To improve the understanding of the World Health Organization (WHO) Prequalification (PQ) requirements amongst Indian medical device manufacturers, a ‘National workshop on WHO Prequalification of In-vitro Diagnostics (IVDs) Programme’ was held in Delhi from 14-16 June 2016.
The workshop aimed at reiterating the regulatory requirements for performance and stability studies for in-vitro diagnostic medical devices and ability to address commonly observed deficiencies. It also provided an opportunity to facilitate sharing of best international practices in the area of in-vitro diagnostics
The WHO Prequalification of In-vitro Diagnostics (IVDs) Programme aims to promote and facilitate access to safe, appropriate and affordable in-vitro diagnostics 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. The WHO Prequalification of IVDs Programme undertakes a comprehensive assessment of individual in-vitro diagnostics through a standardized procedure aimed at determining if the product meets WHO prequalification requirements.
The topics discussed at the workshop were: Overview of contribution of Indian manufacturers to the WHO Prequalification of Medicines and Diagnostics Programme; recent updates on the regulatory requirements of IVDs in India; recent Initiatives in the area of medical devices and health technology in India; and diagnostics and stakeholder perspectives for diagnostics development, regulation and use of In-vitro diagnostics in India.
The workshop was attended by the Central Drugs Standard Control Organization (CDSCO), National Accreditation Board for Hospitals & Healthcare Providers (NABH), Biotechnology Industry Research Assistance Council (BIRAC), National Institute of Biologicals (NIB), Medical Equipment and Hospital Planning Department (MHD), UNAIDS and CDC, and also select Indian manufacturers, amongst others.