The Union Health Ministry recently released a draft of a proposed The Drugs, Medical Devices and Cosmetics Bill, 2022 to replace the existing The Drugs and Cosmetics Act, 1940, and several sets of Rules by which the industry is currently run.
What is the new “Drugs, Medical Devices and Cosmetics Bill, 2022”?
The new Drugs, Medical Devices and Cosmetics Bill, 2022, was drafted to keep pace with changing needs, times and technology
The bill proposes new definitions for clinical trials, over-the-counter drugs, manufacturers, medical devices, new drugs, bioavailability studies, investigational new drugs and imported spurious drugs, among others.
The draft focuses on
regulating medical devices as a separate entity,
makes provision for fines and imprisonment for injury and death related to clinical trials or investigations, and
seeks to regulate e-pharmacies
Key features of draft Bill:
Online pharmacies are currently working completely outside the law. Most of these websites have perhaps a licence for a physical shop or storage unit.
In case of a violation, drug inspectors do not know under which provision of the law or Rule they can proceed against the websites.
The draft Bill states: “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 licence or permission issued in such manner as may be prescribed.”
It also states that the central government can formulate Rules to regulate aspects of the industry for which the old law has no provisions.
Clinical trials and investigations
The draft Bill makes provisions for compensation to participants or their legal heirs for injury or death suffered in clinical trials and investigations for drugs and medical devices.
The draft also lays the onus of providing medical management for any injury arising due to the trial on the investigators.
The draft Bill prohibits clinical trials or clinical investigations of drugs and medical devices without permission from the central licensing authority.
While companies have to seek permission from the regulator to conduct trials even now, this is not specifically mentioned in the existing law.
The draft provides for debarring the investigators and sponsors of a trial or investigation if the laid-down provisions are not followed.
A Drugs Technical Advisory Board (DTAB) and a Medical Devices Technical Advisory Board (MDTAB) are planned to submit recommendations to the government from time to time on policy matters.
Under the ambit of medical devices defined by the draft Bill are diagnostic equipment, their software, implants, devices for assistance with disabilities, life support, instruments used for disinfection, and reagents or kits.
The 1940 Act has medical devices as one of four categories of “drugs”.
The draft proposes to allow the Union government to waive the requirement of conducting clinical investigations for the manufacture or import of a new medical device in public interest.
Drugs and Cosmetics Act, 1940:
The Act regulates the import, manufacture, and distribution of drugs in India.
The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
Section 3 of the Drugs and Cosmetics Act, 1940:
The Central Government, after consultation with the Drugs Technical Advisory Board (DTAB), specifies the devices intended for use in human beings or animals as drugs.