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C.R. Sukumar

A view of the clinical pharmacological unit (CPU) of Vimta Labs Ltd at Charlapally in Hyderabad. The volunteers willing to undergo the tests are known as `Subjects'. Currently, 24 subjects are undergoing tests at the CPU.

HYDERABAD, March 21

CLINICAL trials and bio-equivalence (BE) studies on humans have assumed a new meaning, with the twin cities of Hyderabad and Secunderabad turning out to be an oasis for migrant agricultural labour from various districts across Andhra Pradesh. The migrant poor are finding the clinical trials and bio-equivalence studies to be panacea for their monetary problems.

True, they are unaware that they have become a crucial link in the pharmaceutical companies' efforts to bring out new drugs into the marketplace.

However, they are overwhelmingly happy to earn between Rs 2,000 to Rs 4,000 every time they volunteer for the trials, which are being conducted by the city-based multi-disciplinary testing and contract research laboratory, Vimta Labs Ltd (VLL).

"We can never imagine earning such huge amounts in our village. We had to mortgage everything we had to obtain such amounts as a loan at prohibitively expensive interest rates from the local moneylenders. But after coming to the city, we find this a great opportunity whenever we don't get work for the day," a migrant labourer from the neighbouring Mahaboobnagar district told police officials, while insisting that volunteering for clinical trials and BE studies was a way of life in the industrial belt of Uppal and surrounding areas in the city.

It has become a daily phenomenon for hundreds of migrants who have flocked to the city in search of greener pastures.

The human trials came to light when the Uppal police interrogated an auto driver handed over to them by the local trade union leaders for allegedly wooing the gullible labourers to volunteer for such human tests.

According to the trade union representatives, several poor migrants were seen waiting in front of VLL's doors for the screening tests that go on daily.

Tokens were kept ready in the company's security office to let anyone into the laboratory as a human volunteer. The company would enrol the human subjects after an in-house screening, including a complete health check-up, and a day's rest when they need to keep away from cigarettes and alcohol.

The company claims to have all the valid licences and permissions to conduct BE studies on human volunteers. It said it has been conducting such studies for over a decade and had so far carried out such trials on around 1,200 human volunteers.

Assuring that the BE studies on human subjects were safe and all the contingency measures were being taken to handle the cases of adverse results, the VLL Chairman and Managing Director, Dr S.P. Vasireddi, said, "The BE studies are conducted in healthy human subjects after thorough health check-ups. Every one who volunteers is not admitted. The participation is purely voluntary. Admission to study is taken up after obtaining informed consent from volunteers, which is as per the Helsinki Declaration guidelines.

Literacy has nothing to do with the study, but we are educating the volunteers before taking the signature on the Informed Consent Form."

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