World Health Organization Issues Warning. The Indian clinical research organization, Quest Life Sciences of Chennai, has received a warning from the World Health Organization (WHO) over defective clinical drug trials.
This action follows an earlier scandal over drug testing at GVK Biosciences, which resulted in approvals for hundreds of generic drugs being withdrawn in Europe, Reuters reports.
India produces cheap generic drugs for countries worldwide, but the industry has faced difficulties in recent years over a series of quality problems at various companies, according to Reuters. These problems include manufacturing issues and clinical data irregularities.
Concerns about the quality and safety of Indian drugs
Concerns about the quality and safety of Indian drugs prompted FDA Commissioner Margaret Hamburg to visit Indian drug makers in February 2014. She vowed to help companies improve compliance with manufacturing and testing regulations and she pledged to increase FDA personnel in India. The Indian drug industry sends the U.S. not only finished drugs but also supplies active ingredients for drugs manufactured in the U.S.
In the case of Quest, the WHO said there had been “critical” lapses in a trial of HIV drugs. 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,” the agency said.
WHO inspectors also criticized record keeping in the trial, including apparent attempts to hide documents from inspectors, Reuters reports.
The WHO, the United Nations health agency, regulates medicines used by UN agencies like UNAIDS and UNICEF. The agency issued a “notice of concern” to Quest last week. Joseph Kamlesh, Quest’s head of operations, told Reuters the issue was isolated and could not be compared with the problems at GVK, which concerned multiple regulators.
Kamlesh said Quest expects “this issue will be resolved in six months.” The company, he said, has not “lost any contracts or clients, we have a very good relationship with them.” For the past three years, Quest has been working for 25 companies, according to Kamlesh.
Quest’s work has been used to support drug applications in Europe
Quest’s work has been used to support drug applications in Europe, the United States, Australia, Russia, South Africa and the Philippines, according to the company’s web site. The WHO conducted a surprise audit of audit of Quest’s facilities last October, and since then it have U.S., British, and Spanish regulators also visited.
Kamlesh said the Food and Drug Administration (FDA) has cleared the Quest plant “after making some initial observations,” though Spanish and UK authorities have not yet issued their final responses.
Quest carried out the HIV drug trial of HIV drugs for India’s Micro Labs, which itself was the subject of a WHO “notice of concern” in 2014. Micro Labs officials were not available for comment on the Quest warning.
The Indian pharmaceutical contract research market is expected to reach $1 billion in 2016, from $485 million in 2012, according to industry consultants Frost & Sullivan. Reuters reports that some executives fear this rapid growth could be undermined by the reputation issues.