211 participants in clinical trials in India died from January to June of 2012 due to serious adverse events (SAE). Investigations are now on to ascertain how many of the deaths were caused by drugs administered to the trial subjects.
Union health minister Ghulam Nabi Azad has said that the deaths could be related to diseases such as cancer or administration of drugs and their side-effects.
The Union health ministry says approval for conducting clinical trials now includes a condition in the consent form that in case of a study-related injury or death, the applicant will provide medical care and pay compensation. All trials are now compulsorily registered with the Indian Council of Medical Research.
The compensation, however, is so far, “according to the will” of pharmaceutical companies. This could change as the Central Drugs Standard Control Organization has for the first time proposed a formula “on the basis of age of the deceased, income, seriousness and severity of the disease the subject was suffering at the time of his/her participation in the trial and percentage of permanent disability.”
The Central Drugs Standard Control Organization has for the first time proposed a formula to curb serious adverse events (SAE) during clinical trials.
The CDSCO formula stipulates that the younger the patient, the higher will be the compensation.
“When a 70-year-old patient who is terminally ill dies during a clinical trial due to an adverse reaction of the drug, the compensation should be less than that given to a 22-year-old man in the first stage of the same disease who dies of the same drug,” said a CDSCO official. “The youth could be the sole bread-winner of the family and would have lived longer but for the adverse drug reaction. So, the guidelines quantify accordingly who should get how much compensation. At present, both could get the same amount and it could be abysmally low if decided by the pharmaceutical company.”
The Drug Technical Advisory Board on October 10, 2011 had given its nod to the CDSCO to put in place a “compensation chart” or extensive guidelines that will specify amount to be paid.