Drug trials in India cost over 59 lives in four years: government report

A total of 59 serious adverse events (SAEs) of death attributable to clinical trials were reported in India during the last three years, including 22 deaths in 2010, sixteen each in 2011 and 2012 and five deaths in 2013, where compensation claims have been made, the Lok Sabha was informed today.

The total compensation for the four years – including Rs15,00,000  for the year 2010,  Rs33,83,500 for 201, Rs59,28,670 for 2012 and Rs38,62,300 for 2013 - works out to Rs1,46,74,470 as per figures provided by union minister for health and family welfare Gulam Nabi Azad.

Detailing this in a written statement in the House today, the minister stated that at least one case was reported in 2010 where compensation remained unpaid as the whereabouts of the legal heir could not be located by the investigator and his team.

Out of the cases of SAEs of death reported during the year 2013, the competent authority has so far issued orders for payment of compensation in these five cases only, he said.

The independent expert committee constituted in accordance with the requirements of the Drugs & Cosmetic Rules, 1945 for examination of SAEs of death occurring during the clinical trials had prepared a compensation formula taking into consideration a base amount, age and risk factor  of the subject, he said.

The risk factor, in a scale of 0.5 to 4 is based on the seriousness and severity of the disease, presence of co-morbidities and duration of disease of the trial participant at the time of enrolment in the clinical trial.

However, in case of patients / trial participant whose expected mortality is 90 per cent or more (within 30 days), the committee has recommended that a fixed amount of Rs2 lakh may be given for clinical-trial related death.

Meanwhile, on a civil writ petition filed by NGO Swarthy Adhikar Manch, the Supreme Court, on 30 September 2013, had sought details of the report of the Ranjit Roy Chaudhury Committee and the details of the existing regime which ensures the safety of the subjects of clinical trials while taking note of various measures taken by the government.

A whole lot of sponsor drug companies, both domestic and foreign, were involved in the sponsored drug trial in India, he added.