Ministry of Health and Family Welfare issues the Drugs and Cosmetics (Seventh Amendment) Rules, 2017

Ministry of Health and Family Welfare issues the Drugs and Cosmetics (Seventh Amendment) Rules, 2017

April 21, 2017 Operations 0

The Ministry of Health and Family Welfare (“Ministry”) has issued the Drugs and Cosmetics (Seventh Amendment) Rules, 2017 (“Amendment Rules”) on 3rd April, 2017, thereby amending the Drugs and Cosmetics Rules, 1945 (“Principal Rules”).

The Amendment Rules are effective since 3rd April, 2017.

As per the amendment, item (8), pertaining to ‘Patent status of the drug’ has been removed from details required to be filled on “Particulars of new drug” of Form 44 [Application for grant of permission to import or manufacture a New Drug or to undertake clinical trial], under Schedule A of the Principal Rules.

Source: Egazette

 

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