Medical Device Firms Reject Draft Bill Equating Them with Pharma

India's medical device industry is raising alarms over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which they claim unfairly lumps medical devices with pharmaceuticals. Industry leaders and healthcare groups have voiced concerns that the bill's approach could stifle innovation and deter investment, threatening India's potential as a global hub for medical devices.

Industry Pushback Against Legal Provisions

Key stakeholders, including manufacturers and healthcare providers, have formally expressed their opposition to the draft bill in a letter to the Union Health Minister. The letter warns that treating medical devices like drugs could have severe repercussions on manufacturing and innovation. The bill proposes criminal penalties for regulatory lapses, which the industry argues are inappropriate for engineering products such as medical devices.

The draft bill, currently under inter-ministerial review, is intended to replace the existing 86-year-old regulatory framework for pharmaceuticals in India. However, industry representatives argue that it does not provide the specialized regulatory foundation necessary for the medical devices sector to thrive.

Concerns Over Regulatory Language

The draft document has drawn criticism for employing drug-centric terminology, including terms such as "adulterated," "spurious," and "misbranded." These terms, typically associated with pharmaceuticals, are seen as misaligned with the nature of medical devices, which require distinct regulatory considerations.

Industry advocates stress that globally, medical devices are regulated through risk-based conformity assessments, quality management systems, and post-market surveillance rather than criminal penalties. The proposed bill, however, suggests imprisonment of one to seven years for errors like labelling mistakes, documentation issues, and licensing problems, even when no harm has occurred. This contrasts sharply with practices in regions like the EU, US, Japan, UK, and Australia, where administrative solutions are favored.

Call for Revised Regulatory Approach

Associations representing various stakeholders in the medical device sector have called for a reconsideration of the draft bill. They emphasize the need for a regulatory framework that recognizes the distinct nature of medical devices, separate from pharmaceuticals. Such a framework is crucial for fostering growth, encouraging investment, and enhancing India's competitiveness in the global medical device market.

The debate surrounding the draft bill underscores the complexities of regulating the rapidly evolving medical device industry, which requires policies that balance innovation with safety and compliance.