India's DTAB Proposes Amendment to NDCT Rules to Add GMP Requirements for Trial Batches
核心洞察
India's Drugs Technical Advisory Board (搜索) has recommended amending Rules 55 and 63 of the New Drugs and Clinical Trials Rules, 2019 (搜索) for greater regulatory clarity.
The amendment would require trial batches for clinical trials and BA/BE studies of new drugs and APIs to be made in GMP-compliant facilities.
A new provision would allow manufacture for analytical and non-clinical testing under GMP principles with proper traceability.
The Drugs Technical Advisory Board (搜索) (DTAB) has recommended amending the New Drugs and Clinical Trials (NDCT) Rules, 2019 to clarify that manufacturing of trial batches for clinical trials or bioavailability (BA) and bioequivalence (BE) studies of new drugs and active pharmaceutical ingredients must take place in facilities complying with Good Manufacturing Practices (GMP).
The Board reviewed the regulatory GMP requirements for manufacturing for testing and analysis in non-clinical and clinical studies, and observed that the current system of manufacturing trial batches does not differentiate GMP requirements for clinical and non-clinical purposes. After deliberation, it recommended revision of Rule 55 and Rule 63 for better clarity.
Under the proposed Rule 55 revision, the permission holder would manufacture new drugs for clinical trial or BA/BE study in small quantities in accordance with the rules, at places specified in the permission and in a facility complying with GMP as provided under the Drugs Rules, 1945 (搜索). A proviso would allow manufacture of new drugs for analytical and non-clinical testing purposes in accordance with GMP principles, with proper traceability. The corresponding Rule 63 condition would require that where an unapproved API or its formulation is manufactured for clinical trial or BA/BE study, it be made in a GMP-compliant facility, with a similar proviso for analytical and non-clinical testing.