Hyderabad, August 26: Even as the Drugs Controller General of India (DCGI) lifted the ban on Axis Clinicals, a sister concern of Aurobindo Pharma Ltd, sources said the company was still under the scanner over quality issues.
“We are studying the report and examining some of the documents.
Evidently, there are procedural lapses.
But we still have to establish a case,” a DCGI official in Delhi told Express.
Some of the documents (copies of which are available with Express) including the subject’s well-being questionnaire form, post-study medical examination form and vital signs recording form used for capturing post-medication reaction have been approved by the company-appointed Independent Ethics Committee (IEC) and the Institutional Review Board (IRB) well before the tests were conducted.
For instance, a post-study medical examination for females for EXEM-10248 and subject no: S2 (Ila Dhanalakshmi, Pidugurala village) was reviewed and approved by the IRB and IEC on May 6, 2010, while the drug test was conducted between Jan-Feb, 2011.
When contacted, Axis declined comment.
“Typically, IEC and IRB are terms synonymously used.
We either have an IEC or an IRB.
But I do not understand the need for having both,” Suneil S Reddy, Managing Director, BioServe, said.
Axis conducted a single-dose study sponsored by Mylan Inc which said, “all of our R&D activities, including studies by Axis, are conducted under appropriate ethics committees.
We do not believe there are any issues related to the studies.”
---Agencies
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