Medical Device Industry Opposes Draft Bill Treating Devices as Pharma

India's medical device industry is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to regulate medical devices similarly to pharmaceuticals. Industry groups argue this approach could significantly hamper manufacturing, investment, and innovation within the sector.

Industry Concerns Over Regulatory Approach

Key industry players, including associations representing manufacturers, traders, healthcare providers, and patient groups, have formally expressed their concerns to the Union Health Minister. They argue that the draft bill does not adequately distinguish between medical devices and pharmaceuticals, despite their fundamentally different scientific and engineering bases.

The draft bill, currently under inter-ministerial consultation, seeks to replace the nearly century-old law governing India's pharmaceutical regulations. However, industry representatives contend that equating medical devices with pharmaceuticals could deter investment and undermine India's aspirations to become a global hub for medical devices.

Potential Impact on Innovation and Investment

The draft legislation includes provisions for criminal penalties for regulatory lapses such as labelling errors and documentation mistakes, with potential imprisonment ranging from one to seven years. Industry stakeholders argue that such penalties are inappropriate for medical devices, which are typically governed by risk-based assessments and quality management systems globally.

“Globally, medical devices are regulated through risk-based conformity assessments, quality management systems, post-market surveillance, and recalls, not imprisonment,” stated the industry letter to the ministry. The document highlights that leading regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA employ administrative enforcement rather than criminalisation.

Calls for a Distinct Regulatory Framework

In their detailed submissions dated August 8, industry representatives have urged the government to reconsider the draft bill's language, which they describe as drug-centric, using terms like "adulterated," "spurious," and "misbranded." They emphasize the necessity of a regulatory framework that recognizes the unique nature of medical devices, facilitating innovation and competition on a global scale.

The medical device sector's pushback underscores the importance of tailored regulations that reflect the specificities of engineering products, as opposed to pharmaceuticals. The outcome of this discourse could significantly influence the future landscape of India's medical device industry.