The new draft rules for clinical trials and new drugs in India that are impending legislation in the country will put more responsibility on the pharmaceutical firms regarding injury and death of the participants in clinical trials, as per recent media reports.
According to the draft rules, sponsors will have to ensure proper medical management to their trials. In the event that they fail to do so, their trails will be canceled and also they will be restricted from holding any more trials in future.
Moreover, it spells out requirements on behalf of the pharma company during the conduct of trials. Sponsors have to provide free medical management for as long as required while conducting the trial or bioavailability or bioequivalence (BA/BE) as it measures the rate and extent of absorption of drugs in the human body. Also, they have to provide the necessary medical management and ancillary care if the person is suffering from any other illness during the trial.
“Where the sponsor or the person who has obtained permission from the central licensing authority fails to provide medical management, the licensing authority shall, after affording an opportunity of being heard, suspend or cancel the clinical trial or BA/BE study or restrict the sponsor to conduct any further clinical trial,” quotes Mint.
However, the firms will be granted permission within 45 days for the trials, if they want to conduct trials on drugs proposed to be manufactured and marketed in India. If the central licensing authority fails to communicate, the permission to conduct the clinical trial shall be deemed to have been granted.
Daara B. Patel, secretary general, Indian Drugs Manufacturers’ Association, welcoming the move told Mint, “It’s high time that government takes a balanced view. It should be favourable to the companies so that they take advantage in conducting trials; at the same time, the rules on companies which put the lives of candidates at risk need to be tightened and proper compensation has to be given to those who fall prey to these clinical trials”.
Mint reports that the new draft rules soon be placed for comments by stakeholders.
According to new rules, the companies have to pay interim compensation of 60 percent if the if the patient dies or suffers a permanent disability or the drug fails to provide the intended therapeutic effect during a trial and the compensation is given on the basis of a formula that takes into account the age and health risk of the patient
If the clinical trial is being conducted for an indication for which no alternative therapy is available and the investigational new drug has been found to be beneficial to the trial subject, the post-trial access will be provided by the company free of cost.
“The local trial may not be required if no major unexpected serious adverse events have been reported and there is probability or evidence on the basis of existing knowledge, of difference in India population of the enzymes/gene involved in the metabolism of the new drug,” says the draft.