Medical Device Industry Pushes Back Against India's Draft Bill

In a significant development, India's medical device sector has raised strong objections to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. Industry leaders, patient safety advocates, and healthcare providers argue that the draft legislation, which treats medical devices similarly to pharmaceuticals, could undermine manufacturing, investment, and innovation.

Concerns Over Regulatory Approach

The draft bill, currently under inter-ministerial review, proposes to replace an 86-year-old regulatory framework governing pharmaceuticals in India. However, stakeholders in the medical device industry have expressed concerns that the proposed changes do not adequately recognize the distinct nature of medical devices compared to drugs. They argue that medical devices, being engineering products, should not be subjected to the same regulatory standards as pharmaceuticals.

In a letter dated August 8 to the Union Health Minister, various associations representing manufacturers, traders, healthcare providers, and patient groups highlighted the potential negative impact of the draft bill. The letter emphasized that the draft fails to provide the necessary regulatory foundation for India’s medical devices sector to thrive and compete globally.

Industry Pushback on Criminal Penalties

The draft bill's inclusion of criminal penalties for regulatory lapses has been a focal point of criticism. Industry representatives argue that terms such as "adulterated," "spurious," and "misbranded" are drug-centric and inappropriate for the medical devices sector. The proposed penalties, which include imprisonment for labeling errors, documentation mishaps, licensing issues, and other deviations, are seen as excessive, especially when no harm to patients occurs.

Globally, medical devices are regulated through risk-based conformity assessments and quality management systems rather than criminal penalties. The industry points out that in jurisdictions like the EU, US, Japan, UK, and Australia, administrative enforcement is the norm.

Call for a Separate Regulatory Framework

The medical device sector is urging the government to reconsider the draft bill and develop a regulatory framework that acknowledges the unique characteristics of medical devices. They advocate for a system that supports innovation while ensuring patient safety through appropriate risk management and quality assurance measures.

The outcome of the inter-ministerial consultations on the draft bill will be closely watched by stakeholders both within India and internationally. As the country aims to establish itself as a global hub for medical device manufacturing, the regulatory approach adopted will play a crucial role in shaping the industry's future.