Medical Device Industry Pushes Back Against New Draft Bill
India's medical device sector opposes a draft bill treating devices as pharmaceuticals, citing potential harm to innovation and investment.
The medical device industry in India has raised significant concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which seeks to regulate medical devices in the same manner as pharmaceuticals. Industry leaders and healthcare groups argue that this approach could stifle innovation and deter investment in the sector.
Industry Concerns Over Regulatory Approach
Representatives from various associations, including manufacturers and healthcare providers, have expressed their opposition to the draft bill in a letter to the Union Health Minister. They argue that the proposed regulations fail to recognize the fundamental differences between medical devices and pharmaceutical products. The letter highlights that medical devices are engineering products, not drugs, and should not be subjected to the same regulatory framework as pharmaceuticals.
The draft bill introduces criminal penalties for regulatory lapses, such as labelling errors or documentation mistakes, with potential imprisonment ranging from one to seven years. Industry leaders warn that such stringent measures could harm the growth and innovation of the medical devices sector in India, which is striving to establish itself as a global hub.
Calls for Risk-Based Regulation
Advocates for the medical device industry emphasize that globally, medical devices are regulated through risk-based assessments, quality management systems, and post-market surveillance rather than harsh criminal penalties. They point out that international regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA use administrative enforcement rather than imprisonment for compliance issues.
The industry letter argues that the current draft bill's language, which includes terms like "adulterated" and "spurious," is more suited to pharmaceuticals than engineering products. Such terminology could lead to unnecessary criminalization of technical deviations that do not result in harm, a practice not followed by major international regulatory frameworks.
Implications for India's Medical Device Sector
The opposition to the draft bill comes amid India's efforts to boost its medical device manufacturing capabilities and reduce dependency on imports. Industry leaders believe that the bill, in its current form, could undermine these goals by discouraging both domestic and foreign investment.
The draft legislation is currently under inter-ministerial consultation, and industry stakeholders are hopeful that their concerns will be addressed. They urge the government to consider a regulatory framework that aligns with international best practices and supports the sector's growth and innovation potential.
As the debate continues, the medical device industry remains vigilant, advocating for a balanced approach that ensures patient safety while fostering an environment conducive to technological advancement and economic growth.