In a significant move to modernize India’s healthcare regulatory ecosystem, the Government of India has proposed the Drugs, Medical Devices and Cosmetics Bill, 2026, a comprehensive legislation that seeks to replace the existing Drugs and Cosmetics Act, 1940. The proposed law is expected to create a more robust framework for regulating drugs, medical devices, and cosmetics while encouraging innovation and emerging healthcare technologies.
One of the most notable features of the draft bill is the creation of a dedicated legal framework for medical devices, marking the first time the sector will be governed under a separate statutory structure rather than being regulated as a subset of drugs. The proposed legislation introduces a dedicated chapter for medical devices, covering risk-based classification, licensing, clinical investigations, and performance evaluations of diagnostic devices.
The bill also proposes establishing a Medical Devices Technical Advisory Board and a Central Medical Devices Testing Laboratory, strengthening oversight and quality assurance mechanisms for the rapidly growing medtech sector.
DCGI to Become Drugs and Medical Devices Controller General
The draft legislation seeks to rename the Drugs Controller General of India (DCGI) as the Drugs and Medical Devices Controller General, India, reflecting the regulator’s expanded responsibilities. The new authority would oversee critical functions such as licensing, clinical trials, and regulatory approvals for both pharmaceuticals and medical devices.
The proposed framework also grants the national regulator greater authority to issue directions to state regulators and intervene in cases where compliance is not ensured.
Stronger Enforcement and Penalties
The bill retains stringent penalties for the manufacture and sale of substandard, adulterated, or spurious drugs, including imprisonment and substantial financial penalties in cases leading to serious injury or death. Importantly, a similar offence-and-penalty framework has now been extended to medical devices, bringing them under a dedicated criminal liability regime for the first time.
Another major reform is the inclusion of clinical trial compensation provisions within the primary legislation. Sponsors conducting clinical trials or medical device investigations would face legal consequences for failing to provide medical care or compensation to participants affected during studies.
Industry Seeks Standalone Medical Devices Act
While the proposed bill is being viewed as a major regulatory reform, sections of the medical device industry have expressed concerns. Several industry associations have urged the government to reconsider the framework, arguing that medical devices differ fundamentally from pharmaceuticals and require a separate law tailored to engineering-based products.
Industry representatives contend that extending pharmaceutical-style terminology and criminal provisions to medical devices could discourage innovation, investment, and domestic manufacturing. They have called for a standalone Medical Devices Act, aligning with recommendations from policy bodies and international best practices.
The proposed legislation is expected to undergo further consultations before being finalized, but it signals the government’s intent to create a modern regulatory system capable of supporting India’s ambitions in pharmaceuticals, medical technology, and healthcare innovation.