A clinical research company in Visakhapatnam has come under the scanner of the police and the Drug Control Administration ( DCA) after it allegedly conducted trials of various drugs on several engineering students without the knowledge of their parents.
The firm lured the unsuspecting students with money and conducted the tests slyly.
The incident came to light on Monday when parents of two engineering students — M. Ajay Kumar ( 19) and M. Naresh Reddy ( 20)— lodged a complaint with the Visakhapatnam Police against the firm, Actimus Bio Private Limited, for allegedly confining their children for two days and conducting drug trials on them. Following the complaint, the police registered a case against the company.
On Tuesday, officials of the DCA conducted a raid on Actimus’s office located at Varun Towers in the Siripuram area of Visakhapatnam and seized all the records to verify whether the company had the required permissions from the Drug Controller General of India ( DCGI) and the ethical committee to conduct drug trials; whether it had taken the consent of the students before conducting the tests; and if the students were aware of the tests they underwent.
“ We will submit a comprehensive report to the DCGI and the state government after going through the records and questioning the company authorities,” a DCA official, said.
Ajay, one of the students of Sanketika Vidya Parishad Engineering College who was lured into taking the tests, said an Actimus representative approached the students on Saturday morning and asked them to attend a few lectures as volunteers, with a promise of ` 6,000 per day.
“ We were attracted by the money offered. He took us to the laboratory and told us that we would have to undergo some medical tests. As soon as we entered the laboratory, the staff seized our bags and switched off our mobiles. We were asked to sign some papers, stating that they were essential for medical tests. They gave us a few tablets and thereafter started taking our blood samples every 30- 40 minutes.
In all, they took 20 blood samples from each student,” Ajay said.
The students alleged they were not allowed to contact their parents and were confined for two days. It was only on Monday morning that the students were released. When their parents came to know of the incident they stormed Actimus’s office and demanded an explanation.
However, the authorities told them that the tests were conducted according to the norms and with the students’ consent. The parents were also shown documents to that effect.
When confronted on their failure to inform the parents, the company officials simply said they didn’t need to do that because all the students were adults. Enraged at this, parents of Ajay and Naresh lodged a complaint with the police, alleging their children had suffered from fever, vomiting and rashes because of the tests.
Actimus’s assistant vice- president ( business strategy and finance) B. V. Srinivasa Rao said the company had DCGI’s approval for conducting bioequivalence and bio availability tests.
“ We have not hidden anything from the student volunteers. Only after they agreed to undergo trials, we conducted the tests,” Rao said Last month, a Hyderabad- based pharmaceutical company, Axis Clinicals, had hit the headlines for conducting similar drug trials on poor uninformed women belonging to Piduguralla area of Guntur district.
There, too, the company had lured them with money.
At least nine women who underwent the trials complained of body ache, joint pain, chest pain and extreme weakness after taking the drugs.
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