Indian Medical Device Sector Challenges Drug-Like Regulation in Draft Bill

India's medical device industry, along with healthcare providers and patient safety groups, is voicing strong opposition to the draft Drugs, Medical Devices, and Cosmetics Bill, 2026. The bill, currently undergoing inter-ministerial consultations, proposes regulating medical devices under similar frameworks as pharmaceuticals, a move that industry experts argue could stifle innovation and investment.

Concerns Over Regulating Devices Like Drugs

The draft legislation has sparked concern among multiple stakeholders, including associations representing manufacturers, traders, and healthcare providers. These groups have formally reached out to the Union Health Minister, urging a reconsideration of the draft. They argue that equating medical devices with pharmaceuticals ignores significant scientific and regulatory differences, which could impede India's goal to become a global hub for medical device manufacturing.

In their communication dated August 8, these associations emphasized that the current draft lacks the necessary regulatory framework to support growth and innovation in India's medical device sector. The industry contends that medical devices are fundamentally engineering products, not pharmaceuticals, and thus should not be subjected to the same regulatory criteria.

Potential Impact on Innovation and Investment

The bill introduces stringent penalties, including imprisonment for 1-7 years for errors in labeling, documentation, and licensing, even if no harm results. Industry voices argue that this approach is inconsistent with international practices, where administrative enforcement is the norm. Countries like the US, Japan, and the EU use risk-based assessments and quality management systems instead of criminal penalties for regulatory compliance in medical devices.

Critics of the bill highlight that terms like "adulterated," "spurious," and "misbranded"—traditionally associated with pharmaceuticals—are used in the draft, reinforcing a drug-centric approach. Such language and the associated penalties could deter investment and innovation, as companies might face criminal charges for engineering deviations.

Call for a Rethink

The medical device industry is advocating for a regulatory framework that aligns with global standards, where devices are assessed based on risk and quality rather than being conflated with pharmaceuticals. Stakeholders are pushing for regulations that support post-market surveillance, recalls, and quality management systems without punitive measures that could hinder manufacturing growth.

As the draft bill undergoes further review, the industry's feedback underscores the need for a regulatory environment that fosters innovation while ensuring safety, without imposing excessive burdens on manufacturers. The outcome of this debate will have significant implications for India's medical device sector and its position in the global market.