In news-The Union Health Ministry has recently released the draft ‘Drug, Medical Devices, and Cosmetics Bill-2022’ that seeks for the first time to regulate e-pharmacies.
Key features of the bill-
- The health ministry plans to replace the Drugs and Cosmetics Act of 1940 with an updated law laying down strict regulatory guidelines to keep pace with changing needs and technology.
- Given the need to have comprehensive legislation, a committee was constituted for framing the drugs, medical devices and cosmetics bill, 2022.
- The bill proposes new definitions for clinical trial, over-the-counter drugs, manufacturers, medical devices, new drugs, bioavailability study, investigational new drug and imported spurious drugs, among others.
- It seeks to bring in regulation for online pharmacies and medical devices and penalties such as imprisonment and compensation in case of injury or death during clinical trials for drugs.
- The draft proposes that no clinical trial can be carried out without permission, medical management and compensation for injury or death, the draft proposes.
- It says 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 (e-pharmacy) except under and in accordance with a licence or permission issued in such manner as may be prescribed.
- The government has proposed empowering the Drugs Control Officer with prior approval of the controlling authority to enter into any premises related to clinical trial to inspect the facilities, record, data, documents, books and drugs.
- The Centre has proposed a separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB) to give suggestions to the government from time to time.
- MDTAB will not only include medical professionals, but also people with technical knowledge of the devices.
- Other than officials from the Health ministry, the board will also include people from the 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.
- The draft proposes to allow the Centre to waive the requirement of conducting clinical investigation for manufacture or import of a new medical device in public interest.
- It proposes medical device testing centres on the lines of drug laboratories in states and at the central level.
- It states medical management and compensation has to be provided to persons who are injured while participating in such trials. And, in case of death, the legal heir of the participant should be awarded the compensation.
- The Bill also touches upon the contentious issue of e-pharmacies, which drug store owners say are hard to regulate.
- It specifically states that the Central government must come up with rules to regulate online sale of drugs and for online pharmacies to operate “in accordance with a licence or permission issued”.
- The Bill aslo includes a chapter on Ayurveda, Siddha, Sowa-Rigpa, Unani and Homeopathy, and their respective Drug Technical Advisory Boards.