The Andhra Pradesh Drugs Control Administration, which carried out a detailed probe into the Hyderabad based GVK Biosciences' clinical trials issue has arrived at the conclusion that the company has not violated the Drugs and Copyrights Act, and nor did it conduct any human clinical trials.

The DCA which is yet to submit a comprehensive report to the AP government, revealed that there is nothing that the state drugs department can do on this issue as there has not been any sort of violation.

The four complainants who had alleged that GVK used them illegally for clinical trials, actually had undergone only screening tests and no drugs were administered on them, Ranga Rao, joint director, DCA told Pharmabiz.

The report has also been sent to DCGI to study the whole issue, Rao added.

However, the Police department is investigating on the grounds of alleged cheating, involving two men, Robert (employee of the firm) and his father Yesuratnam who lured four youth to undergo screening tests, promising to offer jobs at GVK, sources informed.

P Ananthasayanam Reddy, director general, drugs and copyright said, GVK has an ethics committee, which looks after the ethical issues in conducting studies, tests or trials and give clearances, comprising legal and pharma experts as its members.

Some sort of licensing or approval should be made obligatory to conduct any tests whether they are bio-equivalence studies or clinical trials, whatever may be the purpose of generating data, which would avoid these kind of complications and confusion, Reddy opined.

Pharmabiz had earlier reported that GVK denied the allegations that it was undertaking illegal clinical trials. The company stated that it is taking up only bio-equivalence (BE) studies on generic drugs, and thus does not require DCGI approval. AP DCA sent a team of drugs officers, last week, to GVK to investigate the whole episode and prepare a report.