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THE PHARMA REVIEW (NOVEMBER - DECEMBER 2010)

Drug Safety, Regulations and Regulatory Agencies

M.D.Nair

Introduction
The leading global pharmaceutical companies over the years have been dependent for their survival and growth on innovation leading to the discovery and development of new drugs to meet the medical needs of populations around the world. Advances in Medical treatment have largely stemmed from the advent of drugs for diseases for which treatments were not available or when available were inadequate, inappropriate or unsuitable due to lack of efficacy or even more importantly of safety. Regulatory agencies have been the custodians for ensuring that the drugs consumed by the patients possess no safety issues and are devoid of the potential to cause harm to the consumers of the medicaments. What are the contours of the job of the regulators and to what extent have they been effective in preventing such harm to the patients are questions being addressed by all stake holders in view of many catastrophic incidents of adverse reactions and even fatalities from the use of drugs in the recent past. These incidents had major impact on the way the agencies are structured and have functioned.

 

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