The Ministry of Health and Family Welfare (MoHFW) on August 28, 2025, 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: -
• The amendments have been issued across 2 new draft notifications.
• Rule 52 which states “Application for permission to manufacture of new drug or investigational new drug for clinical trial or bioavailability and bioequivalence study or for examination, test and analysis” the following sub-rule (1) has been substituted namely: -
“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”
• Rule 59 which states “Application for permission to manufacture unapproved active pharmaceutical ingredient for development of pharmaceutical formulation for test or analysis or clinical trial or bioavailability and bioequivalence study” the following proviso shall be inserted namely: -
“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."
• Rule 31 which states “Bioavailability or bioequivalence study of new drug or investigational new drug” sub-rule (2) the following proviso shall be inserted, namely: -
‘‘Provided that in case of single-dose, two-period, two-sequence, two-treatment, bioavailability or bioequivalence studies in normal healthy adult human volunteers (for export purpose only), of oral dosage form of a drug (other than drugs of Cytotoxic, Hormone, Narcotic and Psychotropic substances categories and not a drug of Narrow Therapeutic Index or a drug having highly variable pharmacokinetics) already approved in the Country or any one of the countries namely, USA, EU, Japan, Australia, Canada and UK, the studies may be conducted after submission of an online application as notification and its acknowledgement by the Central Licensing Authority, subject to certain conditions”
Objections and suggestions may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, or emailed at [email protected] within 30 days.
[Notification No. G.S.R. 587(E), G.S.R. 588(E)]
