‘Made in India’ or masked imports from China? Galgotias row spurs medtech uproar

What began as an embarrassing viral moment for a private university at the India AI Impact Summit 2026 has evolved into a full-blown crisis of confidence for India’s medical technology sector. After Galgotias University was caught presenting a commercially available Chinese “robodog” as its own “Orion” project, domestic medical device manufacturers are now calling for an urgent “regulatory purge.”

Add businessleague.in as a Preferred Source

The Association of Indian Medical Device Industry (AiMeD) argues that the “Galgotias model”—buying Chinese tech and slapping an Indian sticker on it—is currently the standard operating procedure for nearly 40% of the medical equipment sold in India under the “Made in India” banner.

Also Read |Tamil Nadu Voter List Purge: 97 Lakh Names Deleted in SIR Phase 1

The Robodog Fiasco: What Happened at Bharat Mandapam?

On Wednesday, Galgotias University’s stall was shut down and its power cut off after observers identified their “innovative” robot as the Unitree Go2, a Chinese bionic quadruped sold online for roughly ₹3 lakh. While the university later clarified it was a “learning tool,” a viral video of a professor claiming it was developed by their “Center of Excellence” sparked an uproar.

Industry leaders say this is not an isolated academic lapse but a systemic economic issue. “If a university is evicted for this in AI, the same rules must apply to critical life-saving equipment,” says Rajiv Nath, Forum Coordinator of AiMeD.

The “Pseudo-Manufacturing” Crisis in MedTech

India remains heavily dependent on imports, particularly for high-end medical electronics.

• The Scale: India imports nearly ₹12,000 crore worth of devices from China annually.

• The Tactic: Manufacturers claim that traders buy “white-labeled” ventilators, ultrasound machines, and surgical consumables from China, route them through Singapore or Malaysia to mask their origin, and then repackage them in India.

• Market Capture: Because Chinese products are competitively priced, these “pseudo-manufacturers” often win government tenders under the Public Procurement Order (PPO), which is intended to favor genuine local makers.

Also Read |Tamil Nadu Voter List Purge: 97 Lakh Names Deleted in SIR Phase 1

Regulatory Loopholes: The MDR 2017 Debate

At the heart of the outcry is the Medical Device Rules (MDR) 2017. Currently, the definition of “manufacturing” is broad enough to include:

1. Labeling

2. Repackaging

3. Minor Assembly

Domestic innovators, who invest heavily in R&D and 50+ state/central compliance requirements, argue that this definition allows traders to bypass the hard work of “Making in India” while reaping the policy benefits.

Proposed Reforms: QR Codes and Value Addition

AiMeD is preparing a formal petition to the Ministry of Health and the CDSCO (Central Drugs Standard Control Organisation) demanding:

• Exclusion of Repackaging: Stripping “labeling” from the legal definition of manufacturing.

• Domestic Content Thresholds: Requiring at least 20-50% local value addition to earn the “Made in India” logo.

• Traceability: Mandatory QR codes on all devices to show the original manufacturer’s name and the actual country of origin.

Reality Check

The government’s Production Linked Incentive (PLI) scheme has boosted local assembly. Still, for complex electronics like MRI or CT scanners, India lacks a domestic component ecosystem (sensors, high-end chips). Therefore, a “blanket ban” on rebranding might actually lead to a shortage of affordable equipment in Tier-2 and Tier-3 hospitals. In fact, many “Indian” brands are actually saving lives with Chinese hardware because the alternative (US/German tech) is 3x more expensive.

The Loopholes

The current law allows a “Registration Number” for low-risk Class A devices to replace a full “Manufacturing License Number.” In fact, this was intended to “ease business.” Therefore, traders can easily register a Chinese-made glove or bandage under their own name. Still, the Galgotias controversy has made “white-labeling” a politically toxic topic, giving domestic makers the leverage they need to push for the Form MD-44 updates, which mandate more granular batch and raw material disclosure.

Also Read |Tamil Nadu Voter List Purge: 97 Lakh Names Deleted in SIR Phase 1

What This Means for You

If you are a healthcare provider or a patient, realize that the “Made in India” tag on your ventilator or monitor might only refer to the box it came in. First, look for Quality Council of India (QCI) certification on high-end equipment. Then, ask for the “Country of Origin” disclosure, which is mandatory under the Legal Metrology Rules even if the MDR definition is currently vague.

Finally, understand that a “regulatory reset” could lead to a temporary price hike in medical services if cheaper rebranded imports are restricted. You should check the ” .ev Verified” style branding for medical devices that the industry is now proposing. Before making large-scale institutional purchases, verify the manufacturer’s Plant Master File (PMF) through the SUGAM portal to ensure they actually have a factory and aren’t just a warehouse in a free-trade zone.

What’s Next

AiMeD will submit its official “reform roadmap” to the Ministry of Health by early next week. Then, the CDSCO is expected to issue a public notice regarding stricter labeling for imported components. Finally, the Medical Device Rules (MDR) 2026 amendments are likely to be fast-tracked to close the “repackaging scam” loophole before the next fiscal year begins in April.

Also Read |Tamil Nadu Voter List Purge: 97 Lakh Names Deleted in SIR Phase 1

End

Add businessleague.in as a Preferred Source