Medical Device Industry Opposes Draft Bill, Cites Regulatory Concerns

India's medical device industry, alongside healthcare groups and patient safety advocates, has voiced strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The primary concern is the bill's approach to regulate medical devices as if they were pharmaceutical products, which industry representatives argue could significantly impede the growth of the sector.

Concerns Over Regulatory Approach

The draft bill, currently under inter-ministerial review, proposes stringent regulations that include criminal penalties for regulatory infractions. Industry leaders argue that such measures, akin to those applied in the pharmaceutical sector, are inappropriate for medical devices, which are fundamentally engineering products. The bill uses terms like "adulterated," "spurious," and "misbranded," traditionally associated with pharmaceuticals, and applies them to medical devices, which has raised concerns within the industry.

In a letter dated August 8, industry associations urged the Union Health Minister to reconsider the bill, warning that it could deter investment and hinder India's ambitions to become a global hub for medical device manufacturing. The letter emphasized that the draft bill does not provide a suitable regulatory framework for fostering innovation and competition in the medical device sector.

Global Regulatory Standards

Critics of the draft bill highlight that globally, medical devices are regulated through risk-based assessments, quality management systems, and post-market surveillance rather than criminal penalties. The current draft, however, suggests imprisonment ranging from one to seven years for issues such as labelling errors, documentation lapses, and engineering defects, even when these do not result in harm.

The industry points out that such punitive measures are not standard practice in major markets like the European Union, the United States, Japan, the United Kingdom, or Australia, where administrative enforcement is preferred. Associations argue that the proposed regulations could create an unfavourable business environment, stifling innovation and discouraging manufacturers from operating in India.

Industry's Call for Change

Representatives from various sectors within the healthcare industry have reiterated their call for a regulatory framework that recognizes the unique nature of medical devices. They argue for a system that supports growth and innovation while ensuring patient safety through appropriate risk management strategies. The industry is advocating for regulations that align with international standards, facilitating India's integration into the global medical device market.

The draft bill's implications are significant, as the medical device industry is a crucial component of India's healthcare ecosystem. As discussions continue, stakeholders are hopeful that the government will address their concerns and create a regulatory environment that supports the sector's growth and global competitiveness.