The Drugs Technical Advisory Board (DTAB) has recommended amendments to relevant provisions of the New Drugs and Clinical Trials (NDCT) Rules, 2019, to clarify Good Manufacturing Practices (GMP) requirements for the manufacture of trial batches of new drugs and active pharmaceutical ingredients. The recommendation specifies that manufacturing of trial batches for clinical trials or bioavailability (BA) and bioequivalence (BE) studies of new drugs and active pharmaceutical ingredients should be carried out in facilities complying with GMP requirements.

The DTAB has also proposed adding a provision that manufacturing of new drugs and active pharmaceutical ingredients for analytical and non-clinical testing purposes should be carried out in accordance with the principles of GMP, with proper traceability. Under the existing Rule 55, which deals with permission to manufacture new drugs or…