Medical Device Firms Criticize Draft Bill for Treating Devices as Drugs

India's medical device industry is raising alarms over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to regulate medical devices similarly to pharmaceuticals. Industry leaders argue that this approach could stifle innovation and deter investment.

Industry Pushback Against the Draft Bill

The draft bill, currently under inter-ministerial review, has drawn criticism from various stakeholders, including manufacturers, healthcare providers, and patient safety groups. These organizations have written to the Union Health Minister, urging a reconsideration of the proposed regulations. They argue that the bill's pharma-centric language and criminal penalties for regulatory breaches could negatively impact the sector's growth.

According to industry representatives, medical devices should not be classified or regulated in the same manner as pharmaceutical products. They emphasize that these are engineering products with distinct regulatory needs. The draft bill's use of terms such as "adulterated," "spurious," and "misbranded," typically associated with drugs, is a major point of contention.

Potential Impact on Innovation and Investment

Critics of the bill warn that the imposition of severe penalties, including imprisonment for issues like labeling errors or documentation lapses, could deter investment. This punitive approach could also discourage innovation, as companies might be reluctant to develop new products under such stringent regulations.

The industry letter highlights that globally, medical devices are regulated through frameworks that focus on risk-based assessments, quality management systems, and post-market surveillance. These methods prioritize administrative enforcement over criminal penalties, a practice followed by regulatory bodies such as the EU Medical Device Regulation (MDR), the US Food and Drug Administration (FDA), and others.

Call for a Distinct Regulatory Framework

Associations representing the medical device sector argue that the draft bill lacks the necessary regulatory foundation to support the industry's growth and international competitiveness. They advocate for a distinct regulatory framework that acknowledges the unique nature of medical devices and aligns with global best practices.

As the Indian government seeks to update the 86-year-old law governing pharmaceutical regulations, stakeholders in the medical device industry are hopeful for revisions that will foster an environment conducive to innovation and growth, while ensuring patient safety.