Medical Device Industry Criticizes India's Draft Drug Bill

India's medical device industry and healthcare groups are voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes treating medical devices similarly to pharmaceuticals. Critics argue that this approach could negatively impact manufacturing, innovation, and investment in the sector.

Concerns Over Regulatory Approach

The proposed legislation has prompted several associations representing manufacturers, traders, and healthcare providers to reach out to the Union Health Minister. In their communications, they have urged a reconsideration of the bill, warning that it could undermine India's aspirations to become a global hub for medical devices.

Industry representatives emphasize that medical devices are fundamentally engineering products, not pharmaceuticals, and should not be regulated as drugs. They point out significant differences in scientific and regulatory frameworks between the two categories. The draft's application of drug-centric language and penalties, such as imprisonment for labeling errors or documentation lapses, has been a particular point of contention.

International Comparisons Highlight Differences

The industry highlights that globally, medical devices are regulated through risk-based conformity assessments and quality management systems, rather than criminalization for regulatory deviations. They point to international standards set by bodies like the EU Medical Device Regulation (MDR), the US Food and Drug Administration (FDA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and the UK's Medicines and Healthcare products Regulatory Agency (MHRA), which prefer administrative enforcement over criminal penalties.

The draft bill currently under inter-ministerial consultation seeks to replace the 86-year-old law governing the pharmaceutical sector in India. However, stakeholders argue that the bill, as it stands, does not provide the necessary regulatory foundation for the medical device sector to thrive and compete on a global scale.

Call for a Distinct Regulatory Framework

In their August 8 letter to the health ministry, industry associations stressed the need for a distinct regulatory framework that acknowledges the unique nature of medical devices. They argue that a one-size-fits-all approach, treating medical devices as an adjunct to pharmaceuticals, is not viable and fails to recognize the engineering and scientific distinctions between the two.

The call for a separate regulatory framework is aimed at fostering an environment conducive to innovation and growth, aligning India's regulations with international best practices. The industry is advocating for regulations that support quality management and post-market surveillance, rather than punitive measures that could stifle development.

As the draft bill continues to be a topic of debate, the medical device industry remains firm in its stance that the current provisions could hinder the sector's growth and deter potential investors.