9-11 June 2015, New Delhi
The World Health Organization (WHO) organized an international briefing workshop on WHO Prequalification Programme (PQP) for Indian manufacturers of in vitro diagnostics (IVD), in New Delhi from 9-11 June 2015. The workshop was held to support training of manufacturers to improve their understanding of Prequalification (PQ) requirements and ability to address commonly observed deficiencies related to risk management and quality control of IVD.
The inaugural session was addressed by Dr (Prof.) Jagdish Prasad, Director General of Health Services, Ministry of Health & Family Welfare (MoHFW),Dr A.C. Dhariwal, Director, National Vector Borne Disease Control Programme (NVBDCP),; Mr Manoj Jhalani, Joint Secretary - Policy, MoHFW; Dr Eswara Reddy, Joint Drug Controller, CDSCO; Dr Gaby Vercauteren, Senior Advisor, Prequalification Team, Essential Medicines and Health Products Department, WHO, and Dr Madhur Gupta, Technical Officer- Pharmaceuticals, WHO.
Dr (Prof.) Jagdish Prasad, Director General of Health Services, MoHFW highlighted, “WHO Prequalification Programme provides a guarantee that the product is quality and safety wise tested and complies with the international standards. But currently, only three medical diagnostic products from India have been pre-qualified, and hence this workshop is timely and pertinent to focus on the most urgent needs.”
The WHO PQP Programme aims to promote and facilitate access to safe, appropriate and affordable IVD of good quality in an equitable manner. The focus is on IVDs for priority diseases, such as HIV/AIDS, hepatitis and malaria, and their suitability for use in resource-limited settings.
In his address, Mr Manoj Jhalani, Joint Secretary (Policy), MoHFW said, “India is a forerunner in the pharmaceuticals industry but much work is required to strengthen the IVDs market. In the context of Universal Health Coverage, we would need to cater to the urgent and major health care needs of the population.”
India has witnessed dynamic regulatory changes introduced in the area of diagnostics and medical devices. The regulatory authority in India has recently proposed an amendment to the regulation of IVD medical devices in the Drugs & Cosmetics Act. The meeting provided an opportunity to facilitate an exchange of international practices, including WHO PQP requirements for diagnostics with the Indian manufacturers and the regulators.
In his remarks, Dr S Eswara Reddy, Joint Drug Controller, CDSCO outlined, that IVD is an evolving industry in which technology advances with each new generation of medical device. “Due to the evolving scenario, investment in research and development is vital and it is the need of the hour to strengthen our industry,” he added
It was also emphasized that an open dialogue amongst medical device and diagnostic manufacturers could pave the way towards a win-win situation and facilitate the Indian manufacturers to contribute more to the global market with a focus to provide quality care with quality products.
Delegates from Central Drugs Standard Control Organization (CDSCO), UNAIDS, World Bank, Global Fund, UNOPS, UNITAID, UNICEF and select Indian manufacturers participated in the workshop. Critical topics of importance such as most commonly observed non-conformities during inspections and quality control, risk management, WHO PQ requirements, etc were deliberated at the workshop.