Andhra Pradesh MedTech Zone Ltd (AMTZ) has been selected by the World Health Organisation (WHO) to host their pre-qualification cell for In Vitro Diagnostics (IVD) — a first-of-its-kind facility in South East Asia.
WHO officially announced the cell at AMTZ during the first World Conference on Access to Medical Products and International Laws for Trade and Health at New Delhi on Wednesday.
The establishment of pre-qualification cell will provide guidance to Indian manufacturers on the WHO Pre-Qualification of In Vitro Diagnostics (IVDs) Programme, enabling manufacturers to match global quality standards and also participate in UN procurement process for IVD devices.
The IV Diagnostics segment has an estimated market value of Rs 3.54 lakh crores globally out of which India contributes an estimated Rs 2,550 crores. Exports from India in the IVD segment were at Rs 254 crores in FY16 which leaves a huge export opportunity of approximately Rs 3 lakh crores for Indian manufacturers to tap into.
WHO will provide the required training to the support cell staff to guide the manufacturers about WHO Prequalification expectations while AMTZ will handle day to day operations.
A citation plaque was presented by WHO to Dr Poonam Malakondaiah, Principal Secretary Health Medical & Family Welfare, Government of Andhra Pradesh and Dr Jitendar Sharma, MD & CEO, AMTZ, to commemorate the occasion.
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 programme focuses on in vitro diagnostics for priority diseases such as HIV, malaria, hepatitis B and hepatitis C, and their suitability for use in resource-limited settings. It undertakes a comprehensive assessment of in vitro diagnostics through a standardised procedure aimed at determining if the product meets WHO prequalification requirements.