Man undergoing drug test dies in Andhra PradeshDecember 7th, 2008 - 7:28 pm ICT by IANS
Hyderabad, Dec 7 (IANS) The police in Hyderabad are investigating the death of a 25-year-old man who volunteered for the clinical trial of a drug in a laboratory here.However, the pharma company, which conducted the test, denied that the drug caused the death.
According to the police, K. Surendra Friday complained of chest pain before taking the second dose of ‘Felodipine’, a medicine for hypertension patients, at the clinical laboratory of GVK Bio, a city-based pharmaceutical company, at Ameerpet in the city.
Surendra was given emergency treatment by the company’s doctors, and later referred to a hospital but died on the way.
The police registered a case of suspicious death on a complaint by GVK Bio. After the autopsy, Surendra’s viscera was sent to the forensic science laboratory to determine the cause of death.
An official of S. R. Nagar police station said Surendra was a volunteer for different biosciences companies.
Meanwhile, GVK Bio denied that Surendra died undergoing clinical trials at their laboratory and also clarified that the facility at Ameerpet does not conduct any clinical trials.
“It does only bioavailability/bioequivalence studies, which compare an existing drug already in the market with the same drug of another company,” said a company statement released Sunday.
It said Surendra had enrolled for a study conducted for the formulation “Felodipine 10 mg - extended release”. The medicine has been approved by regulatory authorities worldwide including by the Drug Controller General of India (DCGI) and being sold in the country for more than four years.
“As per approved protocol, Surendra was administered the first dose on Nov 26 and discharged in healthy condition on Nov 29. This drug washes out from the body within four days at a maximum.”
He was supposed to report Dec 5 for the second dose to be administered Dec 6.
“He was neither admitted nor dosed for the second period as he complained of chest pain when he came Dec 5. In-house doctors rushed him immediately to a hospital after administering emergency treatment”, the statement said.
The company said they were told Surendra was declared dead by the hospital authorities and immediately lodged a complaint with the local police station.