The Ministry of Health and Family Welfare has, in a Notification dated 11th February, 2020, issued the Drugs and Cosmetics (Amendment) Rules, 2020 (“Amendment Rules”), to amend the Drugs and Cosmetics Rules, 1945 (“Principal Rules”) effective 1st March, 2021.
The Amendment Rules propose to insert the definition of “Marketer” under Rule 2 of the Principal Rules and also new provisions relating to marketing of drugs.
Key Highlights:
- “Marketer” has been proposed to be defined as follows:
“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
- A marketer will be allowed to market any drug manufactured by another manufacturer, by labeling or affixing his name on the label of the drug with a view for its sale and distribution, only under an agreement with such manufacturer
- A marketer, selling or distributing any drug, will be held responsible for the quality of that drug as well as other regulatory compliances, along with the manufacturer of the drug
- In case a drug is marketed by a marketer, besides the details prescribed under the Principal Rules, the name of the marketer of the drug and its address also have to be either printed or written in indelible ink, in a conspicuous manner, on the label of the innermost container of the drug and on every other covering in which the container is packed
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.
Source: Ministry of Health and Family Welfare
