Boost to IVD Manufacturing in India, WHO Establishes Pre-quaification Cell

World health Organization (WHO) has selected Andhra Pradesh MedTech Zone Limited (AMTZ) to host their Pre-Qualification cell for In-Vitro Diagnostics, which is a first of its kind in South East Asia. 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 in New Delhi today. A citation plaque was presented by WHO to Dr Poonam Malakondaiah, Principal Secretary Health Medical & Family Welfare Govt of AP and Dr Jitendar Sharma, MD and CEO, AMTZ to commemorate the occasion.

The In-Vitro Diagnostics segment has an estimated market value of INR 3.54lakh cr. globally out of which India contributes an estimated INR 2550 cr.

Exports from India in the In-Vitro Diagnostics segment were at INR 254 cr in FY- 16 which leaves a huge export opportunity of approximately INR 3 lakh cr for Indian manufacturer to tap into.

This pre-qualification cell, which will provide guidance to Indian manufacturers on the who pre-qualification of In-Vitro Diagnostics program is an important addition to India’s medical device ecosystem as it enables manufacturers to match global quality standards and also participate in UN procurement process for In-Vitro Diagnostics devices enabling export. WHO will provide the required training to the support cell staff to guide the manufacturer about WHO pre-qualification expectations while AMTZ will handle day to day operation.

The WHO pre-qualification of In-Vitro Diagnostics programs aims to promote and facilitate access to safe, appropriate and affordable In-Vitro Diagnostics of good quality in an equitable manner. The program focuses on IVD for priority diseases such as HIV malaria hepatitis B and Hepatitis c and their suitability for use in resource-limited setting. It undertakes a comprehensive assessment of In-Vitro Diagnostics through a standardized  procedure aimed at determining in the product meets who pre-qualification requirements.

“We are delighted with the announcement. This is a big boost to making India a manufacturing hub for medical devices including IVD,” said Rajiv Nath, Forum Coordinator, AiMeD.

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