Comments invited on Draft Drugs and Cosmetics (Amendment) Rules, 2017 till 15th May, 2017
The Ministry of Health and Family Welfare (“Ministry”) has issued the Draft Drugs and Cosmetics (Amendment) Rules, 2017 (“Draft Rules”) on 30th March, 2017 thereby proposing to amend the Drugs and Cosmetics Rules, 1945 (“Principal Rules”).
Any objection or suggestion on the Draft Rules may be addressed to the Under Secretary (Drugs), Ministry, Government of India, Room No. 414 A, D Wing, Nirman Bhawan, New Delhi – 110011 within a period of 45 days from 30th March, 2017, i.e. by 15th May, 2017.
The Draft Rules seek to make the labelling of the Drug more explanatory by mandating further details to be printed on the label of the innermost container of any drug and on every other covering in which the container is packed
The Draft Rules propose to include the following requirements:
i. 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, should be printed or written in a conspicuous manner
ii. The name should be in the same font but at least two font size larger than the brand name or the trade name, if any, and
iii. in other cases the brand name or the trade name, if any, should be written in brackets below or after the proper name.
At present, the Principal Rules state that the proper name of the drug has to be printed or written in a more conspicuous manner than the trade name, if any which should be shown immediately after or under the proper name.