The Central Drugs Standard Control Organisation (CDSCO) has invited public comments to address a long-standing issue in Indian pharmaceutical regulation: the lack of a level playing field between the first company conducting clinical trials for a new drug and subsequent firms seeking approval for the same product. The  new consultation intends to improve pharmaceutical regulation in India by filling gaps in trial criteria for first-time and subsequent drug applicants. 

In a notice dated October 8, 2025, published by the Directorate General of Health Services, the CDSCO stated that the current procedure frequently disadvantages the initial applicant. According to the New Drugs and Clinical Trials Rules of 2019, the first company to submit for a new drug approval must undertake local clinical trials on Indian subjects to ensure safety and efficacy. These studies are time-consuming and costly, but they are critical for public safety and scientific validity. 

However, after a medicine is approved for the initial application, subsequent applicants can frequently obtain approval by submitting just bioequivalence (BE) studies—simplified tests that compare their product's performance to the previously approved drug. Such studies are far less expensive and faster to complete. 

The CDSCO noticed that this discrepancy creates a regulatory imbalance. The first developer faces the entire burden of research investment and regulatory compliance, but subsequent entrants profit from established data with lower obligations. According to officials, the current situation may dissuade corporations from investing in early-stage research and new drug development in India. 

To address this, India's Drugs Controller General (DCGI), Dr Rajeev Singh Raghuvanshi, has called for stakeholder consultations to create a more equitable framework. The notice asks pharmaceutical companies, researchers, and policy experts to provide feedback within 30 days after the release. 

The proposed review aims to strike a balance between innovative incentives and regulatory efficiency, ensuring that India remains a desirable location for both domestic and international drug research. Experts feel that candid consultations can assist in revising policies without jeopardising patient safety. 

India's pharmaceutical industry is one of the world's leading suppliers of generic pharmaceuticals, and fair regulation is critical to maintaining its credibility. The current argument highlights a broader shift in India's pharmaceutical regulation—from a system primarily centred on approvals to one that emphasises equity, innovation, and ethical research. 

By launching this public debate, the CDSCO hopes to create a more uniform and innovative regulatory environment that benefits both developers and patients, ultimately strengthening India's pharmaceutical regulation basis.