by The Welthi Bureau | 30 NOV 2017
The Andhra Pradesh MedTech Zone (AMTZ), India’s first government-funded medical devices manufacturing park, in Visakhapatnam district has been chosen by the World Health Organization (WHO) to host its pre- qualification cell for In Vitro Diagnostics (IVD), which is a first of its kind in South East Asia.
The WHO made an official announcement about the cell at AMTZ during the 1st World Conference on Access to Medical Products and International Laws for Trade and Health organised in New Delhi recently.
The cell will provide guidance to Indian manufacturers on the WHO pre-qualification of IVDs programme and will enable them to produce devices that match global quality standards, apart from helping them to participate in UN procurement process for IVD device, enabling export.
WHO will provide the essential training to the staff of support cell to guide the manufacturers about WHO pre-qualification expectations while the AMTZ will handle day-to- day operations. AMTZ, which will be provided with the necessary scientific facilities, would help manufacturers reduce the cost of manufacturing by more than 40-50 per cent.
The IV diagnostics segment has an estimated market value of `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 `254 crore in 2015-16.
The WHO pre-qualification of IVDs programme aims at promoting and facilitating equitable access to safe, appropriate and affordable in vitro diagnostics of good quality. It focuses on in vitro diagnostics for HIV, malaria,
Hepatitis B and Hepatitis C, and their suitability for use in resource-limited settings.
AMTZ will set up eight medical devices testing labs, in the next eight months, giving an opportunity to all the 180 companies it can accommodate, to test their products. At present, 38 companies have set up 53 units in AMTZ.
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