Amid a raging controversy, the Hyderabad-based Vimta Labs has admitted that it has been conducting bio-equivalence (BE) studies on human beings on behalf of various pharmaceutical companies for their drugs in the last 10 years. The tests were carried out on as many as 1,000 volunteers who were paid a compensation of Rs 1,000 per day.
S P Vasireddi, Chairman and Managing Director of the Lab, talking to newsmen in Hyderabad on Sunday, admitted that company had been conducting BE drug trials since 1994 and 1,000 volunteers had taken part in these trials so far.
According to Vasireddi, the lab was not involved in the testing of new drugs and was only carrying out BE studies in universally and ethically accepted procedures. The purpose of these studies was to ensure the quality of a licensed drug in relation to its inventor drug. These drugs had to be tested on human beings only and the company was following national, international and an independent ethics committee guidelines, he said.
Vasireddi said the lab had been accredited by the National Accreditation Board for Testing and Calibration Laboratories and the Department of Science and Technology for conducting these studies. As the safety and efficacy of the drugs being tested under BE studies had already been established, there was no question of any risk to the volunteers being used for the testing purposes. " In the last 10 years, we have not come across any adverse results as the drugs are proven ones. Adverse results were in very few and they had been managed well. There were no cases of disability or death," he said.
As more and more drugs are likely to be free from patent periods in the near future, the BE tests would become all the more necessary and important, Vasireddi said. The company, he said, had tested various generic drugs like analgesics, anti-inflammatory, anti-pyretics, anti-bacterial, anti-fungal, anti-diabetic, anti-histamines, anti-viral, anti-protozoa, anti-hypertensitive and gastrointestinal drugs so far. He denied reports that the company was indulging in unethical practices by roping in human volunteers, particularly migrant agricultural labour, with the help of agents. He said the tests were being conducted on healthy human subjects only after obtaining their written consent as per the Helsinki Declaration guidelines.
Vasireddi said the company staff would go and meet people within 16 km radius of Cherlapally where the laboratory was located to solicit the volunteers for trials. "They are our ambassadors who spread the word. Again, everyone who volunteers is not admitted. In fact, 50 % of the volunteers are turned away as they fail to meet the stringent health specifications."
A team of police officials headed by Rangareddy District Superintendent of Police recently visited the laboratory and expressed its satisfaction about the selection of volunteers. "The team looked into all our activities and went back. We have nothing to hide. We are transparent," according to a company official.
According to the Rangareddy police, it will write to the Central and State government and the Drug Control Administration on charges against Vimta Labs. Uppal Police station Inspector A Sivaramakrishna said, "The laboratory is following the norms and it seems there is no harm in conducting drug trials on volunteers as the drugs administered are proven drugs. However, action will be initiated if the reply from the drug control authority and the government is negative."
Dr P M Bhargava, noted scientist and social activist, said bio-equivalent testing procedures of generic drugs were totally safe and a widely followed practice the world over. The purpose of BE testing was to find the degree of similarity between the original drug and the licensed drug which is produced by using the same molecules or combinations present in the original drug design. The question of unethical practices or violation of human rights did not arise as the tests were not clinical tests of a new drug. It would become unethical only if the volunteer was deprived of the promised payment and minimum facilities while testing. It was totally justified since nobody volunteered without payment. A sum of Rs 1,000 would be very useful for a poor person, Dr Bhargava said.