The Union Department of Health is revising the outdated Medicines and Cosmetics Act 1940 with an update where greater emphasis will be placed on establishing strict regulatory guidelines to keep up with developments needs and technology. The ministry asked for suggestions, comments and objections from various stakeholders.
The bill proposes new definitions for clinical trials, over-the-counter drugs, manufacturers, medical devices, new drugs, bioavailability studies, investigational new drugs, and fake imported drugs, among others. It aims to introduce regulations for online pharmacies and medical devices and penalties such as imprisonment and compensation for injury or death in clinical drug trials.
The project also proposes that no clinical trial can be carried out without authorization, medical care and compensation in the event of injury or death, the project proposes. The bill further mentions that no person may himself or by any other person on his behalf sell, store or display or offer for sale or distribute any medicine by online mode (e-pharmacy) except under and as a result of a license or authorization issued in this way. as may be prescribed.
The Center has proposed a separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB). In addition to officials from the Ministry of Health, the council will also include people from the Department of Atomic Energy, the Department of Science and Technology, the Ministry of Electronics, DRDO, and experts in the field of biomedical technology, biomaterials and polymer technology. The draft proposes to allow the Center to waive the obligation to conduct a clinical investigation for the manufacture or import of a new medical device in the public interest.
It proposes medical device testing centers modeled on state and central drug labs and stipulates that medical care and compensation be provided to those injured while participating in such trials. And, in the event of death, the participant’s legal heir should be compensated.
The bill proposes that the central government develop rules to regulate the online sale of drugs and for online pharmacies to operate “following a license or authorization issued”. The bill also includes a chapter on Ayurveda, Siddha, Sowa-Rigpa, Unani and Homeopathy, along with their respective technical drug advisory committees.