AP seeks report on clinical trials conducted on poor women

"We are expecting a report from the District Medical and Health Officer (DM&HO) and the Additional Director who was sent by me to Guntur. We will review the situation once we receive the report," state Health Minister D L Ravindra Reddy told reporters here.

The clinical trials were allegedly conducted on a group of persons recently at Piduguralla town in Guntur district.

According to the victims, mostly daily wage earners, they were taken to Hyderabad and administered drugs. Their blood samples were also taken. They were paid remuneration ranging from Rs 1500 to Rs 9000.

The victims, however, later complained of side effects like headache, swollen legs, palpitation of heart and difficulty in breathing.

"I was cheated. They promised to treat my illness. The drug has worsened my health. My legs are swollen," C Chinna Ammayi, one of the victims, said.

The victims are, however, not able to identify the place in Hyderabad where they were taken.

"When I checked up with DM&HO and local doctors, what they say is that it is a fact that they were taken to Hyderabad. Nobody knows where. They don't have any receipt. We wanted to contact the person who took these people to that place and what are the samples that he took," Reddy said.

The minister, however, indicated that the victims are now doing fine.

"We would like to get the entire report because the fact is that when these people were taken to Guntur General Hospital, nothing is there(they were fine). Their ECG was alright," he said.

Reddy also stated that the state government has nothing to do with the trials.
"We have nothing to do with the trials. Normally, what happens is the pharma company has to seek the permission of the Central Drug Authority for clinical trials. Many people are not seeking that. Many people (just) say that they got the permission. That is the problem," he said.

The Health Minister affirmed that tough action will be taken against the guilty if any evidence is found.

"Let us wait for the report. If any evidence (of wrong doing) is found, we will definitely take action against the pharma company," he said.

The state government would take a comprehensive view of the whole issue and request the Central Drug Authority to formulate a new law, he said adding it could be a campaign to malign somebody and an aberration in the system.

"While conducting trials, pharma companies have to mention the number given by Central Drug Authority. They should mention what sample they are taking, how many times they are taking, it is an elaborate procedure. A reputed pharma company might not have done this. It could have been outsourced. Anyway, to know the truth, we are waiting for the report which is expected by evening," he said.