Indian CRO Quest Life Sciences of Chennai saw the results of a clinical trial of HIV drugs rejected by the World Health Organization after an inspection found poor clinical practices on data and bioanalytical procedures that could not be remediated, according to a letter from the Geneva-based United Nations body.
The letter, reported by the Reuters news agency, was signed by Mark McDonald, coordinator of the Prequalification Team for the WHO's Regulation of Medicines and other Health Technologies, Essential Medicines and Health Products.
A WHO spokesman said there was no immediate comment outside of the publicly posted letter.
India's network of contract research firms has seen a slew of regulatory challenges in the past few years on issues such as unethical patient enrollment to other allegations of poor data management and failure on good clinical practice (GCP) procedure that earlier this year saw GVK Biosciences slammed by the European Medicines Agency which called for the suspension of more than 700 products tied to improprieties at a facility in India.
However, recent reports suggested that a spate of M&A among the firms and interest in an initial public offering of Biocon's contract research unit Syngene had seen the sector turn a corner, noting that Quest, through its purchase of Fortis Clinical Research, was one of the firms benefiting.
|Quest Life Sciences managing director T.S. Jaishankar|
T.S. Jaishankar, managing director of Quest Life Sciences, told the Business Standard newspaper last month that earlier challenges were being overcome.
"The industry faced a challenge earlier since there were a lot of negative reports from the media and protests from the non-government organizations about the quality standards of the clinical trials," he said, as quoted by Business Standard. "However, the health ministry and the Drug Controller General of India have taken proper steps to put the standards in place to bring back the industry."
But this latest case, which resulted in a public Notice of Concern by the WHO and comment that it was "informed by other regulatory authorities covered within the scope of our confidentiality agreements, that similar issues were also found for their studies" is likely to have significant blowback, including on prequalification for other drugs manufactured in India for WHO such as vaccines.
Among the WHO findings were that two-thirds of electrocardiograms performed on patients were duplicates with dates and names changed by the company.
"These issues appear to be systemic in nature and occurring many times over a significant period of time, and not only as a one-time incident for the study submitted to WHO," McDonald said in his letter.
"Also, as stated in your response, these ECGs were taken under supervision of the Principal Investigator (or CI) which is of high concern to WHO and could potentially suggest that these compliance issues are performed under supervision of senior management and hence may not be restricted just to ECGs."
Joseph Kamlesh, Quest's head of operations, told Reuters the issue was isolated and could not be compared with the problems at GVK.
"We expect this issue will be resolved in six months. We have not lost any contracts or clients, we have a very good relationship with them," he told the news agency. Quest did not respond to requests for further comment from FiercePharmaAsia.
Reuters said the part of the HIV drugs trial was handled by India's Micro Labs, which was also subject to a WHO Notice of Concern in 2014. Micro Labs officials were not immediately available for comment.
The Indian pharmaceutical contract research market is expected to reach $1 billion in 2016, Reuters said, from $485 million in 2012, citing consultants Frost & Sullivan.