Question : Generic Drugs

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

(a) whether the Government has received proposal for the review of Drug Policy for the conservation of Indian Pharmaceutical industry and to increase the production of generic medicines;

(b) if so, the details thereof and the reaction of the Government thereto;

(c) whether the Government is contemplating to make the compulsory licensing of patent drugs flexible in the country for cheaper generic medicines; and

(d) if so, the time by which the patent drugs and cheaper generic medicines would be made available to the general public?

MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS; MINISTRY OF SHIPPING AND MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

(a): No, Madam.
(b): In view of reply to (a) above, does not arise.
(c): No, Madam.
(d): In view of reply to (c) above, does not arise. Further, the Drug (Prices Control) Order, 2013 does not distinguish between patented and generic/branded medicines. However, para 32 (i) of this order exempts patented products from price control for a period of five years, if the product has a patent in India and not produced elsewhere, and if it has been developed through indigenous research and development. The same therapeutic category of generic medicines is already available to the Indian Public cheaper in comparison to the patented drugs.
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