In a significant regulatory development, the Central Drug Standard Control Organization, (CDSCO) has issued a circular mandating stakeholders to submit prior intimation for bioavailability (BA) and bioequivalence (BE) studies through the sugam portal online. The directive comes into effect from April 21, 2026, aligning with the recent amendment under the New Drugs and Clinical Trials Rules 2019 notified Via G.S.R. 50(E).
Under the revised framework, certain BE or BA studies conducted in healthy adult volunteers for export purposes will no longer require prior approval. Instead, applicants must submit a prior intimation online, simplifying the regulatory process and reducing approval timelines. The acknowledgement generated upon submission will serve as an official confirmation.
However, this relaxation is subjected to specific conditions, including prior approval of the drug in regulated markets such as the US, EU, or Japan, and adherence to a minimum study samples as requirement. Ethics Committee approval remains mandatory to ensure subject safety and regulatory compliance. Applications following outside the notified criteria will continue to follow the existing approval pathway. The move is expected to enhance ease of doing research while maintaining regulatory oversight in India’s clinical trial ecosystem.
By Arundhuti Chatterjee and Sharon Bose
