India’s Drug Controller General (DGCI) has suspended operations at Hyderabad, India-based CRO Axis Clinicals and is vetting all bioavailability and bioequivalence study centers in Andhra Pradesh state after investigations revealed irregularities in a trial conducted by Axis, reported PharmaTimes.
The action follows recent media reports that women from Piduguralla, Andhra Pradesh state had been taken ill after being paid by brokers for a Hyderabad-based pharmaceutical company to undergo tests that included administering an anticancer drug without informed consent.
It comes against a background of renewed concern about clinical trial standards and ethics in India generally, threatening once again to derail the rapid growth in the country’s contract research sector driven by outsourcing and off shoring to achieve cost efficiencies and a broader, available population base for clinical development programs.
DGCI said it had investigated Axis Clinicals’ bioequivalence study center at Serlingampally in Miyapur, Hyderabad state on June 20 and 21, following allegations the CRO had administered the anticancer exemestane to “poor women” from the town Piduguralla without obtaining their informed consent.
Bioequivalence studies with exemestane tablets were conducted at the Serlingampally center between January 27 and February 15, 2011, the DGCI noted.
The inspections revealed “various irregularities” in the conduct of these studies related to subject recruitment and informed consent processes, as well as the independence of the ethics committee involved and its review and decision-making procedures, the regulatory authority reported.
As a result, the DGCI has suspended Axis Clinicals’ license to conduct any bioavailability or bioequivalence studies at its Miyapur centers, citing the public interest. Axis, which has been operating since September 2004 and bills itself as “one of the most experienced and fastest growing” CROs in India, did not comment.
The regulator will also “investigate the working of all bioavailability and bioequivalence study centers in Andhra Pradesh within a period of two months to ensure that such studies are performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines,” it stated.
Last month the chief minister of India’s Karnataka state was forced to reassure industry delegates at a biotechnology trade exhibition after another minister told the media there would be a temporary ban on all clinical trials in the state’s government and private hospitals and medical colleges while a committee was set up to ensure adherence to guidelines.
According to local media reports, chief minister B.S. Yeddyurappa told delegates at the Bangalore India Bio expo that no such ban had been imposed, although he also stressed there would be no compromise on ethical issues when clinical trials were conducted in Karnataka state.