Amendments underway to the Drugs Rules; proposes parallel submission of applications for grant of renewal of manufacturing and sales license for large volume parenterals, vaccines and (r-DNA) derived drugs etc. comments invited till 22.06.202

Ministry of Health and Family Welfare has proposed further amendments to the Drug Rules, 1945. The draft Rules propose to introduce a sub-rule to Rule 75 with a view to allow simultaneous submission of applications for grant of renewal of manufacturing and sales license for large volume parenteral, vaccines and recombinant DNA (r-DNA) derived drugs, applications for grant of manufacturing permission for new drugs under the New Drugs and Clinical Trials Rules, 2019 and application for approval to manufacture new drug under rule 122B of the Drugs Rules. The amendment aims to simplify the process of application of new drugs and reducing the timeline for approval for these applications.

Objections or Suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 437, C Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in by 22nd June, 2022.

A copy of the Notification is attached herewith for ease of reference.

Source: Ministry of Health and Family Welfare