Since January 2013, Indian regulatory authorities have announced a spate of laws and guidelines that will make a huge impact on the clinical trial sector in India. These changes are the need of hour. If made in a pro-active manner over a period of several years, various stakeholders such as the industry, investigators and ethics … Continue reading Guest column : India’s new regulatory environment hostile to clinical trials
Tag: india clinical trials
India and clinical trials : no denoument in sight
There are murmurs among clinical research industry executives that India's health ministry will reexamine some of the clauses in the rules on compensation in case of clinical trial injury that it had notified in the Gazette of India in February and that had caused grave concern among trial sponsors. This follows discussions between the industry … Continue reading India and clinical trials : no denoument in sight
India & clinical trials: PhRMA weighs in
In a guest column, Jay Taylor, vice-president (international affairs) at US-headquartered Pharmaceutical Research and Manufacturers of America (PhRMA), a vocal representative of Big Pharma interests, argues that "much of the characterization of the clinical trial environment has been sensationalized.. (is) overstated or simply wrong." Among other things, he states that the death rate for patients … Continue reading India & clinical trials: PhRMA weighs in
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