India waives off clinical trial requirement for drugs approved abroadApril 2, 2019
India does not require implementing clinical trials on their patients for new drugs which are already approved in other leading markets, declares Health Ministry.
Submission of clinical trial data from local population has been mandatory in obtaining approval for new drugs to be commercialized in India. However, relaxation of clinical trial as per the new regulation in New Drugs & Clinical Trial Rules 2019 is expected to help the patients get easy access to the available new therapies without hindrance.
The Official Gazette notified that the new regulations came into effect from 18th March, 2019. Chapter IV of the revised clinical trial rules which deals with regulation and registration of ethics committees related to biomedical and health research will take effect after 180 days from the date of publication, says the notification.
The revised regulations will apply to all new drugs, investigational new drugs for human use, bioequivalence study, bioavailability study, clinical trial and ethics committee.
Another significant feature of the New Drugs & Clinical Trial Rules 2019 is that they assign well-defined timelines for approving new drug applications. The rules permit 90 working days for the disposal of clinical trial applications for drugs developed abroad. While it provides 30 days to decide on the filings for drugs manufactured in India.
The new rule also states that the application for a drug will be considered approved in case of no communication from the Drugs Controller General of India.