Medical Device Firms Challenge India's Draft Bill on Regulatory Grounds
India's medical device sector opposes a draft bill equating devices with drugs, citing potential harm to innovation and investment.
The Indian medical device industry, along with healthcare providers and patient safety groups, is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Industry leaders argue that the bill mistakenly equates medical devices with pharmaceuticals, imposing stringent drug-related regulations that could stifle innovation and deter investment in the sector.
Industry Concerns Over Regulatory Approach
In a collective response, several associations representing manufacturers, traders, and healthcare providers have communicated their concerns to the Union Health Minister. They argue that the draft bill's approach could negatively impact India's goal of becoming a global leader in the medical device sector. The associations emphasize that medical devices are fundamentally different from pharmaceuticals, requiring distinct regulatory standards.
The letter from these associations, dated August 8, stresses that the bill lacks the necessary regulatory framework to support growth and innovation in the medical devices sector. It highlights that the bill continues to use drug-centric terminology such as "adulterated," "spurious," and "misbranded," which are not applicable to engineering products like medical devices.
Potential Impact on Manufacturing and Innovation
Industry stakeholders fear that treating medical devices as pharmaceuticals could lead to unnecessary criminal penalties for non-compliance with drug-related regulations. The draft bill proposes imprisonment terms ranging from one to seven years for issues such as labeling errors, documentation lapses, and engineering defects, even when no harm occurs. This approach contrasts with the regulatory practices in regions like the EU, US, Japan, UK, and Australia, where administrative enforcement is the norm.
The medical device industry argues that globally, these products are regulated through risk-based assessments, quality management systems, and post-market surveillance, rather than through punitive measures. They warn that the draft bill could discourage investment and manufacturing in India, ultimately hindering the country's ambition to become a global hub for medical devices.
Call for a Rethink
The draft bill is part of an effort to replace an 86-year-old law governing India's pharmaceutical regulations. However, the medical device sector insists that a one-size-fits-all approach is inappropriate. The associations have called for a regulatory framework that reflects the scientific, engineering, and regulatory distinctions between pharmaceuticals and medical devices.
As the draft bill undergoes inter-ministerial consultation, the medical device industry hopes for amendments that will foster a conducive environment for growth and innovation, aligning with international best practices.