Medical Device Industry Challenges India's Draft Regulatory Bill

India's medical device industry is raising alarms over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Industry leaders argue that the draft legislation mistakenly categorizes medical devices as pharmaceuticals, imposing stringent regulations that could impede innovation and deter investment.

Industry Pushback Against Draft Legislation

The draft bill has drawn criticism from various stakeholders, including manufacturers, healthcare providers, and patient advocacy groups. These organizations have collectively expressed their concerns to the Union Health Minister, urging a reconsideration of the proposed law. They argue that the bill's approach could undermine India's ambition to become a global leader in medical device manufacturing.

In a letter submitted on August 8, these associations emphasized that medical devices are fundamentally different from pharmaceuticals. They highlighted that the bill's language and structure fail to recognize the distinct scientific, engineering, and regulatory frameworks that govern medical devices. The associations warned that the bill could disrupt the industry's growth by treating devices as an adjunct to medicines.

Concerns Over Regulatory Approach

The proposed legislation has been criticized for its drug-centric language, using terms like "adulterated," "spurious," and "misbranded." Industry leaders argue that these terms are inapplicable to medical devices, which are primarily engineering products. The draft also proposes criminal penalties for regulatory lapses, such as labelling errors and documentation mistakes, which the industry contends are more appropriately addressed through administrative measures.

Global regulatory practices, such as those in the EU, US, Japan, UK, and Australia, typically rely on risk-based assessments and quality management systems rather than criminalization. The bill's current form could impose imprisonment for issues that are generally managed through administrative enforcement in other countries.

Call for a Revised Regulatory Framework

The medical device industry is advocating for a regulatory framework tailored to the specific needs of medical devices. They argue that a risk-based approach, focused on post-market surveillance and recalls, would be more effective in ensuring safety and innovation. The associations are urging the government to develop regulations that align with global standards and support the sector's growth.

The draft bill is currently undergoing inter-ministerial consultation, and industry leaders hope that their concerns will be addressed before it is finalized. As India seeks to bolster its position in the global medical device market, the outcome of this legislative process could have significant implications for the sector's future.