The Ministry of Health and Family Welfare has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019. These proposed rules, published on 20 January 2026, will be considered after thirty days from public availability. Stakeholders may submit objections or suggestions to the Under Secretary (Drugs). The amendment adds that intravenous infusions and injectables are exempt only when test product excipients match the reference product qualitatively and quantitatively.
The Ministry of Health and Family Welfare has issued a draft notification dated 20 January 2026 proposing amendments to the New Drugs and Clinical Trials Rules, 2019.
These amendments are being introduced under the powers granted by the Drugs and Cosmetics Act, 1940, following consultation with the Drugs Technical Advisory Board. The draft rules will be open for public comments for thirty days from the date the Gazette containing them becomes available.
During this period, stakeholders may submit objections or suggestions to the Under Secretary (Drugs), Ministry of Health and Family Welfare, either by post or via email.
The proposed amendment specifies that, under paragraph 4.2 of Table 2 in the Second Schedule, after the words intravenous infusions and injectables following will be included "except when the test product, in respect of its excipients, is qualitatively and quantitatively same as reference product".