MoHFW notifies the Drugs and Cosmetics (Amendment) Rules, 2020

Feb 13, 2020 | by Avantis RegTech Legal Research Team

Industry Specific Compliance

The Ministry of Health and Family Welfare (MoHFW) on February 11, 2020, notifies the Drugs and Cosmetics (Amendment) Rules, 2020 to further amend the Drugs and Cosmetics Rules, 1945.

The amendments are as under:

 Under Rule 2 which specifies Definitions:

Clause (ea) has been inserted and existing clauses (ea) and (eb) has been re-numbered as clauses (eb) and (ec):

Clause (ea): “Marketer” means a person who as an agent or in any other capacity adopts any drug manufactured by another manufacturer under an agreement for marketing of such drug by labeling or affixing his name on the label of the drug with a view for its sale and distribution.

 Insertion of Rules:

i. Rule 84D - Agreement for marketing

ii. Rule 84E - Responsibility of marketer of the drugs

 Under Rule 96(1) which specifies the manner of labelling, sub-clause (Xiii) has been inserted, namely:

The name of the marketer of the drug and its address, in case the drug is marketed by a marketer:

Provided that if the drug is contained in an ampoule or a similar small container, it shall be enough if only the name of the marketer is shown.

They will come into force on March 01, 2021.

[Notification No. G.S.R. 101 (E)]


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