Retd regulators form IGRF to help pharma & medical device start-ups for marketing authorisation abroad. Monday, February 27, 2023, 08:00 Hrs [IST]: http://www.pharmabiz.com/NewsDetails.aspx?aid=156554&sid=1
With a noble intention to support budding entrepreneurs and to bridge the gap between start-ups and international regulators, a team of intellectuals retired from the Central regulatory agency have formed a global consultancy forum to sensitize entrepreneurs about international regulatory requirements for marketing authorization in foreign markets.
The global forum, christened as IKP Global Regulators Forum or IGRF is headed by former Drug Controller General of India Dr. Surinder Singh who is now holding the position of vice-chancellor of the JSS University in Mysore. The global forum is headquartered in Hyderabad and the process for registration is going on, sources informed.
Dr. D. Roy, former deputy director at the CDSCO office in Chennai and a member of the IGRF core committee, said the purpose of this forum is to convert it in the form of an international organisation and work jointly with the JSS University and the IKP, the International Knowledge Park established in Hyderabad and Bangalore to help the pharma and medical devices companies and the MSMEs.
“Today so many things are happening and several developments are coming up in the pharma and medical devices fields. Because of poor knowledge about national and international regulatory systems the budding entrepreneurs are not in a position to cope up with the marketing authorisation. So, IGRF will act as a unique collaborative platform for entrepreneurs, start-ups and MSMEs to support them in navigating the regulatory challenges and guide them for the same”, said Dr. Roy.
He said the core committee will start collaborating with various national and international regulators and make a digital platform initially to address various problems faced by the innovators/start-ups for marketing authorization of their innovative products and their reasonable solutions. IGRF has been launched to help such entrepreneurs.
When asked whether the efforts of the Pharmaceuticals Export Promotion Council are not sufficient in helping the new entrepreneurs who want to do marketing business in foreign markets, especially in the EU markets, Dr. Roy said Pharmexcil is helping the existing manufacturers, but IGRF targets the start-up entrepreneurships. The primary aim is to bridge the gap between the start-ups and the regulators.
Sharing information with Pharmabiz, he said a meeting was held at the JSS University in Mysore recently under the chairmanship of Dr. Surinder Singh and a seven-member core-committee has been formed. The forum will soon include regulators from foreign countries as members. The second sitting of the Forum will be held in the first week of next month in Hyderabad.
Apart from Dr. Surinder Singh and Dr. D. Roy, the members of the core committee include Dr. K Bangarurajan, former JDC at CDSCO, New Delhi, Dr. Dhananjay Patankar, former head of the pharmaceutical and biopharmaceutical development in Bengaluru, Dr. Tony Raj, Dean, St. John's Research Institute in Karnataka, Ranajit Sen, start-up consultant at IKP in Hyderabad, Dr. Sridhar Ramanathan, senior vice-president at IKP Eden and Dr. Priyankana Mukherjee.