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Global drug regulators at iPHEX show willingness to forge mutual recognition of regulatory approvals, pharmacopoeias

Laxmi Yadav, Mumbai
Wednesday, September 28, 2022, 08:00 Hrs  [IST]

Drug regulators from more than 70 countries, converged at the 8th edition of iPHEX, have shown willingness to forge mutual recognition agreements in regulation of medicines which will allow faster regulatory approval thus improving availability and accessibility of pharmaceutical products. This, in turn, will help increase Indian drug exports.

Besides mutual recognition of the regulatory system, drug regulators also emphasized the need to build local manufacturing capability to tide over the shortage of drugs in the wake of supply chain disruption caused by Covid-19 pandemic.

Held from September 21-23 in Greater Noida, the 8th edition of iPHEX, an international exhibition of pharma and healthcare, has witnessed participation of drug regulators from around 72 countries including Cuba, South Korea, Hungary as well as around 500 international delegates. Over 350 Indian companies from the pharma and healthcare sector exhibited their products and services. The exhibition attracted over 10 000 domestic visitors as well. 
Held by the Pharmaceuticals Export Promotion Council of India (Pharmexcil) with the support of the Department of Commerce, the three-day event showcased the entire spectrum of the pharmaceuticals and healthcare sector to the world.
Said Uday Bhaskar, director general, Pharmexcil, “iPHEX 2022 ended on a high note witnessing participation of drug regulators from NAFTA, EU, Africa, ASEAN, CIS, LAC and WANA regions. The Global Regulators’ conclave which was held under the theme “International Regulatory Convergence to Promote Accessibility and Affordability of Quality Medicines” deliberated on mutual recognition of regulatory approvals and pharmacopoeias. The regulators have unanimously called for mutual recognition of regulatory systems which will cut production cost and regulatory timeframe of Indian drug companies. Furthermore, they also showed inclination towards harmonization of pharmacopoeias providing better support for regulatory agencies and addressing global nature of pharmaceutical manufacturing and supply chain which will ultimately improve availability of lifesaving drugs. The harmonization of pharmacopoeias will help Indian industry serve multiple markets with the same processes and plants.”

Chiming in with him, SV Veeramani, vice chairman, Pharmexcil said, “The three-day iPHEX was a well organised event attracting over 10,000 domestic visitors as well as around 500 international delegates. It offered excellent opportunities to explore business collaboration, technology transfer and investment opportunities in the pharmaceutical industry. Global Regulators’ conclave, one of the main attractions of the event, was also well received by regulators from over 72 countries. Global regulators have recognized Indian drug manufacturing prowess and expressed a desire to forge mutual recognition of regulatory systems to ensure faster drug approval. This is good for India’s drug exports.”
Nipun Jain, chairman, Small and Medium Pharma Manufacturers Association (SMPMA) said “Held after a gap of two years, iPHEX was well received by Indian drugmakers and exporters. Overall, it was a good event. Compared to iPHEX 2019 which witnessed participation from more than 500 Indian companies from pharma and healthcare sectors and 700 foreign delegations from 120 countries, iPHEX 2022 has witnessed participation of just 500 international delegates. We were expecting more foreign delegates this time as compared to 2019, so that there would be more business prospects.”

ICPA Health Products Ltd said “Since iPHEX was organized after two years, there was excitement and enthusiasm to be there. Especially for us, since we have been focusing on exports, iPHEX offered us an opportunity to learn and update our knowledge on the various regulatory requirements of specific countries and regions. Simultaneously, we got to identify new products and negotiate deals that may help us enter new markets and strengthen our presence in existing ones. Overall, it was a great event for the pharma industry and we are glad that we attended it.”


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