India Accelerates Regulatory Reform for Medical Products at PM-STIAC Review

Prof. Sood highlighted that reforms must establish quantifiable long-term milestones, periodic audits, and measurable targets to align India’s system with international gold standards.

The fourth follow-up meeting of the 24th Prime Minister’s Science, Technology and Innovation Advisory Council (PM-STIAC) on “Transforming the Regulatory Ecosystem of Medical Products in India” was convened on August 19, 2025, under the chairmanship of Prof. Ajay Kumar Sood, Principal Scientific Adviser (PSA) to the Government of India. The meeting served as a key review platform for ongoing reforms aimed at ensuring transparency, accountability, innovation, and global credibility in India’s medical product regulation.

Raising Standards in Medical Regulation

The PM-STIAC meeting underscored the need to create a future-ready regulatory system for medical products—covering drugs, biologics, and advanced therapies—that can both safeguard patient safety and enable innovation. It recommended stronger oversight, digital transformation, and global benchmarking to make India a trusted leader in medical regulation.

Prof. Sood highlighted that reforms must establish quantifiable long-term milestones, periodic audits, and measurable targets to align India’s system with international gold standards. “These efforts will strengthen trust in India’s regulatory framework, boost predictability, and enhance our global credibility,” he stated.

Updates from CDSCO: Progress and Milestones

Dr. Rajeev Raghuvanshi, Drug Controller General of India (DCGI), Central Drugs Standard Control Organisation (CDSCO), presented progress in several priority areas:

1. State Drug Regulatory Index (Launched August 12, 2025):

   • Benchmarks state drug regulators based on performance indicators.

   • Establishes an objective evaluation mechanism to improve accountability.

   • Designed to encourage competitive benchmarking among states, thereby raising overall standards of drug regulation in India.

2. Guidance Framework for Subject Expert Committees (SECs):

   • Provides clear guidelines on the review of applications for clinical trials and approvals.

   • Aims to ensure uniformity, predictability, and efficiency in decision-making.

3. Digital Dashboards and Faster Approvals:

   • Global Clinical Trials for Cell and Gene Therapy (CGTs): Application-to-deliberation time reduced from 226 days in 2022 to just 40 days in 2024.

   • Post-Approval Changes in CGTs: Approval timelines reduced from 218 days in 2022 to 98 days in 2024.

   • Demonstrates the impact of digital tools in expediting regulatory processes without compromising safety.

4. Operationalisation of Digital Systems:

   • NSQ (Not of Standard Quality) data integration for national-level tracking.

   • Dual-Use No Objection Certificate (NOC) digitisation.

   • WHO Certificate of Pharmaceutical Product system digitised, enabling harmonised national databases and transparent processes.

5. New Biosimilar Guidance:

   • Prepared in line with global norms, the framework will facilitate access to biologics in India.

   • Expected to support both affordability and industry competitiveness.

Driving Transparency, Safety, and Innovation

These reforms, according to Dr. Raghuvanshi, are not only improving timelines and accountability but also creating an ecosystem where patient safety, domestic innovation, and global competitiveness are mutually reinforcing. By digitising core regulatory processes, India is building trust-based systems that enhance transparency for both patients and manufacturers.

Prof. Sood emphasized that the ultimate goal of the transformation is to give Indian manufacturers a competitive global edge, while also ensuring quicker access to safe and affordable medical products for citizens.

Participation and Broader Policy Support

The review meeting was attended by:

• Dr. Parvinder Maini, Scientific Secretary, Office of PSA

• Dr. Sindura Ganapathi, PSA Fellow

• Dr. Sangeeta Agarwal, Scientist ‘F’, Office of PSA

• Mr. Apoorv Chouhan, Project Manager, One Health PMU, Office of PSA

• Shri Nikhil Gajraj, Joint Secretary, Department of Health and Family Welfare

Their collective inputs reinforced the cross-sectoral nature of regulatory reform, with emphasis on collaboration between science, health, and governance institutions.

Towards a Globally Credible Regulatory Ecosystem

India’s transformation of its medical regulatory ecosystem is expected to:

• Strengthen domestic capacities in pharmaceuticals, biologics, and advanced therapies.

• Build global confidence in Made-in-India medical products.

• Enhance patient safety and access to innovative treatments.

• Position India as a leading regulatory model for emerging economies.

The PM-STIAC review reaffirmed that reforms are on track to modernize India’s regulatory framework, making it more agile, transparent, and internationally credible, while also fostering innovation that benefits both India and the world.