The Ministry of Health and Family Welfare (Department of Health & Family Welfare) (Drugs Regulation Section) (“MOHFW”) has released the Draft of New Drugs, Medical Devices and Cosmetics Bill, 2022 (“Bill”) on July 8, 2022.
Since the Drugs and Cosmetics Act, 1940 (“Act”) is a pre-independence legislation enacted by the Central Legislative Assembly, the need was felt to review the existing law and update the same to accommodate changed requirements and adaptation of new technology. The work of review and updating of the Act and rules thereunder, such as the Drugs and Cosmetics Rules, 1945 was vigorously taken up from the year 2016.
To have a more comprehensive legislation, a committee was constituted for framing the Bill. As per recommendations of the said committee, the MOHFW has proposed this Bill to amend 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 and clinical investigation of investigational medical devices and for matters connected therewith or incidental thereto.
Based on a preliminary review, the notable changes are as follows:
1. New Definitions:
The Bill proposes new definitions for clinical trials, over-the-counter drugs, manufacturers, cosmetics, medical devices, new drugs, bioavailability studies, bioequivalence studies, investigational new drugs, proprietary medicine and imported spurious drugs, among others.
2. Medical Devices:
The Bill introduces a separate definition for medical devices that includes all types of diagnostic equipment and its software. It will also include implants, devices for assistance with disabilities, a life support system, instruments used for disinfection, and any reagents or kits.
3. Medical Devices Technical Advisory Board (MDTAB):
Unlike the Act which put medical devices at par with drugs since the decisions regarding medical devices under the Act are taken by the Drugs Technical Advisory Board, the Bill proposes the creation of a separate MDTAB which shall include medical professionals and people with technical knowledge of the devices. Officials from the Health Ministry, Department of Atomic Energy, Department of Science and Technology, Ministry of Electronics, and experts in the field of biomedical technology, biomaterials, and polymer technology will form a part of the MDTAB.
4. Medical Device Testing Centres:
The Bill proposes medical device testing centres, similar to the drug laboratories, in states and at the central level.
5. Clinical trials or investigations:
The Bill introduces regulations for conducting clinical trials for new drugs and medical devices. It provides that clinical trials or clinical investigations of drugs and medical devices will require compulsory permission from the central licensing authority. Further, medical management and compensation will have to be provided to persons who are injured while participating in clinical trials. In case of death, the legal heir of the participant has to be awarded compensation.
6. Online Pharmacies:
Regarding e-pharmacies, the Bill states that “no person shall himself or by any other person on his behalf sell, or stock or exhibit or offer for sale, or distribute, any drug by online mode except under and in accordance with a license or permission issued in such manner as may be prescribed.”
7. Ayurveda, Siddha, Sowa Rigpa, Unani and Homoeopathy:
The Bill proposes to establish a scientific research board to support the regulatory authority for developing innovative drugs of Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homoeopathy, their safety and efficacy, making devices and other related matters.
This update has been contributed by Namitha Mathews (Partner) and Anukriti Goswami (Associate).
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