Medical Device Industry Opposes Draft Bill Treating Devices as Drugs

India's medical device sector is raising alarm over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which it argues could stifle innovation and investment by treating medical devices as pharmaceuticals. Industry groups and healthcare providers have expressed their concerns to the Union Health Ministry, emphasizing the distinct nature of medical devices compared to drugs.

Industry Pushback Against Regulatory Approach

The draft bill, currently under inter-ministerial review, has faced criticism for its pharmaceutical-centric regulatory framework. Industry representatives argue that medical devices, which are primarily engineering products, require different regulatory mechanisms than those used for drugs. The inclusion of terms such as "adulterated," "spurious," and "misbranded" in the bill has particularly drawn ire, as these are traditionally associated with pharmaceuticals.

In a letter dated August 8, industry associations highlighted the potential negative impact of the draft bill on India's burgeoning medical device sector. They warned that the bill could deter investment and hinder the country's goal of becoming a global hub for medical devices. "The draft continues to treat medical devices as an adjunct to pharmaceuticals, despite clear scientific, engineering, and regulatory distinctions between the two categories," the letter stated.

Concerns Over Criminal Penalties

The draft legislation proposes severe penalties, including imprisonment of 1-7 years for various regulatory lapses such as labeling errors or documentation issues, even if no harm results. This approach diverges significantly from international standards, where administrative enforcement is preferred. The industry pointed out that regions like the EU, US, Japan, UK, and Australia regulate medical devices through risk-based assessments, quality management systems, and post-market surveillance rather than imposing criminal penalties.

Medical device manufacturers argue that the draft bill's punitive measures could discourage innovation and complicate manufacturing processes. They assert that a more tailored regulatory framework, which recognizes the specific needs and challenges of the medical device industry, is essential for fostering growth and ensuring patient safety.

Call for Revised Legislation

The opposition to the draft bill underscores the need for a regulatory framework that accommodates the unique characteristics of medical devices. Stakeholders are urging the government to reconsider the bill's provisions and develop regulations that support the sector's growth while ensuring safety and compliance. The ongoing dialogue between the industry and the government will be crucial in shaping a balanced and effective regulatory environment for medical devices in India.