With Advent of Level Playing Field, Domestic MedTech Industry exclaims ‘Eureka!’

AiMed showers unqualified praise on Government for jettisoning foreign favoritism

New Delhi: Rajiv Nath, one of the greatest champions of Make in India and no nonsense leader of domestic medical device industry, finally seems to be convinced of India becoming Atmnirbhar in medical device domain, thanks to union government’s progressive reforms in public procurement. One, who often oscillated between hope and despair, proclaims advent of level playing field and end of foreign favoritism in no uncertain terms. Nath’s ‘Eureka’ ( I found it) ecstasy clearly points up that Indian medical device industry has eventually found its sheet anchor in the government support. Rajiv Nath is prolific on his praise for the government as never before.

The Association of Indian Medical Device Industry (AiMeD) praised the Government of India for progressive reforms in public procurement and the robust judicial support that ensures the reiteration of the country’s commitment to Atmanirbharta in healthcare which became a national imperative post Covid . With policy, regulations and the judicial framework now aligned, Indian manufacturers look forward to a level playing field for tenders.

“We heartily welcome the initiatives of the Government, the policy makers, and the Judiciary in driving a long-overdue move towards fairness in procurement,” said Rajiv Nath, Forum Coordinator, AiMeD. “The word is now loud and clear: preference to foreigners over Indians is not only archaic—it is no longer legally tenable.”

Through policy reforms, a vision is developing.

The government, from the past to the present, has issued a series of consistent and unabashed directives not to discriminate against Indian manufacturers. In December 2017, the Prime Minister’s Office and therafter the DPITT (Department of Industry & Internal Trade) encouraged all departments to make their tenders compliant with the Public Procurement (Preference to Make in India) Order, 2017.

This was then followed by a 2019 Health Ministry directive that labeled mandatory foreign certifications as being “discriminatory” and asked for their phase-out. Then in 2020, the Finance Ministry issued a circular under Rule 144(iii) of the General Financial Rules (GFR), re-emphasizing the inclusion of Indian standards in tenders unless well justified. And the Department of Pharmaceuticals cautioned against the exclusion of homegrown manufacturers simply for lacking foreign regulatory approval certifications such as USFDA or CE.

Rajiv Nath said, ‘these proved groundbreaking measures towards a more inclusive and self-sufficient procurement system. Recent judicial approval now inspires Confidence. Providing legal weight to the policy direction of the Centre, the Supreme Court’s 2025 judgment in the Gwalior Municipal Corporation case deprecated exclusionary clauses assuming Indian incapability by multinationals. Though the case dealt with municipal procurement, the judgment established the general principle of fairness in competition, and by extension, a precedent that can be applied across industries.

“This judicial clarity provided an additional boost of confidence to the manufacturers in India and sends an emphatic message to the tendering authorities to introspect and improve,” said Nath.

Indian Manufacturers, capable, yet underleveraged

India houses more than 3000 Licensed medical devices manufacturing facilities, the lion’s share of which are MSMEs with sound technical competencies. Yet their share in India’s 16,0000 crore ₹ medical devices market is constrained, with more than 65-70% of the products continuing to be imported. AiMeD estimated that restrictive tender conditions have caused an opportunity loss exceeding ₹100,000 crore over the past decade alone.

Turning Point for Procurement Equity

“With policy, legislation, and industry capability now aligned, we think this is a watershed moment for manufacturers domestically,” Nath said. “particularly for those innovating diagnostics, surgical, and therapeutic devices, this is a window of opportunity to scale impact.”

The association has urged all state governments, PSUs, and public hospitals to not just comply with the guidelines but embrace them as a strategic shift in procurement thinking. We empathise with quality concerns of procurement bodies but the solution is giving preference to Quality Council’s Indian Certification for Medical Devices (ICMED) that’s done on an objective non partisan , 3rd party certification though objective audits by competent auditors from Certification Bodies like TUV , UL , SGS accredited by National Accreditation Board of Certification Bodies to global ISO standards under the IAF ( International Accreditation Forum ) system as a voluntary higher conforming process than the minimum mandatory regulatory requirements by CDSCO under Drug’s Act . In public healthcare lowest price L1 can be detrimental for quality and patient safety so Q1 or QCB(Quality based criteria) is more relevant .

“It’s not only a change in tender terms, it’s a change in orientation,” Nath concluded. “We appreciate the government’s vision and look forward to ongoing support for the extension of such reforms across the country.”

 

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