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THE PHARMA REVIEW (JULY - AUGUST 2013)

Drug Safety Evaluations- An Elusive Practice in India

Anantha Naik Nagappa, Asim Priyendu & Uday Venkat Mateti

Introduction: The documentations of adverse effects of the drugs are a collective responsibility and participation from patients to manufacturer in the chain is very vital. In earlier times, awareness regarding drug safety was not considered very important and it was just sufficient to establish the safety in first three phases of clinical trials and Phase IV was termed as post marketing surveillance which was left to the manufacturer. There was no requirement for Phase IV submissions. In due course, it became evident that some drugs manifest injuries in patients while in use which remain unheard and go overlooked during clinical trials. It was soon realized that the drugs toxicity is usually manifested more prominently during first three phases of clinical trials. The laws were amended to make the post marketing surveillance into a mandatory documentation of drug safety known as pharmacovigilance. Although pharmacovigilance was started as an academic program, but soon its significance was realized across the globe by drug regulators and governments, who are now emphasizing the manufacturer to maintain and submit the safety data periodically for continuing the license for human use. 

 

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