Lucknow: In a major push to strengthen India’s medical device and pharmaceutical manufacturing ecosystem, the Uttar Pradesh govt is working on an ambitious project to establish a US FDA-accredited medical device testing laboratory in the state.Known as the Accreditation Scheme for Conformity Assessment (ASCA) lab, the facility would be part of the UP medical devices park coming up in the Yamuna Expressway Industrial Development Authority. To be established on PPP mode, this facility is being touted as both significant and ambitious, as it promises to create powerful ripples of change in the pharma sector while positioning UP on the national and sub-regional (South East Asian) map.
To note, ASCA is a US Food and Drug Administration framework to certify whether medical devices meet globally recognised quality and safety standards. CEO, YEIDA, RK Singh said that the proposed ASCA lab will provide end-to-end testing, validation, and certification services for medical devices within the state, significantly reducing the need for manufacturers to rely on overseas or out-of-state facilities. “Such certification is mandatory for exporting medical devices to the US market, one of the largest and most regulated healthcare markets globally,” he said. Sectoral experts revealed that globally, there are around 160 ASCA-accredited laboratories, with the overwhelming majority located in the US and Canada. Europe hosts only a limited number, while China has 17 such facilities and Japan 7. India currently does not have an ASCA-accredited lab—a gap which is “critical” given the rapid growth of the country’s pharmaceutical and medical device sectors. “Once operational, the lab is expected to serve not only domestic manufacturers but also companies from South East Asian countries, positioning Uttar Pradesh as a regional hub for advanced medical device testing,” Singh stated. In the long run, the facility would create a ripple effect across the pharma and medical device manufacturing ecosystem by setting higher benchmarks for quality, compliance, and performance. Insiders said that discussions are underway to finalise the framework, and meetings to draft the terms of reference for the tender process are expected to take place soon. By shortening product development timelines, lowering compliance costs, and enabling faster market access—especially for MSMEs—the proposed lab is expected to significantly enhance Uttar Pradesh’s competitiveness in the global medical device value chain.
