GVK Bio, a Hyderabad-based company that conducts clinical trial of drugs on humans on behalf of global pharmaceutical and biotechnology companies, is in a spot following the death of a volunteer.
HYDERABAD: GVK Bio, a Hyderabad-based company that conducts clinical trial of drugs on humans on behalf of global pharmaceutical and biotechnology companies, is in a spot following the death of a volunteer. K Surender, 25, a resident of Hyderabad and volunteer participating in a bioequivalence test for felodipine, a drug being tested to treat high blood pressure, allegedly died during the experiment. The drug had gone off patent in 2007.
According to sources, GVK Bio was testing this drug for one of its clients using volunteers at its Ameerpet lab in Hyderabad. While sources involved in the process said that the tests were being conducted on behalf of Wockhardt Pharma, Sunil Khera, managing director of Wockhardt Pharma, denies it. “We have nothing going on with GVK Bio,” he told DNA.
Surender was administered the first dose of 10mg of felodipine on November 26, 2008 and was discharged on November 29, in healthy condition. He was asked to report for the second dose on December 6. However, on that day, Surender complained of chest pain before he was administered the dosage and was taken to a hospital, which declared him dead on arrival.
The team that has been contracted for these tests has around 60 volunteers. Though sources said other volunteers dropped out after hearing of Surender’s death, a GVK Bio spokesperson said the tests with the second dose continued. “No one dropped out,” she said.
Meanwhile, GVK Bio in a statement said the deceased volunteer was also involved in other tests with other contract research organisations (CROs).
“Surender has been participating in similar bioequivalence studies in various CROs. He has been a part of similar studies in GVK Bio in the past. In this particular case, Surender had enrolled for a study conducted for the formulation of felodipine, which is an approved drug by regulatory authorities worldwide including Drug Controller General of India (DCGI), New Delhi, and is being sold in India for more than four years and prescribed globally to treat hypertension,” the company said.
A complaint was launched with the SR Nagar Police station by the company and the authorities have sent the samples of the volunteer’s viscera to the forensic lab.
Meanwhile, sources said the DCGI has been informed about the incident and the authority would seek a detailed report from GVK Bio. Researchers in a major CRO also told DNA that the death of the volunteer could be due to a variety of reasons.
GVK Bio insists that “this drug washes out from the body within maximum four days”.
However, according to a researcher, felodipine gives abnormal toxic effects when combined with grape juice. “Normally, volunteers participating in these tests keep themselves healthy. One has to find out if the deceased had consumed grape juice after getting the first test done,” a researcher said.
The death, researchers said, could also be due to other drug interactions. “Surender participated in tests with other CROs. GVK Bio should have taken enough care in his case since this particular drug would react with other drugs administered to him by other CROs,” a CRO head said.
ramanadna@gmail.com
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