Draft of Drugs and Cosmetics (Fourth Amendment) Rules, 2019.

Feb 27, 2019 | by Avantis RegTech Legal Research Team

Ministry of Health and Family Welfare (MoHFW) on February 26, 2019, has passed a draft Notification to further amend the Drugs and Cosmetics Rules, 1945, and the new rules may be called as Drugs and Cosmetics (Fourth Amendment) Rules, 2019. It will come into force on the date of their publication in the Official Gazette.

This Notification brought changes in Schedule H, paragraph 5 has been inserted, namely:

  “ Notwithstanding anything contained in these rules, the provisions of rule 65 and rule 97 in respect of drugs specified from serial number 538 to serial number 551 inserted vide Notification number G.S.R. 277(E), dated 23rd March, 2018 published in the Gazette of India, Extraordinary, Part II, Section (3), Sub-section (i) shall be on voluntary basis for a period commencing on the day on which this notification shall come into force and ending on the 31st March, 2019 and thereafter shall be mandatory.”

[Notification No.: G.S.R. 153(E).]


URL: http://egazette.nic.in/WriteReadData/2019/198790.pdf


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