Prof. Ajay Sood, Principal Scientific Adviser (PSA) to the Government of India, chaired the third review meeting on December 18, 2024, to assess advancements in transforming India’s regulatory framework for medical products. This meeting followed an earlier review held on August 21, 2024, and built on recommendations made during the 24th PM-Science Technology Innovation Advisory Council (PM-STIAC) meeting on February 6, 2024. The council emphasized the need for a comprehensive overhaul of regulatory processes to ensure transparency, accountability, and the promotion of innovation while ensuring the availability of safe and affordable medical products.
Progress Highlights by CDSCO
Dr. Rajeev Raghuvanshi, Drug Controller General of India (DCGI), presented updates on key initiatives undertaken by the Central Drugs Standard Control Organisation (CDSCO).
- Maturity Level 3 (ML3) Achievement:
CDSCO successfully maintained India’s Maturity Level 3 (ML3) status in the World Health Organization’s (WHO) National Regulatory Authority (NRA) assessment for vaccines, reflecting the country’s regulatory competence. - Global Collaboration:
CDSCO hosted the International Conference of Drug Regulatory Authorities (ICDRA), with participation from regulators of over 120 countries, further cementing India’s position in global regulatory discourse. - Enhanced Testing Capabilities:
The ninth CDSCO drug testing laboratory was inaugurated in Bhubaneswar, boosting the country’s capacity for drug quality assessment. - Process Improvements:
Kaizen principles are being implemented to streamline internal workflows. Progress was also made on PM-STIAC recommendations, including:- Simplifying Subject Expert Committee (SEC) review processes.
- Engaging innovators through the Medtech Mitra initiative.
- Increasing scientific capacity within CDSCO.
- Expanding digitization efforts.
- Maintaining regular communication with industry stakeholders.
PSA’s Vision for a Robust Ecosystem
Prof. Sood commended CDSCO for its progress and reiterated the importance of a robust regulatory ecosystem in building trust in both domestic and international markets. He highlighted that these efforts would:
- Strengthen India’s position as a global leader in medical product manufacturing.
- Enhance exports and foster innovation.
- Provide a competitive advantage for India in the medical products sector.
The PSA emphasized that a well-structured regulatory framework is essential to promote safe, effective, and affordable medical products, ensuring India remains a trusted partner in the global healthcare industry.
