Ministry of Health and Family Welfare publishes Draft Drugs and Cosmetics (………. Amendment) Rules, 2018 for inviting Comments and Suggestions

Aug 31, 2018 | by Avantis RegTech Legal Research Team


The Central Government proposes to amend the Drugs and Cosmetics Rules, 1945, after consultation with the Drugs Technical Advisory Board. The draft Rules, on August 27, 2018, are published for information of all persons likely to be affected thereby, and notice is given that said draft rules will be taken into consideration on or after the expiry of a period of 45 days from the date on which copies of the Gazette of India containing these draft rules are made available to the public.

In the Drugs and Cosmetics Rules, 1945, in Schedule A,

·         in Form 45, which is a form for obtaining permission to import Finished Formulation of the New Drug, in the condition at serial number (8), at the end the following words shall be inserted, namely:-

“Each saleable unit of the new drug shall accompany by the package insert for providing to the consumer.”;

·         in Form 46, which is a form for obtaining permission / approval for manufacture of new drug formulation, in the condition at serial number (8), at the end the following words shall be inserted, namely:-

“Each saleable unit of the new drug shall accompany by the package insert for providing to the consumer.”.

The amendment rules are proposed to come into force on January 01, 2019.

Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government. Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi - 110011 or emailed at [email protected]. 

[G.S.R. 813(E)]

URL: http://www.egazette.nic.in/WriteReadData/2018/188943.pdf


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