Industry Pushback: Medical Devices Not Pharma, Say Companies

India's medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which aims to regulate medical devices in the same manner as pharmaceuticals. Industry leaders and healthcare organizations argue that such regulation could negatively impact manufacturing, innovation, and investment in the sector.

Industry Concerns Over Regulatory Approach

Medical device manufacturers, along with patient safety groups and healthcare providers, have expressed their objections to the draft bill, which they believe inappropriately classifies medical devices alongside pharmaceuticals. In a letter to the Union Health Minister dated August 8, industry associations warned that the bill could deter investment and hinder India's aspirations to become a global hub for medical device manufacturing.

The associations argue that medical devices, being engineering products, require distinct regulatory approaches compared to pharmaceuticals. They emphasize that the draft bill fails to provide the necessary regulatory framework that would allow the sector to thrive and compete internationally.

Criticism of Penal Measures

The draft bill has been criticized for its use of drug-centric language and for proposing criminal penalties for regulatory lapses. Terms such as "adulterated," "spurious," and "misbranded" are borrowed from pharmaceutical regulations, which the industry deems inappropriate for medical devices.

Notably, the bill suggests imprisonment for periods ranging from one to seven years for errors in labeling, documentation, licensing, and reporting—even when no harm is caused. Industry voices note that such punitive measures are not in line with global practices. Regulatory bodies in regions like the European Union, the United States, Japan, the UK, and Australia typically employ administrative enforcement rather than criminal penalties for similar issues.

Call for a Revised Framework

The ongoing inter-ministerial consultations on the draft bill aim to replace an 86-year-old law governing pharmaceutical regulations in India. However, stakeholders in the medical device sector urge the government to reconsider the current draft, advocating for a separate, risk-based regulatory framework tailored to the unique characteristics of medical devices.

Industry representatives continue to push for regulations that align with international standards, focusing on quality management systems, post-market surveillance, and recalls, rather than punitive actions. They argue that such a framework would better support innovation and growth in the sector, ultimately benefiting healthcare outcomes in India.