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, the Drugs Controller General of India (DCGI) has started auditing of all the clinical research organisations (CROs) in the country.

According to sources, the DCGI office has already completed auditing of CROs in Andhra Pradesh and Mumbai.  Now, the CDSCO panel will start auditing of CROs in other states also.  Earlier, the DCGI had formed panels for auditing of CROs which included assistant drug controllers and drug inspectors.   

The DCGI's decision to go in for a thorough auditing of all the CROs in the country comes in the wake 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.  Though the company claimed that it had permission from the Central Drug Control Authority to conduct clinical trials, there were public criticism that the trials were being carried out in flagrant violations of rules, and instead of rats and guinea pigs, the company was using poor women for the studies.

The DCGI immediately ordered an investigation into the allegation of certain irregularities in conduct of clinical study by M/s Axis Clinicals Ltd, in violation of the norms specified in Schedule Y of the Drugs and Cosmetics Rules.  The investigations have revealed various irregularities in conduct of the above said studies with respect to subject recruitment process, informed consent process, independence of the Ethics Committee and its review and decision making process. The investigations were conducted on 20th and 21st June 2011 at the Bio-equivalence study centre of the company situated at Serlingampally, Miyapur, Hyderabad.

Subsequently, the DCGI suspended the approval for conducting all BA/BE studies at their centres in Miyapur, Hyderabad, in public interest.

The DCGI further decided to investigate the working of all BA/BE study centres in the country to avoid the recurrence of such incidents in the country.