Meeting of the State Health Secretaries
11th and 12th September 2012
Vigyan Bhavan
Structure of Presentation
• ‘Initiative’ for Free Essential Drugs at Public
Health Facilities – New Scheme
• Strengthening of the Drugs Regulatory
Mechanism :» Central Level – Ongoing
» State Level – New Scheme
• Clinical Establishment Act
Free Drugs at Public Health Facilities – New
• Rationale
 India has one of the highest figures for out of pocket (OOP)
expenditure as a proportion of total health expenditure.
 The Planning Commission too accepts that OOP to pay for
healthcare costs is a growing problem in India. It says 39 million
Indians are pushed to poverty because of ill health every year.
 The WHO's World Health Statistics 2012, , states that almost 60%
of total health expenditure in India was paid by the common man
from his own pocket in 2009.
Free Drugs at Public Health Facilities – New
 Rationale ( contd.)
 In Nepal's OOP health expenditure stands at (49%), Sri Lanka
(44%), Indonesia (41%), Maldives (28%), Thailand (15%) and
Bhutan (13%).
 In comparison, only 7% of France total health expenditure in 2009
was OOP, the Netherlands (6%), Monaco (7%), the UK (10%),
Ireland (12%), Denmark and Germany (13%), Norway (15%),
Sweden (17%) and Italy (20%).
 The WHO had earlier said that 3.2% Indians would fall below the
poverty line because of high medical bills with about 70% of Indians
spending their entire income on healthcare and purchasing drugs.
Free Drugs at Public Health Facilities – New
• Present Scenario
• MoHFW is procuring and supplying drugs ( RCH, TB and
• Funds are made available to the States under NRHM for
procurement of drugs
• States procure drugs out of their own funds
• Some States like Tamil Nadu, Rajasthan etc have a Free
Drugs Scheme for those who seek care in PHFs
Free Drugs at Public Health Facilities – New
• The
High Level Expert Group report on
Universal Health Coverage instituted by the
Planning Commission of India states, "We
estimate that an increase in the public
procurement of medicines from around 0.1% to
0.5% of GDP would ensure universal access to
essential drugs, greatly reduce the burden on
private out-of-pocket expenditures and increase
the financial protection for households."
Free Drugs at Public Health Facilities – New
The Model
• To adapt the Tamil Nadu Govt.’s model of bulk purchase of drugs
from the manufacturers based on Essential Drugs List and to supply
free medicines to patients who seek care in PHF’s
• The Central share required for free supply of medicines to be would
be Rs 20000 crore. The sharing pattern under NRHM between
Centre and States would be followed.
• States would be advised to set up TNMSC like institutions for
procurement of free medicines under generic names for free supply
at the Public Health Facilities.
• States shall have to contribute their share for supply of free
medicines up-front
• One time Capital Cost of warehouse/IT systems to be borne by the
• The ‘Initiative’ articulates a transparent procurement
system to bring in efficiency gains and also to
ensure purchase of quality essential medicines at
competitive price.
• All procurement shall follow a two-stage process of
technical pre-qualification and price bid.
• All manufacturers shortlisted for medical supplies will
need to have GMP certificate, minimum annual
turnover and market standing certificate.
Procurement (contd)
• The suppliers should not have been black listed
earlier for quality failure.
• It is also proposed to have a quality reporting system
to test quality, safety and efficacy of medicines.
• Procurement to be made directly from the
manufacturers and supplied through an IT enabled
supply chain management system to the public
through district warehouses.
Critical Interventions
 States to put in place mechanisms for Rational Use of
Drugs through generic prescription and following STGs.
 States need to have an EDL.
 States will follow Standard Treatment Guidelines.
 IEC to create awareness about the Initiative
 Capacity building of the Officials.
Monitoring and Social Audit
Oversight of Rogi Kalyan Samitis.
States to conduct independent sample surveys.
For subsequent release of funds, utilization certificates would be
required along with audit reports.
Displaying names of medicines available ( Local Language)
along with contact details of the Nodal Person
Maintenance of a facility based Complaint/Suggestion Register
to be audited by the Head of that facility periodically.
Information Required from States
• State/UT Governments were requested to provide data regarding
budgeted amounts for free supply of drugs and expenditure made
out of that amount.
• State/UT Governments of Bihar, Maharashtra, Karnataka, Manipur,
Meghalaya, Lakshadweep, Punjab, Delhi, Uttar Pradesh, Jammu
and Kashmir, Arunachal Pradesh, Daman & Diu and Jharkhand
have not responded.
• Responses received from State/UT Governments of Andaman &
Nicobar Islands, Uttrakhand, Andhra Pradesh, Himachal Pradesh,
Mizoram, Sikkim, Chandigarh, Chattisgarh and Madhya Pradesh are
not in the format.
Per Capita Expenditure on Drugs by
12 States/UTs
Per capita Expenditure (in Rs.)
13.72 12.46
Per capita Expenditure (in Rs.)
Per capita Expenditure
(in Rs.)
Strengthening Drugs Regulation
Challenges– Centre and the States
The Drugs Regulatory Mechanism at the Centre and in the States regulates a
Rs.1.3 lakh crore drug industry, Blood Banks and Clinical Trials. There are
several implementation challenges which need to be overcome by :-
Strengthening manpower at the Centre and the State level.
Strengthening infrastructure at the Centre and the State level
Reviving non operational / partly operational testing facilities at the
State level
Providing training to enforcement officials
Creating data base on Drug Regulation
Introducing IT enabled services.
Strengthening Drugs Regulation Challenges–
 Globalization has fundamentally changed the environment for
regulating drug products and created unique regulatory
challenges for CDSCO for the following reasons:
• More foreign manufacturing facilities supplying bulk
Drugs, Medical Devices, Blood Products,
Diagnostics, Anti Cancer drugs to India.
• Increasing volume of imported Medicinal Products
• Greater complexity in supply chain
• Imports coming from countries with less developed
regulatory system
• Export of Medical Products from third countries with
“Made in India” tag to countries tarnishing image of
the Indian industry as well as the Regulator
• Track and trace technologies
Central Level - Strengthening of CDSCO (On
Manpower and Infrastructure
• Creation of additional posts to comply with the recommendations of Dr.
Mashelkar Committee Report (One Drugs Inspector for 50
manufacturing units and One Drugs Inspector for 200 sale premises)
• Setting up of new CDSCO offices
• Creation of new drugs testing labs., and upgradation of existing labs.
• Regulation of Clinical Trials
• Regulation of Medical Devices
Central Level - Strengthening of CDSCO (On
going): contd.
• Mobile Drugs Testing Labs to check spurious drugs
• Co-ordination with the Departments of Commerce and
Industrial Policy and Promotion
• Establishing an e-Governance system with IT Enabled
Services for Networking, Registration and Archiving
• Strengthening the Pharmacovigilance Programme of India to
capture Adverse Drugs Reactions
• New Drug/Medical Devices Advisory Committees to assist the
Strengthening of Drugs Regulatory System in
States – (New Scheme):
• States grant/renew drugs manufacturing licenses
• They have a major role in enforcement
• States have inadequate infrastructure, both physical
and human resource
• States have inadequate resources for strengthening
the Regulatory System
Strengthening of Drugs Regulatory System in
States – (New Scheme):
• Sharing intimation about sub-standard drugs with the
drugs controllers of other State/UTs.
• Regulatory oversight over manufacturing units.
• Regulatory oversight over retail sales shops selling
• Capacities of State Laboratories inadequate.
• Advertisements through media for both scheduled and
the prohibited drugs.
Strengthening of Drugs Regulatory System in
States – (New Scheme):
• Setting up of Designated Courts for speedy trials
(only 14 States/Uts – AP, Bihar, Delhi, J&K,
Karnataka, MP, Arunachal Pradesh, D&D, D&NH, Goa,
Meghalaya, Mizoram, Lakshadweep, Tripura have set
up such Courts)
• Licensing of FDCs and other new drugs without the
approval of the DCG(I)::Direction u/s 33 P of the Act
• Samples drawn by the States/UTs have remained
stagnant for the last few years @ 38000 – 40000
per annum.
Strengthening of Drugs Regulatory System in
States – (New Scheme): contd.
• Considering the above it is proposed to have a
Centrally Sponsored Scheme (CSS) to strengthen
the infrastructure both Physical And Human
Resource in the States.
• State/UT Governments have been requested to
provide data regarding availability of infrastructure
(manpower & physical) and state their requirements.
The Clinical Establishments
(Registration & Regulation)
Act, 2010
Clinical Establishment Act, 2010
• Passed by Parliament in August 2010 and notified on 1st
March, 2012
• National Council for Clinical Establishments notified on
19th March, 2012
• Central Rules notified on 23rd May, 2012 (Section 52)
• Model State Rules required under (Section 54) the Act
have been circulated among the States/UT’s
• The implementation of this Act is being monitored by the
PMO. Hon’ble Health Minister has requested the Chief
Ministers to adopt and implement the Act.
• States - Arunachal Pradesh, Himachal Pradesh,
Mizoram and Sikkim
• Union Territories - Andaman & Nicobar Islands,
Chandigarh, NCT of Delhi, Dadra & Nagar Haveli,
Daman & Diu, Lakshadweep, Puducherry
• States who have adopted the Act - Uttar Pradesh,
Rajasthan and Jharkhand
• Such other States which adopt this Act under
clause (1) of article 252 of the Constitution.
Salient Features & Benefits of the CEA 2010
• All clinical establishments - including diagnostic centres
and single doctor clinics, across all recognized systems
of medicine in both public and private sector. (exception:
establishments of the Defence Forces)
• Assist in compilation of reliable digital registry of all types
of CE at National, State and District level available in
public domain.
• Standard application form has been finalized for
provisional registration of clinical establishments to
ensure uniformity in information being collected.
• Assist government in obtaining information and data
required from clinical establishments for public health
• National Council,
participation and consultative process would classify
clinical establishments into different categories and
determine uniform minimum standards.
• Permanent registration would be undertaken after
categorization, classification and development of
minimum standards
• Provisional registration, through a process of self
declaration, without any inspection.
• Application for registration by post, in person or online
• Mandatory for every clinical establishment to provide
treatment “within the staff and facilities available” to
stabilize the emergency medical condition of any
individual brought to such establishment [Sec-12(2)]
• Establishment of multi stakeholder institutional bodies
1. National Council of Clinical Establishments
2. State Council / Union Territory Council of Clinical
3. District Registering Authority
• Contravention of any provision shall be punished
with monetary penalties
•Details of charges, facilities available would be
prominently displayed at a conspicuous place at
each establishment
• Cancellation of registration, would occur at any
time, if conditions for registration are not compiled
Ensure transparency through online system of registration and
information in the public domain
Financial Support
• Financial support proposed under NRHM
• Coordinators at State / UT & each District level
• Administrative Asst.-cum-DEO at State / UT &
each District level
• Computers and Printers
• Meetings of State / UT Councils & District
Registration Authorities
• Workshops - Dissemination and Capacity
• Operational Expenses at State and District
Action to be Taken
Where CEA 2010 is Applicable
• State Rules under Section 54 of the Act to be notified
• State / Union Territory Council of Clinical Establishments to
be notified
• District Registration Authorities in all districts to be notified
• Provisional registration to begin
• Nodal officer with a team at the state level to be notified for
the implementation of the Act
• Monthly progress report to the MOHFW on the status of the
implementation of the CEA 2010
Where CEA 2010 is presently Not
Adopt the CEA 2010 by passing a
resolution in the State assembly
States Having Legislation
Repeal the Existing Act and
Adopt the CEA 2010 by
passing a resolution in the
state assembly
Thank You