Imported Parts, Indian Label? Panel Seeks Tighter Checks, Preference For Medical Devices With 50% Local Content

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Parliamentary Panel urges tighter checks on “Make in India” medical devices, proposing 50% domestic content preference, 40% local value verification, traceability and third-party audits to curb imported kit assembly.

Medical Devices
Imported Parts, Indian Label? Panel Seeks Tighter Checks, Preference For Medical Devices With 50% Local Content

Calling for tighter checks to ensure that imported medical devices are not being passed off as “Make in India” products, a parliamentary panel has recommended that the Centre give preference in public procurement to Indian-manufactured medical devices with at least 50% domestic content.

The recommendation comes amid concerns within the medical device industry that simply assembling imported components in India can allow companies to qualify for government procurement benefits meant to promote genuine domestic manufacturing.

The Department-related Parliamentary Standing Committee on Health and Family Welfare, in its 176th report on affordability and accessibility of healthcare facilities in the public and private sectors, said genuine indigenous manufacturing, rather than mere assembly of imported components, was essential to building self-reliance in medical technology.

The committee, headed by Member of Parliament Prof. Ram Gopal Yadav, also called for a more rigorous system to verify the actual extent of local value addition in devices bought with public money.

It recommended that Indian-manufactured medical devices containing at least 50% domestic content should be given preference in public procurement.

At the same time, the panel proposed a mandatory verification mechanism requiring a minimum 40% local value addition, component-level traceability and digital Bills of Materials (BoM) from companies participating in government procurement.

The committee said self-certification and statutory documents alone may not be sufficient to establish the origin of components, particularly in high-value and technologically complex medical equipment.

It has therefore recommended periodic third-party audits, disclosure of the country of origin of critical components and independent verification of local content.

The objective is to ensure that the Make in India provision promotes genuine manufacturing and technology development rather than incentivising companies that simply assemble imported parts in the country.

When asked to comment on the Parliamentary panel’s observation, Vishwaprasad Alva, Managing Director, Skanray Technologies, said the concern was not merely theoretical.

“Chinese kits are being assembled in India and then sold to the government as 'Made in India' products. The funny and sad part is that some of these products can also avail PLI and Make in India benefits. There is currently no effective mechanism to check this misuse,” Alva said.

According to the industry sources, the gap lies in distinguishing value addition through genuine manufacturing from the assembly of imported kits. “If a company imports almost the entire product and only assembles it in India, that should not be treated on par with a manufacturer that develops the technology, manufactures components and builds the product domestically,” the sources said.

The parliamentary panel's recommendations could therefore have implications not only for procurement but also for the broader medical technology ecosystem, particularly as India seeks to reduce its dependence on imported devices.

Medical devices, ranging from diagnostic and imaging equipment to implants and critical-care technologies, form an essential part of healthcare delivery. A high import dependence can leave the health system vulnerable to global supply-chain disruptions, currency fluctuations and geopolitical uncertainties.

The committee said strengthening indigenous manufacturing could improve healthcare self-reliance while potentially reducing the lifecycle cost of medical technologies.

It also recommended incentives and preferential procurement for domestically manufactured devices, arguing that government purchasing power could be used to create a stronger market for Indian med-tech companies.

This could be particularly important for start-ups and MSMEs that successfully develop and validate new technologies but struggle to secure their first major orders.

The panel took note of the MedTech Mitra platform, which has mentored more than 400 innovators, as well as Centres of Excellence established across seven IITs. These centres have reportedly contributed to 43 indigenous medical technologies and 16 start-ups.

It recommended expanding the Centres of Excellence model to other premier engineering and medical institutions and creating a dedicated procurement quota within national health programmes for indigenously developed and validated technologies.

Such a mechanism, the panel said, could help promising start-ups and MSMEs cross the so-called “valley of death” between developing a product and achieving commercial scale.

The committee also linked domestic medical technology development with the larger objective of making healthcare more affordable. It argued that greater self-reliance could eventually help lower the cost of critical treatments and healthcare products.

For the industry, however, the success of such a policy will depend on how effectively local-content claims are verified.

A manufacturer said the government needs to establish a transparent and uniform system that clearly defines what qualifies as domestic manufacturing and what constitutes mere assembly.

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