Industry Pushes Back Against India's Draft Bill on Medical Devices

India's medical device industry, along with healthcare providers and patient safety groups, has raised significant concerns over the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The proposed legislation, which seeks to overhaul the country's regulatory framework for medical products, is being criticized for treating medical devices similarly to pharmaceutical products. Industry representatives argue that this approach could undermine manufacturing, deter investment, and hinder innovation.

Industry's Call for Distinct Regulations

The draft bill has sparked alarm among several associations representing manufacturers, traders, and healthcare providers. They have formally addressed their concerns to the Union Health Minister, urging a reconsideration of the draft's provisions. These groups emphasize that medical devices are distinctly different from pharmaceutical products, both scientifically and in terms of engineering, and should not be regulated under the same framework.

The letter sent to the ministry on August 8 highlights the industry's dissatisfaction with the bill's language and approach. It points out that the bill continues to categorize medical devices as an adjunct to pharmaceuticals, ignoring the clear distinctions between these two categories. The industry argues that this could impede India's goal of becoming a global hub for medical device manufacturing and innovation.

Concerns Over Criminal Penalties

A major point of contention is the draft bill's imposition of criminal penalties for regulatory lapses. The industry argues that terms like "adulterated," "spurious," and "misbranded," commonly used in pharmaceutical regulation, are inappropriate for medical devices. The bill proposes imprisonment ranging from one to seven years for various infractions, including labeling errors and documentation lapses, even if no harm results.

Industry representatives have pointed out that such stringent measures are not typical in other major markets such as the European Union, the United States, Japan, the United Kingdom, or Australia. These regions rely on administrative enforcement, focusing on risk-based conformity assessments, quality management systems, and post-market surveillance rather than criminalization.

Potential Impact on Investment and Innovation

The medical device sector is concerned that the proposed bill could deter investment and stifle innovation within the industry. By treating medical devices as pharmaceutical products, the draft bill might create a regulatory environment that is less conducive to the development and growth of this engineering-focused field.

Industry leaders stress that a more tailored regulatory framework is necessary to support the unique needs of the medical device sector. They advocate for a system that facilitates growth and innovation while ensuring patient safety, aligning more closely with international standards and practices.

As the draft bill undergoes inter-ministerial consultation, stakeholders in the medical device industry remain hopeful that their concerns will be addressed, leading to a regulatory environment that fosters both innovation and safety.