The CDSCO has issued a notice inviting stakeholder comments to address disparities in new drug approvals. Currently, the first applicant must conduct clinical trials, while subsequent applicants may gain approval based only on bioequivalence data. This creates an uneven regulatory burden. The initiative aims to foster fairness and encourage innovation by revisiting approval norms through stakeholder consultation.
The Central Drugs Standard Control Organization (CDSCO) has released a notice seeking stakeholder feedback to ensure a level playing field in the approval process for new drugs in India.
Under the New Drugs and Clinical Trials Rules, 2019, local clinical trials are generally required for drugs approved abroad. However, waivers are possible, and multiple applicants often submit protocols for clinical trials and bioequivalence (BE) studies.In practice, only one applicant typically conducts the full clinical trial and BE study, while others later submit BE data alone to gain approval for the same drug.
This results in unequal regulatory obligations, with the first applicant bearing higher costs and effort. To address this imbalance and promote equitable drug development, CDSCO is initiating discussions with stakeholders and relevant departments.Feedback is invited within 30 days of the notice to help shape a balanced policy that supports innovation while maintaining regulatory fairness.
Comments can be sent to dci@nic.in and snd@cdsco.nic.in.