Industry Pushback Against Draft Bill Equating Medical Devices with Pharma

The draft Drugs, Medical Devices and Cosmetics Bill, 2026, has drawn significant opposition from India's medical device industry and healthcare groups. Stakeholders argue that the proposed legislation, which treats medical devices similarly to pharmaceuticals, could hinder manufacturing, innovation, and investment.

Organizations representing manufacturers, healthcare providers, and patient safety groups have expressed concerns in a letter to the Union Health Minister. They warn that the bill could deter investment and disrupt India's goal of becoming a leading hub for medical device production.

Medical Devices and Pharmaceuticals: Key Differences

Critics of the draft bill emphasize that medical devices are fundamentally engineering products, not pharmaceuticals, and should not be regulated under the same framework. The letter, seen by The Economic Times, highlights the need for a distinct regulatory approach that acknowledges the scientific and technical differences between these categories.

The industry argues that the draft bill continues to employ drug-centric language, using terms such as "adulterated," "spurious," and "misbranded." It also proposes severe penalties for regulatory lapses, including imprisonment for labeling errors, documentation issues, and other non-harmful deviations.

Concerns Over Regulatory Approach

The proposed bill suggests imprisonment terms ranging from one to seven years for various administrative errors. Industry leaders point out that this approach is not aligned with international practices. Regulatory bodies in regions like the EU, US, Japan, UK, and Australia typically focus on administrative enforcement rather than criminal penalties for similar issues.

Associations have urged a reconsideration of the bill, highlighting that a risk-based regulatory framework, quality management systems, and post-market surveillance are more appropriate for the medical device sector. Such frameworks are standard practice in other major markets and do not involve criminalization for administrative errors.

Call for Policy Reassessment

The draft bill is currently undergoing inter-ministerial consultation. As discussions continue, the medical device industry remains vocal about the potential negative impacts of equating medical devices with pharmaceuticals. Stakeholders are advocating for a regulatory environment that supports growth and aligns with global standards.

The outcome of this legislative process is crucial for the future trajectory of India's medical device industry, which seeks to maintain its competitiveness and innovate without the constraints of a pharmaceutical-style regulatory framework.