HYDERABAD: With city-based GVK Biosciences Pvt Ltd coming under the European regulator’s lens, contract research organisations (CROs) conducting bio-equivalence (BE)/bio-availability (BA) studies on behalf of pharmaceutical companies have come under sharp focus.
Though there have been past incidents flagging concerns over the credibility of these studies, the recent European regulator’s decision to ban drugs citing insufficient drug trial data by GVK Bio is likely to have an adverse impact on the sector.
“The reputation of Indian CROs will be affected as, unfortunately, it’s not just one international agency making allegations (against GVK Bio) but multiple state-level regulators within the European Union have raised issues,” says a senior official of Axis Clinicals Ltd, a sister concern of Aurobindo Pharma Ltd.
GVK Bio, which counts major pharmaceutical players like Teva, Abbott, Mylan Laboratories and Zydus as customers, has taken a severe hit. Set up in 2001, the company conducts BE/BA studies for 50 per cent of its 400-odd clients. But now, that’s dwindling. The number of studies fell from about 15 a month to almost none. “Our existing clients have asked us to stop until the issue is cleared up,” said Manni Kantipudi, CEO, GVK Bio. Worse, the company couldn’t bag even one fresh order since August.
While Indian regulations are far more stringent, CROs seem to be missing out on following some of the norms. For instance, when DCGI suspended operations of Axis Clinicals in 2011, it was observed that the composition of Ethical Committee (EC), which oversees a trial, was not as prescribed.
The DCGI also said there were some procedural lapses, particularly related to the role of ECs. The report, to which Express has access, noted, “EC claims to be independent... It is doubtful that the EC is only carrying approvals fro all studies formally and there were no records for having reviewed each study protocol, study process and post-study reactions. No records evident of the minutes of the meeting held on various days except attendance records and approvals without actually recording the reviewing and monitoring studies approved by them.”
In the GVK episode, the French regulator said the ECGs the company had taken were not signed by volunteers and that employees seem to have mixed up data. “Sometimes when you do conduct multiple studies, data gets mixed up. What’s important to note is whether this data relates to core drug data or the general health of the patient,” said an official of Vimta Labs in support of GVK Bio.
Of the 78 DCGI-approved BE/BA centres in the country, eight are in Hyderabad and one is in Visakhapatnam. On an average, each study costs `30 lakh and takes between eight weeks and three months. Companies spend `50,000 to `1 lakh per volunteer towards medical expenses, consultation fee for physician, travel allowance, food and compensation. All the studies have to be first approved by DCGI. The number of volunteers for any BE/BA study should not be fewer than 16 unless justified for ethical reasons and will not exceed more than 70.
Industry analysts admit that business has been bleak compared to a few years ago. From about 20-30 studies a month, it has reduced to 10.