Drug marketers to take onus for quality of drugs, regulatory compliance: Health Ministry Gazette

New Delhi: Through a recent gazette notification, the Union Health Ministry has amended the Drugs and Cosmetics Rules, 1945, wherein, drug marketers along with the manufacturers will be equally responsible for the quality, efficacy and other regulatory compliance for the drugs sold or distributed by them. This will come into effect from March 1 2021.

The move calls for equal distribution of the responsibilities right from its manufacture, market and sale till the time it reached the public; both the manufacture and the marketer will be accountable for the quality of drugs. Moreover, the name of the marketer has to be shown on the container.

Prior to the amendment, the Health Ministry had circulated a draft of the same in the public domain, seeking suggestions and objections. Objections and suggestions were received and considered by the Government.

Also Read: Drug Marketers As Liable As Drug Manufacturers For Quality, Efficacy, Regulatory Compliance: Health Ministry Issues Draft

Thereafter, in exercise of the powers conferred under sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board (DTAB) made certain amends to the Drugs and Cosmetics Rules, 1945. The amendments broaden the onus of manufacturing and distributing drugs by setting transparency via clear mention of the individual's name on the drug distributed. In this regard, a revised definition of "Marketer" has been inserted in the said rule as;

'(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 the marketing of such drug by labelling or affixing his name on the label of the drug with a view for its sale and distribution;

The gazette notification further mentions about another integral amendment that holds drug marketer responsible for the quality of drugs they distribute. For this, ' Agreement for marketing' after rule 84C has been inserted in the said rule that read;

"84D. Agreement for marketing.- No marketer shall adopt any drug manufactured by another manufacturer for the marketing of such drug by labelling 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.

84E. Responsibility of marketer of the drugs.- Any marketer who sells or distributes any drug shall be responsible for the quality of that drug as well as other regulatory compliances along with the manufacturer under these rules.".

Further, in rule 96, after sub-clause (xii) of clause (1), the following sub-clause shall be inserted, namely:―

"(xiii) 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.".

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