The Ministry of Health and Family Welfare (MoH&FW) on February 4, 2026, issued the Draft New Drugs and Clinical Trials (.. Amendment) Rules, 2026, to further amend the New Drugs and Clinical Trials Rules, 2019.
The following has been stated:
• After clause (ix) of rule 77, a new clause shall be inserted: - ‟(x) In the event of any change in manufacturing process, or excipients, or packaging, or shelf life, or specifications, or testing, or documentation etc. as the case may be, the manufacturer or his authorized agent shall inform the licensing authority in writing for such changes.”
• After clause (viii) of rule 82, a new clause shall be inserted: - ‟(ix) In the event of any change in manufacturing process, or excipients, or packaging, or shelf life, or specifications, or testing, or documentation etc. as the case may be, the manufacturer shall inform the licensing authority in writing for such changes.”
• Objections and suggestions may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall- C Wing, first floor, Kartavya Bhawan-1, New Delhi, 110001 or emailed at [email protected], by March 06, 2026.
[Notification no. - G.S.R. 97(E)]
