The Ministry of Health and Family Welfare (MoH&FW), on January 20, 2026, issued the Draft New Drugs and Clinical Trials (...... Amendment) Rules, 2025, to further amend the New Drugs and Clinical Trials Rules, 2019.
The following has been stated namely: -
• In para 4.2 of 4 of Table 2 of Second Schedule, after the words “intravenous infusion and injectables” the words shall be inserted, namely:- “except when the test product, in respect of its excipients, is qualitatively and quantitatively same as reference product”.
• Objections and suggestions, if any, 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] and within February 19, 2026.
[Notification No. G.S.R. 45(E)]
