Medical Device Industry Challenges New Legislation
Industry leaders argue against the draft bill treating devices like drugs, citing potential harm to innovation and investment.
In a significant pushback, India’s medical device industry and healthcare groups have voiced strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. They argue that the proposed legislation equates medical devices with pharmaceutical products, a move they claim could stifle manufacturing, innovation, and investment.
Concerns Over Equating Devices with Pharmaceuticals
Industry associations, including manufacturers, healthcare providers, and patient safety advocates, have formally addressed their concerns to the Union Health Minister. Their primary contention is that the draft bill fails to distinguish between medical devices and pharmaceutical drugs, despite the clear differences in their scientific, engineering, and regulatory frameworks.
“The draft continues to treat medical devices as an adjunct to pharmaceuticals, despite clear scientific, engineering, and regulatory distinctions between the two categories,” stated a letter from the associations. The bill's language, they argue, is heavily drug-centric, using terms such as "adulterated," "spurious," and "misbranded," which are inappropriate for the regulation of engineering products like medical devices.
Potential Impact on Innovation and Investment
The draft bill's approach includes imposing criminal penalties, with imprisonment terms ranging from one to seven years for infractions such as labeling errors or documentation lapses. Industry leaders argue that such measures are not aligned with global practices. For instance, regions like the EU, US, Japan, UK, and Australia typically employ administrative enforcement rather than criminal penalties for regulatory issues in the medical device sector.
The associations warn that these stringent measures could deter investment and hinder India’s goal of becoming a global hub for medical device manufacturing. They emphasize the need for a regulatory framework that supports growth, innovation, and competitiveness in the global market.
Call for a Revised Regulatory Approach
The draft bill, which is currently under inter-ministerial review, aims to update the 86-year-old law governing India’s pharmaceutical regulations. However, the medical device industry is urging the government to reconsider its approach. They advocate for regulations that reflect the unique nature of medical devices, focusing on risk-based conformity assessments, quality management systems, and post-market surveillance instead of criminalization.
As the government reviews feedback from various stakeholders, the outcome of this legislative process could significantly impact the future landscape of India's medical device industry.