Axis labs trials violated norms, says probe team

PIDUGURALLA: A three-member team of officials from the Central Drugs Standard Control Organisation confirmed that clinical trials were conducted on 14 women and one man from Adarshnagar Colony here. The trials by a pharmaceutical company, Axis Clinical Labs, are reported to have led to adverse consequences for the subjects.The expert committee visited the Government General Hospital where two women subjects -- Chinnamma and Pitchamma -- of the trials are undergoing treatment. Committee members noted that the company administered Excmestane tablets (25 mg) to treat these women with breast cancer in an advance stage.The committee, comprising Dr Prasad, deputy director, Central Drugs Standard Control Organisation, Chenai, Dr A Ramakrishna, assistant drugs controller, and N Praveen, chief of lab technology, also recorded the statements of 13 other people. Local medical and health officials were not allowed to be present while the statements were recorded.The experts said that companies conducting clinical trials ought to furnish records of the trials and mention the number of people undergoing them. They also should conduct the trials in the presence of local drug control officers. But Axis Clinical Labs violated the guidelines, they observed.Some victims reportedly told the committee they were among hundreds of people drafted for the trials during which they were harassed by laboratory staff. They complained that they had only agreed to give blood, for which they were promised `9,000. ‘’Now we are not even able to go to work,’’ one subject told the committee.