Andhra clinical research organisations plan reforms to avoid microfinance fate

Fall in line before getting crushed seems to be the lesson the clinical research organisations (CROs) in Andhra Pradesh have learnt from the ongoing microfinance institutions’ episode, whose wings were clipped following allegations of tough recovery methods.

Even as the Andhra Pradesh government was flexing its hands to keep the CROs under tabs, the drug testing companies have decided to join hands to lobby positively with the governments both at the Centre and the state.

“We have always been transparent. We now working to be more transparent and comply with every regulation that is in place,” Suneil Reddy, managing director of QPS Bioserve, said while speaking on behalf of the other CROs.

The CROs have now decided to form a forum - Forum for AP CROs - to take up the issues concerning the clinical research business in AP, which is considered to be a key testing ground for many generic drugs waiting to be launched in India by pharma majors.

“We have already started audio and video recording of the process of taking consent from the volunteers. We are also working on putting in place a common volunteer database to prevent cross participation. Similarly, we are requesting the DCGI to conduct audits every year instead of the existing system of biennial audit only to ensure that all of us are complying with the procedure for conducting drug tests,” he said.

The CROs in the state have come under scanner with the volunteers in various districts of the state complaining about exploitation.

The CROs are accused of taking advantage of the poor literacy levels and coercing the “volunteers” to take part in drug trials. The authorities had earlier cancelled the licence of Axis Clinical, a major testing lab, on the allegations of a volunteer falling ill after a certain drug administration on her as part of the trials.

The state government, too, took the issue seriously though the drug trials including the bio-equivalence tests are governed by the central norms. The state was asking the Centre to allow it to have surveillance over the CROs. The state government has already written to the Centre to further strengthen the laws regulating the CROs.

“None of us is into drug trials. We conduct bio-equivalence tests for generic drug makers. However, in case of a mishap due to a variety of reasons concerning the volunteer’s health, the authorities are finding fault with us. Even in our case, the volunteer reported sickness almost after three months of her being administered a single dose of a particular drug. We do not allow the volunteer to carry the drug for so long and there are various methods of testing the absorption of the drug, the half life of the drug and the washout,” P Sarath Chandra Reddy, managing director of Axis Clinicals, said.

According to the representatives of the forum, after a series of incidents involving the volunteers the recruitment of illiterate volunteers is not being preferred by the CROs.

“We are preferring only those who can read the consent form, and in case the volunteer is healthy but illiterate we are asking them to bring their legal heir, who is educated. In case the legal heir is also equally illiterate, we are not preferring the volunteer,” Reddy said.

About 12 CROs are operating in AP of the 35 in the country in the clinical research space.