Drugs which have already been on the market in well-regulated countries with good post-marketing surveillance (PMS) for more than four years with a satisfactory report may be granted marketing licence in India.
In a major development, an expert committee headed by Prof. Ranjit Roy Chaudhury that has been working on the policy for approval of new drugs has said that though the approval of these drugs should be subject to strict PMS for four to six years, this period may be reduced or waived off in cases where no therapy or only palliative therapy is available, or in national healthcare emergencies.
In its 99-page-long report, the panel has recommended that an informed consent from each participant is a mandatory prerequisite for a clinical trial. “In circumstances where informed consent has to be obtained from special groups of people who have diminished capacity to protect their interests or give consent for themselves, the consent given by the guardian should be witnessed by an independent person who also has to sign the informed consent document,” it said. The committee has advised that an audiovisual recording of the informed consent process should be undertaken.
According to the experts, in cases of clinical trials being carried out on patients suffering from terminal illnesses such as cancer, compensation may be payable if the institute ethics committee (IEC) is of the considered opinion that there is an increase in the number of serious adverse effects (SAE) occurring in such a patient as compared to a standard treatment, and which may be irreversible or life expectancy has been severely curtailed.
However, for such patients, compensation may not be given if the primary end-point is death, as per the clinical trial protocol.
The report said that in case SAE occurs during a clinical trial, the sponsor investigator will be responsible for providing medical treatment and care to the patient at his/their cost till the resolution of the adverse effect/SAE. This is to be given irrespective of whether the patient is in the control group, placebo group, standard drug treatment group or the test drug-administered group.
However, it further said that compensation need not be paid for injury or death due to totally proven unrelated causes. “In all other cases of death or injury/disability, compensation should be paid to the participant or his legal heirs. No compensation needs to be paid for therapeutic inefficiency, since the very purpose of a clinical trial is to determine the efficacy and safety of a given drug/vaccine/ device,” it added.
The report suggested that Phases I to IV clinical trials of all new entities developed in India to be marketed in India will need to be carried out in India. Constituted by the Union health ministry, the expert committee has recommended sweeping changes in all these sectors and recommended that a Central Accreditation Council should be set up to oversee the accreditation of institutes, clinical investigators and institute ethics committees for clinical trials in the country.