International generic pharmaceutical companies and contract research organisations working in India may be producing unreliable data to support their products, according to a new report from Reuters.
At least one international company, Novartis, says that it is stepping up its own checks. “We can’t rely on the regulators … we’re increasing our own audits,” a spokesman told a Hyderabad conference
Most of the reports based on the Reuters’ investigation, centre on a man named Vasudeva Prakesh. Formerly a mechanic in Hyderabad, the man has opted to pursue what he deems as a more lucrative career: participation in medical trials. In this case, amongst others, he had participated in drugs trials for contract research organisations (CROs) for pharmaceutical companies involved in HIV/AIDS drugs trials.
The issue which arises here is that Prakesh had been disregarding international regulations set out by the World Health Organization (WHO) by participating in trials back to back in order to maximise profits. This is despite the WHO saying that participants should observe a waiting period of 90 days between trials.
The requirement is a necessity to provide accurate data regarding the new medication, as many medications may have side effects that are long lasting and so may still be occurring well into the next clinical trial, contaminating the results of the study. Furthermore, serious health issues can occur when taking two varieties of medication within a short period of time, meaning those that pursue this business venture of back to back trials not only potentially invalidate the study but also risk their lives.
These WHO guidelines are not legally binding in India, and while state law does regulate the CROs there is no specified limit between clinical trials. These drugs, however, were intended for international consumption, and so non-adherence to WHO guidelines has brought about this condemnation.
This is reminiscent of an incident last year of a similar manner, in which 700 generic drugs tested by the contract research company GVK Biosciences were banned by the EU. The Hyderabad based company was allegedly altering the data of their clinical trials, fixing the numbers of electrocardiograms (ECGs) during trials of generic medications. Deemed to have occurred over a five year period and involving a high number of employees, the organisations products were disreputed, hence the ban of so many medications.
GVK has reportedly had no involvement in this incident; however, documents were gathered from Prakash who was taking part in several trials in a short period of time implicating a number of other companies. Amongst them: Apotex Research Pvt Ltd, a Canadian owned company, Lotus Labs, owned by U.S. generic drugs giant Actavis, Ethics Bio Lab, another American owned company and India’s Semler Research Center Pvt Ltd.
This is an issue that could draw scrutiny to a number of large international pharmaceutical companies that all use Indian CROs to trial run numerous new medications. Combined with previous controversy in the same area this could undermine confidence in Indian pharmaceuticals testing and potentially reduce foreign investment in the area.