Medical Device Industry Challenges Draft Bill Treating Devices as Drugs

India's medical device industry is raising concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which seeks to regulate medical devices similarly to pharmaceuticals. Industry groups argue that this approach could stifle innovation and deter investment, potentially hindering India's goal of becoming a global hub for medical devices.

Industry Pushback Against the Draft Bill

The draft bill, currently under inter-ministerial review, has drawn criticism from various stakeholders, including manufacturers, healthcare providers, and patient safety groups. They have collectively urged the Union health minister to reconsider the legislation. These groups emphasize that medical devices, being engineering products, should not be subjected to the same regulatory framework as drugs.

A letter dated August 8, addressed to the health minister, highlights that the draft does not lay a suitable regulatory foundation for the growth and global competitiveness of India's medical device sector. It stresses the scientific and engineering distinctions between medical devices and pharmaceuticals, which the current draft overlooks.

Concerns Over Regulatory Language and Penalties

The medical device industry has expressed particular concern over the draft's use of pharmaceutical-centric language, with terms such as "adulterated," "spurious," and "misbranded." These terms, along with the application of criminal penalties for regulatory lapses, have raised alarms. The bill proposes imprisonment ranging from one to seven years for infractions like labeling mistakes, documentation errors, and licensing issues, even when these do not result in harm.

Industry representatives argue that internationally, regulatory bodies such as the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA enforce compliance through administrative measures rather than criminal penalties. The draft's stringent approach is seen as a departure from global norms and could pose significant challenges for manufacturers operating in India.

Potential Impact on Innovation and Investment

Stakeholders caution that the draft bill's current framework could discourage investment and innovation in the medical device sector. They argue that the proposed regulations may make it difficult for India to attract the necessary resources and expertise to develop a competitive edge in the global market.

With the bill under review, the medical device industry hopes for a regulatory approach that aligns more closely with international practices, emphasizing risk-based assessment and quality management systems. Such an approach, they argue, would support the sector's growth and innovation while ensuring patient safety.