2nd Annual Regulators Conclave for Central and State Regulatory Authorities

23-24 August 2018, Kasauli, Himachal Pradesh

The Second Annual Regulators Conclave for Central and State Regulatory Authorities in India, organised jointly by the Central Drugs Standard Control Organisation (CDSCO), Union Ministry of Health & Family Welfare (MoHFW), Government of Himachal Pradesh and World Health Organization (WHO), brought together senior officials from CDSCO and MoHFW, regulators from central and state levels, international experts from WHO, industry representatives and other important stakeholders on a single platform.

Speaking on the occasion, Dr R.K. Vats, Additional Secretary, MoHFW said that sustained engagement, interaction and commitment by CDSCO and state regulatory agencies will enable cross-fertilization of ideas and adoption of best practices for strengthening of regulatory systems in India.

The deliberations focused attention on global best practices; holistic approach for quality medical products through micro, small & medium enterprises; innovation in health technologies; standards and validation for medical devices and diagnostics; India’s readiness for pharmaceutical inspection convention and pharmaceutical inspection cooperation scheme; and the revision of WHO certification scheme on quality of pharmaceutical products.

Speaking at the inaugural session, Dr Emer Cooke, Director, Regulatory System Strengthening, WHO HQ, said, “With the evolving landscape of the global market for pharmaceuticals and medical products, there is a need for strong regulatory systems, quality manufacturing, efficient supply chains, effective post-market surveillance and greater affordability of health products. WHO’s global programme of work fully ensures the strategic vision of empowering Member States, ensuring access to safe and affordable medicines and health products, especially in low- and middle-income countries.”

Other prominent dignitaries at the inaugural session were: Mr Sudhir Kumar, Joint Secretary, MOHFW; Dr Eswara Reddy, Drugs Controller General of India; Dr N.K. Lath, Director, Government of Himachal Pradesh; Dr R.K. Bajaj, DDG, Bureau of Indian Standards; Dr Jitender Sharma, Chairman, Kalam Institute of Health Technology; Dr Gagandeep Kang, Director, Translational Health Science Technology Institute; Ms Neeraj Saraff, MD Karnataka Antibiotics Pvt. Ltd; Dr Raj Long, Deputy Director, Global Health, Bill and Melinda Gates Foundation. The event was live web-streamed across the country.

The Indian pharmaceuticals market is the third largest in terms of volume and thirteenth largest in value. The pharmaceutical sector is one of the 25 key sectors identified by the Government of India under the ‘Make in India’ initiative and is expected to provide the necessary impetus to the sector.

An effective regulatory ecosystem is an essential component of health system strengthening and ensuring better public health outcomes. In this context, WHO provides technical and operational assistance for strengthening the Indian National Regulatory Authority, and endeavours to scale-p support to other product areas including medicines at both central and state levels.