New Delhi: The Union health ministry has proposed mandatory audio-visual recording of participants in clinical trials, making it tougher for drug companies to shrink responsibility when testing of their medicine reacts adversely on patients.
Significantly, the new recommendations by a panel headed by Medical Council Of India (MCI) member Prof Ranjit Roy Chaudhury, the investigator can be debarred from clinical trials in case a violation is witnessed on their part.
According to the new rules, in circumstances where informed consent has to be obtained from people with diminished capacity, the consent given by the guardian should be witnessed by an independent person who also has to sign the informed consent document.
Consent from each participant is a mandatory for a clinical trial. The draft rules have already been published for making audio/video recording of informed consent process mandatory.
The rules will be finalised after due consultation. “The recordings will be preserved, adhering to the principles of confidentiality,” the new rules suggested.
For better transparency, Prof. Roy Chaudhury also suggested that information technology to be used at all steps of a clinical trial.
“From the first step when the application is filed, every step will be recorded and made available in the public domain,” it added.
The idea gains significance, as recently a some of petitioners complained in the Supreme Court about the lax in implementation of the clinical trial regime and alleges that MNC exploiting their subjects.
“The audio-visual recording will help the subjects. The companies will not more be able to pass the buck in case any untoward incident happens during a clinical trial. This will act as a proof for the family in case a subject suffers serious adverse affect during the trial,” said an official.
The health ministry also proposes no restriction on the number of trials in the country.
As per the new rules there should not be any fixed number of drug trials that should be approved in the country. Drug trials would be approved based on merit.
“Even in countries like the USA, the UK, and in the EU, no such provisions exist to restrict the number of drugs to be approved or drug trials that should be conducted in those countries,” the recommendation said....