Medical Device Makers Seek "Made in India" Reset After Robodog Fiasco

Top Summary

• What happened: Medical device manufacturers are calling for a regulatory overhaul after a robodog incident exposed loopholes allowing Chinese products to be sold as 'Made in India.'
• Why it matters: Current regulations permit minimal processes like labeling to qualify as 'manufacturing,' undermining genuine domestic production and potentially compromising patient safety.
• What changes for people: Stricter labeling and origin disclosure rules could ensure greater transparency and allow consumers and healthcare providers to make informed decisions.
• Who is affected: Indian medical device manufacturers, hospitals, patients, and the government's Make in India initiative are all impacted.

'Made in India' Medical Device Controversy

Following the robodog controversy at the India AI Impact Summit, Indian medical device manufacturers are demanding a regulatory reset. They claim loopholes allow Chinese products to be sold as "Made in India" without significant value addition.

The Association of Indian Medical Device Industry (AiMeD) is preparing to petition the government to amend the Drugs and Cosmetics Act and the Medical Device Rules (MDR) 2017. Their concern is the existing law allows activities like labeling and repackaging to qualify as manufacturing.

Regulatory Loopholes Exploited

Industry insiders estimate that nearly 40% of medical devices imported from China are distributed as “Made in India” products. These so-called “pseudo-manufacturers” are exploiting regulatory loopholes.

India imports approximately Rs 12,000 crore worth of medical devices annually from China, making it the second-largest supplier after the US. This includes everything from consumables to critical-care equipment.

Rajiv Nath, forum coordinator of AiMeD, noted that some imports from Malaysia and Singapore actually originate in China. These are routed through Southeast Asia for tariff advantages, 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.

Market Domination by Chinese Products

Unlike American and European firms, many Chinese manufacturers partner with Indian companies. These partnerships often involve white-labeling agreements, allowing imported products to be marketed as locally manufactured.

According to a co-founder of an Indian ventilator manufacturing firm, Chinese products offer competitive prices and have captured a significant market share. This practice has now expanded into government procurement, undermining the Public Procurement Order (PPO).

Demands for Regulatory Reform

AiMeD is calling for a redefinition of “manufacturing” under MDR 2017. They propose excluding mere labeling and repackaging from the definition. They also seek stronger labeling rules that mandate clear disclosure of the country of origin and the extent of value addition in India.

Other recommendations include:

• Supplier classification thresholds (e.g., over 50% or at least 20% domestic content)
• Random audits for transparency
• QR-code-based traceability systems
• Certification of the Make in India logo by the Quality Council of India

Nath emphasized the need to stop the "repackaging scam" to protect genuine Indian manufacturing and patient safety. He added that negligible tariffs have incentivized businesses to shift from manufacturing to importing, bypassing compliance requirements.

"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.

CDSCO Response Awaited

Industry sources claim the Central Drugs Standard Control Organisation (CDSCO) has not adequately addressed these concerns. India Today reached out to Rajeev Singh Raghuvanshi, Drug Controller General of India (DCGI), for comment, but a response is pending.

What to Watch Next

The medical device industry will continue to push for amendments to the Drugs and Cosmetics Act and MDR 2017. The government's response to AiMeD's petition and any subsequent regulatory changes will significantly impact the future of domestic medical device manufacturing in India.