The union Health and Family Welfare Ministry has come out with a notification on implementation of Drugs and Cosmetics (Amendment) Rules, 2020, which holds marketers along with the manufacturers responsible for ensuring quality and regulatory compliances of the marketed drugs in the country.1
Background
The Ministry of Union Health and Family Welfare, on February 13, 2020, issued a notification where shall be replaced as clause (eb) containing definition of "Marketer" which 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.
Apart from this amendment, after Rule 83C Rule 84D and Rule 84E have been inserted in Drugs and Cosmetics Rules, 1945, to define agreement for marketing and responsibility of marketer of the drugs respectively.
The newly inserted Rule 84D containing agreement for marketing states that no marketer shall adopt any drug manufactured by another manufacturer 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 without an agreement as referred to in clause (ea) of Rule 2. The other rule 84E comprising of responsibility of marketer of the drugs states that "any marketer who sells or distributes any drug shall be responsible for quality of that drug as well as other regulatory compliances along with the manufacturer under these rules."
Sub-clause (xiii) shall be inserted after sub-clause (xii) of clause (1) in Rule 96 of Drugs and Cosmetics Rules stating that a drug pack shall contain the name of the marketer of the drug and its address, in case the drug is marketed by a marketer. 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.
Note: This amended rule is known as the Drugs and Cosmetics (Amendment) Rules, 2020 and shall come into force on the 1st day of March 2021.
Conclusion
The recent amendment in the Drug and Cosmetic Act shall will prevent pharmaceutical companies from marketing drugs manufactured by another pharmaceutical company by labeling their own company name, hence preventing drug duplication. This will help in selling the original product to the public and will prevent serious adverse events associated with drug duplication.
Footnotes
Originally published 28 April, 2020
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