MOHFW proposes to amend Drugs and Cosmetics Rules; releases draft for consideration till 11th April, 2019; applicant of license to furnish undertaking that similar brand/trade already not in existence

MOHFW proposes to amend Drugs and Cosmetics Rules; releases draft for consideration till 11th April, 2019; applicant of license to furnish undertaking that similar brand/trade already not in existence

March 4, 2019 OPS, Pharmaceuticals, states 0

The Ministry of Health and Family Welfare has recently in a notification on 26th February, 2019 proposed to amend Drugs and Cosmetics Rules, 1945 and has released the draft Drugs and Cosmetics (…. Amendment) Rules, 2019.

Comments and suggestions are invited, to be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414A, D Wing, Nirman Bhavan, New Delhi -110011 or emailed at drugsdiv-mohfw@gov.in by 11th April, 2019.

Key Highlight:

  • Four new conditions for the grant/renewal of various licences under Drugs and Cosmetics Act, 1945 have been proposed to be inserted. They are Rules 71A(5) ,71B(v) , 76(11), and 76A(v). They imply  that,  in case the applicant intends to market the drug under a brand name or trade name, the applicant will have to furnish an undertaking to the licensing authority, that such or similar brand name or trade name is not already in existence so that the brand name or the trade name to be used by the applicant does not lead to any confusion or deception in the market.

[Rule 71A deals with conditions for the grant or renewal of a licence in Form 25B Rule 71B Conditions for the grant of renewal of a licence in Form 25A.

Rule 76 and 76A deal with Forms of licence to manufacture drugs specified in Schedules C and C(1), [excluding those specified in Part XB and Schedule X], or drugs specified in Schedules C, C(1) and X and the conditions for the grant or renewal of such licences and Form of loan licence to manufacture for sale or for distribution] drugs specified in Schedules C and C(1) excluding the drugs specified in Schedule X] and conditions for the grant or renewal of such licence respectively.]

SourceMinistry of Health and Family Welfare

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