New Delhi: Medical device industry, patient safety groups and healthcare providers have opposed the draft Drugs, Medical Devices and Cosmetics Bill, 2026, saying it treats medical devices like medicines and will hurt manufacturing and innovation, people in the know told ET.
Several associations representing manufacturers, traders, healthcare providers and patient groups have written to the Union health minister urging a rethink of the draft, warning that it will hurt investment, discourage manufacturing and set back India’s ambition of becoming a global medical device hub.
In its pushback against the draft bill, the medical device industry has cited that medical devices are engineering products not pharmaceuticals and cannot be regulated as drugs.
ET was first to report that the government was preparing to replace the 86-year-old law governing India’s pharmaceuticals regulations.
The draft bill is currently under inter-ministerial consultation.
The associations in their August 8 letter have submitted that the draft bill does not provide the regulatory foundation required for India’s medical devices sector to grow, innovate, and compete globally.
“The draft continues to treat medical devices as an adjunct to pharmaceuticals, despite clear scientific, engineering, and regulatory distinctions between the two categories,” the letter said. ET has seen the copy of letter.
The industry has expressed their concern over the draft as it continues to use drug-centric language with terms like “adulterated”, “spurious”, and “misbranded,” and applies pharma-style criminalisation to engineering deviations.
“Globally, medical devices are regulated through risk-based conformity assessments, quality management systems, post-market surveillance, and recalls, not imprisonment,” it said.
The draft bill imposes imprisonment of 1-7 years for labelling errors, documentation lapses, licensing issues, PMS reporting mistakes, engineering defects, even when no harm occurs.
“This is not practiced in EU MDR, US FDA, Japan PMDA, UK MHRA, or Australia TGA, where administrative enforcement is the norm,” it said.
