Two very different letters landed on the same desk in New Delhi this year.

One came from a group of Indian manufacturers, arguing they'd invested enough, had built enough factories and had earned enough test certifications to be trusted with the equipments that the government still lets hospitals import freely. "Take these devices off the exemption list, since ee can make them now".

The other came from multinational device makers and hospital procurement bodies, asking for almost the opposite. Add roughly 320 more devices to that same list, they argued. Indian manufacturers don't yet make these to the specification hospitals actually need.

Both letters are about the same document, both are still open and whichever way the Department of Pharmaceuticals rules, will decide who gets to sell what to India's public hospitals for years.

I'm Boudhhayan Duttaa, founder of Batti Jalao, an AI-led healthcare marketing agency. We build content and agentic marketing systems such as BattiLynk AI, BattiSense and other custom agentic AI across India's healthcare sub-segments, MedTech among them. This is a piece about a live policy fight most device companies are watching from the sidelines instead of positioning themselves inside it.

How Should Medical Device Companies Market Domestic

Manufacturing Credentials as Make in India Rules Tighten in 2026?

Start with the number everyone quotes and almost nobody sources properly. India imports somewhere between 70% and 85% of it's medical devices, depending on which industry estimate you read, spending tens of thousands of crores a year on equipment built somewhere else. That gap is exactly what the Global Tender Enquiry exemption list exists to manage. Under the Public Procurement (Preference to Make in India) Order, government agencies must prefer domestic suppliers who meet an 80% local-content threshold, except for the 354 devices on this list, which can be imported without that requirement, because domestic supply hasn't caught-up yet.

The Department of Pharmaceuticals opened a public review of that exact list in February 2026, with stakeholder submissions deadline on 15 July, however nothing is settled yet.

The Devices Splitting the Room

The proposed deletions and the proposed additions aren't random. Domestic manufacturers are pushing hardest to remove categories where Indian capacity has genuinely scaled like diagnostics, basic surgical instruments, some imaging components, etc. Multinationals and procurement agencies are pushing to add categories where they argue the gap is real and current such as advanced imaging systems, robotic surgical platforms, specialised ICU monitors, etc. Both sides are right in a way and that's what makes this a genuine fight rather than a formality.

Here's the detail that undercuts the tidy 'Imports are shrinking' narrative. US medical device exports to India rose to 66% between FY20 and FY24, from roughly $872 million to $1.45 billion. Policy is tightening, yet trade is still growing. That's an interesting paradox.

What This Means for How a Device Company Should Actually Market Itself

1. If you're a domestic manufacturer, provenance is now a sales asset, not paperwork. A hospital procurement committee deciding between an Indian and an imported device increasingly needs to justify that decision in writing. Make the justification easy with clear domestic-content documentation, test certifications and manufacturing-site detail, presented the way a procurement officer needs to file it, not buried in a PDF nobody asked for.
   

2. If you're a multinational, the 'Not yet made in India to spec' argument needs to be provable, not just asserted. The companies getting heard in this review are the ones showing exactly which specification-gap exists, not the ones just requesting for an exemption based on principle.
   

3. Either way, this needs to be an evergreen content, not a one-time press release. The exemption list gets revisited periodically. A company that already has clear, structured, checkable credentials in place doesn't have to scramble each time the list reopens.

What This Looks Like in Practice

A mid-sized Indian device manufacturer making, say, patient monitors doesn't need a rebrand. It needs one clear page a procurement committee can actually use with insights on local content percentage, test license numbers, manufacturing location and a plain answer to 'Why should we trust this over an import?'. That page should be built to be shared internally inside a hospital's own procurement process, which is a different writing job than a marketing brochure and most device companies are still using the brochure.

Common Mistakes in This Moment

Mistake One: Treating 'Make in India' as a slogan to put on a banner rather than a specific, checkable claim a procurement committee needs to verify.

Mistake Two: Staying silent while the review is open. Submissions closed on 15th July 2026, however the outcome will shape procurement conversations for months after and the companies with verifiable credentials have already documented their walk into those conversations first.

Mistake Three: Assuming this is purely a government-relations issue, not a marketing one. The GTE list decides who's even eligible to be considered while the marketing decides who gets chosen once both options are.

Does This Only Matter for Companies Selling Directly to Government Hospitals?

No. Private hospitals are watching this review too, for the same reason. Procurement committees increasingly want the same domestic-content clarity regardless of who's paying, because the reputational and supply-chain questions are identical either way.

Two letters, one desk and a decision that will quietly decide a lot of sales conversations that haven't happened yet. Worth making sure your own paperwork is the kind that helps your case instead of getting asked-for after the meeting already happened. 

Think Proactively, Think HATKE!💡