(Un)ethical Clinical Trial Outsourcing

January 16, 2012

Since 2000, when business process outsourcing started, American companies have been doing clinical trial outsourcing to save money by testing potential drugs on the large Indian population. Seeing the huge opportunity, many Indian companies have started setting up clinical trial centers in India to perform various clinical trial outsourcing activities on behalf of American companies.

Ethics in clinical trial outsourcing has been an issue for the Indian companies since its inception in early 2000. Both American and Indian companies have strict and detailed guidelines on how to recruit patients and test the drugs, yet new accusations started coming up. A new report is accusing companies of recruiting people from rural tribal areas and from slums to test the drugs without properly explaining the consequences of taking the new drugs. Companies are recruiting patients by telling them the drugs are free now, that it is not in the market but it will be launched all over the world. Though American companies have strict guidelines on how to recruit and test, Indian companies are not following the proper consent process.

Another report says that for the  Bill and Melinda Gates Foundation  several girls from the tribal region have been recruited without their parent’s knowledge. During the study several girls were killed and the controversial study was stopped by the government of India. The report also found that drug companies used several victims of the Bhopal gas tragedy for drug trials without proper consent from the people.

India is a main destination for American companies to send their clinical trial work which will reduce 60% of their cost. In the future more clinical work will be outsourced to India to take advantage of exploding population of India. In most of cases American companies and Indian companies follow the strict consent process set forth by the FDA and Central Drug Standards Control Organization. But the process is not fully monitored by the government organizations, and corrupt individuals exploiting the uneducated public to make quick money are making the  ethical clinical trial outsourcing unethical.


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