Medical Device Industry Challenges Draft Bill Over Pharma Classification

India's medical device industry and healthcare organizations have voiced strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. They argue that the bill's approach of regulating medical devices as pharmaceuticals could stifle innovation, deter investment, and damage the manufacturing sector. These concerns were raised in a letter to the Union Health Minister, emphasizing the need for a distinct regulatory framework for medical devices.

Industry's Pushback Against Draft Bill

The draft bill, currently under inter-ministerial review, aims to replace an 86-year-old law governing pharmaceuticals. However, stakeholders from the medical device sector argue that the bill does not adequately differentiate between medical devices and drugs. In their letter dated August 8, industry representatives highlighted that medical devices are fundamentally engineering products and should not be subject to the same regulatory standards as pharmaceuticals.

The letter criticizes the draft for its use of drug-centric terminology such as "adulterated," "spurious," and "misbranded," and for imposing severe penalties, including imprisonment for up to seven years for regulatory breaches like labelling errors or documentation lapses. The industry contends that such punitive measures are not in line with global practices, which typically favor administrative enforcement over criminal penalties.

Global Regulatory Practices Highlighted

The medical device sector points out that countries such as the United States, European Union, Japan, and Australia regulate medical devices through risk-based assessments, quality management systems, and post-market surveillance, rather than criminalization. These international frameworks focus on ensuring safety and compliance without resorting to punitive measures unless there is demonstrable harm.

Industry leaders argue that the draft bill's current form could hinder India's ambitions to become a global hub for medical device manufacturing. They emphasize that a conducive regulatory environment is crucial for fostering innovation and attracting investment in this sector, which is essential for meeting both domestic and international healthcare needs.

Calls for Regulatory Reform

The opposition to the draft bill reflects broader concerns about the need for a regulatory framework that recognizes the unique characteristics of medical devices. Industry associations are calling for a more tailored approach that supports growth and innovation while ensuring patient safety. They urge the government to reconsider the draft bill's provisions and align them with international standards to facilitate the sector's development.

As the draft bill undergoes further consultation, the medical device industry remains hopeful for amendments that will address their concerns and support the sector's growth. The outcome of these discussions will be pivotal in shaping the future regulatory landscape for medical devices in India.