information on various methods of
contraception, could be distributed.
Facility surveys show that less than 20 percent of the PHCs have telephone
connections. For efficient referral services and monitoring of the programmes,
telephone connections are essential. It is therefore important to provide telephone
connections to every PHCs, FRUs and CHCs. PHCs and FRUs receiving at least 10
outpatients/maternity cases in a day in EAG states could be identified for the supply of
DVD/CD Players and TV sets. For moving the TV set between OPD and inpatient
ward, a trolley could also be provided. During fixed hours in a day, DVD/CDs on RCH
and family planning could be played for viewing by the outpatients/women coming for
delivery. DVD/CD players and TVs could also be supplied to Mahila Mandals on the
condition that they would arrange DVD/CD viewing sessions (along with TV shows) at
fixed hours in a day. ANMs during their field visits should check whether these are
effectively used. The production of DVD/CDs could be out-sourced. Telephone
connections should be supplied to all PHC/FRU/CHCs. There should be a fixed budget
line to cover monthly telephone bills and maintenance, as in other government offices.
Arranging Group Meetings of Newly Wedded Couples and Pregnant and Nursing
Mothers
In India, about 10 marriages occur for every 1,000 population. Many women
marry at young age. It is therefore extremely necessary to impart knowledge on the
responsibilities of parenthood to newly weds as early as possible. Similarly, group
meetings of pregnant and nursing mothers can be arranged to provide them
information about maternal and child heath care and contraception. It is not sufficient to
just ask the ANMs to make home visits for IEC as it is difficult to monitor such activities.
Surveys show that heath workers visit less thanlO percent of eligible women during a
whole year. To give a formal platform for such communication strategies, ANMs with
the help of SACs, and ASHAs should be asked to arrange group meetings of newly
weds in a village every year. Such formal meetings will also give the required visibility
to the programme.
14
In villages with population more than one 1,000 the ANMs with the help of
ASHAs and SACs will organise group meetings of newly weds, and pregnant and
nursing mothers at least twice in a year. In villages with less than 1,000 populations,
such meetings may be held once in a year. In these meetings, ANMs should provide
information and knowledge on prenatal, natal and post natal care of women, new-born
care, child immunization, virtues of small family size, interval between births, methods
of contraception and abortion, STI/RTI and HIV/AIDS, with the aid of illustrative
pamphlets and booklets. The active cooperation of Panchayat members should be
sought to arrange these meetings.
Social Marketing
In spite of longstanding social marketing programme for condoms and oral pills,
the use of these methods has not picked up. The growing epidemic of HIV/AIDS
provides an opportunity to promote the use of condoms. The experience of our
neighbouring countries suggests that substantial potential for greater use of pills by
younger couples, if supported by counselling and I EC activities. The social marketing
programme has suffered from (i) strong urban bias in the distribution network; (ii) low
incentive to commercial participants; (iii) limited product range and (iv) simultaneous
presence of wasteful, free distribution system.
Surveys have disclosed large unmet need for contraceptives, particularly in EAG
states. Apparently, the government delivery system is not reaching the needy. As per
the NFHS data, less than 10 percent of rural women report that they are visited by the
ANMs during a year. This implies that ANMs are able to visit less than 100 households
in a whole year. On the other hand, there is a large pool of formally or informally
qualified Rural Health Practitioners (RHPs) who meet the day-to-day health care needs
of rural folks. It is proposed to use them in the delivery of non-clinical methods of
contraception and referring the clinical cases to the PHCs or FRUs, for a nominal fee.
The successful experimentation of this approach by Janani in Bihar gives hope that this
scheme could work if implemented with care and imagination.
Involvement of Private Sector
There is an urgent need to increase the involvement of private sector in the
delivery of family planning services, especially in areas where the pubic sector is weak.
This includes inner-city slum areas and large parts of EAG states. It is estimated that
private medical practitioners provide more than two-thirds of all health care in India (see
Annexure: D). In rural areas, they are more respected and accessible than
government grassroots heath workers. As experience of Janani in Bihar has shown,
rural heath practitioners could be recruited for social marketing of non-clinical methods
and for referring clinical methods to public/private health institutions.
Increasing the Visibility of the Population Stabilization Programme
The inverted red triangle, the eye-catching logo of the Indian family planning
programme of yesteryears, has slowly fading from the public memory. There is an
urgent need to bring back the visibility to the population stabilization programme. The
paradigm shift in the programme calls for a new but simple logo. An award may be
announced for developing a simple but effective logo. A private agency could be hired
15
at the national level to publicise the logo and the programme. The strong presence of
electronic media, particularly television, can be used for popularising small family norm
and population stabilization programmes, both in rural and urban areas.
Strengthening Family Welfare Infrastructure
The sub-centre, manned by an auxiliary nurse midwife (ANM), is the most
peripheral health institution available to the rural population. As per the norms
established under the Basic Minimum Services programme in 1997, there should be
one sub-centre for every 5,000 population in plain areas, and for every 3,000
population in hilly/tribal areas. In 2002, there were 1,37,271 sub-centres, or one sub
centre for 4,579 rural population.
The primary health centre (PHC) is a first referral unit for six sub-centres. In
2002, there were 22,975 PHCs , one for every 27,364 rural population. PHCs provide
outpatient services and have 4-6 inpatient beds. According to the norm they should
have one medical officer and 14 paramedical and other supporting staff. But in many
remote areas there are no functional PHCs .
Community Heath Centres (CHC) are planned as first referral units (FRUs) for
four PHCs for offering specialized care. According to the norm they should have at
least 30 beds, one operation there, X-ray machine, labour room and laboratory
facilities. The staff should consist of at least four specialists, a surgeon, a physician, a
gynaecologist and a paediatrician who should be supported by 21 paramedical and
other staff. Currently there are 2,935 community heath centres, or one for 2,14,000
population. But majority of CHCs do not function as FRUs as they either do not have
the required number of specialists or the facilities.
The facility survey undertaken as a part of ROH project has brought out the
serious shortfalls in physical infrastructure, staff and supplies at pubic heath institutions.
The survey considered a heath institution as adequately equipped if it had 60 percent
of the critical inputs. According to this criterion, at the all India level, only 36 percent of
the PHCs had adequate physical infrastructure such as building, water and electricity
supply, laboratory and labour room, vehicle etc., 38 percent had adequate staff in
position, 31 percent had adequate supplies of kits, drugs, vaccines and contraceptives,
and 56 percent had the adequate equipments in function, such as weighing machine,
vaccine carrier, BP instruments, autoclave, etc. The position of CHCs, FRUs, and
district hospitals were somewhat better, but they too had severe shortage of supplies.
Only 10-15 percent of them had adequate supplies. The staff in position in CHCs (25
%) and FRUs (46%) was also far from adequate. In EAG states, the position of PHCs
was far worse than the all India average. Only15-20 percent of them had adequate
infrastructure, staff and supplies. It was also observed that only 12 percent of medical
and paramedical staff (only 4 percent in EAG states) had received adequate in-service
training. The FRUs/CHC and district hospitals attended only about 10 referred cases of
delivery in a month.
Involvement of Local Self-Governments
The 73rd and 74th Constitutional Amendments made health and family welfare a
responsibility of local bodies. Being closer to the people, a decentralized institution is
16
expected to meet their needs and preferences. The whole idea of decentralized
governance is based on some key factors like people’s participation, accountability,
transparency and fiscal transfers. How far decentralization of services helps in
improving the quality and coverage of healthcare delivery? Experiences from across
the country indicate a precondition for enhancing the effectiveness in delivery of
public health services is community participation in decision-making and programme
implementation. This can be facilitated through the intervention of the PRIs by
making health services responsive to local needs, more accountable to the local
population, focusing on local problems, prioritizing the requirements, generating
public demand for the services, and efficient use of available resources. The
National Population Policy (NPP-200) reiterates the crucial role of panchayats in
planning and implementation of health and family welfare programmes.
Decentralization is expected to bridge the existing gap between the service providers
and the clients to a great extent. However, for the PRIs to be effective in health
service delivery, more responsibilities need to be given in the sector-specific budget
allocations, revenue-raising powers and training. In reality, the functions and powers
devolved to the Panchayats vary considerably across the states. Since one-third of
elected members at the local bodies are women, this is a good opportunity to
promote a gender sensitive, multi-sectoral agenda for population stabilization with
the help of village level health committees. Under the National Rural Health Mission
(NRHM), ASHAs would be selected by and be accountable to the village panchayats
(the coverage under NRHM for various health facilities/functionaries is presented in
Annexure E).
Expected Level of Achievement
Although the actual impact of the forgoing strategies to reach population
stabilization is difficult to predict, if effectively perused, they should able to bring
down the birth rate faster than what is projected by the Technical Group on
Population Projections. Through these measures, it is anticipated that TFR would
reach replacement if not by 2010, by 2015 - roughly by five years earlier than that
projected by the Technical Group. By the end of the eleventh plan, at the all-lndia
level, crude birth rate (CBR) is expected decline from 24 in 2004 to 19, and couple
protection rate (CPR) to increase from 53 percent in 2002-04 to 64 percent. It is
expected that the increase in CPR would result from reducing the unmet need for
contraception by half, i.e., from 21 percent to 11 percent. The expected levels of
achievement for the states are shown in Table 8.
17
Table 8. Expected Level of Achievement for CBR and CPR by the End of
11th Plan
State
Andhra Pradesh
Assam
Bihar
Chhattisgarh
Delhi *
Gujarat
Haryana
Himachal Pradesh
Jammu & Kashmir
Jharkhand
Karnataka
Kerala
Madhya Pradesh
Maharashtra
Orissa
Punjab
Rajasthan
Tamil Nadu
Uttar Pradesh
Uttaranchal
West Bengal
North-eastern states
India
Crude birth rate
ELA
SRS
2004
2012
16
19.0
20
25.1
21
30.2
21
27.4
16
18.4
16
24.3
17
25.1
15
19.2
18
18.7
26.2
20
16
20.9
14
15.2
22
29.8
16
19.1
17
22.1
15
18.7
21
29.0
14
17.1
25
30.8
16
20.5
16
19.3
_ 17
17.6
19
24.1
18
Contraceptive use
ELA
DLHS
2002-04
2012
62.8
68.7
57.5
68.8
31.0
49.4
46.6
57.5
72.3
64.1
59.2
67.4
67.7
60.3
70.1
76.0
67.2
54.8
54.4
37.9
66.9
59.3
68.5
76.1
50.5
61.0
69.6
63.3
54.7
64.3
73.4
68.2
46.9
57.8
57.7
66.8
35.6
52.4
48.7
62.2
74.1
79.6
40.2
58.1
53.0
63.6
Unmet need
DLHS ELA
2002-04 2012
11.7
5.9
22.5 11.3
36.7
18.4
21.7 10.9
16.4
8.2
8.2
16.3
14.7
7.4
11.8
5.9
24.8 12.4
32.9 16.5
15.1
7.6
15.2
7.6
21.0 10.5
6.3
12.6
19.1
9.6
10.4
5.2
21.8 10.9
18.1
9.1
33.6 16.8
26.9 13.5
11.0
5.5
35.7 17.9
10.6
21.1
Chapter 4
Research and Financial Requirements
Research Needs
Research studies on family planning and population stabilization are being
undertaken by various governmental and private agencies. The International Institute
for Population Sciences (UPS) is the nodal agency for conducting the National
Family Health Surveys (NFHS) and the District Level Household Surveys (DLHSRCH) for the country as a whole. These surveys provided very valuable information
on issues related to antenatal care, immunization, safe delivery, contraceptive
prevalence, unmet need for family planning, awareness about RTIs and STIs, and
utilization of government health services and user’s satisfaction. The DLHS Round II
survey is completed during 2002-04 in 593 districts. The second phase of facility
survey was carried out in 307 districts in 2003 to assess the availability of healthcare
facilities and their utilization in SCs, PHCs, CHCs and other hospitals. At the state
level, the Population Research Centres (PRCs) are in a position to conduct studies
related to the changing demographic and health requirements. The data collected
periodically through Census, Sample Registration System and other governmental
agencies are also helpful in assessing various demographic and health indicators.
Over the decades, though many micro-level research studies and large-scale
demographic surveys have helped in strengthening India’s family welfare
programmes, more focused research may be required to address emerging issues
and dimensions of demographic, epidemiological and health transitions in India.
Though the fertility has declined throughout the country, the factors responsible for
reduction in fertility considerably vary across the states. Well-organized and
executed demographic surveys can highlight the reasons behind the declines in
fertility and mortality and the changing attitudes of couples towards contraception.
1. The demographic research should focus on testing and validating of
relationship between acceptance of family planning and socio-economic
conditions of population. In recent decades there is a significant shift in the
process from provision of family planning to quality of services. The research
should highlight the current status and future requirements to understand the
needs of women and children.
2. Research studies should be undertaken to document the successful family
planning interventions in both pubic and private sectors, within India and
abroad, and analyze the reasons for their success so that they could be
implemented elsewhere.
3. The cost effectiveness and financial requirements of various health and family
welfare programmes are yet to be studied in detail. This is a pre-requisite for
future planning and programme implementation.
19
4. Rapidly demographic changes in the country call for more research in areas
such as demographic dividend, labour migration and outsourcing of jobs,
population ageing, and imbalances in population sex ratio.
5. With the introduction of new contraceptive methods and RCH services, it is
necessary to find out the acceptability of contraceptive methods for men and
women belonged to various socio-economic strata. This will help in
understanding the misconceptions as well as side effects of various birth
control methods. Based on the findings of these studies, the programme can
be fine-tuned to meet the requirements.
6. The demographic surveys should also address factors responsible for
changing value of children, gender preferences, and the attitude towards
small family norms.
7. Demographic and behavioural surveys should also address issues related to
reproductive rights, male involvement in family planning, adolescent
reproductive health, and women’s health status and autonomy.
8. Bio-medical research needs to be strengthened to develop appropriate
contraceptive technologies. Institutions such as Indian Council of Medical
Research (ICMR), National Institute of Health and Family Welfare (NIHFW)
and Central Drugs Research Institute (CDRI) can play an important role in this
regard.
9. Specific studies are required to find out the acceptability of emergency
contraception in the Indian context.
Monitoring and Evaluation:
Regular procedures should be developed to evaluate and monitor various
RCH programmes both at the district and state levels. This will also help in
popularizing successful experiments and to draw lessons for better programme
implementation. Regular monitoring will also help in identifying area specific
problems and will facilitate the programme mangers to chalk out remedial measures.
The DLHS surveys provided valuable inputs for evaluating the impact RCH
programmes at district level. However, it should be noted that such surveys are not
substitutes for monitoring the programmes through a regular management feedback
system. If effective mechanisms were developed to fill and analyze the data in the
forms devised under the Community Needs Assessment Approach, (CNAA), much
of the current problems in monitoring the programmes could be solved. The
dependency on annual surveys for evaluation could be reduced, and better informed
planning by local bodies would be possible, if the civil registration system is
streamlined and strengthened. Unfortunately, such long-term measures to improve
the statistical system do not receive the attention they deserve.
Financial Implications
The National Rural Health Mission (NRHM) has envisaged increasing the share of
central and state governments on healthcare from the current 20-80 to 40-60 sharing
20
in the long run. During the 11th Plan period the states would be expected to
contribute 15 percent to make the share of the central government 85 percent.
Regarding the additional resource needs, the National Commission on Macro
Economics and Health (NCMH) had made a detailed assessment of investment
requirements. The Commission has recommended additional non-recurring
investment of Rs. 33,811 crores and a recurring investment of Rs. 41,006 crores, the
expenditure to be made over a period of five to seven years. If we broadly agree with
the overall calculation of the NCMH and allow for local variations within the overall
resource envelope, the broad resource need for NRHM will be an additional Rs.
30,000 crores of non-recurring resources and a recurring need of Rs. 36,000 crores,
over and above the current allocations for NRHM in 2005-2006.
11th Plan - Requirements
Table 9: Annual Resource needs for NRHM
Central
Govt.
NRHM
Allocation
Recurring
NonRecurring
State
Contribution
Total
6,500
2005-06
6,500
2006-07
9,500
9000
500
2007-08
12,350
11000
1350
2,179
14,529
2008-09
17,290
13000
4290
3,051
20,341
2009-10
24,206
16206
8000
4,272
28,478
2010-11
33,884
23884
10000
5,980
39,864
2011-12
47,439
42439
5000
8,372
55,811
9,500
Source: National Rural Health Mission, Framework for Implementation
21
Chapter 5
Recommendations
There are different ways of improving the responsiveness of health and family
welfare system. Just increasing the budgetary provision will not yield the desired
results unless it is accompanied by strategic reforms and programmes to involve
communities in population stabilization. Health outcomes can be improved if local
communities have a greater say in the provision of basic healthcare. To improve
efficiency, based on the experiences so far, the following recommendations have
been made:
1. Despite five decades of effort to promote the use of family planning methods, a
large percentage of couples report unmet need for contraception. If this unmet
need could be met, population stabilization goal would be achieved. Even
meeting half of the unmet need could make significant dent on the birth rate.
ANMs and ASHAs could be asked to identify the couples with unmet need in
their area, and address their concerns. As more than half of the unmet need is
for limiting family size, meeting the unmet need would call for significant
expansion of sterilization services, especially in the large north Indian states,
although the NHRM launched by the Government of India acknowledged this
issue.
2. India’s Family Welfare programme placed heavy emphasize on sterilization as
the major method of family planning. Many other Asian countries started their
family planning programmes with spacing methods and then gradually
introduced sterilization. Providing sterilization services requires well-trained
medical personnel and well-equipped facilities. A permanent method may not
be preferred when levels of infant and child mortality are high, or because of
religious beliefs. Therefore, sterilization should be the last resort than the first
one in the contraceptive choices given to the public. So there is a need to
expand the range of choices of contraceptives as well as to improve the quality
of services provided to couples, both in rural and urban areas.
3. There is an urgent need to restructure the existing PHOs and SCs. Does it
make sense to have the same number of ANMs per population in every state,
given that birth-rates differ considerably from state to state? Whether the
Government has the capacity and funds to adequately maintain and to operate
the current level of infrastructure? How best we can attract qualified doctors to
government health care institutions in rural areas. Answers to such persisting
questions should be immediately found within the framework of NHRM. Some
successful experiments made to address these concerns should be carefully
looked into for implementation at a wider scale.
4. There is a need for specially focusing on poorly performing districts based on
the available data from the DLHS and Facility Surveys. To bridge the gap in
essential health infrastructure and manpower, state should have a more flexible
approach. Care should be taken to ensure the uninterrupted supply of essential
22
drugs, vaccines and contraceptives of required quality and quantity to all the
CHCs, PHCs and SCs.
5. The Panchayati Raj Institutions should play a bigger role in the supervision and
monitoring of PHCs. In most states the PRI involvement is not very effective
mainly because the health management committees are not functioning or not
representing the poor. Even when the health committees are active they have
no authority over medical and paramedical personnel. In many cases, there is
the need to develop better co-ordination mechanism between local selfgovernments and health care institutions. It is necessary to orient the PRI
members about their roles and responsibilities in providing better public health
services as well as the need for assigning top priority to health issues among
the activities of the PRIs. Although the NRHM Framework for implementation
approved by the Union Cabinet specifically addresses this issue, the challenge
lies in its implementation.
6. Concerted efforts are necessary to improve the coverage and quality of
registration of births, deaths, marriages and pregnancies. A motivated ANM,
Anganwadi Worker or ASHA can play an important role in this regard. The
responsibility of ensuring the complete registration can be entrusted to the local
bodies with clear-cut guidelines.
7. Strict enforcement of the Child Marriage Restraint Act, 1976, implying
prevention of marriages of girls and boys below the legally permissible ages of
18 and 21, respectively, would facilitate not only reduction of high risk teenage
pregnancies but also help in human resource development amongst these
younger girls and boys during their formative years towards improvement in the
quality of life in the long run. The Group recommends a national campaign
against Child Marriages, sex selection against the girl child & for promoting
institutional delivery by the Central & State Governments.
8. Focused attention on antenatal and institutional delivery care would help
towards reduction in neo-natal component of infant mortality as well as maternal
mortality, which in turn has externalities towards better acceptance of the
family welfare program interventions and thus accelerate the process of fertility
transition and population stabilization.
9. To improve the operational efficiency of the programmes, the Health
Management Information System (HMIS) needs to be strengthened. The timely
and accurate information gives the health managers the ability to monitor inputs
and outputs of the system and help them to assess the costs and returns from
various procedures. In many cases, measuring performance and distributing
that information will automatically provide certain incentives for the service
providers to perform.
10. The success of the Family Welfare Programme depends to a great extent on
the personnel working in various institutions. Regular in-service training to
enhance their knowledge and skills and to familiarize them with the new
programmes should become a part of regular activity of the health department.
23
They should also be in a position to develop local level health plans taking into
account the health conditions of the people and their requirements.
11.lt is important to periodically assess the utilization of health services and
customer satisfaction. Regular surveys, both for clients as well as for health
care providers, to be undertaken. The findings from these periodic surveys
should provide feedback to the health department as well as to the local bodies.
24
Annexure: A
India in comparison with other countries
______ Indicator______
IMR/1000 live-births
Under-5 mortality/1000
live-births____________
Fully Immunized (%)
Births by skilled
attendants___________
Health expenditure as %
of GDP______________
Government share of
Total Expenditure (%)
Government health
spending to total
government spending
Sri Lanka
Thailand
8
8
15
15
26
84
97
93
99
99
97
94
99
4.8
5.8
14.6
3.7
4.4
21.3
33.7
44.9
48.7
69.7
4.4
10
23.1
6
17.1
96
261
5274
131
321
68
87
China
<30
37
USA
2
67
43
India
(%)___________________
Per capita spending in
international dollars
Source: World Health Report, 2005, World Health Organization, Geneva
25
Annex 1A
No. 2(12)/ 06-H&F.W
Government of India
Planning Commission
(Health, Family Welfare & Nutrition)
Yojana Bhawan
Sansad Marg
New Delhi
25th May, 2006
ORDER
Subject: Constitution of Working Group on Population Stabilization for the Eleventh
Five-Year Plan (2007-2012).
In the context of formulation of the Eleventh Five Year Plan (2007-12), it has been
decided to set up a Working Group on Population Stabilization under the Chairmanship of
Secretary, Department of Health & Family Welfare, Government of India. The composition of
the Working Group will be as follows:
1.
Secretary, Department of Health & Family Welfare, New Delhi.
Chairman
2.
Representative, National Commission on Population, New Delhi
Member
3.
Member
Representative, Deptt. of AYUSH, Ministry of Health & Family
Welfare, New Delhi._____________________________________
4.
Representative, Department of Elementary Education & Literacy,
Ministry of Human Resource Development, New Delhi.
Member
5.
Representative, Ministry of Panchayati Raj, New Delhi
Member
6.
Representative, Ministry of Information & Broadcasting, New Delhi
Member
7.
Representative, Ministry of Youth Affairs & Sports, New Delhi
Member
8.
Representative, Ministry of Rural Development, New Delhi.
Member
9.
DGZ Representative, Central Statistical Organization, New Delhi
Member
10.
Representative, M/o Women & Child Development, New Delhi
Member
11.
Registrar General of India/ Representative, New Delhi
Member
12.
Secretary (H&FW), Govt, of Punjab, Chandigarh
Member
13.
Secretary (H&FW)/Representative, Govt, of Chhattisgarh, Raipur
Member
14.
Shri. A. Kumar, H&FW Division, Planning Commission, New Delhi
Member
15.
Shri. K.M. Gupta, Director, Ministry of Finance, New Delhi
Member
16.
Representative, PP Division, Planning Commission
Member
17.
Representative, LEM Division, Planning Commission
Member
18.
Director, International Institute for Population Sciences, Mumbai
Member
19.
Director, National Institute of Health & Family Welfare, New Delhi
Member
20.
Dr. S.C. Gulati, Professor, Institute of Economic Growth, Delhi.
Member
21.
Prof. Ashish Bose, New Delhi
Member
22.
Representative, FICCI, New Delhi
Member
23.
Executive Director/Representative, Population Foundation of India, Member
New Delhi
26
24.
Dr. G Rama Rao, Former Director, UPS, Mumbai
Member
25.
Joint Secretary, NCP, Ministry of Health & Family Welfare, N.Delhi
MemberSecretary
The terms of reference of the Working Group will be as follows:
2.
D To review:
a. The current demographic projections for the Eleventh Plan and beyond and
the time by which the country’s population is likely to stabilize;
b. The goals indicated in the National Population Policy (NPP) 2000.
2) Keeping in view the current mortality, fertility and couple protection rate in different
states, to suggest:
a. A strategy for achieving population stabilization as early as possible;
b. Fixation of goals for the Eleventh plan i.e. by the terminal year 2012 and
individual years for birth rate and IMR, etc state wise;
c. Fixation of state wise goals for couple protection rates, immunization/ ante
natal, intrapartum, neonatal and child health care, etc;
3) To assess the current status and future requirement (short, medium and long-term)
of demographic, bio-medical, social and behavioral research aimed at meeting the
felt needs for health care of women and children, adolescents and aged during the
Eleventh Plan.
financial implications for implementation of the Family Welfare
4) To project
Programme during the XI Plan including the plan and non-plan requirements and the
Centre-State participation in the funding.
5)
To deliberate and give recommendations on any other matter relevant to the topic.
The Chairman may, form sub-groups
3.
_ . and co-opt official or non-official members as
needed. The Working Group will submit its report by 31st August, 2006.
Ms. Radha R. Ashrit, SRO (H & FW), Room No. 343, Planning Commission, New
4.
Delhi-110001 will be the nodal officer for all further communications. (Tel.No. 230966662383 Email radha-pc@nic.in).
The expenditure on TA/DA in connection with the meetings of the Working Group in
5.
respect of the official members will be borne by the parent Department /Ministry to which the
official belongs as per the rules of entitlement applicable to them. The non- official members
of the Working Group will be entitled to TA/DA as permissible to Grade I officers of the
Government of India under SR 190 (a) and this expenditure will be borne by the Planning
Commission.
(Ambrish Kumar)
27
Director (H & FW)
23096530
(ambrish. kumar@nic.in)
To Chairman and Members of the Working Group.
Copy to:
1. PS to Deputy Chairman/MOS(Planning)/ Members(KP)/(AS)/(VLC)/(BLM)/SH/(BNY)/(AH)/
2.
3.
4.
5.
6.
Member-Secretary, Planning Commission, New Delhi
All Pr. Advisers/Advisers/ HODs in Planning Commission,
Prime Minister’s Office, South Block, New Delhi
Cabinet Secretariat, Rashtrapati Bhawan, New Delhi
US(Admin.l) / Pay & Accounts Officer/ Accounts-I-Section, Planning Commission /
DDO, Planning Commission
Information Officer, Planning Commission
(Ambrish Kumar)
Director (H & FW)
28
Annexure: C
Time lag between Kerala and other States in Selected Demographic
Parameters in 2002
State/lndia
CBR
2002
CDR
2002
IMR
2002
Andhra Pradesh
Assam________
Bihar_________
Gujarat________
Haryana_______
Karnataka_____
Madhya Pradesh
Maharashtra
Orissa_________
Punjab________
Rajasthan______
Tamil Nadu
Uttar Pradesh
West Bengal
India
20.7
26.6
30.9
24.7
26.6
22.1
8.1
9.2
7.9
7.7
7.1
7.2
9.8
62
70
61
60
62
55
85
45
87
51
78
44
80
49
63
30.4
20.3
23.2
20.8
30.6
18.5
31.6
20.5
25.0
7.3
9.8
7.1
7.7
7.7
9.7
6.7
8.1
Time
lag for
CBR
14
27
23
19
27
17
30
14
18
15
24
12
30
14
20
Time
lag for
CDR
25
31
25
24
23
23
32
23
32
23
24
24
32
20
25
Time
lag for
IMR
32
35
31
31
30
26
38
22
39
25
37
23
37
24
30
Source: K. Srinivasan, Proceedings of the Dr. C. Chandrasekaran Memorial
Lecture, UPS Newsletter, 2006, UPS, Mumbai.
29
Annexure: D
Healthcare Workforce and Health Facilities in Public and Private Sectors in
India.
Value
Indicator and measure
Doctors
Total number (1998) (includes all systems)
(CBHI)
Population per Doctor
Percentage of doctors in rural areas (1981)
(census)
Percentage of all doctors in private sector
(estimated)
Nurses
1,109,853
880
41
80-85
Total number (1996)
Population per nurse
Doctor per nurse (1996)
Hospitals
867,184
976
1.4
Total Number (1996)
Population per hospital
Percentage of hospital in private sector
Estimated total number of hospitals
Estimated population per hospital
Estimated percentage of hospitals in private
sector
Hospital beds
15,097
56,058
68
71,860
11,744
93
623,819
1,357
21
37
1,217,427
693
64
Total number (1996) (CBHI)
Population per hospital bed
Percentage of beds in rural areas
Percentage of beds in Private sector
Estimated total number of beds
Estimated population per bed
Percentage of beds in private sector
PHCs
22,975
27,364
Total number
Rural population per PHC
Note: The estimate for manpower is based on Medical Council lists. The estimate for the
number of hospitals and beds are based on the extent of underestimation in government. Data
found in Andhra Pradesh in a 1993 census of all hospitals by the Director of Health Services
and the Vaidya Vidhan Parishad; they found 2,802 hospitals and 42,192 hospital beds in the
private sector in Andhra Pradesh as against only 266 hospitals and 11,103 beds officially
reported by CBHI in that year. Thus, compared with the official (CBHI) data, the number of
private hospital was larger by a factor of 10.5, and the number of beds by a factor of 3.8.
Source: as cited by Peters et al, Better Health Systems for India’s Poor: Findings,
Analysis and Options, The World Bank, Washington DC, 2002.
30
Annexure: E
The Coverage under NRHM
The Mission has the foiiowing coverage:
740 million
Population coverage
148 million (approx.)
Households
26.6,
nearly 20 million births
Birth Rate in Rural Areas
1,75,000
( on population, distance
Sub Health Centres
and work load norm)
27,000 (single MO, 2 MO, 1 AYUSH)
PHCs
7,000 (every Block)
CH Cs
1,800
Sub Divisional/Taluk Hospitals
600
District Hospital
3.50 lakhs
ANMs at SHC
81,000
Staff Nurses at PHC
63,000
Staff Nurses at CHC
40,500
MOs in PHCs
49,000
Specialists in CHCs
4-5 lakhs, in all distant
ASHAs
habitations/villages
7 lakhs - in all villages/big hamlets
Village Health & Sanitation
Committees
Source: National Rural Health Mission, Framework for Implementation
2005-2012, Government of India.
31
Annexure: F
Human Development Goals for India as Outlined in
Tenth Five Year Plan, 2002-2007
Goal
Reduction in poverty ratio_______
Schooling for children: % 6-11 year
old attending school
Boys
Girls
All
Reduction in gender gap in literacy
Reduction in IMR_____________
Reduction in MMR____________
% with provision of drinking water
Rural
Urban
Situation
Circa 1990
36
Situation
Circa 2000
27
Goal for
2007
22
76
59
66
85
78
82
100
100
100
0.71
76
780
0.77
70
407
1.0
45
200
61
88
79
95
100
100
Source: Government of India, Population and Development: Ten Years after
ICPD, India Country Report, 2004.
32
Goal for
2012
15
1.0
28
100
!»
i
KEY INDICATORS, INDIA
t
<
£
£
c
c
£
F
I >l!»11 tICT LEVEL HOUSEHOLD SURVEY- REPRODUCTIVE AND CHILD HEALTH, (DLHS-RCH), 2002-04
Smnplo size
Hoiiimholdp surveyed
< hirrnntly morrlod women age 15-44
I limbnnd'o of eligible women
Chnrnctorlstlcs of households
I'monnl nirol
I'nrnnnl I llndu
I'wtownl Muslim
I'MKimtl other religion (Christian)
I'woont aohoduled caste
...........
I'aronnl scheduled tribe
I’wKMiU with electricity
I'wnmnl with flush toilet
..........
I 'nment with no toilet facility
t'oioent living In Kachcha houses
........
Pernonl living In Pucca houses
I'fflWtt with low standard of living
..........
I'ament with high standard of living
I 'aitiani with Idoizod salt (15+ppm)
Clmrnctorlatlcs of currently married
women ngo 15-44 years
I'ammit below age 30..................................•
I'ament with ngo at first cohabitation below age 18.
Pamant llllterato
Cement hnvlng 10 or more years of schooling
Cement with Illiterate husband
I 'amanl will) husband 10+ years of schooling
MnrHrtgo
Mnen eye nl marriage for boys
Menn ngn marriage for girls
Cement of boys married below age 21
Cement of girls married below age 18
loitillty
Moen uhlldron over born women age 40-44 years...
Cnnienl of births of order 3 and above’
Currant uao of family planning method
Any method
Any modern method
Pill
IUD
Condom
I emnln nlorlllzatlon
Mele etoilllzatlon
Any lindltlonal method
Ilhylhm/nnfo period
Wlllutmwal
Unmot nood for family planning
Cement with unmet need for spacing
Cement with unmet need for limiting
Pomonl wllh total unmet need
Miilornal care2
Pomonl of women received antenatal check-ups
Antenatal chock-up at home
Antenatal check-up in first trimester
Three or more visit for ANC
.......
Two or more tetanus toxoid Injections.
6,20,107
5,07,622
3,30,820
66.9
86.4
8.6
3.5
22.7
5.8
73.1
26.2
60.8
30.4
31.1
42.3
23.9
29.7
51.2
55.2
48.5
19.3
26.7
34.6
24.5
19.5
20.5
28.0
4.0
42.0
53.0
45.7
3.5
1.9
4.8
34.3
0.9
7.3
4.1
2.7
8.5
12.7
21.5
73.4
06.1
40.2
50.1
71.8
Adequate Iron folic acid tablets/syrup3.
Full antenatal check-up4
.2
Delivery characteristics
Delivery at home
Delivery at government health institutions
Delivery at private health institutions
Delivery attendant by skilled persons5
Child health
Percent of children whose mother squeezed out milk
from her breast0
Percent of children7 with diarrhoea8 who received
ORS
Percent of children7 with pneumonia8 who were taken
to a health facility or provider
Percent of children who received
vaccinations9
BCG...........................................................................
DPT (3 injections)
Polio (3 drops)
......
Measles......................................................................
All vaccinations10
No vaccination at all
...........
Percentage of women who had
Pregnancy complication2
Delivery complication2
Post delivery complication2
Symptoms of RTI/STI
Problems of vaginal discharge
.................
Menstruation related problem
Awareness of RTI/STI and HIV/AIDS
Percent of women who have heard of RTI/STI
Percent of women who have heard of HIV/AIDS
Utilization of government health services
Antenatal care
Treatment for pregnancy complication
Treatment for post-delivery complication
Treatment for vaginal discharge
Treatment for children with diarrhoea
Treatment for children with pneumonia
Quality of family planning services
Percent non-users ever advised to adopt the family
planning method
Percent users told about side effects of method
Percent users who received follow-up services
11.7
28.0
26.2
Characteristics of husband of eligible
women
Percent of husband knowing NSV
Percent of men who have heard of RTI/STI
Percent of men who have heard of HIV/AIDS....
Percentage who had any symptoms of RTI/STI.
Sought treatment for RTI/STI
34.4
52.9
75.8
7.6
40.2
20.4
16.4
59.0
18.7
21.8
47.6
56.6
29.7
73.7
74.7
59.0
58.2
58.0
47.6
19.8
34.2
40.8
31.4
32.3
15.8
17.2
44.2
53.6
32.9
32.1
24.4
27.2
19.8
18.2
’ F or births In past three years,2 For live/still births during three years preceding the survey, 3 100 or more IFA tablets/Syrup,4 A
minimum of three visits for ANC, atleast one TT injections and 100 or more IFA tablets/syrup,5 Either Institutional delivery or home
dolivory assisted by Doctor/ANM/nurse,6 Children age below 3 years, 7 Last but one living children below age 3 years,8 Last two
weeks preceding the survey,8 Last but one living children (age 12-35 months) bom during three years preceding the survey.10 BCG,
Ihroo Injections of DPT, three drops of polio and measles.
3
3
T
I
*
>
3
KEY INDICATORS, (RURAL) INDIA
KEY INDICATORS, INDIA
DIJJTRICT LEVEL HOUSEHOLD SURVEY, 2002-04
i ii :phoductive and child health
FACILITY SURVEY, 2003
REPRODUCTIVE AND CHILD HEALTH
Chnrncterlstics of currently married women
ngt) 15-44 years
I’wuont bolow age 30
........... ...
I 'aruont with age at first cohabitation below age 18...
I'ttiount lllltoroto
I'urudnt having 10 or more years of schooling
I’nroont with Illiterate hueband
...........
Pmoant with hueband 10+ years of schooling
Current use of family planning method
Any method
Any modern method
.
Pill
IUD
Condom
Female •torillzatlon
.
Malo atorlllzatlon
Any traditional method
.............
Hhythm/aafo period
Withdrawal
......... ...
Unmet need for family planning
Percent with unmet need for spacing
Percent with unmet need for limiting
...........
Percent with total unmet need
......................
Mntornal care2
Percent of women received antenatal check-ups
Antenatal check-up at home
Anlenatnl check-up In first trimester
Throe or more visit for ANC
Two or moro tetanus toxoid Injections
............
Adequate Iron folic acid tablets/syrup3
hull antenatal check-up4
.
Delivery characteristics,21
Delivery nt home
Delivery ot government health institutions
Delivery at private health Institutions...?r.'.
Delivery attendant by skilled persons5
Percent of children who received
vaccinations®
HDCl.......................................................................
DPT (3 ln|octlons)...f
Polio (3 drops)
Moatitan......................................................... .......
All vnoolnntlons10
No vaccination at all
Quality of family planning services
Porcont non-users ever advised to adopt the family
planning method
Pornont users told about side effects of method
Percent users who received follow-up services
Sample size
District Hospitals surveyed
First Referral Units surveyed
Community Health Centres surveyed
Primary Health Centers surveyed
Sub Centers surveyed
ISM&H Hospitals sun/eyed
...............
ISM&H Dispensaries surveyed
District hospital adequately equipped
Infrastructure
Staff
Supply
Equipment
.
Percentage of DH utilized as referral10
First referral units adequately equipped
Infrastructure
Staff
Supply
Equipment
Percentage of FRU utilized as referral>11
1
CHCs adequately equipped
Infrastructure
Staff
Supply
Equipment
.
Percentage of CHCs utilized as referral12
53.9
63.3
59.0
10.4
33.0
26.3
48.8
42.0
3.0
1.1
2.8
34.1
0.9
6.8
4.0
2.2
9.7
13.5
23.2
67.5
7.9
33.3
41.9
67.6
16.9
12.8
69.8
15.0
14.8
37.2
70.1
53.2
52.5
52.3
41.7
23.5
PHCs adequately equipped
Infrastructure
.
Staff
Supply
.................................
Equipment
.......................
Training
................. ..............
Medical officer (at least one)
Female medical officer
Sub Centres
Female health worker13
Male health worker13
Functioning in govt, building
Tap water supply14
ANM staying in allotted quarter
ISM&H hospital
Own building
Medical officer (at least one)
Staff nurse (at least one)
Pharmacist (at least one)
370
1,882
1,625
9,688
18,385
2,151
7,064
92.7
79.5
44.9
84.1
37.2
75.8
37.0
31.6
61.3
39.4
I-
62.8
14.2
24.1
46.0
46.4
31.8
48.2
39.9
41.3
19.9
78.2
15.5
I
95.1
67.7
45.2
21.1
22.5
I
16.7
76.8
76.0
84.4
11.4
27.9
31.9
’ For IIvo/stlll births during three years preceding (he survey,
3100 or more IFA tablets/Syrup,4 A minimum of three visits for
ANC, nt least one TT Injections and 100 or more IFA
tablets/syrup,5 Either Institutional delivery or home delivery
assisted by Doctor/ANM/nurse,9 Last but one living children (age
12-35 months) born during three years preceding the survey.1<r
BCG, three Injections of DPT, three drops of polio and measles.
I
wReferred cases are taken from those DHs which have
conducted delivery,11 Referred cases are taken from those
FRUs which have conducted delivery, ,2Referred cases are
taken from those CHCs which have conducted delivery.
13 Staff in position Is for number of health facilities having
sanctioned post.14 For those functioning In government
building•
I
I
Tt
m* Tu WV «<W
ANNEXURE : B
KEY INDICATORS FOR STATES AW UMOM TBSVTORES
District Level Household Survey (2002-04) & Fachty Survey (2003) - Reproductive & Chid FfrcWi
Census. 2001
State/ Union territory
India
North
Delhi
Haryana
Himachal Pradesh
Jammu & Kashmir
Punjab
Rajasthan
Uttaranchal
Central
Chhatishgarh
Madhya Pradesh x
Uttar Pradesh
East
Bihar
Jharkhand
Orissa
West Bengal
Northeast
Arunachal Pradesh
Assam
Manipur
Megahalaya
Mizoram
Nagaland
Sikkim
Tripura
West
Goa
Gujarat
Maharashtra
South
Andhra Pradesh
Karnataka
Kerala
Tamil Nadu
Union Territory
A & Nicobar Islands
Chandigarh
Dadra & Nagar Haveli
Daman & Diu
Lakshadweep
Pondichhery
Percent of households
Population
in millions
Percent
female1
literacy
With
electricity
With
drinking
water
With
toilet
facflity
With
lowSU
Ustog
kxfzed
salt3
Giris
marriage
below 18
years
1028.6
53.7
73.1
88^
392
42J3
29.7
28.0
13.9
21.1
6.1
10.1
24.4
56.5
8.5
74.5
55.7
67.4
43.0
63.4
43,9
59.6
98.7
91.2
97.9
80.4
962
64.9
67.1
90.6
48.7
43.7
78.7
60.3
34.1
50.8
962
91.7
86.5
82.3
98.8
79.0
77.3
22
19.3
252
20.6
11.8
45.3
37.5
81.8
55.3
78.0
45.0
64.8
33.0
8.6
20.8
60.3
1662
51.9
50.3
422
67.6
76.2
41.5
21.0
302
332
822
76.1
90.8
63.5
55.6
542
83.0
26.9
36.8
80.2
33.1
38.9
50.5
59.6
24.7
38.7
47.3
51.6
30.1
262
25.6
55.6
932
54.4
73.0
93.1
1.1
26.7
2.2
2.3
0.9
2.0
0.5
3.2
43.5
54.6
60.5
59.6
86.7
61.5
60.4
64.9
69.5
43.6
80.8
57.1
83.8
78.6
882
76.8
75.4
75.4
92.7
63.5
97.9
91.8
85.3
98.1
1.3
50.7
96.9
75.4
57.8
67.0
96.3
862
83.6
762
62.9
31.8
62.4
50.4
56.9
87.7
64.4
0.4
0.9
02
02
0.1
1.0
75.2
76.5
402
65.6
80.5
73.9
Mean age at
maniage
Girl
Percent
of rural
women4
Birth
order 3+
24.5
19.5
682
42.0
10.8
27.8
2.9
5.1
10.2
49.4
9.8
23.8
22.7
26.0
25.9
23.8
20.6
24.6
20.6
19.0
21.7
22.8
20.9
17.3
20.5
6.3
70.8
782
762
68.9
70.8
72.6
42.2
38.4
24.4
32.1
32.4
47.4
45.9
33.1
40.8
13.7
31.1
43.5
41.4
22.7 .
21.8
21.5
19.0
182
18.1
69.8
68.9
70.4
44.9
49.4
56.9
66.3
65.8
62.4
51.8
29.6
37.2
36.6
54.8
51.5
43.8
23.1
45.9
21.9
22.8
25.4
24.7
17.4
18.3
20.5
18.5
72.6
68.8
71.1
67.6
54.4
48.9
42.1
31.0
81.7
72.9
442
50.2
73.1
652
80.6
83.8
50.0
56.3
46.9
64.8
39.7
48.2
342
382
67.1
53.4
79.6
41.2
56.8
39.9
60.9
44.5
26.6
23.8
9.6
16.7
14.0
7.4
12.0
21.6
23.4
272
27.5
22.8
25.1
27.1
24.5
27.3
19.5
20.7
24.1
20.8
21.6
22.5
21.9
20.9
72.8
73.0
81.0
75.9
64.3
71.8
87.5
70.6
48.8
40.6
43.1
59.5
41.5
57.7
30.5
17.9
72.8
47.5
41.7
85.4
87.4
82.0
12.1
34.6
41.1
60.5
35.1
46.9
3.6
24.6
21.1
29.0
22.3
24.6
24.4
19.4
19.1
49.3
65.4
63.6
20.0
38.1
32.4
84.1
87.0
79.0
87.0
42.1
39.5
91.0
41.0
87.3
90.9
65.3
92.6
38.5
44.6
16.1
33.0
24.8
22.9
56.3
24.9
38.6
31.4
6.6
15.5
232
25.1
28.0
26.4
18.4
19.1
21.9
20.7
66.3
67.7
67.3
56.6
22.5
29.6
15.5
21.6
84.8
97.8
97.7
962
99.7
94.9
64.4
87.1
56.3
48.4
98.4
71.1
86.6
99.9
94.9
83.0
26.3
97.6
22.8
7.3
40.4
13.4
1.3
15.0
94.9
73.8
50.5
53.3
54.3
49.1
4.3
4.4
25.6
12.3
13.7
4.9
25.8
24.6
22.9
26.7
26.7
27.6
212
22.8
19.7
23.0
20.7
22.4
82.8
12.6
70.5
60.7
50.1
202
17.1
38.5
37.6
32.5
46.6
13.6
Boy
1 age 7+ years 2Piped or from hand pump.3 Cooking salt that has an iodine content of at least 15 parts per million (ppm).4 Currently married women age 15-44 years.
Annexure B key indicators contf.
District Level Household Survey (2002-04) & Facility Survey (2003) - Reproductive & CMd Heatlh
Unmet need for
family planning
Contraceptive prevalence rate
State/ Union territory
India
North
Delhi
Haryana
Himachal Pradesh
Jammu & Kashmir
Punjab
Rajasthan
Uttaranchal
Central
Chhatishgarh
Madhya Pradesh
Uttar Pradesh
East
Bihar
Jharkhand
Orissa
West Bengal
Northeast
Arunachal Pradesh
Assam
Manipur
Megahalaya
Mizoram
Nagaland
Sikkim
Tripura
West
Goa
Gujarat
Maharashtra
South
Andhra Pradesh
Karnataka
Kerala
Tamil Nadu
Union Territory
A & Nicobar Islands
Chandigarh
Dadra & Nagar Haveli
Daman & Diu
Lakshadweep
Pondichhery
Antenatal care6
Dcfiwery chaGMAMisfics6
Spacing
3+
ANC
visit
At least
oneTT
injection
Received
IFA
tabtets
Govt
Insbtute
Home
Assisted
by skilled
person7
8.5
50.1
80.1
20.4
18.7
59.0
47.6
11.4
9.2
8.4
10.7
7.6
13.7
17.1
5.0
5.5
3.4
14.1
2.7
8.1
9.8
67.3
48.6
68.0
80.5
64.5
33.3
28.0
82.5
85.8
89.6
80.8
872
69.0
712
45.7
17.1
42.8
53.7
20.3
8.0
20.0
29.5
10.6
36.9
55.9
9.5
19.4
10.7
49.3
64.8
54.3
28.4
51.1
68.0
76.2
59.9
43.2
51.4
73.1
64.3
44.4
32.5
2.6
52
7.3
12.4
13.6
20.3
9.3
7.4
13.3
48.7
34.6
24.7
79.3
77.5
69.5
16.5
8.5
8.7
9.6
17.6
8.5
79.6
71.5
77.2
29.1
35.5
28.7
27.3
33.3
41.9
51.0
2.0
2.9
2.7
4.6
21.8
19.3
13.1
6.6
14.9
13.6
6.0
4.4
19.6
32.8
47.3
64.6
75.4
712
84.8
92.0
8.1
12.6
24.3
18.1
5.4
5.3
25.6
34.3
76.8
77.3
64.4
51.6
29.5
27.8
43.5
54.1
38.8
57.5
33.5
17.1
53.8
39.6
65.3
54.4
35.6
28.7
21.1
14.7
52.6
33.0
55.3
42.7
1.8
2.3
3.5
2.4
2.3
6.1
5.9
10.9
21.9
14.3
25.6
19.5
8.9
14.7
12.9
18.5
13.3
8.2
15.3
36.2
16.1
192
5.2
6.6
40.9
42.6
582
43.8
56.3
33.1
67.9
66.4
54.2
65.9
78.4
48.1
72.1
61.5
85.9
71.4
12.9
13.4
12.2
14.1
28.5
11.8
30.3
15.9
27.1
13.9
372
23.7
47.1
8.2
53.4
57.4
64.9
71.9
54.9
68.9
46.8
81.8
40.9
37.5
37.7
33.2
57.8
34.5
60.6
29.6
61.9
65.1
33.5
59.2
63.3
29.8
52.4
60.8
52
4.8
4.9
28.5
9.5
7.1
14.6
6.8
5.5
84.2
61.4
72.0
88.3
85.8
90.9
57.7
30.2
28.1
40.0
12.7
24.1
8.6
47.5
41.7
93.3
62.1
62.6
62.8
59.3
68.5
57.7
62.4
57.7
54.7
55.0
0.4
1.4
4.3
2.1
6.1
8.5
5.4
12.7
5.6
6.6
9.8
5.4
88.1
80.1
96.9
96.1
87.9
85.6
95.4
97.4
48.3
33.3
73.6
24.7
22.1
29.0
40.5
44.5
38.6
41.9
2.0
13.4
69.0
66.6
98.3
892
592
60.9
50.4
55.6
30.4
63.3
58.5
58.0
45.1
52.8
10.6
57.6
5.1
22.4
6.3
4.8
3.1
5.2
15.0
13.8
142
12.8
6.8
12.1
11.3
4.0
5.9
10.8
37.9
4.5
96.5
75.6
79.1
83.7
96.6
97.9
94.2
862
91.7
89.7
96.9
97.5
85.6
43.6
34.3
36.7
73.6
30.2
71.6
36.8
15.6
23.6
73.0
70.2
252
52.6
53.3
31.9
19.8
2.3
76.9
59.1
54.7
71.5
83.8
98.5
Any
method
Any
modern
method5
Condom
Limiting
53.0
45.7
4.8
12.7
64.1
60.3
70.1
54.8
682
46.9
48.7
55.8
54.4
65.4
51.9
572
42.3
442
19.3
10.0
12.9
18.1
15.8
6.2
11.1
46.6
50.5
35.6
41.7
47.3
262
31.0
37.9
54.7
74.1
f
5
Include Female sterilization, Male sterilization. IUD, Pills or Condom.6 Women who were given their last live/still births during three years preceding the survey. 7Either
institutional delivery or home delivery assisted by Doctor/ANM/Nurse.
/.
* &
I
f
’
...
V It V V <6 v
+ + + <4 to <6 Q
Annexure B
/
il
t
.
j
•
• eoa a ooo t
/
t t V V v t
key indicators contd.
District Level Household Survey (2002*04) & Facility Survey (2003) - Reproductive & Child Health
Immunizafion8
State/ Union territory
India
North
Delhi
Haryana
Himachal Pradesh
Jammu & Kashmir
Punjab
Rajasthan
Uttaranchal
Central
Chhatishgarh
Madhya Pradesh
Uttar Pradesh
East
Bihar
Jharkhand
Orissa
West Bengal
Northeast
Arunachal Pradesh
Assam
Manipur
Megahalaya
Mizoram
Nagaland
Sikkim
Tripura
West
Goa
Gujarat
Maharashtra
South
Andhra Pradesh
Karnataka
Kerala
Tamil Nadu
Union Territory
A & Nicobar islands
Chandigarh
Dadra & Nagar Haveli
Daman & Diu
Lakshadweep
Pondichhery
Ranking
of the
state10
DPT 3
infections
Measles
Full9
Percent
received
ORS
59.0
58.0
47.6
29.7
71.1
75.7
91.2
48.1
82.8
36.4
57.7
76.4
69.2
89.7
83.0
79.1
36.8
56.9
61.0
62.9
79.4
38.6
75.3
25.4
472
37.6
32.1
50.9
69.5
26.2
29.4
21.4
10
21
5
8
7
31
70.5
43.9
37.9
70.2
50.1
37.7
60.9
32.5
28.1
422
25.7
15.5
35.0
39.3
70.0
69.8
28.2
34.5
69.9
67.6
24.4
29.3
55.1
54.4
36.0
39.5
48.8
312
48.7
32.5
74.0
47.9
39.3
39.1
55.6
30.3
61.6
40.2
82.6
44.7
87.7
68.9
88.5
Percent of PHC adequately equipped
Infrastru
cture11
Staff12
Supply11
Equipment11
Training11
EO
care
Kit13
31.8
4316
39.9
41.4
19.9
32.2
60.0
54.6
39.7
31.4
40.8
332
27.8
60.0
59.3
29.9
27.8
57.4
28.0
40.5
80.0
462
442
28.6
43.7
692
23.6
80.0
42.7
40.3
43.7
53.9
27.1
0.0
50.4
20.1
30.3
19.7
14.8
7.6
20.0
282
25.1
12.4
36.6
36.1
132
25
28
33
2.8
9.9
172
26.7
34.7
472
14.1
32.0
19.5
8:8
262
28.6
3.8
11.4
12.4
50.6
32.6
22.1
142
25.1
48.4
44.0
35
32
23
20
8.9
9.8
3.2
12.0
17.4
26.9
5.2
23.2
11.4
50.5
3.5
23.0
62
21.4
15.1
8.6
15.5
42.5
13.4
9.1
28.4
24.9
10.3
10.0
22.5
19.3
37.0
14.1
35.3
14.4
502
26.7
51.8
45.1
63.4
.45.5
61.6
32.8
48.0
53.7
29
27
26
34
22
30
11
19
70.7
21.0
12.5
56.0
70.4
59.5
100.0
100.0
43.8
27.5
64.0
58.3
55.7
50.0
62.5
56.6
31.7
50.0
56.3
60.0
44.4
59.5
45.8
100.0
26.8
32.4
28.1
68.0
96.3
40.5
100.0
81.8
19.5
29.7
37.5
56.0
59.3
18.9
67.7
100.0
36.6
38.6
46.9
44.0
59.3
48.6
12.5
81.8
93.1
69.4
88.0
81.5
57.7
74.3
74.6
24.4
42.0
9
18
12
100.0
89.0
76.5
88.2
76.3
78.4
58.8
83.4
67.4
882
80.6
91.4
64.7
17.1
31.9
58.8
71.3
48.7
78.7
84.5
90.7
96.8
74.4
80.4
90.0
95.7
62.9
74.1
81.2
92.1
58.6
32.7
54.2
35.8
13
15
1
4
592
58.1
42.9
64.7
64.8
37.3
49.8
72.9
40.3
88.9
55.7
77.8
84.5
61.1
34.3
92.2
34.5
23.1
18.6
27.7
34.5
76.5
32.9
14.4
86.3
78.6
92.1
77.7
86.9
93.8
90.4
79.0
87.0
78.6
91.8
95.8
47.7
53.3
85.2
57.3
67.6
89.4
81.9
46.6
54.3
28.4
72.6
47.7
3
6
16
14
17
2
100.0
50.0
83.3
100.0
100.0
57.9
52.9
0.0
100.0
100.0
75.0
21.1
52.9
50.0
100.0
66.7
75.0
632
76.5
0.0
83.3
66.7
100.0
68.4
47.1
0.0
16.6
0.0
50.0
21.1
64.7
0.0
100.0
100.0
100.0
73.7
21
412
.
fl’uT k?1*
,'vin9 children (age 12-35 months) born during three years prior to the survey.9 BCG+3 DPT injection+ 3 Polio drops+ Measles. io
Based on 10 RCH indicators.
Having at least 60 percent of critical input (based on Phase-2 only). ,2Having at least 60 percent of staff (base on Phasel and Phase2). 131Essential
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obstetric care kit
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