The clinical trial industry in the country is annoyed over the continued delay in giving approvals for the clinical trials, including the bioavailability and bioequivalance (BA/BE) studies, by the office of the Drug Controller General of India (DCGI).
Industry sources said that ever since the controversy surrounding the Hyderabad-based CRO Axis Clinicals hit the headlines, the DCGI office has virtually stopped giving clearance to clinical trials including the BA/BE studies and ordered auditing of all the Clinical Research Organisations (CROs) in the country to ensure that these studies are performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines in the country.
Admitting that the clinical studies should be done strictly in accordance with the prescribed guidelines in the country, industry sources however said that the inordinate delay in getting approval from the DCGI office is adversely affecting the clinical trial sector as a whole in the country as the business is gradually shifting to other countries where decision making is fast and prompt.
They said 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. Due to its several factors including cheap labour and skilled workforce, India is becoming a hotspot for clinical research activities in the world. But this kind of attitude by the Indian regulators will act against the overall interest of the CROs in the country, they said.
The regulators started tightening the regulations on the clinical trial sector in the country after the controversy in June this year 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. The incident created such a hue and cry in the country over the illegal activities of the CROs that the DCGI ordered auditing of all the CROs in the country.
His decision was prompted by 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.