WHO selects AMTZ to host pre-qualification cell for in vitro diagnosticsPublish Date : Nov 23, 2017
The World Health Organization (WHO) has selected Andhra Pradesh MedTech Zone Ltd (AMTZ), India’s first government funded medical devices manufacturing park, to host its pre-qualification cell for In Vitro Diagnostics (IVD) which is a first of its kind in South East Asia.
This pre-qualification cell, which will provide guidance to Indian manufacturers on the WHO pre-qualification of IVDs Programme and will also enable manufacturers to match global quality standards. It will also help manufacturers to participate in UN procurement process for IVD devices enabling export.
WHO will provide the required training to the support cell staff to guide the manufacturers about WHO pre-qualification expectations while AMTZ will handle day to day operations. AMTZ with in-house high investment scientific facilities would help manufacturers reduce the cost of manufacturing by more than 40 per cent to 50 per cent.
The cell at AMTZ was officially announced by WHO during the ‘1st World Conference on Access to Medical Products and International Laws for Trade and Health’ organised in New Delhi recently.
The IV Diagnostics segment has an estimated market value of Rs.3.54 lakh crore globally out of which India contributes an estimated Rs.2,550 crore. 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 crore for Indian manufacturers to tap into.
WHO pre-qualification of 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 standardized procedure aimed at determining if the product meets WHO pre-qualification requirements.
AMTZ will soon set up eight medical device testing labs under one roof. This will provide medical device testing facilities to around 180 companies at AMTZ in the coming eight months time.
Currently 38 companies have set up 53 units in AMTZ which has a total capacity of 180 companies. These companies can set up a total 240 units in the coming time. A comprehensive facility to test all medical devices under one roof will also be provided to the companies in AMTZ in coming eight months time.