The Central Drugs Standard Control Organization (CDSCO) has issued a notice inviting comments from all stakeholders regarding a regulatory discrepancy that affects the cost and complexity of obtaining approval for a new drug in India. The move is intended to initiate discussions on establishing a level playing field and fostering domestic research and development (R&D).
The Discrepancy
Under the New Drugs and Clinical Trials (NDCT) Rules, 2019, the approval process generally requires an applicant for a new drug to conduct a local clinical trial (unless waived).
The CDSCO has observed a significant financial and regulatory burden imbalance between the initial applicant and subsequent applicants for the same drug:
First Applicant: In many instances, the first company to obtain approval bears the high cost of conducting both local clinical trials and bioequivalence (BE) studies.
Subsequent Applicants: Once the new drug is approved for the first applicant, other companies seeking approval for the same drug are exempted from conducting the costly clinical trial. Their approval is granted based only on chemical, pharmaceutical data, and bioequivalence study data.
This practice results in a much lower cost of regulatory compliance for subsequent applicants, creating a “lack of level playing field” compared to the first applicant who invested heavily in proving the drug’s safety and efficacy in the Indian population.
Call for Stakeholder Input
The CDSCO has determined that this issue requires deliberation with stakeholders and concerned departments to formulate a balanced policy that addresses the discrepancy while encouraging the development of new drugs.
- Submission Deadline: Stakeholders are requested to submit their comments and suggestions on the subject within 30 days from the issue of the notice (October 8, 2025).
- Submission Emails: Feedback should be sent to dci@nic.in and snd@cdsco.nic.in.
The feedback received will be instrumental in formulating a revised policy that ensures fair competition and continues to foster R&D within the country.