Medical Device Firms Challenge Draft Bill's Pharma-Like Regulations

India's medical device industry is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes treating medical devices similarly to pharmaceuticals. Industry leaders and healthcare groups argue that this approach could negatively impact manufacturing, innovation, and investment in the sector.

Concerns Over Regulatory Approach

The draft bill, currently under inter-ministerial consultation, has sparked concern among various associations representing manufacturers, traders, healthcare providers, and patient safety groups. These associations have collectively written to the Union Health Minister, urging a reconsideration of the proposed regulations. They warn that the bill's approach could impede India's ambitions of becoming a global hub for medical devices.

Critics of the bill argue that medical devices, which are fundamentally engineering products, should not be regulated in the same manner as pharmaceuticals. They emphasize that the draft continues to use drug-centric language, applying terms like "adulterated," "spurious," and "misbranded" to devices, which the industry finds inappropriate.

Potential Impact on the Industry

According to industry representatives, the draft bill's provisions could lead to severe consequences for the medical device sector. It proposes criminal penalties, including imprisonment of one to seven years, for various regulatory lapses such as labeling errors, documentation issues, and engineering defects, even when no harm is caused. This is a stark contrast to international practices, where administrative enforcement is the norm.

Globally, countries like those in the EU, the US, Japan, the UK, and Australia regulate medical devices through risk-based assessments, quality management systems, and post-market surveillance rather than through criminal penalties. Industry stakeholders argue that adopting a similar approach in India would be more beneficial and conducive to growth.

Industry's Call for Rethink

The letter submitted by the associations on August 8 highlights the necessity for a regulatory framework that recognizes the distinct nature of medical devices compared to pharmaceuticals. The industry is calling for regulations that support innovation and competitiveness in the global market, rather than stifling it with stringent, drug-like regulations.

The draft bill aims to replace the existing 86-year-old law governing India's pharmaceuticals regulations. However, the medical device industry is advocating for a separate, tailored regulatory framework that acknowledges the unique characteristics and requirements of medical devices.

As the draft bill undergoes further consultation, the medical device sector hopes for revisions that will foster an environment conducive to growth, aligning with international standards and practices.