Ministry of Health and Family Welfare (Department of Health and Family Welfare) has published the following draft rules for amending the New Drugs and Clinical Trial Rules, 2019, 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 New Drugs and Clinical Trial Rules, 2019, the following proviso shall be inserted in the Fifth Schedule after para 1(5)(C)(iii):

“Provided that:

1. For new drugs as detailed under (iv) of Rule 2(1)(w) of the New Drugs and Clinical Trial Rules, 2019, the periodic safety update reports shall be submitted every six months for the first two years after approval of the drug is granted to the applicant. For subsequent two years, the periodic safety update reports shall continue to be submitted annually and thereafter once every three years until the drug product is marketed.
2. For new drugs as detailed under (v) of Rule 2(1)(w) of the New Drugs and Clinical Trial Rules, 2019, the periodic safety update reports shall be submitted every six months for the first two years after approval of the drug is granted to the applicant. For subsequent years, the periodic safety update reports shall continue to be submitted annually until the drug product is marketed.”

The proposed amendment applies to the Fifth Schedule of the New Drugs and Clinical Trial Rules, 2019. Applicants holding approvals for new drugs covered under Rule 2(1)(w)(iv) and Rule 2(1)(w)(v) are impacted to the extent of the periodic safety update report submission frequencies specified in the inserted proviso. This is a draft notification; the rules have not yet come into force.