The Ministry of Health and Family Welfare has on 6th March, 2019 proposed changes in Drugs and Cosmetics Rules, 1945 which will impact Form 45 and 46 of Schedule I. Form 45 and Form 46 deal with Conditions for Grant of Approval / Permission to import Finished Formulation of a New Drug and Permission / Approval for manufacture of a new drug formulation, respectively.
The key changes proposed in the Conditions for Grant of Approval / Permission to import Finished Formulation of a new drug and manufacture of a new drug formulation are:
- 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, needs to be printed or written in a conspicuous manner which should be at least two font size larger than the brand name or the trade name. In all other cases, the brand name or the trade name, if any, needs to 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.
- The label of the innermost container of the drug and every other covering in which the container is packed will bear 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 relating to Labelling of Medicines, in legible black coloured font size in a completely red rectangular box without disturbing the other conditions printed on the label to depict it as prescription drug.
Source: Ministry of Health and Family Welfare
