On July 8, 2022, a new draft was released to change the New Drugs, Medical Devices, and Cosmetics Bill by the Union Health Ministry. The purpose of the new bill is to change the 83-year-old Drugs and Cosmetics Act of 1940, which comprises manufacturing, importing, distributing, and selling drugs, medical devices, and cosmetics in India.
This bill was issued by the Ministry of Health under the guidance of an Expert Committee to consolidate laws on drugs, medical devices, and cosmetics for the quality, efficacy, and safety of drugs. The bill was issued to regulate the clinical trials of new drugs and medical devices.
The new bill also introduces new definitions and provisions for over-the-counter drugs and retains some of the rules of the Drugs and Cosmetics Act made in 1940. The bill also has separate chapters for drugs, cosmetics, and medical devices, which describe the standards to develop, manufacture, and distribute them. The bill also has a chapter for laboratory tests and testing officers.
According to Chapter 2 of the draft, the decision regarding medical devices is taken by the Medical Devices Technical Advisory Board. The board consists of medical professionals, people with technical knowledge of devices, officers from the Health Ministry, the Ministry of Electronics, experts in biomedical technology and biomaterials, and people from the Department of Atomic Energy and the Department of Science and Technology.
According to Chapter 4 of the draft, clinical trials and clinical investigations should get approval from the central licensing authority. It also addresses the differences between central and state licensing authorities, which makes it transparent in manufacturing and marketing approvals. It also has a state-level tracking system to monitor the approval process for manufacturing applications.
Chapter 5 of the draft proposed the advancement of innovative drugs in Ayurveda, Siddha, Unani, and Homeopathy, which for the first time integrated modern science and technology with natural medicines.
The bill consists of the regulatory framework to maintain high standards of quality, safety, and efficacy of drugs and medical devices. It also considers the benefits to patients in terms of accessibility to safe and quality health services.
(Input from various sources)