GVK Biosciences has denied the allegations that it is undertaking illegal clinical trials, following recent reports in the media. The company stated that it is taking up only bio-equivalence (BE) studies on generic drugs, and thus does not require DCGI approval.
According to officials in the AP Drug Control Department, which has been appointed to investigate the issue, GVK had conducted BE studies, bioavailability studies and comparative tests on drugs such as Azithromycin, Clarithromycin (both are antibiotics) for Ranbaxy, New Delhi and Oxibutanin for Glenmark, Mumbai with that of drugs of US pharma majors including Pfizer.
It may be recalled that the Hyderabad Police had filed a case against the company, which has begun the BE studies this March at its 60 bedded hospital/testing centre here, on Monday based on the complaints received from four unemployed youths who alleged that they were paid merely Rs. 30 after taking blood samples, as part of the tests.
The Police also have arrested the labour contractors Robert and Yasuratnam for cheating the four people, under section 420, who brought them for tests, saying that they will provide employment at GVK.
It is interesting to note that Dr Kamalakar, head of the clinical division at GVK, who stated in the beginning of the investigation by the Police that the two individuals were not the employees, changed his version later. B Limba Reddy, a police officer is investigating the entire case.
The State Government has ordered a probe into the issue through Andhra Pradesh Drugs Control Administration (AP DCA), following which, a team of drugs officers comprising Pramodh Reddy, assistant director and G Koteshwar Rao, drugs inspector, visited the company on Tuesday to investigate the whole episode and have prepared a report and submitted the same to the director of the department on Tuesday, and the director is likely to submit the detailed report to the Chief Secretary, Govt. of AP, sources informed Pharmabiz.
GVK stated that it has formed an ethical committee chaired by a retired High Court judge, to supervise BE studies and give clearance to conduct them. Such committees mainly comprise experts from pharmacology department, a couple of clinicians, and medical scientists. GVK claimed that it is conducting sample projects to submit before DCGI to obtain accreditation for its facility to conduct BE tests in future.
The studies are conducted on the existing drugs and they were not conducting clinical trials on new drugs. There is no requirement for any kind of approval from DCGI as per Drugs and Cosmetics Act, 1940 to conduct such studies. But, the report prepared by AP DCA on GVK issue will be submitted to the DCGI, for further investigation into the matter, the source added.
The sources also revealed that the blood tests were to be sent to a centre at Mumbai, where any company can verify whether the people (healthy) from whom blood samples are collected are fit for further studies or not.