On December 18, 2024, Professor Ajay Sood, the Principal Scientific Adviser (PSA) to the Government of India, chaired the third meeting to assess the progress made in transforming India’s regulatory system for medical products. This meeting followed up on the earlier review held on August 21, 2024, and aligned with the discussions from the 24th PM-Science Technology Innovation Advisory Council (PM-STIAC) meeting in February 2024. The overarching goal of the transformation is to overhaul the regulatory processes to ensure greater transparency, accountability, and the promotion of innovation, all while ensuring the safety and affordability of medical products in India and globally.
Dr. Rajeev Raghuvanshi, the Drug Controller General of India (DCGI) and head of the Central Drugs Standard Control Organisation (CDSCO), presented an update on several initiatives that have been undertaken to streamline and enhance regulatory processes. He shared that India had successfully maintained its Maturity Level 3 (ML3) position in the National Regulatory Authority (NRA) assessment for vaccines by the World Health Organization (WHO), a significant achievement for India’s regulatory standards. Furthermore, CDSCO hosted the International Conference of Drug Regulatory Authorities (ICDRA), attended by regulators from over 120 countries, underscoring India’s growing leadership in global regulatory discussions.
In addition, Dr. Raghuvanshi highlighted the inauguration of the 9th CDSCO drug testing laboratory in Bhubaneswar, aimed at boosting India’s drug testing capacity. CDSCO has also been implementing continuous process improvements through methods like Kaizen to enhance internal efficiencies. Key advancements aligned with PM-STIAC recommendations include streamlining the Subject Expert Committee (SEC) review process, engaging with innovators through the Medtech Mitra initiative, and strengthening CDSCO’s scientific capacity. The efforts have been complemented by a push toward increased digitization and improved industry engagement.
Professor Sood commended CDSCO’s efforts and stressed the importance of a robust and efficient regulatory ecosystem in building trust both domestically and internationally. He noted that these ongoing efforts would bolster India’s competitive advantage in medical product manufacturing, drive exports, and foster further innovation in the healthcare sector. The continued progress on these initiatives is expected to significantly contribute to India’s position as a leader in medical product regulation and innovation on the global stage.