New law for labelling Drugs, Fixed Dose Combinations: Govt issues Gazette

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 e-mailed at drugsdiv-mohfw@gov.in.

New Delhi: Through a recent Gazette notification, the Central Government has amended the Drugs and Cosmetics Rules, 1945, wherein labelling norms for various drugs and Fixed Dose Combinations (FDCs) is elaborated. The amendment will come into force from April 1 2019.

The elaboration will help in establishing clarity in naming various drugs and FDCs. The issued law will ensure naming drugs and FDCs in a comprehensible manner wherein the name, font, size, colour code to be printed on the drug case/covering has been emphasized. This will provide relief to consumers while purchasing the same.

The Gazette clearly mentioned that the government, in consultation with the Drugs Technical Advisory Board, has published for information of all persons likely to be affected thereby and notice has been 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 are invited from any person within the period specified above and 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 e-mailed at drugsdiv-mohfw@gov.in.

The issued Rule states, 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 following words shall be substituted namely;

"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"

(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 following words shall be substituted namely;

"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"

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