Cops in Bharuch say there could be more than meets the eye in the case. Like human drug trials. This after a 22-year-old from Bharuch, Dharmesh Vasava, was hospitalised following severe complications after drug trials. He is suffering from renal failure, respiratory problems, pneumonia and gangrene in upper left and lower right limbs.
A case was registered on Monday against officials of Pharmaceuticals and two agents, Raju and Dilip, who allegedly provided poor youth for the trials, luring them with promise of easy money.
Don’t blame us, says Sun
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VADODARA: SUN Pharmaceuticals Ltd conducted tests on Dharmesh Vasava as part of its Phase IV test for Citolaprum, an anti-psychotic drug. The company has been marketing the drug for 8 months after permission from the DCI. Director Sailesh Desai said 11 other volunteers did not develop complications. ‘‘How can we be held responsible for what happened to him after four days?’’ he said. (ENS) |
A case has also been registered against Narhari Hospital here which had rented out a floor to the company. Police chief Amarsinh Vasava said no arrests have been made so far but a hunt is on for the agents. “Investigations have indicated that there is a network of agents. But we have been able to identify two.’’
Vasava is now battling for his life in the Shiv Critical Care Centre. Managing director Dr Kartik Josh said he learnt from the ‘‘patient’s history’’ that 20 blood samples of 6 ml each were drawn from his left arm. Dharmesh was believed to have been approached by the agents who took him to Narhari Hospital on August 22. The hospital said he was not their patient, but they had rented out one floor to SPARC Bioresearch, the clinical unit of Sun. “According to our agreement, the clinical trials responsibility is with SPARC,’’ said administrative officer N.J. Shah.
Dharmesh told his family that he and 25 others were given tablets and their blood samples taken. He developed complications and was kept in Vadodara for two days.
His family later took him to Vadodara hospital, where two men from the ‘‘company’’ came to meet him. The men consulted Dr Jayanti Vasava, a surgeon in Bharuch, who said the condition was septicemia and renal failure, and referred the case to the Vadodara-based Shiv Critical Care.
An expert said: ‘‘It could be either due to repeated drawing of blood or faulty method of vein insertion. The vein chosen must have been deep-seated and repeated action led to thrombosis.’’
Ahmedabad-based Commissioner of Food and Drugs Administration Subhash Adeshara said no company would conduct trials without permission of the Drug Controller. An ‘‘informed consent’’ of the volunteer is taken, he said.
Neither Dr Joshi nor Dharmesh’s brother Mukesh could throw any light on who’s footing the bill for the treatment. A battery of doctors is attending to Dharmesh round the clock. Dr Vasava in Bharuch has not received payment.
Mukesh said he was paid Rs 60 daily for meals. ‘‘The company men come for 5 minutes and make the payment,’’ he said.