The Health Ministry has recently notified New Drugs and Clinical Trials Rules, 2019, with a goal to promote clinical research in the nation, for lowering the time of application approval to 30 days for drugs developed in India and 90 days for the ones manufactured outside the nation.
S Eswara Reddy, Drugs Controller General of India (DCGI), mentioned that these new rules would ensure patient safety, since these will be enlisted for trial with informed consent. The committee of ethics would be monitoring the trials, as well as decide on the compensation amount in cases of an adverse event.
Reddy mentioned that in case of a clinical trial subject’s injury, medical management would be offered as long as required according to the investigator’s opinion or till a time it is instituted that the injury does not relate to the clinical trial. Moreover, compensation in cases of permanent disability and death or any other injury to the trial subject would be determined by the Drug Controller General.
Apparently, these rules would be applied to the new drugs and regulation of ethics committee that relates to the biomedical health research and clinical trial, bio-equivalence or bio-availability study.
Reddy further said that the aim is promoting clinical research in India, have effective, transparent and predictable regulations for such trials, along with making rapid accessibility of new drugs to the population of India.
Sources familiar with the matter cited that these new rules would offer disposal of clinical trial applications, by the way of rejection or approval or looking for further information within 90 days for drugs that are manufactured outside the nation.
Though, in case of an application for investigational new drug as a part of research, discovery and manufacture, or for conducting clinical trial of a new drug, the application would purportedly be disposed of within 30 days.