Call for Clinical Data Exclusivity to Boost MSME Pharma Innovation in India

Industry experts are urging the introduction of clinical data exclusivity to support MSME drug innovators in India, following a consultation notice by the Drugs Controller General of India. The notice highlights an uneven system where the first applicant conducts costly clinical trials, while subsequent applicants can gain approval using limited data.

Under current New Drugs and Clinical Trials Rules 2019, innovators bear the full burden of research, approvals, and investment. However, competitors often enter the market quickly without similar effort, creating a disincentive for innovation—especially for MSMEs.

Experts propose a 3–5 year exclusivity window, preventing others from relying on the original clinical data during that period. This would allow innovators time to recover investments without blocking competition long term.

While initiatives like PRIP Scheme support R&D, stakeholders believe regulatory protection is essential to strengthen India’s ambition of becoming a global pharmaceutical innovation hub.

02-04-2026