Drugs and Cosmetics (Thirteenth Amendment) Rules, 2019

Nov 11, 2019 | by Avantis RegTech Legal Research Team


Industry Specific Compliance

The Ministry of Health and Family Welfare (MoHFW) on November 06, 2019, notifies the Drugs and Cosmetics (Thirteenth Amendment) Rules, 2019 to further amend the Drugs and Cosmetics Rules, 1945. This Notification shall be effective from November 06, 2019.

The amendments are made in Rule 71 (Conditions for the grant or renewal of a licence in Form 25 or Form 25-F); Rule 71A (Conditions for the grant or renewal of a licence in Form 25-B); Rule 71B (Conditions for the grant or renewal of a licence in Form 25-A), Rule 76 (Forms of licences to manufacture drugs specified in Schedules C and C(1), excluding those specified in Part X-B and Schedule X, or drugs specified in Schedules C, C(1) and X and the conditions for the grant or renewal of such licences); Rule 76A (Forms of loan licenses to manufacture for sale or for distribution drugs specified in Schedule C and C1 excluding drugs specified in Schedule X or of Large Volume Parenterals, Sera and Vaccine and recombinant DNA (r-DNA) derived drugs, and conditions for the grant or renewal of such license) of the Drugs and Cosmetics Rules, 1945 under which a proviso has been inserted, namely:-

“In case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking in Form 51 to the licensing authority to the effect that to the best of his knowledge based on search in trade marks registry, central data base for brand name or trade name of drugs maintained by Central Drugs Standard Control Organisation, literature and reference books on details of drug formulations in India, and internet, such or similar brand name or trade name is not already in existence with respect to any drug in the country and the proposed brand name or trade name shall not lead to any confusion or deception in the market.”

In Schedule A, a new Form 51 related to “Form of undertaking to the licensing authority for marketing a drug under a brand name or trade name” has been inserted.

[Notification No. G.S.R. 828(E)]


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