Medical Device Industry Opposes Draft Bill Treating Devices as Drugs

India’s medical device industry is raising alarm over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which they argue unjustly categorizes medical devices alongside pharmaceuticals. Industry representatives, alongside patient safety and healthcare groups, have expressed concerns that the bill could stifle innovation and deter investment by imposing stringent regulations similar to those applied to drugs.

Industry Pushback Against Regulatory Approach

The draft bill, currently under review, seeks to replace the existing 86-year-old law governing pharmaceutical regulations in India. However, industry stakeholders argue that the bill fails to recognize the fundamental differences between medical devices and pharmaceuticals. They assert that medical devices are engineering products that require distinct regulatory frameworks, unlike the drug-centric approach proposed in the bill.

In a letter dated August 8, industry associations appealed to the Union Health Minister, urging a reevaluation of the draft. The letter highlighted that the bill’s language remains heavily influenced by pharmaceutical terminology, using words like "adulterated," "spurious," and "misbranded." The associations argue these terms are inappropriate for medical devices and that the bill’s punitive measures, including potential imprisonment for labeling errors or documentation lapses, are excessive and could hinder the sector's growth.

Global Standards and Local Concerns

The proposed penalties within the draft bill range from one to seven years of imprisonment for various regulatory breaches, even in cases where no harm is caused. This approach contrasts sharply with international norms, where regulatory bodies such as the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA favor administrative enforcement over criminal penalties.

Industry advocates argue that India’s ambition to become a global hub for medical devices is at risk if the bill is enacted without significant revisions. They emphasize that the bill does not provide a conducive regulatory foundation for fostering innovation and competition on a global scale. Instead, it could drive manufacturers away and discourage potential investors wary of the stringent regulatory environment.

Call for a Balanced Regulatory Framework

The medical device sector is calling for a regulatory framework that aligns with global standards, focusing on risk-based conformity assessments, quality management systems, and post-market surveillance. Such a framework would facilitate growth and innovation while ensuring patient safety without resorting to harsh criminal penalties.

The draft bill remains under inter-ministerial consultation, with stakeholders hoping that their concerns will prompt a reconsideration of the proposed regulations. As the discussion continues, the industry remains vigilant, advocating for policies that recognize the unique nature of medical devices and support the sector’s development.