Medical Device Industry Opposes New Draft Bill on Regulation
Indian medical device firms challenge draft bill equating devices with drugs, citing potential harm to innovation.
The Indian medical device industry, along with healthcare and patient safety groups, has voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation, which aims to overhaul the regulatory framework governing medical devices, is facing criticism for treating these devices akin to pharmaceutical products.
Concerns Over Regulatory Framework
Industry representatives argue that the draft bill's current form could negatively impact manufacturing and innovation by imposing drug-like regulations on medical devices. In a letter addressed to the Union Health Minister, associations representing manufacturers, traders, healthcare providers, and patient groups have called for a reconsideration of the bill. The letter warns that the proposed regulations may deter investment and hinder India's goal of becoming a global hub for medical devices.
The associations emphasize that medical devices are fundamentally different from pharmaceuticals, being primarily engineering products. Therefore, they argue, the regulatory approach should reflect these differences rather than subjecting devices to pharmaceutical-style oversight.
Criticism of Criminal Penalties
One of the most contentious aspects of the draft bill is the imposition of criminal penalties for regulatory lapses. The bill suggests imprisonment ranging from one to seven years for issues such as labelling errors, documentation lapses, and licensing problems, even in the absence of harm. Industry leaders point out that such punitive measures are not practiced in other major markets, including the European Union, United States, Japan, United Kingdom, and Australia, where administrative enforcement is the norm.
The draft's use of pharmaceutical terminology, such as "adulterated," "spurious," and "misbranded," has further fueled concerns. Critics argue that these terms are inappropriate for engineering deviations, which should be regulated through risk-based conformity assessments and quality management systems.
Calls for a Distinct Regulatory Approach
The medical device sector insists that the draft bill fails to establish the necessary regulatory foundation for growth and innovation. By conflating medical devices with pharmaceuticals, the bill overlooks the distinct scientific, engineering, and regulatory characteristics of these products. Stakeholders are advocating for a separate regulatory framework that aligns with international best practices and supports the sector's development.
The draft bill is currently undergoing inter-ministerial consultation, and the government has yet to finalize its stance. As the debate continues, the medical device industry remains hopeful that the government will consider their concerns and adopt a more tailored regulatory approach.