18 June 2011
Govt Seals Offices Of Pharma Co For Testing Cancer Drug Which Is Yet To Get Approval
"Company staff admitted some women were tested with drugs which are yet to get permission," said officials. Drug control authorities also seized Axis Lab near Miyapur in Hyderabad where the trials were carried out.
The trial on human beings, reportedly conducted without taking permission from the state government, came to light on Thursday when eight of 30 women tested fell ill in Piduguralla town, about 300km from Hyderabad. The women developed acute joint pains, swelling in arms and throat infections and were admitted to Guntur hospital.
Protests broke out in Piduguralla on Friday demanding action against the pharma major. A case has been filed against the middlemen under Sections 420 (cheating) and 336 (endangering public life) of IPC.
With the State Human Rights Commission expressing anguish, health minister D L Ravindra Reddy ordered a probe into the incident. District medical and health officer M Gopi Naik, who conducted preliminary probes, sent a report to the government confirming the charges against the pharma company.
Most of the women who went to the clinical tests are farm workers. "The pharma company promised to pay us huge amounts before conducting the tests, but it paid me only Rs 9,000," said Shaik Bibi, one of the women who underwent the tests.
A counselling session was conducted for the selected people and they were asked to sign on a bond before undergoing the tests. The company allegedly didn’t provide any information to the women on the nature of the tests to be conducted on them.
"If everything goes well after taking a tablet, the person is asked to visit the lab after 10 days when an injection is given. Another dose is injected after 10 days. We were paid Rs 9,000 for the three rounds of tests," said a victim, Jakka Kumari.
"If any abnormalities in the blood samples are found or any woman develops complications, she is sent back by handing over Rs 1,000," said another victim, Kommu Karunamma.
Andhra Pradesh accounts for almost 28% of total clinical trials in the country. The value of the clinical trial research outsourced to India has touched $1.5 billion -$2 billion in 2010.