India to Allow Manufacture of New Drugs for Clinical Trials, BA/BE Studies After Notification

Government of India is amending the New Drugs and Clinical Trials (NDCT) Rules 2019 permitting manufacture a new drug or an investigational new drug for clinical trials, BA/BE studies or examination, test and analysis after submitting online application for notification to manufacture such new drug or investigational new drug. The applicant can manufacture such drugs after notification and need not wait for permission, which is a requirement as per existing rules. As per the gazette notification G.S.R. 588(E) dated 27th August, 2025, the sub-rule (1)  & (2) of rule 52 of the New Drugs and Clinical Trials (NDCT) Rules 2019 is being revised as:

• (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 or the notification as referred in proviso to sub-rule (2) of rule 52 to the Central Licensing Authority, as the case may be, to manufacture such new drug or investigational new drug
• (2) Provided that in case of manufacture of new drug or Investigational new drug for Analytical and preclinical testing (excluding the new drug and Investigational new drug of category of sex hormones, cytotoxic, beta lactum, Biologics with live microorganism and narcotics & psychotropic drugs) an online application shall be submitted as notification and applicant can manufacture such drugs based on the notification.”

The amendments also permit manufacture of unapproved active pharmaceutical ingredients (APIs) for development of the pharmaceutical formulation for test or analysis or clinical trial or BA/BE studies after notification. A new provision is introduced under rule 59 as:

• (2) Provided that in case of manufacture of new drug or Investigational new drug for Analytical and preclinical testing (excluding the new drug and Investigational new drug of category of sex hormones, cytotoxic, beta lactum, Biologics with live microorganism and narcotics & psychotropic drugs) an online application shall be submitted as notification and applicant can manufacture such drugs based on the notification.

The amendments also provide for grant of permission to manufacture new drug, investigational new drug and unapproved active pharmaceutical ingredients for test or analysis or clinical trial or BA/BE studies within a period of forty-five working days instead of ninety working days.

Gazette Notification G.S.R. 588(E) dated 27th August, 2025 – Amendments to  New Drugs And Clinical Trials Rules, 2019