India Pharma Outlook Team | Tuesday, 11 August 2026
Medical device industry groups are pushing back against the government's proposed regulatory framework.
Eleven medtech groups have written to Union Health Minister J P Nadda seeking a separate law for medical devices.
The demand comes days after the government circulated the draft Drugs, Medical Devices and Cosmetics Bill, 2026, for industry consultation. A leading domestic medical device industry body said the draft cannot be supported in its current form.
The groups argue that medical devices need rules designed around their engineering, technology and risk levels. They say the current draft follows a largely pharma-focused approach.
The industry says medical devices differ significantly from drugs. Their design, manufacturing process, risk classification and product life cycles require different regulatory approaches.
Rajiv Nath, forum coordinator at the Association of Indian Medical Device Industry (AiMeD), raised concerns over the draft's terminology and penalties.
The bill uses terms such as adulterated and spurious, which are commonly associated with pharmaceutical products. The industry believes these terms do not fit the technical nature of medical devices.
Nath also said the draft takes a criminal approach toward technical non-conformities. This could include issues related to labeling, documentation or other engineering requirements.
The groups want regulation to be based on the actual risk posed by a device. They say penalties and enforcement should reflect the device's risk class and potential harm.
Nath said even misbranding could involve relatively minor issues. These could include an incorrect font size, symbol or Unique Device Identification (UDI) placement.
The industry wants India's medical device regulations to follow international practices. It has specifically pointed to the European Union's Medical Device Regulation and US Food and Drug Administration standards.
The associations have proposed several changes, including:
The groups have also asked the government to form a new committee. The proposed committee would include engineering experts, clinicians, biomedical specialists, industry representatives and patient safety groups.
The associations have also proposed an autonomous national medical devices regulatory authority. They want the regulator to have clear oversight over state regulators and conformity assessment bodies. The proposed authority could operate along the lines of the Telecom Regulatory Authority of India (Trai).
The industry believes a dedicated regulator would help create clearer rules for India's growing medical device sector. It could also reduce regulatory uncertainty for manufacturers and investors. The demand highlights a wider concern within India's medtech industry.
Companies want stronger oversight but also want regulations suited to the technical nature of medical devices. The final outcome will depend on how the government responds to industry feedback on the 2026 draft bill.
