The ministry of Health and Family welfare ( MoHFW) released a draft of New drugs and medical devices and Cosmetics Bill 2022, to keep pace with changing needs, time and technology. The existing Drugs and cosmetics Act, 1940, is a pre-independence legislation enacted by the Central Legislative Assembly. It said there is a need to review the obsolete laws with the changing requirements and trending technology.
Points proposed:
The bill proposes new definition of clinical trials, over the counter drugs and manufacturers, cosmetics, medical devices, new drugs, bio availability studies, bio equivalence studies, investigational new drugs, proprietary medicines, and imported spurious drugs and others. The bill introduces a new definition on medical devices for all types of diagnostic equipment, implants, devices for assistance for disabilities, life support system, disinfectant instruments ,reagents and kits. A medical devices technical advisory board shall be formed with professionals from health ministry, department of atomic energy, department of science and technology, bio materials and polymer technology. At present the decision regarding medical advices are taken by the drug technical advisory board. It also proposes medical devices testing centre on the state and national level.
The center can restrict and control the import of drugs. If the use of drugs or cosmetic tend to pose risks to humans or animals, or if any drug does not have any therapeutic value as it may claim to be , the government on notification in the official gazette, can prohibit those drugs on interests of the public. Penalties are also mentioned if there is a breach of the proposed regulation.
Even though in the existing law it is not mentioned clearly , the companies still require permission from the apex drug regulator. But henceforth , it shall all be well-mentioned in the proposed legislation. It also mentions the compensation awarded to the persons who undergo clinical trials who are injured or in case of death to their legal heirs. The penalty in breach is imposed with imprisonment or fine. 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.
A scientific research board shall be formulated and established to regulate the developments of innovative drugs in Ayurvedha, Siddha, Sowa-Rigpa, Unani and Homeopathy, their safety and efficacy and their making of other devices in the same field. The current bill only regulates Ayurveda, Siddha and Unani drugs and cosmetics under the Ayush branch of medicines.
The draft recognises 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 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.” It also prohibits such sales for the category of medical devices.
