Aimed at promoting clinical research in the country, the health ministry on Monday notified the New Drugs and Clinical Trials Rules, 2019, reducing the time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
The new rules will ensure patient safety, as they will be enlisted for trials with informed consent. The ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events, Drugs Controller General of India (DCGI) S. Eswara Reddy said.
“In case of injury to a clinical trial subject, medical management will be provided as long as required as per the opinion of the investigator or till such time it is established that the injury is not related to the clinical trial.
“Also, compensation in cases of death and permanent disability or other injuries to a trial subject will be decided by the Drug Controller General,” Reddy said.
These rules will apply to clinical trial, bio-availability or bio-equivalence study, new drugs and regulation of ethics committee relating to clinical trial and biomedical health research.
“The aim is to promote clinical research in India, have predictable, transparent and effective regulations for such trials and also make faster accessibility of new drugs to the Indian population,” he said.
These rules provide for the disposal of clinical trial applications by way of approval or rejection or seeking further information within 90 days for drugs developed outside India.
However, in case of an application for conducting a clinical trial of a new drug or investigational new drug as part of discovery, research and manufacture in India, the application is to be disposed of within 30 days.
In case of no communication from DCGI, the application will be deemed to have been approved, the rules stated.
The requirement of a local clinical trial may be waived for approval of a new drug if it is approved and marketed in any of the countries to be specified by the DCG with the approval of government from time to time and certain other conditions.
A local clinical trial may also be waived if the application is for import of a new drug for which the DCGI had already granted permission to conduct a global clinical trial which is ongoing in India and in the meantime the new drug has been approved for marketing in a country specified by the DCGI and certain other conditions.