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4A: In India, the primary driver for clinical trials is cost-savings, which runs upwards of 50 to 60 percent as compared to trials in the U.S. However, government and regulatory rules are changing very quickly, more quickly than foreign pharmaceutical companies can keep up. Guidelines for audio-video recording of informed consent have been implemented, trial registration has been mandated, a call for compulsory accreditation of independent ethics committees has been answered, panels of experts for clinical trial application approval and serious adverse events reviews have been compiled, GCP compliance is being ensured by India’s new clinical trial inspection program, and safety update reports are required to be submitted every six months during the trial. Coupled with lost patent cases by Novartis, Roche, Merck, Gilead, and Pfizer in the country, have led to a decline in trials initiated in India since 2010.
SOURCE: Thomson Reuters Cortellis Competitive Intelligence
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