India's PSA Reviews Progress in Regulatory Transformation for Medical Products

The Medtech Mitra initiative was highlighted as a platform to connect innovators and streamline the Subject Expert Committee (SEC) review processes.

India's Principal Scientific Adviser (PSA) to the Government of India, Prof. Ajay Sood, chaired the third review meeting on the progress of transforming the country’s regulatory system for medical products. This meeting was a follow-up to the 21st August 2024 review and built on discussions from the 24th PM-Science Technology Innovation Advisory Council (PM-STIAC) meeting, held on 6th February 2024, focusing on transforming the regulatory ecosystem for medical products in India.

The PM-STIAC had recommended a comprehensive overhaul of regulatory processes to foster transparency, accountability, and innovation, ensuring the introduction of safe and affordable medical products for both domestic and global markets.

Dr. Rajeev Raghuvanshi, the Drug Controller General of India (DCGI), provided an update on priority initiatives, highlighting the following achievements:

WHO’s Maturity Level 3 (ML3) Position: India successfully retained its ML3 position in the National Regulatory Authority (NRA) assessment for vaccines, affirming its credibility in ensuring vaccine safety and efficacy.

International Engagement: CDSCO hosted the International Conference of Drug Regulatory Authorities (ICDRA), which saw participation from regulators representing over 120 countries.

Enhanced Drug Testing Capabilities: The inauguration of the 9th CDSCO drug testing lab in Bhubaneswar marked a step forward in strengthening the country’s pharmaceutical testing infrastructure.

Process Improvements: CDSCO implemented Kaizen methodologies to streamline internal processes, ensuring greater efficiency.

The Medtech Mitra initiative was highlighted as a platform to connect innovators and streamline the Subject Expert Committee (SEC) review processes. Progress has also been made in increasing scientific capacity, digitization, and enhancing industry collaborations through regular check-ins.

Building Trust and Global Competitiveness

During the meeting, PSA Prof. Ajay Sood lauded CDSCO’s efforts and emphasized the importance of a robust regulatory ecosystem in enhancing trust within domestic and international markets. He underlined that these measures will not only bolster India’s manufacturing and export capabilities but also spur innovation in the medical products sector, positioning India as a global leader.

“India’s competitive advantage in medical product manufacturing can be significantly augmented with a strong regulatory framework. These reforms will build confidence among stakeholders, attract investments, and further the nation’s progress in health innovation,” Prof. Sood remarked.

Additional Developments

Digitization Initiatives: CDSCO is accelerating the adoption of digital tools to simplify regulatory processes, reduce timelines, and ensure real-time tracking for stakeholders.

Industry Collaboration: Through its industry engagement programs, CDSCO is addressing industry challenges and aligning regulatory goals with market needs to enhance ease of doing business.

Capacity Building: Efforts to train regulatory personnel are underway, aimed at increasing their expertise in cutting-edge medical technologies and global best practices.

Looking Ahead

The PSA underscored the significance of aligning India’s regulatory ecosystem with international standards while maintaining affordability and accessibility. He stressed the role of these reforms in enabling India to meet its healthcare demands while contributing to global health through innovation and exports.

With a focus on transforming regulatory systems, building partnerships with innovators, and investing in capacity building, India is poised to strengthen its position as a hub for safe, affordable, and innovative medical products.