Medical Device Industry Opposes Draft Bill Treating Devices as Drugs
India's medical device sector challenges a draft bill that treats devices as pharmaceuticals, citing potential harm to innovation and investment.
India's medical device industry and associated healthcare groups have expressed strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The bill, which aims to revise the country's regulatory framework for medical products, has sparked concerns over its approach to treating medical devices like pharmaceuticals.
Industry Concerns Over Regulatory Approach
Industry representatives argue that the draft bill could stifle innovation and deter investment by imposing pharmaceutical-style regulations on medical devices. Unlike drugs, which are chemical-based, medical devices are engineering products, and stakeholders insist that they should not be subjected to the same regulatory criteria.
In a letter dated August 8, several associations representing manufacturers, healthcare providers, and patient safety groups urged the Union Health Minister to reconsider the bill. They warned that the current draft could hinder India's aspirations to become a global leader in medical device manufacturing.
Potential Impact on Manufacturing and Innovation
The draft bill proposes criminal penalties, including imprisonment for up to seven years, for regulatory lapses such as labeling errors and documentation mistakes. Industry leaders argue that these penalties are disproportionate and could dissuade companies from investing in the Indian market.
Globally, medical devices are regulated through risk-based assessments and quality management systems rather than criminalization. The industry points to regulatory practices in the EU, US, Japan, UK, and Australia, where administrative enforcement is the norm, as a more suitable model for India to follow.
Calls for a Distinct Regulatory Framework
The draft bill's use of drug-centric language, with terms like "adulterated," "spurious," and "misbranded," has been criticized for failing to recognize the fundamental differences between pharmaceuticals and medical devices. Stakeholders emphasize the need for a separate regulatory framework that reflects the unique nature of medical devices.
The draft is currently under inter-ministerial review, and the industry is hopeful that their concerns will lead to significant revisions. As the debate continues, the outcome of this legislative process could have lasting implications for India's medical device industry and its role in the global market.