A controversy surrounding Galgotias University at the India AI Impact Summit has snowballed into a larger reckoning for India’s medical device sector. The university reportedly showcased a robodog developed by a Chinese startup as its own innovation, triggering swift action from authorities and huge backlash online.
Now, India’s domestic medical device manufacturers say the episode exposes a much deeper malaise — one that allows imported Chinese medical equipment to be sold locally under the label “Made in India.”
Under the banner of the Association of Indian Medical Device Industry (AiMeD), several domestic manufacturers are preparing to write to the government seeking urgent amendments to the Drugs and Cosmetics Act and the Medical Device Rules (MDR) 2017.
Their core complaint: the law currently allows activities such as labelling and repackaging to qualify as “manufacturing,” enabling traders and distributors to pass off imported equipment as domestically produced.
Industry insiders told India Today that nearly 40 percent of devices imported from China are distributed locally as “Made in India” products by what they describe as “pseudo-manufacturers.”
They argue that regulatory loopholes have created a parallel ecosystem in which genuine manufacturers — those investing in facilities, quality compliance, and workforce — are forced to compete with traders who simply rebrand imported goods.
REGULATORY LOOPHOLES
India imports medical devices worth approximately Rs 12,000 crore annually from China, making it the country’s second-largest supplier of medical equipment after the US. These imports span the spectrum — from everyday consumables such as surgical gloves, needles and infusion sets to critical-care equipment like ventilators, apart from ultrasound machines.
What worries domestic manufacturers even more is the complexity of import routes.
Rajiv Nath, forum coordinator of AiMeD, pointed out that a significant portion of devices imported from Malaysia and Singapore actually originate in China but are routed through these countries for tariff advantages. On paper, they appear as imports from Southeast Asia, masking their true source.
“Following the robodog controversy, the University was asked to vacate the summit and it was a good step on the government’s part. But if such restrictions apply to universities in AI, they must extend to pseudo-manufacturing in critical sectors like medical devices,” Nath said.
Government estimates for 2023–24 show medical device imports touching nearly Rs 69,000 crore, with Germany, Singapore and the Netherlands emerging as major suppliers after the US and China.
Industry sources argue that without stricter definitions and disclosure norms, tracing the true origin of these products becomes increasingly difficult.
MARKET CAPTURE
Unlike American and European medical device giants, which operate through established distribution networks in India, many Chinese manufacturers rely on partnerships with Indian firms.
These arrangements, industry sources claim, often involve white-labelling agreements that allow the Indian partner to market the imported product as locally manufactured.
“Since Chinese products — especially those by large manufacturers — are generally good and offer competitive prices compared to Indian counterparts, they have been able to capture the market in a big way,” said the co-founder of an Indian ventilator manufacturing firm.
Earlier, this practice was largely confined to private hospital procurement. However, industry executives now claim the issue has seeped into government procurement as well, undermining the intent of the Public Procurement Order (PPO), which gives preference to domestically manufactured goods.
REFORM ROADMAP
At the heart of the industry’s demands is a redefinition of “manufacturing” under MDR 2017. Currently, even minimal processes such as labelling or repackaging qualify.
Domestic manufacturers argue this misleads consumers and healthcare providers about product origin and safety standards, while rendering domestic preference policies ineffective.
AiMeD has proposed excluding mere labelling and repackaging from the definition of manufacturing. It is also pushing for stronger labelling rules mandating clear disclosure of the actual country of origin, the original manufacturer’s name and address, and the extent of value addition carried out in India.
Other recommendations include supplier classification thresholds — such as requiring over 50 percent or at least 20 percent domestic content — random audits to enforce transparency, QR-code-based traceability systems, and certification of the Make in India logo by the Quality Council of India.
“Amending packaging rules for consumer protection and MDR 2017 for ensuring patient safety concerns are essential to stop this repackaging scam, which not only undermines genuine Indian manufacturing like termites but poses grave patient safety risks from unvetted imports,” Nath said.
He added that negligible tariffs have incentivised many businesses to shift from manufacturing to importing, allowing them to bypass more than 50 state and central compliance requirements that burden genuine medtech producers.
“Make in India cannot have any shortcuts,” Nath insisted.
As the Galgotias episode fades from headlines, India’s medical device industry says they will try to ensure it leaves behind more than embarrassment — pushing instead for a structural overhaul that could redefine what truly qualifies as “Made in India.”
Sources in the industry also claimed the Central Drugs Standard Control Organisation (CDSCO) did not seem interested in addressing the concerns despite the reservations by genuine Indian manufacturers.
India Today reached out to Rajeev Singh Raghuvanshi, Drug Controller General of India (DCGI), who heads the CDSCO over a phone call. This copy will be updated if and when there is a response from him.
