Govt plans new drugs law to overhaul pharma, medical device regulation

New Delhi: The government is preparing to replace the 86-year-old law governing India's pharmaceutical regulations with a new regime addressing the definitions of modern drugs, clinical trials, cosmetics as well as medical devices.

The health ministry has prepared a draft Drugs, Medical Devices and Cosmetics Bill, 2026, and sent it to other ministries and departments seeking feedback, said people in the know. It seeks to repeal and replace the Drugs and Cosmetics Act of 1940.

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The draft, which ET has seen, proposes to give more teeth to the Drugs Controller General of India (DCGI), who would serve as the country's top drug and medical device regulator, as well as make bail conditions stringent for offences such as producing and selling substandard or fake drugs.

For serious offences involving making or selling not-of-standard-quality, adulterated, spurious, counterfeit or misbranded drugs, it proposes to make bail highly restricted.

DCGI Empowerment
According to the draft, the public prosecutor would be given an opportunity to oppose bail in such cases, and the court, before granting bail, must be satisfied that there were reasonable grounds to believe the accused was not guilty and was not likely to commit further offences.

It is easier to obtain bail for such offences under the current rules.

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The proposed framework "reflects the gravity with which such offences are treated under the new draft law", said a person in the know.

These conditions would be in addition to those under the criminal law. High courts would retain special powers to grant bail in such cases.

The draft proposes to introduce a dedicated chapter on medical devices. Under the existing framework, certain medical devices are legally notified and regulated as drugs.

As per the proposals, the drugs and medical devices controller general could issue binding orders to state drug regulators and, if a state failed to act, could step in directly. Under the existing framework, the central government can issue such directions to any state government, but the DCGI does not have that power. Under the proposals, states must appoint state drugs and medical devices controllers to enforce the regulations locally.

Quick Approvals, Recalls
The national regulatory authority, Central Drugs Standard Control Organisation, would be empowered to fast-track approvals and authorise the use of new drugs or medical devices quickly, as per the draft, and the regulator could even waive certain trial data requirements if public health demanded that.

If a drug, device or cosmetic is found to be unsafe or non-compliant, the regulator could order it to be pulled from the market immediately. The government can also grant, suspend or cancel licences and order products to be destroyed if they do not meet standards, it proposes.

Like the existing Drugs Technical Advisory Board (DTAB), the draft proposes to set up a Medical Devices Technical Advisory Board (MDTAB). It would have members from government, academia and industry. Both boards - DTAB and MDTAB - will meet at least once in six months.

Nominated members of the boards would hold office for three years and be eligible for renomination, as per the draft.

A Central Advisory Committee would be constituted to advise the DTAB and MDTAB on technical matters pertaining to drugs, cosmetics and medical devices. States would constitute similar state advisory committees.

The draft also proposes to constitute a Drugs, Medical Devices and Cosmetics Consultative Committee to advise the central government, state governments, and the DTAB and MDTAB on any matter tending to secure uniformity.