With a view to keep pace with changing needs, times, and technology, the Ministry of Health and Family Welfare (“Ministry”) has proposed the Draft New Drugs, Medical Devices and Cosmetics Bill, 2022 (“Draft Bill”) to replace the Drugs and Cosmetics Act, 1940 (“Act”).
The Ministry has invited suggestions / comments / objections that may be sent within 22nd August, 2022 by email to drugsdivmohfw@gov.in or by post to Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Room No. 434, C Wing, Nirman Bhawan, New Delhi – 110011.
Some Key Highlights of the Draft Bill-
• For more clarity, smooth functioning and implementation, the Draft Bill introduces various new definitions including
i. Medical device,
ii. New drugs,
iii. Over the-counter (OTC) drugs,
iv. Clinical investigation,
v. Controlling Authority,
vi. Manufacturer.
• The Bill introduces the provisions for regulation of medical devices. Currently, medical devices are treated as drugs and there is no separate definition for them. A separate chapter for medical devices in the Draft Bill will give distinct treatment to it in line with international practices to boost quality and consumer confidence. Further, provisions have been made for risk-based classification of medical devices based on their intended use, risk, and vulnerability to the human body. In the Draft Bill, provisions have been incorporated to designate or establish medical device testing centres by the central government for testing and evaluation of medical devices for regulators and industry.
• Under Chapter III, the Draft Bill has provided metrics for an adulterated drug or cosmetic. The penalties for offences related to import of drugs and cosmetics have been enhanced.
• Under Chapter IV, the Draft Bill provides for regulation of clinical trial of new drugs, investigational new drugs, ethics committee, etc. Similar to that of drugs, the Draft Bill envisages provisions relating to clinical investigation in respect of investigational medical devices.
However, in the interest of public health or extreme urgency of drugs, the central government is empowered to make provisions for Central Licensing Authority to waive the requirement of conducting clinical trial for manufacture or import of a new drugs or investigational new drugs in the country.
Where a participant during a clinical trial suffers injury or death on account of his participation in such investigation, provision has been made to provide compensation and medical management to such participants. If any person permitted under sub-section (1) of section 72 fails to provide the required medical management or compensation under section 73, the Draft Bill makes it punishable with imprisonment which may extend to one year or with fine which shall not be less than twice the amount of compensation.
Currently, conduct of clinical trials for new drugs and medical devices and the provisions for compensation for injury or death on account of participation in clinical trials are regulated under the New Drugs and Clinical Trials Rules, 2019 (“Rules”). Now those provisions have been incorporated in the Draft Bill. However, in the existing Rules, there is no provision to impose penalties such as imprisonment on the erring firms or persons for failure to provide compensation to trial participants in the clinical trial for both drugs and medical devices.
• Under Chapter V for AYUSH drugs, the Draft Bill proposes to regulate Sowa Rigpa and Homeopathy for the first time. The existing Act regulates Ayurveda, Unani and Siddha drugs and cosmetics.
• Under the Draft Bill, permission must be taken to operate an e-pharmacy. Under section 41, 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 (e-pharmacy) except under and in accordance with a licence or permission issued in such manner as may be prescribed,” the draft said.
• Under Chapter II, the Draft Bill proposes to introduce several advisory boards and committees such as the Drugs Technical Advisory Board and the Medical Devices Technical Advisory Board and the Drugs and Cosmetics Consultative Committee to primarily advise the Central and State Governments on technical matters. The tenure of nominated members shall be 3 years from the date on which they enter upon their office and shall be eligible for re-nomination.
• Under section 50, every police officer shall be bound to assist a drugs control officer demanding his assistance in the investigation and preventing the escape of any person who is suspected to commit an offence under this Draft Bill or in the prevention of any injury attempted by the person to be committed against the drugs control officer.
A Copy of the Draft Rules has been attached herewith for your ease of reference.
Source: Ministry of Health and Family Welfare
