What began as a controversy at the India AI Impact Summit has now snowballed into a serious reckoning for India’s medical device industry. Galgotias University reportedly showcased a robodog developed by a Chinese startup as its own innovation, prompting swift government action and backlash online. However, industry leaders say the incident merely exposed a much deeper systemic issue.
Under the banner of Association of Indian Medical Device Industry (AiMeD), domestic manufacturers are preparing to approach the government seeking urgent amendments to the Drugs and Cosmetics Act and the Medical Device Rules (MDR) 2017.
Their key concern is a regulatory loophole that allows minimal processes such as labelling and repackaging to qualify as “manufacturing.” According to industry insiders, nearly 40% of medical devices imported from China are allegedly distributed locally as “Made in India” products by so-called “pseudo-manufacturers.”
India imports medical devices worth approximately Rs 12,000 crore annually from China, covering everything from surgical gloves and infusion sets to ventilators and ultrasound machines. Total medical device imports for 2023–24 have reportedly touched nearly Rs 69,000 crore, with major suppliers including the US, China, Germany, Singapore, and the Netherlands.
Industry leaders also warn about complex import routes, where Chinese-origin devices are shipped through countries like Malaysia and Singapore to gain tariff advantages, masking their true source on paper.
Unlike American and European medtech giants that operate through established distribution networks, many Chinese firms partner with Indian companies under white-label arrangements. These partnerships allegedly allow imported products to be marketed as locally manufactured, sometimes even qualifying for preference under the Public Procurement Order (PPO), which is meant to promote domestic goods.
AiMeD has proposed reforms including:
Redefining “manufacturing” under MDR 2017 to exclude mere labelling and repackaging
Mandatory disclosure of actual country of origin and original manufacturer details
Domestic value-addition thresholds (20%–50%)
Random compliance audits
QR-code-based traceability systems
Certification of the Make in India logo by the Quality Council of India
Industry representatives argue that negligible tariffs and heavy compliance burdens have incentivised traders to shift from manufacturing to importing, creating unfair competition for genuine Indian manufacturers investing in infrastructure, quality control, and workforce development.
As the immediate controversy fades, India’s medtech industry hopes it will lead to structural reforms that clearly define what truly qualifies as “Made in India” — not just in branding, but in substance.
