Drugs and Cosmetics (Eleventh Amendment) Rules, 2019

Jul 18, 2019 | by Avantis RegTech Legal Research Team


The Ministry of Health and Family Welfare (MoHFW) on July 17, 2019, in consultation with the Drugs Technical Advisory Board has published the Drugs and Cosmetics (Eleventh Amendment) Rules, 2019 to further amend the Drugs and Cosmetics Rules, 1945. It will come into force on the date of its publication in the Official Gazette.

The amendments made in the Drugs and Cosmetics Rules, 1945 are:

 A new Rules 77 and 83 has been inserted specifying duration of license and loan license where a license issued in Form 28, Form 28B and Form 28D shall remain valid, if the licensee deposits a license retention fee before the expiry of period of every succeeding five years from the date of its issue, unless it is suspended or cancelled by the licensing authority.

 The FORM 33 has been omitted and a new Form 32A has been substituted.

 The Rule 150J which talks about renewal of certificates has been omitted.

 Amendments are made in Schedule A, in Form 24C, Form 26J and Form 37.

[Notification No. G.S.R. 499(E)]


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