World Health Organisation faults Tamil Nadu company on clinical trials

London/Mumbai: Another Indian clinical research organisation, Quest Life Sciences of Chennai, is in trouble over defective trials, according to a warning issued by the World Health Organisation (WHO). The action by the United Nations health agency follows an earlier scandal over drug testing at GVK Biosciences, which resulted in approvals for hundreds of generic drugs being withdrawn in Europe.

India’s drug industry, a source of cheap generic medicines to countries worldwide, has been tarnished in recent years by a series of quality problems at various companies, including manufacturing and clinical data shortfalls.

In the case of Quest, the World Health Organisation said there had been “critical” lapses in a trial of HIV drugs, including the fact that two-thirds of patients' electrocardiograms (ECGs) turned out to be duplicates.

“Subject details ... and dates had been changed by the company, in the majority of cases, to make the ECGs appear as if they were from each of the different subjects,” it said. The WHO inspectors also criticised the standard of record-keeping in the trial, including apparent attempts to hide documents from inspectors.