In a regulatory update aimed at streamlining drug export processes, the Central Drugs Standard Control Organization (CDSCO) has announced the implementation of a Prior Intimation System for Form CT-05 applications. The new system will come into force from April 21, 2026, following amendments introduced under Gazette Notification G.S.R. 50(E).
The notification outlines that stakeholders involved in clinical trial-related export activities must now submit applications online through the Sugam portal. These applications will serve as prior intimation rather than requiring traditional approval routes, marking a shift toward faster and more efficient processing.
The new framework applies specifically to bioavailability and bioequivalence studies conducted on healthy adult volunteers for export purposes. It also covers oral dosage drugs that are not part of restricted categories such as cytotoxic, hormonal, narcotic, or psychotropic substances, and those without a narrow therapeutic index or highly variable pharmacokinetics.
Additionally, the drugs must already be approved either in India or in at least one recognized international market, including the United States, European Union, Japan, Australia, Canada, or the United Kingdom. Applications must also include approval from an Ethics Committee registered with the Central Licensing Authority.
This step is expected to simplify regulatory procedures and encourage smoother export-oriented clinical research activities. The new system is designed to reduce administrative delays while maintaining compliance with safety and ethical standards. However, stakeholders are advised to ensure that all requirements are carefully met before submission to avoid rejection or delays.
