Drugs Marketers to be held liable for quality of drugs and other regulatory non-compliances followed by manufacturer

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The Ministry of Health and Family Welfare vide its notification dated 11th February, 2020, notifies the Drugs and Cosmetics (Amendment) Rules, 2020 to further amend the Drugs and Cosmetics Rules, 1945.

Key Highlights of the amendment:

  • Under Rule 2 which specifies Definitions in which Clause (ea) has been inserted and existing clauses (ea) and (eb) has been re-numbered as clauses (eb) and (ec)
  •  The amendment defines the term “Marketer”. under the definition clause in Rule 2, sub-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”.
  • Further the agreement for marketing and the Responsibility of marketer of the drugs has been inserted through this Amendment  
  • Under Rule 96(1) which specifies the manner of labeling, sub-clause (Xiii) has been inserted, namely which provides that the drug packet shall contain, The name of the marketer of the drug and 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 in the package.

Click here to read the Notification.

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