Written By: Shraddha Rupavate | Published : December 15, 2014 11:24 AM IST
Medications: Analgesics and antipyretics are commonly used to relieve body pain and fever. Antihistamines and decongestants work best to reduce runny and stuffy nose. However, antibiotics have no effect against viral infections.
The clinical trial industry in India is constantly growing every year. Despite the growth, the conditions don't seem to be improving at all. Reports reveal that there have been at least 370 deaths as a result of adverse events during clinical trials since February 2013. However, not all of them all received compensation from the government. According to a statement to TOI, the amount of compensation ranges from 4 lakh to 40 lakh. (Read: Supreme Court stands firm on clinical trial ban)
Out of the total 370 death cases, only 222 have been analysed on the grounds of eligibility for compensation by regulatory authorities on clinical trials. According to officials, only 21 cases were found to be eligible for compensation since the drugs were found to be the cause of death.
The scrutiny could be taking time because of ambiguity about the eligibility criteria for compensation. Also, since the data on adverse events is directly reported by investigators involved in the trial at the site, checking the authenticity of the data becomes difficult for the regulatory authorities. (Read: No more clinical trials till you can monitor them: Supreme Court to Centre)
In a statement to TOI, CM Gulati, editor of Monthly Index of Medical Specialities and an advocate of public health said, 'The investigator who reports adverse impacts of a drug under trial has conflict of interest because he is paid by the pharmaceutical company conducting the trial.' (Read: Concern over clinical trials conducted by India s GVK Biosciences)
After legal analysis of these cases and Supreme Court's order, the drug controller general of India (DCGI), releases detailed guidelines highlighting the conduct of clinical trials and the procedure to report deaths. A mechanism to pay compensation to the families who have lost their lives due to adverse events during these trials has also been put in place.
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