The Ministry of Health and Family Welfare (MoH&FW), on January 15, 2026, issued the New Drugs and Clinical Trials (Amendment) Rules, 2026, to further amend the New Drugs and Clinical Trials Rules, 2019.
The following amendments have been stated namely:-
• In rule 52, in the marginal heading, for the word “permission”, the words shall be substituted, namely:- “permission or prior intimation”.
• In rule 52, for the sub-rule (1), the following sub-rule shall be substituted, namely: ― “(1) No person shall manufacture a new drug or an investigational new drug to conduct clinical trial or bioavailability or bioequivalence study or for examination, test and analysis without obtaining permission, by making an application in Form CT-10 to the Central Licencing Authority to manufacture such new drug or investigational new drug, from the Central Licencing Authority:
Provided that in case of manufacture of new drug or investigational new drug for analytical and non-clinical testing (excluding the new drug and investigational new drug of category of sex hormones, cytotoxic, beta lactum, biologics with live microorganism and narcotics and psychotropic drugs) an online application in Form CT-10 to the Central Licencing Authority shall be submitted as prior intimation and the applicant may manufacture such drugs based on the acknowledgment of such intimation.";
• In rule 52, sub-rule (2) shall be omitted.
• In rule 52, sub-rule (3), for the word, brackets and figure “sub-rule (2)”, the word, brackets and figure shall be substituted, namely:- “sub-rule (1)”.
[Notification No. G.S.R. 46(E)]
