New Delhi: The health ministry has tightened the norms for clinical trials by making it mandatory for companies to compensate patients who may suffer injury or death while participating in the trials even if they have not been caused by the drugs being tested.
So far, the compensation has been restricted only to cases where the medication being tested had caused either injury or death. The gazette notification, issued on 30 January, could potentially make clinical trials in India more expensive.
The developments are a part of reforms in clinical trials initiated after the Supreme Court’s intervention to amend the Drugs and Cosmetics Act. Earlier this month, the apex court had directed the health ministry to monitor all clinical trials, revoking the powers of the Central Drugs Standard Control Organization.
In a drastic shift from the present scenario wherein only physical injuries are compensated for after establishing a direct connection with trial drugs, the notification states that in “the case of an injury occurring to the clinical trial subject, he or she shall be given free medical management as long as required”.
Crucially, if the drug being tested fails to improve a patient’s condition or causes adverse effects, the company would be liable to compensate the patient. Similarly, companies would have to compensate for any harm suffered by a pregnant woman’s child while she is participating in a clinical trial.
The new norms would be extended even to the so-called placebo-controlled trials.
Placebos, or “sugar pills”, are part of a standard clinical trial practice in which a few out of a group of patients who consent to being part of a trial don’t receive the drug being tested, but are instead given a harmless pill. This is done to measure the effectiveness of a drug by comparing the condition of patients taking the therapy and those being administered the placebos, and to isolate improvement in a patient’s condition to the drug being tested.
Given that the number of tested drugs that fail far exceeds the successful ones and most trials use a placebo, the number of patients who would be potentially compensated under the new rules will be much higher.
Zakir Thomas, who coordinates the government-run Council of Scientific and Industrial Research’s (CSIR’s) open source drug discovery project, said the use of a placebo was central to a drug trial. “I haven’t read the notification, but a placebo is essential to the conduct of any trial and I don’t know how you can replace it,” he said.
CSIR in the future hopes to be able to test new molecules to make tuberculosis drugs.
Industry experts maintain that any trial subject could be eligible for compensation under the factors listed because of lack of clarity in the document.
“The notification covers every category of patients without making the distinction between trial-related and non-trial related injuries,” said Arun Bhatt, a member of the executive committee at the Indian Society for Clinical Research.
“The notification requires more clarity. Who will decide the period of free medical treatment? The notification simply mentions ‘as long as required’. Earlier injuries meant only physical injuries. This leaves room for all (kinds of) claims. Besides the industry, this will hurt individual doctors and institutions conducting trials,” he said.
Activists dismissed such concerns.
“Most clinical trials are multi-centred and spread across countries. It is unfair that Indian trial subjects should get compensated on the basis of their minimum wages while subjects of the same trial in developed countries get significant amounts of compensation to rehabilitate them for life,” said Amulya Nidhi, an activist with the Swasthya Adhikar Manch and a petitioner in the Supreme Court case.
“The move to treat any injury as trial-related is welcome as certain amount of liability has to be placed on sponsors and investigators. So far, it has been extremely challenging to attribute any injury or death directly to the trial because there are no guidelines to establish the link. This is in the best interest of trial subjects,” he added.
According to documents submitted by the health ministry in the apex court, 475 human clinical trials for “new chemical entities not approved as drugs for human use anywhere in the world” were approved by the Indian drug regulator between January 2005 and 30 June 2012. Out of the 475 experimental drugs, 17 have been given approval for marketing, according to court records. During the period, 11,972 serious adverse events, excluding deaths, were reported, out of which 506 have been attributed to clinical trials. None of the victims has been compensated.