Medical Device Firms Oppose Regulatory Bill Treating Them as Pharma

India's medical device industry, alongside healthcare and patient safety groups, has raised strong objections to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. Industry representatives argue that the bill's approach of categorizing medical devices similarly to pharmaceutical products could impede manufacturing capabilities and innovation, ultimately hindering the country's goal of becoming a global hub for medical devices.

Industry Concerns Over Regulatory Approach

Several associations, representing manufacturers, traders, and healthcare providers, have formally communicated their concerns to the Union Health Minister. In their letter dated August 8, they cautioned that the draft bill, currently under inter-ministerial review, lacks the necessary regulatory framework to foster growth and competitiveness in India's medical device sector.

The letter highlights that medical devices are fundamentally engineering products, distinct from pharmaceuticals, and should not be regulated as drugs. The industry argues that the bill continues to use language and penalties typical of pharmaceutical regulation, such as "adulterated," "spurious," and "misbranded," which are inappropriate for the medical device sector.

Potential Impact on Investment and Innovation

The draft bill proposes severe penalties, including imprisonment ranging from one to seven years for issues such as labeling errors or documentation lapses, even when no harm has occurred. Industry stakeholders argue that such stringent measures are not aligned with global practices observed in regions like the EU, US, Japan, UK, and Australia, where administrative enforcement is preferred over criminal penalties.

By equating medical devices with pharmaceuticals, the draft bill could deter potential investors and innovators from entering the Indian market, fearing punitive measures that do not align with international standards. This misalignment could undermine India's strategic ambitions to become a leader in the global medical device industry.

Calls for a Distinct Regulatory Framework

Industry leaders are advocating for a regulatory framework that recognizes the unique nature of medical devices, emphasizing risk-based conformity assessments, quality management systems, and post-market surveillance rather than criminalization. Such a framework, they argue, would better support the sector's growth and innovation, aligning with international best practices.

As the bill undergoes further consultations, stakeholders from the medical device industry remain hopeful that their concerns will be addressed, ensuring that the regulatory environment supports rather than stifles the sector's development.