Medical device, diagnostic equipment makers flay govt's draft Drugs, Medical Devices & Cosmetics Bill, 2026
ADVERTISEMENT
The central government’s plans to introduce an overarching law that governs medicines, medical devices and related products have met with stiff resistance from the stakeholder industries.
In a letter to Union Health Minister Jagat Prakash Nadda, eleven industry associations representing manufacturers, traders, healthcare providers, hospitals, clinicians, and patient advisory groups have called for a re-examination of the draft Drugs, Medical Devices & Cosmetics Bill, 2026, currently under circulation for stakeholder comments.
The associations complain that the draft bill, in its current form, continues to treat medical devices as an adjunct to pharmaceuticals, despite clear scientific, engineering, and regulatory distinctions. This approach, they argue, undermines India’s ambition to become a global medical device manufacturing hub, reduce import dependency, and achieve exports exceeding ₹1,00,000 crore in the next 5–7 years.
“India’s medical devices sector cannot be shackled by a pharma‑centric law. Eleven national associations, backed by earlier recommendations from Parliamentary Committees, NITI Aayog, and WHO principles, 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” Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD), said.
The letter says the Bill retains pharma‑style terminology such as “adulterated” and “spurious,” applying criminalisation to engineering deviations. It points out that the Bill proposes imprisonment of 1–7 years for labelling errors, documentation lapses, and licensing issues — contrary to global norms where administrative enforcement is the standard. The arrest and cessation powers proposed to be given to the inspectors under the draft law creates a climate of regulatory fear that deters investment, they point out.
According to the industry associations, despite repeated recommendations, the Bill fails to establish a dedicated National Medical Devices Regulatory Authority. It also highlights the omission of engineering concepts and key standards such as biocompatibility (ISO 10993), usability engineering (IEC 62366), and software lifecycle safety (IEC 62304) in the Bill. According to the stakeholders, the Bill applies the same punitive framework across low‑risk and high‑risk devices, ignoring risk proportionate regulation.
“Medical devices are engineering products, not pharmaceuticals. India must adopt smarter, risk‑proportionate regulation that safeguards patients while fostering innovation. and urge a dedicated Medical Devices Act”, Bejon Kumar Misra, Founder, Patient Safety and Access Initiative of India Foundation (PSAIIF), said.
The signatories of the letter include associations such as AiMeD, PSAIIF, Association of Diagnostics Manufacturers of India, Association of Healthcare Providers of India, Orthopaedic Implant Manufacturers Association and All India Syringe and Needle Manufacturers Association, among others.