The Drugs and Cosmetics Act 1940, has been recently amended, vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R.187(E), dated the 6th March 2019. Amendments are related to the Conditions for License / Approval in Form 45 (Approval for import of New Drugs into India) and Form 46 (Approval for the manufacture of new drugs) in Schedule A.
The Conditions for License/Approval for Form 45 and Form 46 has undergone the following change:
- 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
- The name of the Drug shall be at least two font size larger than the brand name or the trade name
- 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
- In para 3 of the Conditions for License/Approval, for both Form 45 and Form 46, the words “conspicuous red and vertical line on the left side running throughout the body of the label which shall not be less than 1 mm in width and”, shall be substituted with the following words “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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