Generic Name and Warning on Drugs to be Displayed in Larger Type

[Ministry of Health and Family Welfare G.S.R.187(E) dated 6th March 2019]

The following draft of certain rules, further to amend the Drugs and Cosmetics

Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in consultation with the Drugs Technical Advisory Board, is hereby published for information of all persons likely to be affected thereby and notice is hereby given that said draft rules shall be taken into consideration on or after the expiry of a period of 10 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. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in.

DRAFT RULES

1. (1) These rules may be called the Drugs and Cosmetics (……Amendment) Rules, 2019.

(2) They shall come into force on the First day of April, 2019.

2. In the Drugs and Cosmetics Rules, 1945, in Schedule A,-

(i) in Form 45, under ‘Conditions for Grant of Approval / Permission”,-

(a) for condition (2), the following condition shall be substituted, namely:-

“(2) The proper name of the drug or fixed dose combination drug other than fixed dose combinations of vitamin and other fixed dose combinations containing three or more drugs, shall be printed or written in a conspicuous manner which shall be at least two font size larger than the brand name or the trade name, if any, and in other cases the brand name or the trade name, if any, shall be written below or after the proper name on the label of the innermost container of the drug or every other covering in which the container is packed.”;

(b) in condition (3), for the words “conspicuous red vertical line on the left side running throughout the body of the label which shall not be less than 1 mm in width and”, the words “a caution or warning, as applicable, depending on whether the drug is covered under Schedule G or Schedule H or Schedule H1 or Schedule X, as specified in rule 97, in legible black coloured font size in a completely red rectangular box” shall be substituted.

(ii) in Form 46, under ‘Conditions for Grant of Approval / Permission”,-

(a) for condition (2), the following condition shall be substituted, namely:-

“(2) The proper name of the drug or fixed dose combination drug other than fixed dose combinations of vitamin and other fixed dose combinations containing three or more drugs, shall be printed or written in a conspicuous manner which shall be at least two font size larger than the brand name or the trade name, if any, and in other cases the brand name or the trade name, if any, shall be written below or after the proper name on the label of the innermost container of the drug or every other covering in which the container is packed.”;

(b) in condition (3), for the words “conspicuous red vertical line on the left side running throughout the body of the label which shall not be less than 1 mm in width and”, the words “a caution or warning, as applicable, depending on whether the drug is covered under Schedule G or Schedule H or Schedule H1 or Schedule X, as specified in rule 97, in legible black coloured font size in a completely red rectangular box” shall be substituted.

[F. No. X.11014/37/2018-DR]