The Government of India has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019, open for public comments within 30 days. The proposed New Drugs and Clinical Trials (Amendment) Rules, 2026 require manufacturers to inform the licensing authority of any changes in manufacturing, excipients, packaging, shelf life, specifications, testing, or documentation. Major (Level I) and moderate (Level II) quality changes need prior approval, while minor (Level III) changes may be implemented directly, with annual reporting.
The Government of India has released draft amendments to the New Drugs and Clinical Trials Rules, 2019, inviting public comments within 30 days. These proposed New Drugs and Clinical Trials (Amendment) Rules, 2026 aim to strengthen regulatory oversight of changes made by manufacturers.
The draft specifies that any modifications in manufacturing processes, excipients, packaging, shelf life, specifications, testing, or documentation must be formally communicated to the licensing authority.
The rules classify changes into three levels:
- Level I (Major): Substantial changes with potential adverse impact on drug identity, strength, quality, purity, or potency. Prior approval from the licensing authority is mandatory.
- Level II (Moderate): Changes with moderate potential impact also require prior approval.
- Level III (Minor): Changes with minimal impact may be implemented without prior approval, except for shelf life changes. These must be reported annually to the authority in the first quarter of each calendar year.
This amendment ensures timely regulatory communication and safeguards drug quality standards.