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Goa Indian Investigators May Be Conducting Rogue Clinical Trials for Money Without Following the Law

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Goa Indian Investigators May Be Conducting Rogue Clinical Trials for Money Without Following the Law

The Goa, India Health Minister Vishwajit Rane, ordered a probe of a prominent physician from the Goa Medical College following accusations that he was violating rules and ethics by, among other things, participating in “foreign-funded” clinical trials utilizing patients that were in the care of state-run hospitals.

Background

Dr. Amit Dias, a lecturer with Goa Medical College’s Preventive and Social Medicine department is accused of misusing his status and position to conduct foreign-funded clinical research, utilizing patients in the state-run hospitals at Mandur, Santa Cruz, and Goa Medical College.

Serious Conflicts?

Apparently, Dr. Dias is a member of the Goa Medical Committee Ethics Committee (EC). The recent write up in The Indian Express comments that the doctor actually sanctioned himself from the study—exhibiting, if true, serious ethics conflicts. The paper reports that the clinical trial is funded, but that the EC has not received documentation.

Moreover, it was reported that minister Rane points that there have been previous complaints against Dias involving “serious lapses in the use of medical infrastructure.” The Goa minister, it would appear, has launched a formal inquiry into Dr. Dias.

More Pervasive Problem in India?

The Herald also reported on this story alleging that Dias had up to 45 clinical trials running “while the government and the Goa Medical College are in the dark.” The Herald further notes that their investigators have found nearly a dozen Goa Medical College doctors involved in the conduct of clinical trials without disclosing the funding source to the government—rather cutting deals with NGOs and unauthorized channels.

Summary

We cannot conclude the accuracy of the accusations but they appear to be serious and garnering attention at high levels of Indian state government. More than likely, most play by the rules there, but, undoubtedly, there could be a few bad apples that can spoil the bunch. We will continue to track this. India is a very important place—the second largest population in the world; extremely diverse and many health challenges. Clinical research can bring incredibly good there, but its sponsors and participants must follow the law. We suggest multinational sponsors conducting clinical research programs in India ensure that they are fully qualifying CROs, investigator sites, and investigators.

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