n engl j med 352;16www.nejm.orgapril 21, 20051634PERSPECTIVEtrials will not normally be permitted in India. Theold rule was designed to protect Indians from be-ing used as guinea pigs in the testing of unproveddrugs of foreign origin; trials of domestically dis-covered drugs were not subject to this provision.The change was made in response to vociferousdemands from multinational drug companies andprivate organizations that conduct clinical researchfor a relaxation of the rules for drug trials — thosenecessary hurdles whose price tags can run to 40percent of the cost of drug development.1It has be-come increasingly difficult to test drugs in West-ern countries, with their strict regulations, elabo-rate safety and compensation requirements, andsmall populations, all of which make the recruit-ment of research subjects slow and expensive. Con-sequently, many research-based companies are nowoutsourcing some of their trials to Third Worldcountries such as China, Indonesia, Thailand, andIndia.India is a particularly attractive site for such tri-als because of its genetically diverse population ofmore than 1 billion people who have not been ex-posed to many medications but have myriad dis-eases, ranging from tropical infections to degen-erative disorders. Virtually all Indian doctors speak
This is the end of the preview.
access the rest of the document.
Clinical trial, Conducting Clinical Trials in India, domestically discovered drugs, multinational drug companies