India to host drug regulators from 46 nations on Sep 21

India will host one of the biggest congregations of drug regulators from over 46 countries as part of a Global Regulators Conclave being organised by the Pharmaceutical Export Promotion Council (Pharmexcil) in India Expo Centre, Greater Noida, near Delhi during September 21-23. The drug regulators will deliberate upon the need for mutual recognition of regulatory approvals for pharmaceutical products among these countries.

The initiative turns significant as the regions these drug regulators represent – mostly from Africa, South America, CIS region and parts of Asia – account for over 50% of India’s $24.6 billion pharmaceutical exports. Any mutual recognition of the regulatory framework can further ease India’s trade of medicines and pharmaceutical products to these countries. While India’s pharma product exports are estimated to be growing at 10% annually, the rate of growth is higher in its developing country markets.

Mojisola Christianah Adeyeye, Director General of Nigeria’s National Agency for Food & Drug Administration, Vlasdislav Shestakov, Director, State Institute of Drugs and Good Practices, Russia, Pablo Sanchez Gastelum and Yuri Werner Quisbert Aruquipa, Executive Director General, State Agency for Medicines & Health Technologies are among the key regulators who have confirmed their presence for the event.

“The focus of the conclave is international regulatory convergence to promote accessibility and affordability of quality medicines”, Udaya Bhaskar, Director General, Pharmexcil, said. According to him, the event will also see 350 Indian exporters exhibiting their products to over 700 overseas buyers from over 100 countries. “It is a niche event with exclusive one to one business meetings and deliberations with regulatory officials covering NAFTA, EU, Africa, ASEAN, CIS, LAC and WANA regions”, he adds.

The conclave will have special discussions on the global expectations from India sourced generic drugs, learning from Covid-19 pandemic and the need for regulatory enablers for fast track approvals and supply changes resiliency, regulatory preparedness for healthcare emergencies, and the need for migration from routine to risk-based regulatory inspections to optimize human resources in the post-pandemic days.

The Indian drug regulator – Central Drugs Standard Control Organization or CDSCO – is the co-organizer of the event. The event is supported by the Commerce Ministry. Around 100 Indian regulatory officials are also expected to participate in the event.