New Drugs Bill Proposes To Rename DCGI, Bring Medical Devices Under Law For First Time

Published 11 August 2026 · india

News india New Drugs Bill Proposes To Rename DCGI, Bring Medical Devices Under Law For First Time New Drugs Bill Proposes To Rename DCGI, Bring

News india New Drugs Bill Proposes To Rename DCGI, Bring Medical Devices Under Law For First Time New Drugs Bill Proposes To Rename DCGI, Bring Medical Devices Under Law For First Time Reported By, Edited By Last Updated: August 11, 2026, 10:11 IST The draft Drugs, Medical Devices and Cosmetics Bill, 2026, seeks to repeal the Drugs and Cosmetics Act, 1940, with a graded penalty structure and a dedicated framework for devices Rapid Read Eleven associations have called for urgent re-examination of the draft, noting that it undermines India’s ambition to become a global medical device manufacturing hub. (Image for Representation) India is working on a new drug law that could replace the 86-year-old Drugs and Cosmetics Act and, for the first time, give medical devices a standalone statutory framework, according to a draft bill seen by News18. The draft, titled the Drugs, Medical Devices and Cosmetics Bill, 2026, and circulated by the legislative department on June 9, proposes to repeal and consolidate the existing law on the import, manufacture, distribution and sale of drugs, medical devices, and cosmetics into a single 190-section statute spread across eight chapters. Medical Devices Get Their Own Chapter Under the current 1940 Act, medical devices are regulated only because a February 2020 notification brought all devices within the definition of “drug", building on the Medical Devices Rules, 2017. The draft bill changes that by creating a dedicated Chapter V covering risk-based classification, licensing, clinical investigation of investigational devices, and clinical performance evaluation of new in vitro diagnostic devices, along with a separate Medical Devices Technical Advisory Board, which is distinct from the Drugs Technical Advisory Board. A separate central medical devices testing laboratory has also been proposed. The bill is described as one “to repeal and consolidate the law relating to the import, manufacture, distribution and sale of drugs, medical devices and cosmetics to ensure their quality, safety, efficacy, performance and clinical trial of new drugs, clinical investigation of investigational medical devices and clinical performance evaluation of new in vitro diagnostic medical devices, for encouraging innovation and emerging technologies".

DCGI Renamed, Role Expanded The bill proposes renaming the Drugs Controller General of India as the “Drugs and Medical Devices Controller General, India." It states the central government “shall by notification, appoint an officer, having such qualifications and experience, as may be prescribed, as the Drugs and Medical Devices Controller General, India." It designates that officer as the national regulatory authority, though only for a specified list of provisions covering import and manufacture licensing, clinical trials, and clinical investigations. The same section also provides for separate controllers general for drugs and for medical devices, and for a central drugs, medical devices and cosmetics regulatory authority (AUSSH) covering Ayurveda, Unani, Siddha, Sowa-Rigpa and Homoeopathy systems—the acronym the draft uses in place of the wider AYUSH. Some sections of the draft give the national regulator new leverage over the states: it may issue binding directions to state drug controllers, and where a controller fails or refuses to comply, may act in that controller’s place, with such action deemed to be the state controller’s own. The draft brings AUSSH drugs, medical devices and cosmetics into a single chapter with their own technical advisory board and testing laboratories, rather than governing them through separate and overlapping frameworks as at present. Penalty Structure Retained, Extended To Devices Section 74 of the draft retains the graded penalty structure introduced through the 2008 amendment to the 1940 Act. Manufacture, sale or distribution of a drug that is not of standard quality, adulterated or spurious, and which is likely to cause death or grievous hurt — now defined by reference to Section 116 of the Bharatiya Nyaya Sanhita, 2023 — continues to carry a minimum sentence of 10 years, extendable to life imprisonment, with a fine of not less than Rs 10 lakh or three times the value of the drugs confiscated, whichever is higher.