The Ministry of Health and Family Welfare (MoH&FW) on June 22, 2026, issued the Draft New Drugs and Clinical Trial Rules, 2019 (......Amendment) Rules, 2026, further to amend the New Drugs and Clinical Trial Rules, 2019.
It states that a new proviso shall be inserted in the Fifth Schedule after para 1 (5) (C) (iii):
Provided that:
• 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.
• 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.
Comments/Suggestions are invited till July 26, 2026.
[Notification no. - G.S.R. 504(E)]
