Industry Pushback on India's Draft Medical Devices Bill 2026

India's medical device industry is raising concerns over the Draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it unjustly aligns medical devices with pharmaceuticals. Key industry associations, healthcare providers, and patient safety groups have voiced that this approach could negatively impact manufacturing and innovation within the sector.

Industry Concerns Over Regulatory Approach

Industry leaders have criticized the draft bill for its pharmaceutical-centric regulatory framework, which includes criminal penalties for regulatory lapses. According to sources familiar with the matter, the bill's provisions could deter investment and hinder India's potential to become a global hub for medical devices.

The draft legislation proposes treating medical devices similarly to drugs, a move the industry argues is inappropriate given the distinct scientific and engineering characteristics of devices. In a letter to the Union health minister dated August 8, industry representatives urged a reconsideration of the draft, emphasizing the need for a regulatory environment that supports growth and competitiveness in the global market.

Debate Over Criminal Penalties

The draft bill includes severe penalties, such as imprisonment ranging from one to seven years for issues like labeling errors and documentation lapses. Industry groups argue that such punitive measures are not aligned with international standards, where administrative approaches are typically favored.

Globally, regulatory frameworks like the EU MDR, US FDA, and others rely on risk-based assessments, quality management systems, and post-market surveillance rather than criminalization. The Indian draft, however, employs drug-related terminologies such as "adulterated" and "spurious," which the industry believes are unsuitable for engineering products.

Call for a Distinct Regulatory Framework

The industry's opposition to the draft stems from a belief that medical devices require a tailored regulatory framework, distinct from pharmaceuticals. The bill, currently under inter-ministerial consultation, is seen as lacking the necessary provisions to foster innovation and investment in the sector.

The pushback highlights the need for a regulatory approach that recognizes the unique nature of medical devices and supports the sector's role in advancing healthcare technology. As the draft bill undergoes further review, industry stakeholders continue to advocate for adjustments that align with global best practices and support India's ambitions in the medical device industry.