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Global Regulators Conclave of iPHEX 2022 to push for mutual recognition of regulatory approvals and pharmacopoeias
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Laxmi Yadav, Mumbai
September 17 , 2022
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With an aim to boost Indian drug export by reducing development cost and regulatory approval timeframe, the upcoming 8th edition of the International Exhibition of Pharma and Healthcare (iPHEX) 2022, will hold Global Regulators Conclave to deliberate on mutual recognition of regulatory approvals and pharmacopoeias.
iPHEX 2022, coinciding with the 75 years of Indian independence celebrations, is scheduled to be held from September 21-23 in Greater Noida. It is expecting 75 regulators from more than 50 countries including US, Nigeria, South Korea, South Africa, Russia, Hungary, etc and is poised to be a first of its kind event organised anywhere in the world.
The Global Regulators Conclave to be held under the theme, “International Regulatory Convergence to Promote Accessibility and Affordability of Quality Medicines”, is set to facilitate convergence of like-minded drug regulators. Like acceptance of US FDA’s inspection in a number of countries, if like-minded countries accept Indian drug regulator’s inspection, it will reduce production cost and regulatory approval timeframe of Indian drug makers and exporters. The DCGI will lead the discussions along with state and central regulators,” said Pharmaceuticals Export Promotion Council of India (Pharmexcil) director general Ravi Udaya Bhaskar.
Besides this, this regulatory conclave will also provide an opportunity to the Indian industry to interact with international regulators, he added.
The conclave is taking place at a time when discussion on mutual recognition of regulatory approvals and pharmacopoeia under India-UAE free trade agreement is going on. There are chances that mutual recognition of pharmacopoeias under the India-UAE pact may take place during the conclave. The free trade pact signed between India and the UAE came into force from May 1 this year.
Besides this, the conclave is also quite significant as it is being conducted at a time when a significant number of Indian drug companies are waiting for inspection of their facilities by regulators of several countries for renewal of their approval and approval of their new plants. It will deliberate on the fast-track approvals granted during Covid-19 could be continued in future as well. The conclave is also likely to deliberate on resuming inspection of Indian drug plants by European Union regulators which they ceased in the wake of Covid-19.
iPHEX chairman and Laurus Labs CEO C. Satyanarayana said “India can play a significant role in harmonising regulations across the globe. If a country’s regulatory approval gets accepted in a number of countries, it is also an indication of the strength of a regulatory body. Drugs approved by Indian regulators should get accepted in emerging countries who show the path forward to countries which lack enough regulators for drug approvals. India can demonstrate that it can offer solutions to emerging countries. It will reduce cost of product development and approval timeframe.”
Regulatory approvals in African countries have become easier as compared to earlier thanks to consortium of African countries and efforts of Pharmexcil. iPHEX will improve the image of the Indian drug industry, added Satyanarayana.
The main aim of the event is to showcase the advancement and achievement of Indian industry to the globe. Besides this, we also aim to bring regulators from various countries to showcase the strength of the Indian regulatory system and find an opportunity to harmonise regulations, so that drugs approved in India get approved in emerging countries easily, he stated.
He also lauded the production linked incentive (PLI) scheme launched by the government to boost growth of drug industry, saying that it will attract foreign investments in the pharma sector.
He also emphasised the need for improving infrastructure to spur the growth of the industry.
iPHEX 2022 is an international exhibition and expo on pharma and healthcare. It will offer the industry majors from India and all across the world a great platform to connect and do business. It will provide you with an opportunity to meet new and existing customers actively looking for new suppliers, or looking to assess the current progress of existing projects. In this edition 350 Indian exporters are exhibiting their products and expecting 700 overseas buyers from more than 100 countries.
In addition to the business meetings, iPHEX 2022 also features number of panel discussions on subjects like India sourced generic drugs-global expectations, Learning from Covid-19 pandemic-regulatory enablers for fast track approvals and supply chain resiliency and regulatory preparedness for healthcare emergencies, Accessibility, affordability and equitable distribution of Covid-19 vaccines & therapeutics, Migrating from routine to risk based inspections -optimising the human resources in post pandemic, Effective use of pharmacopoeias, added Pharmexcil director general.
This conference certainly will help showcase the capabilities of the Indian pharmaceutical industry and also build up confidence among the global regulators and international public procurement agencies. India has exported USD 24.6 billion in fiscal 2021-22. The Department of Commerce has given a target of USD 27. 43 billion for FY 22-23 and we are optimistic that we can achieve the target, he stated.
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