Medical Device Industry Opposes India's Draft Bill on Regulation
India's medical device sector criticizes a draft bill equating devices with drugs, fearing it stifles innovation.
In India, medical device manufacturers and healthcare groups are voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. They argue that the draft legislation, which treats medical devices as pharmaceutical products, could significantly hinder manufacturing, investment, and innovation within the industry.
Industry Concerns Over Regulatory Approach
Several industry associations, including those representing manufacturers, traders, and healthcare providers, have formally expressed their concerns to the Union Health Minister. In a letter dated August 8, these groups warned that the bill's approach could deter investment and undermine India's efforts to establish itself as a global leader in medical device manufacturing.
The draft bill, currently under inter-ministerial review, proposes criminal penalties for regulatory lapses, which industry representatives argue is inappropriate for medical devices. They emphasize that medical devices are engineering products, distinct from pharmaceuticals, and should not be regulated in the same manner.
Global Regulatory Practices
The letter highlights that globally, medical devices are governed by risk-based conformity assessments, quality management systems, post-market surveillance, and recalls. The draft bill, however, proposes imprisonment for labeling errors, documentation lapses, and other minor issues, even when no harm has occurred. This approach contrasts with global norms, such as the EU Medical Device Regulation (MDR), US FDA, Japan's PMDA, the UK's MHRA, and Australia's TGA, which favor administrative enforcement over criminal penalties.
Industry leaders argue that the bill's use of drug-centric language, including terms like "adulterated," "spurious," and "misbranded," further conflates medical devices with pharmaceuticals. This misalignment, they claim, does not provide the necessary regulatory foundation for the sector's growth and innovation.
Call for a Revised Regulatory Framework
The opposition to the draft bill underscores the need for a distinct regulatory framework for medical devices that recognizes their unique characteristics. Industry stakeholders are advocating for regulations that facilitate innovation and competitiveness without imposing undue burdens that could stifle progress.
As the draft bill undergoes further consultation, the medical device industry is hopeful for revisions that will align with international standards and support India's ambitions in the global medical device market.