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New Delhi, December 19, 2024 – Prof. Ajay Sood, Principal Scientific Adviser (PSA) to the Government of India, chaired the third review meeting to assess the progress of transforming India’s regulatory system for medical products. The meeting followed up on earlier deliberations held on August 21, 2024, and was in line with the recommendations made during the 24th PM-Science Technology Innovation Advisory Council (PM-STIAC) meeting on February 6, 2024.
The PM-STIAC meeting emphasized the need for a comprehensive overhaul of regulatory processes, aiming to create a system that fosters transparency, accountability, and innovation while ensuring the availability of safe and affordable medical products for India and global markets.
Progress Highlights
Dr. Rajeev Raghuvanshi, Drug Controller General of India (DCGI) from the Central Drugs Standard Control Organisation (CDSCO), presented significant updates:
- Sustaining NRA Recognition: India successfully maintained its Maturity Level 3 (ML3) position in the National Regulatory Authority (NRA) assessment for vaccines by the World Health Organization (WHO).
- Global Engagements: CDSCO hosted the International Conference of Drug Regulatory Authorities (ICDRA), attracting participation from regulators of over 120 countries, bolstering global collaboration.
- Enhanced Infrastructure: The inauguration of the ninth CDSCO drug testing laboratory in Bhubaneswar marks an effort to strengthen testing capabilities across the country.
- Process Optimization: By adopting Kaizen methodologies, CDSCO is streamlining internal processes to improve efficiency.
- Innovation and Industry Support: Initiatives like the Medtech Mitra program have been launched to engage directly with innovators. Efforts are also underway to enhance the scientific capacity of CDSCO, digitize processes, and establish regular industry check-ins.
Dr. Raghuvanshi also reported progress on streamlining Subject Expert Committee (SEC) reviews, a key recommendation from PM-STIAC.
Vision for a Competitive Edge
Prof. Sood commended CDSCO’s efforts, emphasizing that a robust and enabling regulatory ecosystem would instill trust in both domestic and international markets. He highlighted how these initiatives would boost India’s manufacturing capabilities, enhance exports, and position the country as a leader in medical product innovation.
“India’s competitive advantage in the medical products sector can be further augmented through a transparent and dynamic regulatory framework. This will not only ensure the availability of safe and affordable products but also spur innovation in the sector,” Prof. Sood stated.
The ongoing transformation of India’s regulatory ecosystem aligns with the government’s broader vision of strengthening the healthcare sector and making India a global hub for medical products.
Looking Ahead
The PSA’s office, alongside CDSCO and other stakeholders, continues to prioritize reforms that will accelerate the introduction of cutting-edge, safe medical products. These efforts mark a significant step toward building a globally recognized regulatory system and fostering an ecosystem that supports innovation and economic growth.
The next review meeting will assess further progress and ensure alignment with the PM-STIAC’s vision for transforming the regulatory landscape in India.
