Indigenous and Other Systems of Medicines
21. Various aspects relating to development and promotion
of Ayurvedic, Unani, Sidha, Homeopathic and traditional systems of
medicines would be actively pursued and the machinery for carrying out
these tasks would be adequately strengthened. To provide better focus to
this important work it is felt that there is need to create a separate
Department, to look after all matters relating to development and
promotion of these systems of medicines.
Decisions in regard to Modification in Drug
decided to modify the Drug Policy, 1986 as follows :
Para 22.1.1 Industrial
Licensing for all bulk drugs cleared by Drug Controller (India) and all
their intermediates will be abolished, except in the cases of
(i) 5 identified
bulk drugs which are to continue to be exclusively reserved for the Public
Sector as mentioned in Para 22.3 below,
(ii) bulk drugs produced by the
use of recombinant DNA technology, and
(iii)bulk drugs requiring
in-vivo use of nucleic acids as the active principles.
stipulating mandatory supply of a percentage of bulk drug production to
Non-associated Formulators will be abolished.
shall be abolished for formulations except in cases of specific
cell/tissue targeted formulations.
parameters linking bulk drugs and formulations production and limiting the
use of imported bulk drugs will stand abolished.
locational restrictions and grant of COB licenses will be in accordance
with the Industrial Policy.
of information prescribed by the Department of Industrial Development
shall include an Addendum, to meet the additional requirement of the Drugs
& Pharmaceuticals industry, as would be devised by the Department of
Chemicals and Petrochemicals.)
22.2 BASIC STAGE
manufacture from the basic stages and arresting the regression towards
manufacturing from later stage intermediates/penultimates, the tariff
mechanism would be utilized. Imports of critical
intermediates/penultimates may also be put in the negative list so as to
arrest regression from basic stage manufacturing.
22.4.1 Investment upto 51 per cent will be permitted in the
case of all bulk drugs, their intermediates and formulations.
22.4.2 Investment above 51 per cent will be considered
on a case by case basis in areas where investment is otherwise not
forthcoming, particularly in the manufacture of bulk drugs from basic
stages and their intermediates, and bulk drugs produced by the use of
recombinant DNA technology as well as the specific cell/tissue targeted
22.5 FOREIGN TECHNOLOGY
approval for foreign technology agreements shall be given in the case of
all bulk drugs, their intermediates and formulations except those produced
by the use of recombinant DNA technology, for which the existing procedure
22.6 ENCOURAGEMENT TO
RESEARCH & DEVELOPMENT (R&D) EFFORTS
22.6.1 A new drug which has not been produced elsewhere,
if developed through indigenous R&D would be put outside price control
for a period of 10 years from the date of commercial production in favor
of the Company who undertook the R&D.
22.6.2 The Department of Chemicals Petrochemicals would
set up an Inter-Ministerial group to decide, within a set time frame, on
measures to give further impetus to R&D in the Drug Sector.
Ministry of Health and Family Welfare would further streamline the
required procedures and steps for the quick evaluation and clearance
of new drug applications, specially those developed through indigenous