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BA/BE studies come to a standstill as DCGI stops clearance

Ramesh Shankar, Mumbai | Monday, August 8, 2011, 08:00 Hrs [IST]

The bioavailability and bioequivalance (BA/BE) studies have virtually come to a standstill in the country as the Drug Controller General of India (DCGI) has stopped giving clearance to these studies in the aftermath of the recent controversy surrounding the Hyderabad-based CRO, Axis Clinicals, in which the company is alleged to have conducted clinical trials of a breast cancer drug on nearly 30 illiterate agriculture labourers after luring them with Rs.10,000 each.

Sources in the industry said that for the last around two months since the untoward incident involving Axis Clinicals, not a single clearance has been given by the DCGI for conducting the BA/BE studies in the country. Even though several applications for conducting BA/BE studies by Clinical Research Organisations (CROs) across the country are pending with the DCGI office, not a single one has been approved as a fallout of the Axis Clinicals incident, sources said.

Industry leaders regretted that at a time when there is intense competition in the field, the non-clearance of these studies by the Indian regulators will adversely affect the Indian CROs. At a time the country, due to its several factors including cheap labour and skilled workforce, is becoming a hotspot for clinical research activities in the world, this kind of attitude by the Indian regulators will act against the overall interest of the CROs in the country, they said.

BA/BE studies, which take about three months time, are conducted for finding the bioavailability and bioequivalance of a drug, especially the generic drugs and the combination drugs which are already in the market. For getting the license for a new combination drug or generic drug, it is mandatory to submit the BA/BE study results to the DCGI office.

Meanwhile, the DCGI has started auditing of all the CROs in the country to ensure that the bio-availability and bio-equivalence (BA/BE) studies are performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines in the country. His decision follows the findings in the investigations on Axis Clinicals which revealed that there were various irregularities in conduct of BA/BE studies with respect to subject recruitment process, informed consent process, independence of the Ethics Committee and its review and decision making process.

Comments

kavita mittal

Aug 9, 2011 4:18 PM

Audits play very important role in checking the irregularities taking place in conducting the BA/BE studies or clinical trials.
This is Ethics committee's role and Investigator's responsibilities which can prevent the misconduct or fraud.

Instead of denying permission to CRO's, DCGI should blacklist the Ethics committee and the investigators who conducted these studies . This in turn automatically will make CRO's more vigilant and strict in selecting sites and investigators for their trials.

ThePsychoBuddha

Aug 7, 2011 12:42 PM

The problems are with DCGI, Pharmaceutical Industry, the CRO's and more importantly with the physicians in-charge of the studies.

The Deceleration of Helsinki is quite explicit, yet there is a failure to understand and implement to the rigor of ethical and moral maturity needed, leaving aside the requirements of law.

There is a tendency to by-pass or short cut the process, purely for financial gain.

Let' us put strict guidelines in place and have people who know the pharma industry and have the courage and convictions to stand up to pressure from pharma and CRO to conduct poor research. Let such organizations be barred from life for conducting human studies of any kind.

Let the issues of informed consent be understood and applied

Let the ethics committees be formed of people who have an ethical standing

Let the pharma research industry aim for international standards of human research

Let the country build skills to have the ability to conduct real R & D