Indian Medical Device Sector Pushes Back Against Draft Bill

The medical device industry in India, alongside patient safety groups and healthcare providers, has expressed strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Stakeholders argue that the bill erroneously categorizes medical devices as pharmaceuticals, which could stifle innovation and deter investment in the sector.

Concerns Over Regulatory Approach

Industry representatives have raised alarms over the draft bill's approach to regulating medical devices. They argue that it lacks the necessary framework to support growth and innovation in the sector. A key concern is the bill's application of pharmaceutical-centric language and punitive measures to medical devices, which are fundamentally different in nature and function from drugs.

In a letter dated August 8, addressed to the Union Health Minister, associations representing manufacturers, traders, and healthcare providers emphasized the need for a distinct regulatory pathway for medical devices. They stressed that these products are engineering-based and should not be governed under the same parameters as pharmaceuticals.

Potential Impact on Innovation and Investment

The draft legislation is perceived as a threat to India's ambition to become a global hub for medical devices. By imposing criminal penalties for regulatory lapses typically handled administratively in other major markets, such as the EU and the US, the bill could deter both domestic and foreign investments.

The draft proposes imprisonment of one to seven years for issues such as labeling errors or documentation mistakes, even in cases where no harm has occurred. This contrasts with global practices where administrative enforcement, such as fines or recalls, is the norm.

Call for a Revised Regulatory Framework

Industry advocates are urging the government to reconsider the draft bill and propose a regulatory framework that aligns with international standards. They argue that a risk-based approach, incorporating quality management systems and post-market surveillance, would better serve the sector's needs.

As the draft bill remains under inter-ministerial consultation, stakeholders hope for a revision that acknowledges the unique nature of medical devices and supports their development without imposing undue burdens.