Medical Device Industry Opposes Draft Bill Equating Devices with Drugs

India's medical device industry, along with healthcare groups, is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. Industry representatives argue that the bill's approach of treating medical devices as pharmaceutical products could significantly hinder manufacturing, investment, and innovation within the sector.

Concerns Over Regulatory Framework

The draft legislation has sparked concern among various associations representing manufacturers, healthcare providers, and patient safety groups. These organizations have collectively urged the Union Health Minister to reconsider the bill's provisions, warning that its current form could derail India's ambitions of becoming a global hub for medical devices. The industry argues that medical devices, being engineering products, have distinct regulatory needs compared to pharmaceuticals and should not be subjected to the same legal framework.

The draft bill, which is currently under inter-ministerial consultation, aims to replace existing regulations that have governed India's pharmaceutical landscape for 86 years. However, the medical device sector contends that the bill does not establish a robust foundation necessary for the industry's growth and global competitiveness. A letter from the industry to the Union Health Minister, dated August 8, highlights these concerns, emphasizing the scientific and regulatory differences between medical devices and drugs.

Criticism of Criminal Penalties

A major point of contention is the bill's use of drug-centric terminology, such as "adulterated," "spurious," and "misbranded," which the industry claims is inappropriate for engineering products. Furthermore, the bill proposes criminal penalties, including imprisonment ranging from one to seven years for infractions like labelling errors and documentation lapses, even if no harm occurs. This approach contrasts with global practices, where administrative enforcement rather than criminal penalties is the norm.

The industry points to international regulatory bodies such as the European Union Medical Device Regulation (EU MDR), the United States Food and Drug Administration (US FDA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and Australia's Therapeutic Goods Administration (TGA), which rely on administrative measures like risk-based conformity assessments and post-market surveillance.

Call for Tailored Regulations

The associations argue that the draft bill's current language and approach are not conducive to fostering a conducive environment for innovation in the medical devices sector. They advocate for regulations that are specifically tailored to the unique nature of medical devices, emphasizing the need for a risk-based approach to conformity assessments, quality management systems, and post-market surveillance.

As the consultation process continues, the medical device industry remains hopeful that their concerns will be addressed, allowing for a regulatory framework that supports growth and innovation while ensuring patient safety.