Industry Pushback: Medical Devices Oppose India's 2026 Draft Bill

India's medical device industry has raised significant concerns over the draft Drugs, Medical Devices, and Cosmetics Bill, 2026. Industry leaders argue that the bill's approach to regulating medical devices as pharmaceuticals could stifle innovation and deter investment.

Industry Concerns Over Regulatory Approach

The draft bill has been met with resistance from various stakeholders, including manufacturers, healthcare providers, and patient safety groups. They contend that the bill fails to recognize the distinct nature of medical devices compared to pharmaceuticals. These devices, they argue, are engineering products and should not be subjected to the same regulatory framework as drugs.

In their communication to the Union Health Minister, industry representatives have emphasized that treating medical devices like pharmaceuticals could undermine India's goal of becoming a leading global hub for medical device manufacturing. They warned that the draft bill, which is currently under inter-ministerial consultation, lacks the necessary regulatory foundation to support growth and innovation in the sector.

Criticism of Proposed Penalties

The draft legislation proposes stringent penalties, including imprisonment for labeling errors, documentation issues, and other regulatory lapses. The industry argues that such pharma-style criminalization is inappropriate for engineering deviations, which are better managed through administrative enforcement.

Globally, medical devices are regulated by risk-based assessments and quality management systems rather than through criminal penalties. Industry leaders have pointed out that major markets like the EU, US, Japan, UK, and Australia do not impose imprisonment for regulatory non-compliance in the medical device sector.

Call for Distinct Regulatory Framework

The industry’s letter, dated August 8, clearly states that the draft bill's drug-centric language, using terms such as "adulterated," "spurious," and "misbranded," does not align with the scientific and regulatory realities of medical devices. Stakeholders are urging a reconsideration of the bill's provisions to establish a more suitable regulatory framework that does not hinder the sector's potential to innovate and grow.

This opposition highlights the need for a nuanced approach that separates the regulatory paths of pharmaceuticals and medical devices. As the draft bill moves through the consultation phase, stakeholders hope for adjustments that will accommodate the unique characteristics of medical devices, ensuring that regulatory measures support rather than hinder industry advancement.