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Friday 2 August 2013

ISCR expresses concern over steady drop in approvals for clinical trials

Indian Society for Clinical Research (ISCR), an association of clinical trials professionals, has alleged that there was a slow-down in granting approvals for trials in the recent past and also urged the regulatory authorities to address the issue.“ISCR is fully supportive of the initiatives undertaken to create a more robust and regulated environment in India for the conduct of clinical research, one which ensures the practice of the highest standards of ethics and quality and where patient rights and safety are protected. However, ISCR would like to express its concern with regard to the slowdown in granting approvals for clinical trials in the country which has the greatest impact on patients for many of whom clinical trial provides early access to a new treatment and for others, the last option or hope of a cure. Without clinical trials there can be no new therapies,” a spokesman of ISCR said in a statement.The association pointed that the Working Group on Disease Burden for the 12th Five Year Plan referred to the “triple burden of disease” that developing countries like India were facing arising from communicable diseases, emerging non-communicable diseases related to lifestyles and emerging infectious diseases.“In the larger context of India’s unique healthcare requirements and the growing incidence of endemic diseases and emerging lifestyle diseases, we need clinical research to develop new and effective medicines and vaccines to tackle our mammoth disease burden and unmet medical need. India has 16 per cent of the world’s population and 20 per cent of the global disease burden and yet, less than two per cent of global trials take place in India. Clinical trials should not come to a standstill and impede the process of finding better and more effective medicines for our population,” the statement said.“We hope that in the greater interest of patients, the regulatory authorities will address this concern on priority,” it said.
Source:Pharmabiz

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