Prof. Ajay Kumar Sood, the Principal Scientific Adviser (PSA) to the Government of India, recently convened a meeting to assess advancements in transforming India’s regulatory framework for medical products. This review took place during the 24th PM-Science Technology Innovation Advisory Council (PM-STIAC) meeting, which was chaired by Prof. Sood on February 6, 2024. The session focused on the ongoing efforts to overhaul the regulatory processes for medical products in India.
The PM-STIAC had previously recommended a comprehensive overhaul of these processes to enhance transparency, accountability, and innovation while ensuring the availability of safe and affordable medical products.
Dr. Rajeev Raghuvanshi, the Drug Controller General of India (DCGI) at the Central Drugs Standard Control Organisation (CDSCO), provided an update on key initiatives. These include streamlining the Subject Expert Committee (SEC) review process, improving internal procedures with the assistance of an independent external agency, and developing a comprehensive digital infrastructure for the regulatory ecosystem. Additional efforts include consolidating the Review Committee on Genetic Manipulation (RCGM) into a single-window system to expedite approvals, advancing CDSCO’s scientific capabilities, increasing digitization, and implementing recent rule changes to simplify access to medical products.
Prof. Sood commended CDSCO’s progress and highlighted that a strong regulatory framework will enhance trust in both domestic and international markets, drive manufacturing and exports, and strengthen India’s competitive edge in medical product innovation.
