- The recent amendment brought to the compensation guidelines in carrying out clinical trials in the country has cleared “major hurdles” for testing of new drugs, especially for those diseases for which cure is not yet available in India.
- The revised regulations are balanced and will address various issues, because of which sponsors have earlier been either not participating in or withdrawing from trials.
- It will also seek to streamline the ‘institutional ethical committee’ to make sure the trials are carried out in the safest way.
- Compensation guidelines are balanced and ensure safety of patients, and the compensation offered would be based on the severity of the injury if any sustained by the patient during the course of the trial.
Source: PTI News