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Labelling Norms Forgeneric Drugs

Writer's picture: Sanjay TrivediSanjay Trivedi

In order to ensure that the consumer is well informed about the generic medicine, Ministry of Health & Family Welfare published a draft notification for public comments vide GSR 302 (E) dated 30.03.2017 for amendment of Rule 96 to provide that the proper name of the drugs shall be printed in a conspicuous manner which shall be in the same font but at level two font size larger than the brand name or the trade name, if any. It will come to force after completion of due formalities as per the provisions of the Drugs & Cosmetics Act, 1940.

Indian Drug Manufacturers Association (IDMA) was invited to the stakeholders meeting held on 12.12.2017 in Central Drugs Standard Control Organisation (CDSCO) and they conveyed their inability to attend the meeting. However, they had already provided their suggestions/ comments on the draft notification vide letter dated, 11.05.2017 which has been received in the Ministry. The Minister of State (Health and Family Welfare), Sh Ashwini Kumar Choubey stated this in a written reply in the Lok Sabha.

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