The Ministry of Health and Family Welfare (“Ministry”) has, in a Notification dated 3rd December, 2018, issued the Drugs and Cosmetics (Eighth Amendment) Rules, 2018 (“Amendment Rules”) to amend the Drugs and Cosmetics Rules, 1945 (“Principal Rules”).
The Amendment Rules have amended sub-clause (A) of Rule 96 of the Principal Rules as follows:
The Amendment Rules remove the requirement for the proper name of a drug to be printed in the same font as that of its trade or brand name.
Now, the proper name of the drugs can be printed in any font style, which can be similar or different from the font of its brand name, provided it is at least two font sizes larger than the brand name and has been printed in a conspicuous manner.
The Amendment Rules have also inserted a new sub-clause (AA) under the Rule 96 whereby the labelling requirements, specified by Notification number G.S.R. 222(E) dated the 13thMarch, 2018, for proper name of drugs, fixed dose combination drugs, other than fixed dose combinations of vitamin, and other fixed dose combinations, containing three or more drugs,have been made voluntary for the period between 13th September,2018 to 31st March, 2019.
Such labelling requirements shall become mandatory from 31st March, 2019 onwards.
Source: Ministry of Health and Family Welfare
