Ensuring abundant availability of good quality of drugs and pharmaceuticals at reasonable prices within the country.
Objectives
The
main objectives of the Pharmaceutical Policy-2002 are:
(i) Ensuring
abundant availability of good quality of drugs and pharmaceuticals at
reasonable prices within the country.
(ii) Strengthening the capabilities for cost effective
production of quality drugs.
(iii)
Creating an encouraging environment and a good network for introduction of new
drugs and technologies by ensuring new investments in Indian pharmaceutical
industry.
(iv) Encouraging
export of drugs/drug formulations by reducing barriers to the trade in
pharmaceutical sector.
(v) Promoting rational use of pharmaceuticals.
(vi) Strengthening
the system of quality control of drugs and pharmaceuticals
(vii) Encouraging
R&D ventures in pharmaceutical sector especially, with focus on diseases
endemic or relevant to India.
The
Pharmaceutical Research and Development Committee (PRDC) was constituted in
1999 under the Chairmanship of Director General of CSIR to make recommendations
for strengthening research and development in pharmaceutical industry and to
identify areas where Government support is required for domestic R&D
efforts. The PRDC suggested following conditions (Gold Standards).
(i) Investment of 5%
turnover of industrial production in R&D
(ii) Employment of
atleast 100 research scientists in R&D in India.
(iii) Investment of
atleast Rs. 10 crore per annum in innovative research in India including, new
drug development, new delivery systems, etc.
(iv) A minimum of 10 patents for research done in India.
(v) Facilities for Own and Operate Manufacturing in India.
(vi) Establishment
of a Drug Development Promotion Foundation (DDPF) and Pharmaceutical Research
and Development Support Foundation (PRDSF)
A Committee called
the Drugs Price Control Review Committee (DPCRC) under the Chairmanship of the
Secretary, Department of Chemicals and Petrochemicals was set up in 1999. The
recommendations in the report of this Committee have been examined while
formulating "Pharmaceutical Policy-2002".
Keeping
in view the interest of the weaker sections of the society, Government reserves
the right of intervening in cases where prices behave abnormally.
The
Central Government has taken following important decisions -
1.
Industrial licencing for all bulk drugs cleared by Drugs
Controller General ofIndia shall be abolished except, for bulk drugs produced
by recombinant DNA technology and bulk drugs requiring in-vivo use of nucleic acids.
2.
Foreign investment upto 100% will be permitted, subject to
stipulations laid down in Industrial Policy.
3.
Imports of drugs and pharmaceuticals will be as per the EXIM
policy in force.
4.
Liberalized approval policy for foreign technology
agreements.
5.
Establishment of Pharmaceutical Research and Development
Support Fund (PRDSF) under the control of DST.
6.
Constitution of Drug Development Promotion Board to
administer utilization of PRDSF.
7.
Provision of fiscal incentives to promote indigenous R&D
efforts.
8.
279 items appearing in National Essential Drug List, 1996 of
Ministry of Health and Family Welfare and other 173 items considered important
by the same ministry in various health programmes, emergency care, etc. shall
be for price regulation. The ORG-MARG data shall be the basis for determining
the span of price control as suggested by Drugs Price Control Review Committee
(DPCRC)
9.
Bulk drugs shall be under price regulation if-
(a) Moving Annual Total
(MAT) value for the drug is more than Rs. 25 crores and percentage share is 50%
or more (b) The total MAT value for a particular drug is less than Rs. 25 crore
but more than Rs. 10 crore and percentage share is 90% or more.
10. Maximum Allowable
Post-manufacturing Expenses (MAPE) will be 100% for indigenously manufactured
formulations.
11. For imported
formulations, the margin covering selling and distribution expenses including
interest and importers' profit shall not be more than 50% of the landed cost.
12. The time frame of
two months from the date of the receipt of complete prescribed information for
granting price approvals shall be fixed.
13. Ceiling prices of
any formulation may be fixed which will be obligatory for all to follow.
14. A new drug developed
through indigenous R&D efforts would be exempted from price control for 15
years.
15. A formulation
involving a new delivery system developed through indigenous R&D and
patented shall be exempted from price control till the expiry of the patent.
16. The NPPA (National
Pharmaceutical Pricing Authority) will be authorized to exempt such formulation
from price control, if its cost to consumer-patient does not exceed Rs. two per
day.
17. The NPPA will be
revamped and reoriented to monitor prices of decontrolled drugs and
formulations and over-see implementation of DPCO.
18. It shall be mandatory
for manufacturer to furnish alI information called by NPPA.
19. The Government's
endeavor will be to upgrade the standards of pharmacy education and R&D
through NIPER (National Institute of Pharmaceutical Education Research),
Mohali, Punjab.
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