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The Ministry of Health and Family Welfare has issued a significant draft notification aimed at simplifying the administrative process for clinical trials in India. Released on February 2, 2026, this proposal seeks to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019, specifically targeting the registration process for Ethics Committees.
The primary focus of the New Drugs and Clinical Trials (Amendment) Rules, 2026, is to eliminate the requirement for "provisional" certificates. Under the proposed changes:
By removing the middle step of provisional registration, the government aims to reduce the "red tape" associated with setting up clinical trial oversight. This move is expected to speed up the commencement of clinical trials while maintaining strict adherence to safety and ethical standards.
As this is a draft notification, the Central Government is actively seeking input from stakeholders and the public.
These rules will officially come into force on the date specified by the Government during their final publication in the Official Gazette.
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