Industry Pushback Against Draft Bill Treating Devices as Pharma

India's medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which aims to regulate medical devices in the same manner as pharmaceuticals. Industry representatives, along with healthcare providers and patient safety groups, argue that this approach could significantly hinder manufacturing, innovation, and investment in the sector.

Concerns Over Regulatory Approach

The draft bill, currently under inter-ministerial consultation, has drawn criticism for not distinguishing between the engineering nature of medical devices and pharmaceutical products. Associations representing manufacturers and healthcare providers have communicated their concerns to the Union health minister, emphasizing that the bill's provisions could deter India's goal of becoming a global hub for medical devices.

In a letter dated August 8, these associations highlighted that the bill fails to establish a regulatory framework conducive to the growth and competitiveness of India's medical devices sector. They noted that the bill treats devices as an extension of pharmaceuticals, despite clear distinctions in their scientific and regulatory requirements.

Criticism of Proposed Penalties

The draft legislation has also been criticized for its use of pharmaceutical-centric language, including terms like "adulterated," "spurious," and "misbranded." The industry is particularly concerned about the proposed criminal penalties, which include imprisonment of one to seven years for various regulatory infractions such as labeling errors and documentation lapses, even if no harm occurs.

Industry experts argue that such stringent measures are not aligned with international practices. They point out that regions like the European Union, United States, Japan, United Kingdom, and Australia primarily rely on administrative enforcement, focusing on risk-based assessments and quality management systems rather than criminal penalties.

Call for a Separate Regulatory Framework

The medical device sector is urging the government to reconsider the draft bill and establish a distinct regulatory framework that addresses the unique characteristics of medical devices. They advocate for a system that emphasizes conformity assessments, post-market surveillance, and recalls, similar to global regulatory standards.

As the draft bill undergoes further consultations, stakeholders from the medical device industry continue to push for revisions that would foster a more supportive environment for innovation and investment in India. The outcome of these discussions could have significant implications for the future of the country's medical device industry.