DTMT Network
From March 1, 2021, 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 the newly amended Drugs and Cosmetics Rules.

The amended rules, known as Drugs and Cosmetics (Amendment) Rules, 2020, will come into force from March 1, 2021, reads a Gazette Notification issued by the Union Health Ministry on February 11, 2020.

Presently, marketing companies are not held responsible for any defect in drug quality. The onus of ensuring drug quality solely falls on drug manufacturers.

In the notification, the ministry has also defined the marketer. Under the new rules, 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.

The rules further read 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.