BackGovernment tightens guidelines for clinical trials
Developments a part of reforms initiated after apex court’s intervention to amend Drugs and Cosmetics Act
PremiumNew 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.
Activists dismissed such concerns.
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