DCGI cancels Axis Clinicals licence

Written by BV Mahalakshmi | Hyderabad | Updated: Jun 29 2011, 06:45am hrs
The Drugs Controller General of India (DCGI) has cancelled the licence of Axis Clinicals the company in the midst of a clinical trial controversy in Andhra Pradesh thereby putting a stop to all the bio-equivalence (BE) and bio-availability (BA) studies conducted by the firm.

This stems from the recent scandal involving poor women from Piduguralla town in Andhra Pradesh who complained of complications after a generic anti-cancer drug was tested on these women without their consent.

DCGI officials investigated Axis Clinicals facility in Hyderabad after the state government demanded an inquiry. The inspections revealed various irregularities in the conduct of these studies. The regulator has suspended Axis Clinicals licence to conduct any bioavailability or bioequivalence studies at its Miyapur centres, citing public interest, sources added. When contacted, Abhijit Chowdhary, AGM, Business Development, Axis, said that all the clinical activities were currently put on hold and that he had no further information to reveal.

The ministry of health and family welfare had launchedan investigation atPiduguralla town of Guntur district to ascertain the recent public outcry and media reports of clinical trials on innocent rural women. A fact-finding team of expertswas sent to investigatethe entire affair.

More than 650 clinical trials are currently taking place in the country and all the leading global pharmaceutical companies have started moving their key trials to India. The country has a large number of patients in areas for clinical research, such as diabetes, cardiovascular disease, HIV and oncology.

There are several reasons why drug companies are drawn to India. These include a technically competent workforce, patient availability and a friendly drug-control system. However, the booming clinical trial industry is raising concerns because of a lack of regulation of private trials and proper ethics review, says a WHO report.