Eleven medical device industry associations have written to Union Health Minister J P Nadda seeking separate legislation for regulating medical devices, days after the government circulated a draft Drugs, Medical Devices and Cosmetics Bill for industry consultations.
In its final submission, a prominent domestic medical device group said the 2026 draft Drugs, Medical Devices and Cosmetics Bill could not be supported in its current form.
“It is pharma-centric, criminalisation heavy and misaligned with global norms,” the submission stated.
The associations have argued that medical devices require a regulatory framework distinct from drugs, given differences in their design, manufacturing, risk classification, technology and life cycle.
Rajiv Nath, forum coordinator for the Association of Indian Medical Device Industry (AiMeD), said the draft bill continued to use drug-centric terminology such as “adulterated” and “spurious”, while applying pharma-style criminalisation to engineering deviations.
He added that criminalisation for technical non-conformities such as labelling errors and documentation issues could discourage manufacturing, as the approach differs from global medtech standards such as the European Union’s Medical Device Regulation (EU MDR) and those of the United States Food and Drug Administration (USFDA).
According to a copy of the draft bill seen by Business Standard, an instance of technical non-conformity by medical device manufacturers can lead to cessation orders, criminal proceedings and imprisonment ranging from six months to seven years.
“There needs to be a risk-proportional and engineering-aligned regulation. Penalties, licensing, surveillance and enforcement should be based on risk class and actual potential of harm,” Nath said.
He added that misbranding for devices could simply mean an incorrect font size, symbol or unique device identification (UDI) placement.
The associations have sought the constitution of a new committee comprising engineering experts, clinicians, biomedical specialists, industry representatives and patient safety groups.
The group could advise on the enactment of a separate medical devices Act aligned with internationally recognised practices.
They have also sought the establishment of an autonomous national medical devices regulatory authority on the lines of the Telecom Regulatory Authority of India (Trai), with clear oversight over state regulators and conformity assessment bodies.
