Regulatory Focus™ > News Articles > India's Clinical Trials Attract Patients, Scrutiny

India's Clinical Trials Attract Patients, Scrutiny

Posted 04 January 2012 | By Alexander Gaffney, RAC 

Global pharmaceutical manufacturers have been flocking to India since 2005 when guidelines restricting clinical trials were eased.  The result: roughly 150,000 Indians participated in clinical trials in 2011-a phenomenal rise given that the country had almost no patients enrolled as of 2004.

Now pushback from patients and the government are causing some to rethink that rise in clinical trial participation, writes Rama Lakshmi, as ethical lapses, adverse events, lax trial oversight, and money start to pile up.

Roughly 1,700 participants in clinical trials died between 2007 and 2010, though the cause of death was not necessarily attributable to the pharmaceutical product being received. While some of the families have received compensation for the loss of family members, monies paid out as compensation pales in comparison to the overall revenues generated to the Indian economy-some $300 million in 2010 alone.

Ethical lapses, including uninformed consent, lack of compensation for victims of injury suffered as a result of the trials, falsification of records, and improper payments to doctors to enroll patients are causing blow-back from activists and patients alike.  One medical journal editor referred to Indian patients as "guinea pigs" when describing their treatment.

The US Food and Drug Administration is apparently investigating some of the claims made by Indian activists against western pharmaceutical companies, and the Indian Council for Medical Research has proposed draft guidelines for compensating victims of clinical-trial-related injuries.

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