Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:
(a) whether it is mandatory for a drug manufacturer to provide drug literature along with their products and if so, the details thereof;
(b) whether the Government is aware of the fact that drug manufacturers have stopped providing drug literature along with their products and if so, the details thereof; and
(c) the action taken by the Government in this regard?:
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): Yes, Madam. As per Schedule Y of Drugs and Cosmetics Act, 1940 and Rules, 1945, manufacturer of new drug is required to submit product literature as a part of new drug application for marketing. The drafts of label and carton texts should comply with the provisions of Rules, 96 and 97.
(b): No incidence of not providing product literature with their product has been reported to Central Drugs Standard Control Organization (CDSCO).
(c): In view of reply to (b) above, does not arise.
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