Principal Scientific Adviser (PSA) To Goi Reviews Progress To Transform India’s Regulatory Ecosystem For Medical Products.

New Delhi, Delhi, 18th of December, 2024 : Prof. Ajay Sood, Principal Scientific Adviser (PSA) to Government of India chaired the third meeting to review the progress made towards transformation of India’s regulatory system, which was a follow-up of the earlier review meeting held on 21^st August 2024. The 24th PM-Science Technology Innovation Advisory Council (PM-STIAC) meeting which was held on the 6th of February 2024 on ‘Transforming the regulatory ecosystem of the medical products in India’ discussed this matter. The PM-STIAC meeting, chaired by PSA, recommended to comprehensively overhaul the regulatory processes and work towards building a system that ensures transparency, accountability and at the same time promotes innovation and introduction of safe and affordable medical products for India and the world.

Dr. Rajeev Raghuvanshi, Drug Controller General of India (DCGI), Central Drugs Standard Control Organisation (CDSCO) updated the progress in priority areas, and informed that several initiatives have been undertaken such as successfully continuing India’s Maturity Level 3 (ML3) position in NRA (National Regulatory Authority) assessment for vaccines by WHO. Further, CDSCO also hosted the International Conference of Drug Regulatory Authorities (ICDRA), in which regulators of over 120 countries participated.  DCGI also informed that they have inaugurated the 9^th CDSCO drug testing lab at Bhubaneswar in an effort to enhance testing capability.  Significant process improvements are being made to streamline the internal processes by using Kaizen processes. He also elaborated the progress made on PMSTIAC recommendations such as streamlining of the Subject Expert Committee (SEC) review process, connecting with the innovators through the Medtech Mitra initiative, increasing the scientific capacity of CDSCO, increased digitization, and regular check-ins with the industry among others.

PSA appreciated the efforts of CDSCO and emphasized that a robust and enabling regulatory ecosystem will help to build trust in domestic and international markets, boost manufacturing and exports. He said that these efforts will further augment the competitive advantage that India has in the manufacturing of medical products and spur innovations in the entire sector.

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