Medical Device Industry Rejects Draft Bill, Cites Misclassification

India's medical device industry and healthcare groups have voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation, which treats medical devices similarly to pharmaceuticals, has raised concerns about its potential impact on manufacturing, investment, and innovation within the sector.

Industry Concerns Over Regulatory Approach

Key industry associations, including those representing manufacturers, traders, and healthcare providers, have formally reached out to the Union health minister. Their August 8 letter highlights the fundamental differences between medical devices and pharmaceuticals, asserting that devices should not be regulated as drugs. The letter criticizes the draft for failing to establish a suitable regulatory framework that would enable the sector to thrive and compete on a global scale.

One of the primary objections is the draft's use of drug-centric terminology, such as "adulterated," "spurious," and "misbranded," which the industry says is inappropriate for engineering products. Furthermore, the bill proposes stringent penalties, including imprisonment for minor infractions like labeling errors or documentation mistakes, which the industry argues is disproportionate and not aligned with global practices.

Global Standards and Practices

The medical device sector points to international standards, where devices are regulated through risk-based conformity assessments, quality management systems, and post-market surveillance rather than criminal penalties. Countries such as those in the European Union, the United States, Japan, the United Kingdom, and Australia typically employ administrative enforcement for regulatory compliance, avoiding imprisonment unless significant harm occurs.

By imposing severe penalties for regulatory lapses, the industry fears that the draft bill could stifle innovation and deter investment. The associations warn that this approach may hinder India's aspirations to become a hub for medical device manufacturing and innovation.

Call for a Revised Regulatory Framework

The draft bill is currently undergoing inter-ministerial consultations as part of the process to replace the existing 86-year-old law governing pharmaceuticals. The medical device industry is advocating for a revised regulatory framework that recognizes the distinct nature of medical devices and supports their development and growth.

Industry leaders are calling for regulations that are aligned with international best practices, ensuring that the sector's growth is not hampered by outdated or inappropriate legal frameworks. As the consultation process continues, stakeholders remain hopeful that their concerns will be addressed, leading to a more balanced and effective regulatory environment for medical devices in India.