Drugs and Cosmetics (Eighth Amendment) Rules, 2019

Mar 19, 2019 | by Avantis RegTech Legal Research Team


The Ministry of Health and Family Welfare (MoHFW) on March 18, 2019, after consultation with the Drugs Technical Advisory Board, has published the Drugs and Cosmetics (Eighth Amendment) Rules, 2019 to further amend the Drugs and Cosmetics Rules, 1945. It will come into force on March 19, 2019.

•The Amendment Rule amends the heading of PART XV(A) of the Drugs and Cosmetics Rules, 1945, which specifies:

“Approval of institutions for carrying out tests on drugs, cosmetics and  raw materials used in their manufacture on behalf of licensees for manufacture for sale of drugs or cosmetics or an individual or organisation or procurement agency.”

•The Amendment Rule amends Rule 150B(1) of the Rules 1945 as follows:

“Application for grant or renewal of approval for carrying out tests for identity, purity, quality and strength of drugs or cosmetics or the raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs and cosmetics or an individual or organisation or procurement agency shall be made in Form 36 to the Licensing Authority appointed by the State Government”

•The Amended Rules have also inserted a few words in Rule 150C(1) whereby:

“Approval for carrying out such tests of identity, purity, quality and strength of drugs or cosmetics as may be required under the provisions of these rules, on behalf of a licensee for the manufacture of drugs or cosmetics or an individual or organisation or procurement agency shall be granted in Form 37”

•The Amended Rules amends Rule 150E(f) namely: 

“The approved institution shall furnish reports of the results of test or analysis on the samples received from manufacturer in Form 39 and from an individual or organisation or procurement agency in Form 39A.”

•The Amended Rules also inserted a new Form 39A which specifies report of test or analysis by approved institution for an Individual or Organisation or Procurement agency.

[Notification No. G.S.R. 223(E)]

Click here to download the Notification.

 

 


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