The CDSCO set out the requirements in guidance documents published last week – available here – that covered a wide range of clinical trial regulations.
Highlights included making sponsors and contract research organisations (CROs) responsible for ensuring that the design of placebo-controlled studies – relatively rare in India according to the CDSCO – is appropriate and that investigators work on a maximum of three trials simultaneously .
The new guidelines also touch on the issue of compensation for the families of trial participants who die or are injured during studies, which has long been a controversial issue for the Indian clinical research sector .
The CDSCO says that: “Sponsors, manufacturers, clinical trial applicants are hereby advised to provide compensation to the trial participant/his/her nominee as the case may be if any drug-related anomaly is discerned at a later stage and accepted to be drug related injury or death.”
Another potentially controversial topic covered by the new guidelines is trial participant ethnicity, both in terms of whether approved drugs need to be trialled in India – they do unless there is an urgent need – and how much weight is given to role ethnicity plays in therapeutic efficacy .
The CDSCO also makes clear which subject expert committees will be responsible for assessing which types of drugs , when an institutional ethics committee can approve an academic trial , what level of care sponsors should provide for participants and the type of research needed for medical devices .
Indians in trials
The CDSCO also examined the idea of accelerating approvals based on the results of clinical trials conducted outside the country that involved Indian participants.
It concluded that experts should “evaluate applications of such new drugs” if “the number of Indian participants that took part is considered adequate for considering approval of the drug in India.”