Drugs Technical Advisory Board proposes amendments to the Drugs and Cosmetics Act, 1940

Drugs Technical Advisory Board proposes amendments to the Drugs and Cosmetics Act, 1940

July 14, 2017 Industry Specific 0

The Drugs Technical Advisory Board (“DTAB”) held its 77th meeting on 16th June, 2017 at Nirman Bhawan, New Delhi to discuss proposed amendments under various provisions of the Drugs and Cosmetics Act, 1940 and the Rules.

Key highlights of the proposed amendments are as follows:

  1. Additionof the provisions onstem cells and cell based products which have been approved as per the 76th Meeting of DTAB.
  1. Amendment toForm 12-B(Format for permit to import small quantities of drugs for personal use).
  2. Amendment toSchedule Hto include certain steroid preparations which are usually misused as topical steroids leading to extensive tinea infections.
  1. Inclusion of“Stem Cells and Cell Based Products” under the definition of New Drug under Rule 122-E of the Drugs and Cosmetics Rules, 1945.
  1. Engagement ofpharmacist having relevant qualification mandatorily forblood banks / blood storage centers.

We will update you once the amendments are issued in the Official Gazette.

Source: Drugs Technical Advisory Board.

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