The Ministry of health and family welfare vide notification dated 6th November 2019, has amended the Drugs and Cosmetics Rules. The amended rules shall be effective from 6th November 2019.
The Drug Controller General of India has directed all manufacturers Ap to submit a Form – 51 to the licensing authority for marketing a drug under a brand name or trade name clearly mentioning name of the drug, dosage form and composition along with an undertaking that the respective drug doesn’t bear name of similar brand names of any drug in the country to the best of their informed belief, and the proposed brand name or trade name of the respective company shall not lead to any confusion or deception in the market. Based on this the amendments are brought under the following sections:
- Rule 71(9) (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 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.
click here to read the Notification
