Medical Device Industry Rejects Pharma-Like Regulation in Draft Bill

The Indian medical device industry is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes regulating medical devices under the same framework as pharmaceuticals. Industry stakeholders argue that such regulations could impede innovation and deter investment in the sector.

Concerns Over Proposed Regulations

In a letter addressed to the Union Health Minister, various associations representing manufacturers, traders, healthcare providers, and patient groups have highlighted their concerns. They warn that equating medical devices with pharmaceuticals could undermine India's goal of becoming a global hub for medical devices. The draft bill, currently under inter-ministerial review, seeks to replace the existing 86-year-old pharmaceutical regulation law.

The industry argues that medical devices are fundamentally different from pharmaceuticals. Unlike drugs, medical devices are engineering products and should not be subjected to the same regulatory standards. The draft bill's language, which includes terms like "adulterated," "spurious," and "misbranded," is deemed inappropriate for medical devices, which require distinct regulatory treatment.

Industry Pushback on Criminal Penalties

One of the primary concerns is the imposition of criminal penalties for regulatory lapses, including labeling errors and documentation mistakes. The draft bill proposes imprisonment ranging from one to seven years for such infractions, even when no harm has occurred. Industry leaders point out that this approach contrasts with international practices. In regions like the EU, US, Japan, UK, and Australia, administrative enforcement is preferred over criminal penalties.

Globally, medical devices are regulated through risk-based conformity assessments, quality management systems, post-market surveillance, and recalls. These methods ensure safety and compliance without resorting to criminalization, a stance the Indian industry advocates for.

Call for a Separate Regulatory Framework

The associations urge the government to establish a regulatory framework that acknowledges the unique characteristics of medical devices. They emphasize the need for a system that supports growth, innovation, and global competitiveness. The current draft, they argue, lacks the foundational structure necessary to foster a thriving medical device sector.

As the draft bill undergoes further consultation, the medical device industry remains hopeful that their concerns will be addressed. They continue to advocate for a tailored regulatory approach that aligns with international standards and supports India's aspirations in the medical device arena.