Medical Device Industry Opposes New Regulatory Bill in India

The Indian medical device industry, along with healthcare groups, is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation, currently under inter-ministerial review, aims to overhaul the country's regulatory framework but has sparked concern among stakeholders who argue it equates medical devices with pharmaceuticals, potentially hindering growth and innovation.

Concerns Over Regulatory Approach

Industry representatives have articulated their objections in a letter to the Union Health Minister, emphasizing that medical devices, being engineering products, require a distinct regulatory approach compared to pharmaceuticals. They argue that the draft bill's language and penal provisions are more suited to drug regulations, thereby imposing undue constraints on device manufacturers.

The letter, dated August 8, points out that the draft continues to categorize medical devices as an adjunct to pharmaceuticals despite significant differences in scientific and regulatory requirements. The industry fears that this approach could deter investment and manufacturing in India, undermining the country's potential to become a global hub for medical devices.

Potential Impact on Innovation and Investment

Critics of the bill highlight its stringent penalties, including imprisonment for minor infractions such as labeling errors or documentation lapses, even when no harm is caused. They contend that such punitive measures are not aligned with international standards. In regions like the EU, USA, Japan, UK, and Australia, regulatory enforcement for medical devices typically involves administrative actions rather than criminal penalties.

The draft bill's adoption of pharmaceutical-centric terms like "adulterated" and "spurious" for engineering deviations further exacerbates industry concerns. The associations argue that the bill lacks a solid regulatory foundation necessary for fostering a competitive and innovative medical device sector in India.

Call for a Revised Framework

Medical device manufacturers and healthcare providers are urging the government to rethink the draft bill, proposing a framework that better reflects the unique nature of medical devices. They advocate for a regulatory approach that emphasizes risk-based assessments, quality management systems, and post-market surveillance, aligning more closely with global practices.

The pushback from the industry underscores the need for a regulatory environment that supports innovation while ensuring patient safety. As the draft bill undergoes further consultations, stakeholders hope for revisions that will promote, rather than stifle, the growth of India's medical device industry.