DTAB Recommends Clearer GMP Rules for Trial-Batch Manufacturing

The Drugs Technical Advisory Board (DTAB) has recommended changes to India’s New Drugs and Clinical Trials (NDCT) Rules, 2019, to bring greater clarity to the Good Manufacturing Practices (GMP) requirements applicable to trial-batch manufacturing.

The recommendation follows discussions on the regulatory requirements for manufacturing new drugs and active pharmaceutical ingredients (APIs) used in clinical trials, bioavailability (BA) and bioequivalence (BE) studies, as well as analytical and non-clinical testing.

Under the proposed changes, new drugs manufactured in small quantities for clinical trials or BA/BE studies would have to be produced at approved locations in facilities that comply with the GMP requirements prescribed under the Drugs Rules, 1945. The proposal is intended to make the manufacturing expectations for such batches more explicit.

DTAB has also proposed a separate provision for drugs and APIs manufactured for analytical and non-clinical testing. Such materials would need to be produced in line with GMP principles, with appropriate traceability maintained throughout the process.

The Board also reviewed the existing provisions under Rules 55 and 63 of the NDCT Rules. At present, these rules require products intended for clinical trials and BA/BE studies to be manufactured according to GMP principles. However, DTAB observed that the existing framework does not clearly distinguish the requirements applicable to clinical and non-clinical purposes.

The proposed amendments to Rules 55 and 63 are therefore aimed at improving regulatory clarity and establishing a more clearly defined manufacturing framework for different stages of drug development.

21-09-2026