DTAB Proposes Separate Good Manufacturing Practices (GMP) Frameworks for Clinical and Non-Clinical Drug Research

The Drugs Technical Advisory Board (DTAB) has recommended significant regulatory updates concerning the manufacturing standards for drugs utilized in clinical trials, bioavailability and bioequivalence (BA/BE) studies, analytical testing, and non-clinical research. These recommendations were finalized during the 94th DTAB meeting held on August 27, 2026, to address the lack of clear differentiation under current trial batch manufacturing systems between clinical and non-clinical GMP requirements.

Proposed Amendments to the NDCT Rules, 2019

To establish a clear regulatory boundary, DTAB has recommended amending Rule 55 and Rule 63 of the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules, 2019).

Rule 55 Amendments (New Drugs):
- Clinical and BA/BE Studies: Permission holders must manufacture new drugs intended for clinical trials or BA/BE studies in small quantities at specified locations, fully complying with the Good Manufacturing Practices prescribed under the Drugs Rules, 1945.
- Analytical and Non-Clinical Testing: Drugs manufactured specifically for analytical and non-clinical testing purposes may be produced in accordance with the principles of GMP, supported by proper traceability.
Rule 63 Amendments (APIs and Formulations):
- Clinical and BA/BE Studies: Active pharmaceutical ingredients (APIs) or pharmaceutical formulations intended for clinical trials or BA/BE studies must be manufactured in facilities that comply with applicable GMP requirements under the Drugs Rules, 1945.
- Analytical and Non-Clinical Testing: When manufactured specifically for analytical and non-clinical research, production is allowed under the principles of GMP with proper traceability.

Industry Implications and Next Steps

Regulatory Distinction: The proposed changes create a definitive separation between materials manufactured for human clinical or BA/BE evaluations versus those produced solely for analytical or non-clinical testing.
Impact on Stakeholders: This distinction is expected to streamline operations for pharmaceutical companies, research organizations, and analytical laboratories that require small quantities of drug substances or formulations for non-clinical workflows.
Status of Implementation: The recorded minutes from the 94th meeting do not constitute an immediate final amendment. The proposed framework must go through the standard rule-making process before acquiring legal enforceability.