In a Notification dated 24th June, 2019, the Ministry of Health and Family Welfare (“Ministry”) has published the Draft Drugs and Cosmetics (…. Amendment) Rules, 2019 (“Draft Rules”) proposing to amend the existing provisions of the Drugs and Cosmetics Rules, 1945 (“Rules”).
The Draft Rules proposes to bring in a ‘Marketer’ of drugs within the purview of the Rules and also proposes to hold a marketer of a drug equally responsible as a manufacturer of a drug.
The Ministry has invited objections and suggestions, if any, on the Draft Rules and the same may be addressed to the “Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110 011 or emailed at drugsdiv-mohfw@gov.in” by 24th July, 2019.
Key Highlights-
- The Draft Rules proposes to define a “Marketer” under the definition clause in Rule 2, sub-clause (e)
‘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.” The proposed insertion will make a marketer equally responsible as a manufacturer for the quality of the drug that is sold is distributed.
- A new clause, namely Rule 84E under the Rules will soon be inserted to make a Marketer of drug liable for the quality of drugs as well as for the other regulatory compliances which a manufacturer will have to comply with.
“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.”
- As per the Draft Amendment, the labelling of the drugs to soon reflect 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.
In light of the above, a new sub-clause, namely (xiii) under Rule 96(1) (Manner of Labelling) is proposed to be inserted.
- Manner of Labelling— (1) Subject to the other provisions of these Rules, the following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any drug and on every other covering in which the container is packed, 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.”
Source: Ministry of Health and Family Welfare
