India's Medical Device Industry Opposes Draft Bill Equating Devices with Drugs
Medical device firms object to a draft bill treating devices like drugs, citing potential harm to innovation and investment.
India's medical device manufacturers and healthcare groups are voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The bill, which suggests treating medical devices as pharmaceuticals, has sparked concerns over its potential impact on manufacturing, innovation, and investment in the sector.
Industry Concerns Over Regulatory Approach
Key industry stakeholders, including patient safety groups and healthcare providers, have expressed their disapproval of the draft legislation. They argue that the bill's approach of treating medical devices akin to pharmaceuticals undermines the distinct scientific and engineering nature of these products. The industry's apprehension is rooted in the belief that such regulation could stifle innovation and discourage investment, hindering India's potential to become a global leader in medical device manufacturing.
The draft bill introduces stringent penalties, including imprisonment for regulatory lapses such as labeling errors or documentation issues, even when no harm has occurred. This approach contrasts sharply with international standards, where administrative enforcement is the norm.
Call for a Distinct Regulatory Framework
In a letter dated August 8, addressed to the Union health minister, various associations representing manufacturers, traders, and patient groups have urged a reconsideration of the bill. They emphasize that the current draft fails to establish a regulatory foundation that supports the growth and global competitiveness of India's medical devices sector.
Critics of the bill argue that it continues to employ drug-centric language, using terms such as "adulterated," "spurious," and "misbranded," which are inappropriate for engineering products. The letter highlights that globally, medical devices are regulated through risk-based assessments and quality management systems rather than criminal penalties.
Global Standards vs. Proposed Indian Regulations
The draft bill's provisions for imprisonment of one to seven years for various infractions are seen as excessive and misaligned with international practices. Regulatory bodies in the EU, US, Japan, UK, and Australia typically focus on administrative measures, such as post-market surveillance and recalls, rather than criminal prosecution.
The medical device industry is urging lawmakers to adopt a regulatory framework that recognizes the unique characteristics of medical devices. By doing so, they believe India can foster innovation and attract investment, ultimately enhancing its position in the global market.