Clinical trials: GVK Biosciences, Axis Clinical face inspection

Our Bureau Updated - November 13, 2017 at 12:31 AM.

The Director General of Drugs and Copyrights, Andhra Pradesh, has ordered an inspection of records of GVK Biosciences and Axis Clinical Ltd.

Two teams of officials headed by senior deputy directors were directed to verify the records of the two companies in connections with clinical trials, Mr R.P. Meena, Director-General, Drugs and Copyrights-Andhra Pradesh, said on Friday.

The inspection was ordered in the wake of media reports on Friday that at least 20 poor women in Adarsh Nagar, Guntur fell ill after participating in clinical trials conducted by a leading Hyderabad-based pharma company.

It was also alleged that the pharma companies had injected the trial medicines into some labourers under the guise of conducting blood tests.

The Director General of Drugs had also submitted a comprehensive proposal to the State Government who may take up the matter with the Govt of India to curb the illegal contention in the name of clinical trials.

At present, the Drug Controller General of India is the competent authority for approval of clinical trials.

Meanwhile, the Andhra Pradesh human rights Commission called for a report from the State Government on the allegations of clinical trials on labourers in Guntur district without their knowledge (by some companies).

The Principal Secretary (Health), Govt of AP was also directed to identify all the victims of clinical tests and get them treated free of cost.

Published on June 17, 2011 16:40