PXL/HO/Cir-076/2025-26                                                                                            Date: 15.10.2025

Hyderabad

Dear Sir/Madam,

Subject:Invitation for Comments/Suggestions on Regulatory Gap in New Drug Approvals – Ensuring Level Playing Field and Promoting R&D in India

Members are kindly aware CDCSO has issued a Notice dt :08.Oct.2025 (copy linked)on the subject Inviting comments to ensure a level playing field in New Drug Approval in India. The Central Drugs Standard Control Organization (CDSCO) has identified a regulatory gap in the approval process for new drugs in India.

Currently, first-time applicants are required to conduct both clinical trials and bioequivalence (BE) studies, whereas subsequent applicants for the same drug are only mandated to submit BE study data. This discrepancy imposes a disproportionate cost burden on first movers and creates a competitive disadvantage, potentially discouraging innovation and investment in new drug development.

In light of this, CDSCO is seeking comments and suggestions from all stakeholders to help formulate a balanced and equitable policy framework that:

• Ensures a level playing field in new drug approvals
• Encourages research and development (R&D) and innovation in India’s pharmaceutical sector

We request you to submit your comments/suggestions to exportfacilitationdesk@pharmexcil.com, no later than 31st October 2025.

We look forward to your valuable inputs in shaping a more equitable and innovation-friendly regulatory environment for India’s pharmaceutical sector.

With regards,

Raja Bhanu
Director General
 

ENCL: CDSCO NOTICE