New Delhi: With an aim to address the existing disparity between the first applicant who conducts full-scale clinical and bioequivalence (BE) studies for a new drug and subsequent applicants who secure approval for the same product without undertaking similar trials, the Central Drugs Standard Control Organisation (CDSCO) has invited comments from stakeholders to help formulate a fair and balanced policy for new drug approvals in India.

All stakeholders have been requested to submit their comments and suggestions on the matter within 30 days of this notice by emailing dci@nic.in and snd@cdsco.nic.in

According to the New Drugs and Clinical Trials (NDCT) Rules, 2019, applicants seeking approval for a new drug already approved in another country are generally required to conduct local clin

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