Medical Device Industry Criticizes Draft Bill Treating Devices as Drugs

India's medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Industry leaders argue that the bill inappropriately categorizes medical devices as pharmaceuticals, which could impede manufacturing and innovation. Concerns are also rising over the possibility of criminal penalties for regulatory lapses, which stakeholders say could deter investment.

Industry Concerns Over Regulatory Approach

The draft bill aims to replace an 86-year-old law governing pharmaceutical regulations, but its approach to medical devices has sparked controversy. Representatives from various associations, including manufacturers, healthcare providers, and patient advocacy groups, have formally requested the Union Health Minister to reconsider the bill's provisions. Critics argue that the bill's framework does not reflect the engineering and scientific distinctions between medical devices and pharmaceuticals.

In a letter dated August 8, industry associations highlighted that the draft bill's language remains drug-centric, using terms like "adulterated," "spurious," and "misbranded." They expressed concerns over the proposed criminal penalties for issues such as labeling errors and documentation lapses, which are typically managed through administrative actions in other countries.

Global Standards and Local Challenges

Globally, medical devices are regulated based on risk assessments, quality management systems, and post-market surveillance rather than through criminal penalties. The industry points to standards set by the EU MDR, US FDA, and other international bodies, which focus on administrative enforcement. The draft bill's approach, which includes imprisonment for regulatory deviations, is seen as misaligned with these global practices.

Stakeholders argue that the draft bill could undermine India's goal of becoming a global medical device hub. The potential for harsh penalties might discourage both local and foreign investment, stifling the sector's growth and innovation. The medical device industry is urging the government to adopt a regulatory framework that supports the sector's unique needs.

Call for a Specialized Regulatory Framework

The medical device sector is advocating for a regulatory approach that recognizes the distinct nature of medical devices. Industry leaders emphasize the need for a framework that fosters innovation and competitiveness without imposing undue burdens. They argue that a specialized approach would better align with global standards and support India's ambitions in the medical device market.

The draft bill is currently under inter-ministerial consultation, and stakeholders are hopeful that their concerns will be addressed. As the debate continues, the medical device industry remains committed to engaging with policymakers to ensure a balanced and effective regulatory environment.