Drugs and Cosmetics (Third Amendment) Rules, 2019

Jan 29, 2019 | by Avantis RegTech Legal Research Team

The Department of Health and Family Welfare on January 25, 2019 has published the Drugs and Cosmetics (Third Amendment) Rules, 2019 to add serial number 38 regarding sterile solutions intended for parenteral administration in Schedule K of Drugs and Cosmetics Rules, 1945.

In Schedule K which specifies the class of drugs, after serial number 37 and the entries relating thereto, the following serial number and entries shall be inserted, namely:

Class of Drugs

Extent and Conditions of Exemption

“38. Sterile solutions intended for parenteral administration with 100 ml in one container of the finished dosage form for single use manufactured for export only.

The provisions of Chapter IV of the Act and rules made thereunder which require them to obtain a licence in Form 28D or 28DA from the Central Licence Approving Authority subject to the condition that such drugs have been manufactured for export purpose only under a licence granted by the State Licensing Authority.”.


The Rules shall come into force on the date of their publication in the Official Gazette.

[Notification No. G.S.R. 47(E)]

URL: http://egazette.nic.in/WriteReadData/2019/196180.pdf



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