Drug marketers as liable as Drug Manufacturers for quality, efficacy, regulatory compliance: Health Ministry Issues Draft
New Delhi: Through a recent draft Gazette notification, the Ministry of Health and Family Welfare has informed that not just drugmakers but drug marketers too will be held accountable for the quality, efficacy and other regulatory compliance for the drugs sold or distributed by them. The notification also invites suggestions on the policy move adding that Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414A, D Wing, Nirman Bhavan, New Delhi - 110011 or emailed at firstname.lastname@example.org within 30 days of the publication. The notification was released on 24th June 2019
The Government has released a draft Gazette in this regard, that talks about the insertion of a clause related to the responsibility of marketer of the drugs, thereby amending the Drugs and Cosmetics Rules, 1945.
Providing an elaborated idea of the term Marketer, the notification talks about the addition of a definition for the said term in order to establish clarity of understanding wherein;
In the Drugs and Cosmetics Rules, 1945, in rule 2, (which talks about the "Definition");
- after clause (e), the following clause shall be inserted, namely:―
“(ea) ‘Marketer’ means a person who as an agent or in any other capacity adopts 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.”
After defining the term marketer, the gazette notification also fixed the responsibility of the marketer towards that drugs sold by them by inserting the following after the rule ule 84D in the Drugs and Cosmetics Rules, 1945,
“84E. Responsibility of marketer of the drugs: 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.”
Further, in rule 96, after sub-clause (xii) of clause (1), the following sub-clause shall be inserted, namely:―
“(xiii) (a) 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.”
The said draft rules will be taken into consideration on or after the expiry of a period of thirty days from the date on which copies of the Gazette of India containing these draft rules are made available to the public. Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government.
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414A, D Wing, Nirman Bhavan, New Delhi - 110011 or emailed at email@example.com.