The Drug Controller General (India) has revoked the suspension of approvals on city-based Axis Clinicals, which was asked to stop drug trials following health-related complaints from a group of rural women. These women were used as human volunteers for testing a cancer drug by the laboratory in June.
Axis is a subsidiary of Hyderabad-based Aurobindo Pharma.
The decision came after a team of DCGI officials from Delhi inspected the company’s facility at Miyapur in the city and after rectification in certain protocols by the clinical research organisation (CRO), sources in the DCGI said.
The DCGI had suspended Axis’ licences citing lapses in recruitment of human subjects and informed consent process following reports of hospitalisation of these women from Piduguralla in Guntur district.
The CRO had also come in for criticism for having enrolled illiterate women for the trials whose ability to comprehend the implications of their reported consent was doubtful. However, the Axis management refuted these charges stating it had followed all the protocols in conducting the above trials.
Abhijit Choudhary, general manager (Business Development) of Axis Clinicals, confirmed the revocation of suspension by the DCGI.
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He, however, said they were being subjected to unjust trial by the media even after clarifying all the issues raised with regard to the drug studies, including prior consent from the volunteers. One such clarification was that it had been doing bioequivalent studies related to existing drugs and not the clinical trials of a new drug as had been reported.
For now, Axis Clinicals has been asked to video record the consent process of each human subject for future studies, an official told Business Standard.
A set of improved guidelines on clinical and bioequivalent studies is being worked out by the DCGI in the aftermath of controversies surrounding drug trials in AP, according to the official. It also wants to strengthen the role of ethical committees by properly defining their functions apart from making registration of such committees mandatory, it is said.
SHARP DECLINE IN CRO ACTIVITIES
Meanwhile, the activities of CROs in Hyderabad had declined steeply as the sponsors of these studies are opting for similar organisations in Karnataka, Maharashtra and Gujarat — the three states that host clinical trials on a much larger scale.
“Earlier each of these laboratories used to conduct 7-8 studies a month. Now, it has come down to just 1-2. Some laboratories have also started downsizing their staff,” said an industry representative, who did not want to be named.
About eight CROs are operating in Hyderabad. These are Sipra Laboratories, QPS Bioserve Clinical Research Private Limited, Piramal Clinical Research, RA Chem (CR Bio) Pharma Limited, Aizant Drug Research Solutions, GVK Bio, Axis Clinicals and Vimta Laboratories.
While there are no issues with the infrastructure facilities created by these firms for conducting studies, certain shortcomings on recruitment of human subjects have been noticed by some agencies in recent inspections, according to an official, who is involved in the exercise.