11 Industry Bodies Urge Nadda to Drop Pharma-Centric Approach in Draft Bill, Seek Separate Medical Devices Act

• Drug‑centric framework: The bill retains pharma‑style terminology such as “adulterated” and “spurious,” applying criminalisation to engineering deviations.

• Criminalisation of technical lapses: Imprisonment of 1–7 years for labelling errors, documentation lapses, and licensing issues — contrary to global norms where administrative enforcement is the standard.

• Expanded police‑style powers: Arrest and cessation powers for inspectors, creating a climate of regulatory fear that deters investment.

• No independent authority: Despite repeated recommendations, the bill fails to establish a dedicated National Medical Devices Regulatory Authority.

• Omission of engineering concepts: Key standards such as biocompatibility (ISO 10993), usability engineering (IEC 62366), and software lifecycle safety (IEC 62304) are absent.

• Uniform penalties: The bill applies the same punitive framework across low‑risk and high‑risk devices, ignoring risk‑proportionate regulation.

Authoritative Support

This position is strongly reinforced by:

• Parliamentary Standing Committee Reports 138 & 146, explicitly recommending a separate law and department for medical devices.

• NITI Aayog’s Draft Medical Devices Bill (2019), which proposed a modern, engineering‑aligned framework.

• WHO’s global principles, emphasising risk‑management, lifecycle safety, and shared responsibility.

• Collective signatures from manufacturers, hospitals, patient safety groups, and user organisations.

Prof Bejon Kumar Misra, Founder, Patient Safety and Access Initiative of India Foundation, said,“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.”

“Retaining medical devices under the same law as Drugs will create complex compliance requirements, particularly for MSMEs, potentially hurting competition, innovation and increasing healthcare costs. We urge the Government to establish a separate Act with an independent regulator,” said Puneet Bhasin, President, Surgical Manufacturers & Traders Association (SMTA).

Joint Plea

The joint plea was submitted by 11 national associations — Association of Indian Medical Device Industry (AiMeD), Association of Diagnostics Manufacturers of India (ADMI), Association of Healthcare Providers India (AHPI), Sterile Disposable Medical Association of India (SDMAI), Orthopaedic Implant Manufacturers Association (iMA), Personal Wearable Medical Association of India (PWMAI), Patient Safety and Access Initiative of India Foundation, Surgical Instrument Development Society (SIDS), All India Syringe and Needle Manufacturers Association (AISNMA), Orthopaedic Rehabilitation Aid Manufacturers Association (ORAMAI), and Surgical Manufacturers and Traders Association (SMTA) — which have jointly urged Union Health Minister Jagat Prakash Nadda to reconsider the Draft Drugs, Medical Devices & Cosmetics Bill, 2026 and establish a separate regulatory framework for medical devices.

The associations respectfully request:

1. Constitution of a new expert committee with engineering, biomedical, clinical, and patient safety representation.

2. Enactment of a separate Medical Devices Act, aligned with EU MDR, US FDA, IMDRF, and NITI Aayog’s 2019 draft.

3. Decriminalisation of non‑mensrea offences, replacing imprisonment with administrative enforcement.

4. Establishment of a National Medical Devices Regulatory Authority, with autonomy akin to TRAI/IRDAI.

5. Risk‑proportionate, engineering‑aligned regulation to encourage innovation and investment.

6. Structured stakeholder consultation of relevant organisations.