3 weeks ago
Medical device groups seek separate regulatory authority in India
Some people who make things like hospital machines and health gadgets in India wrote a letter to the government.
They want a special new agency that only looks after medical devices.
Right now, medical devices are treated like medicines, but they are very different.
The letter was sent to the Health Minister, JP Nadda.
The industry says the new medicine-device law has punishments that are too harsh.
For example, people could go to jail for small mistakes like a wrong label.
That scares companies from investing in India, they say.
They want a new law just for medical devices.
This would help India make more devices at home and sell more to other countries.
They hope India can sell devices worth over ₹1,00,000 crore within the next five to seven years.
Eleven medical device, healthcare and civil society organisations jointly sought a dedicated National Medical Devices Regulatory Authority.
The letter to Union Health Minister JP Nadda argues medical devices are wrongly treated as 'an adjunct to pharmaceuticals'.
The groups called for re-examination of the draft Drugs, Medical Devices & Cosmetics Bill, 2026, and enactment of a standalone Medical Devices Act.
Industry bodies warned that criminalising engineering, labelling and documentation lapses with up to seven years' imprisonment deters investment.
India aims to become a global medical device manufacturing hub with exports exceeding ₹1,00,000 crore within 5-7 years.
- Who
- Eleven medical device, healthcare and civil society associations led by industry body AiMed, addressing Union Health Minister JP Nadda.
- What
- A demand for a dedicated National Medical Devices Regulatory Authority and a standalone Medical Devices Act, with re-examination of the draft Drugs, Medical Devices & Cosmetics Bill, 2026.
- Where
- India
- When
- The joint letter was reported on August 11, 2026.
- Why
- Industry groups say the drug-centric regulatory framework criminalises technical lapses, deters investment, and undermines India's ambition to become a global medical device manufacturing hub.
Key facts
- Demand
- National Medical Devices Regulatory Authority
- Signatory organisations
- 11 associations including manufacturers, traders, healthcare providers, hospitals, clinicians and patient advisory groups
- Addressed to
- Union Health Minister JP Nadda
- Bill in question
- Draft Drugs, Medical Devices & Cosmetics Bill, 2026
- Export goal
- Exceeding ₹1,00,000 crore in the next 5-7 years
- Standards cited as missing
- ISO 10993, IEC 62366, IEC 62304
- Supported by
- Parliamentary Standing Committee Reports 138 & 146, NITI Aayog's Draft Medical Devices Bill (2019), WHO principles
- Published
- August 11, 2026
Quotes
Medical device associations
Coalition of 11 medical‑device and civil society organisations
“India’s medical devices sector cannot be shackled by a pharma‑centric law. Eleven national associations urge the government to enact a standalone Medical Devices Act. Without this, India risks discouraging investment, innovation, and patient safety — undermining Make in India and Atmanirbhar Bharat.”
thehindubusinessline.com
“medical devices continue to be seen as “an adjunct to pharmaceuticals””
thehindubusinessline.com
Sources
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