New clinical trial rules to fast-track access to drugs

Requirement of a local clinical trial may be waived for approval of new drug if it is approved and marketed in any of the countries to be specified by the drug controller general of India (DCGI) with approval of government from time to time and certain other conditions.

The government on Monday notified New Drugs and Clinical Trials Rules, 2019, which will not only fast-track access to new drugs by reducing the time of granting approvals for clinical trials but will also ensure that death, permanent disability or injury to any patient is adequately compensated.

New clinical trial rules to fast-track access to drugs (Getty Images/iStockphoto)

Requirement of a local clinical trial may be waived for approval of new drug if it is approved and marketed in any of the countries to be specified by the drug controller general of India (DCGI) with approval of government from time to time and certain other conditions.

Local trials may also be waived in case of import of a new drug for which the DCGI has already granted permission for trials to be conducted in India as part of a global clinical trial, and the drug has been approved for marketing in the government-approved country.