Ministry of Health and Family Welfare (Department of Health and Family Welfare) has published the following draft rules for amending the Drugs Rules, 1945, after consultation with the Drugs Technical Advisory Board. The draft rules are published for information of all persons likely to be affected. Objections and suggestions shall be considered by the Central Government if received within thirty days from the date copies of the Gazette are made available to the public. Objections and suggestions may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, U-6, Work Hall-C Wing, First Floor, Kartavya Bhawan-1, New Delhi – 110001, or emailed to drugsdiv-mohfw@gov.in.

In the Drugs Rules, 1945, in Rule 31, the second proviso shall be substituted as follows:

“Provided further that the licensing authority shall not allow the import of any drug having less than one year residual shelf-life period as on the date of import. However, in the case of Biological drugs and Radiopharmaceuticals, 60% of the labelled shelf-life may be allowed.”

The proposed amendment applies to Rule 31 of the Drugs Rules, 1945. Licensing authorities and importers of drugs, Biological drugs, and Radiopharmaceuticals are impacted to the extent of the substituted proviso. This is a draft notification; the rules have not yet come into force.