Last Updated on December 30, 2023 by The Health Master
Highlights: Drugs, Medical Devices and Cosmetics Bill 2022
New Delhi: The Ministry of Health and Family Welfare (MoHFW) released a draft of the New Drugs, Medical Devices, and Cosmetics Bill 2022 to keep pace with changing needs, time, and technology.
The draft bill has been put up on the ministry’s website and suggestions, comments, and objections from the public and stakeholders have been sought within 45 days from the date of issue of the notice.
The draft bill seeks to replace the existing Drugs and Cosmetics Act of 1940, to accommodate the changed requirements and adaptation of new technology.
Why was there a need to replace the existing 1940 Act?
The ministry said that “The Drugs and Cosmetics Act, 1940 is pre-Independence legislation enacted by the Central Legislative Assembly.”
“The review of obsolete laws and updating of the existing laws is a continuing process to accommodate changed requirements and adapt to new technology.” With the need to review obsolete laws and to “periodically repeal and amend laws.”
What are the important definitions mentioned in the draft bill?
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,
- Imported spurious drugs.
The bill introduces a separate definition for medical devices that includes all types of diagnostic equipment and their software.
It will also include implants, devices for assistance with disabilities, a life support system, instruments used for disinfection, and any reagents or kits. The previous 1940 Act regulated medical devices on par with drugs.
What will change for medical devices?
In Chapter II of the draft, the ministry made a provision for the creation of a ‘medical devices technical advisory board’.
This board will 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, DRDO, and experts in the field of biomedical technology, biomaterials, and polymer technology will be part of the board.
At present, the decisions regarding medical devices are taken by the ‘drugs technical advisory board’.
The bill also proposes medical device testing centers along the lines of drug laboratories in states and at the central level.
Also read: Medical Device Alert: Lists
What will change in the import of drugs and cosmetics?
Chapter III of the draft, states that the center can regulate or restrict the import of drugs, in the public interest if the drug is essential to meet the requirements of an emergency due to epidemic or natural calamities.
If the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed for it, the government may, by notification in the Official Gazette, prohibit the import of such drugs and cosmetics in the public interest.
It also mentions the penalty for the import of drugs or cosmetics in breach of the proposed regulation.
For the first time, regulations for conducting clinical trials for new drugs and medical devices have been highlighted.
Also, read related news:
Draft of Drugs, Medical Devices and Cosmetics Bill 2022: Could be a Game Changer
What will change for clinical trials or clinical investigations?
Chapter IV of the draft states that clinical trials or clinical investigations of drugs and medical devices will need compulsory permission from the central licensing authority.
At present also the companies have to seek permission from the apex drug regulator to conduct trials but it was not mentioned in the previous law.
It also mentions that medical management and compensation have to be provided to people who are injured while participating in clinical trials.
In case of death, the legal heir of the participant should be awarded compensation. The one who fails to provide the same will be punishable with imprisonment or a fine.
What are the provisions relating to Ayurveda, Siddha, Sowa Rigpa, Unani and Homoeopathy drugs?
Chapter V of the draft proposes to establish a scientific research board to support the regulatory authority on the advances used for developing innovative drugs in Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homoeopathy, their safety and efficacy, making devices, and other related matters.
For the first time, there is a separate segment that proposes to regulate Sowa Rigpa and Homeopathy, under AYUSH, encouraging the use of modern science and technology to develop innovative drugs and devices across the AYUSH branch of medicine. The current bill only regulates Ayurveda, Siddha, and Unani drugs and cosmetics.
What does the draft mention about the manufacture, sale, distribution and clinical trial of medical devices?
In Chapter VI of the draft, regulations for medical devices, investigational medical devices, clinical trials of investigational medical devices, etc., have been mentioned.
In the interest of public health or extreme emergency of medical devices, the central government is empowered to waive the requirement of conducting a clinical investigation for the manufacture or import of a new medical device in the country.
Similar to drug clinical trials, medical management and compensation have to be provided to persons who are injured while participating in such an investigation.
What does the draft mention about online pharmacies?
The draft recognizes the issue of e-pharmacies and states that the Union government would come up with rules and regulations to regulate the online sale of drugs.
It mentions that “no person shall himself or by any other person on his behalf sell, or stock, exhibit, 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.” It also prohibits such sales in the category of medical devices.
At the end of the draft, the first schedule mentions standards to be complied with by imported drugs and by drugs manufactured for sale, sold, stocked, or exhibited for sale or distributed. The second schedule mentions the fee payable for a license, permission, registration certificate, and approval.
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