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Involvement of private players in pharmacovigilance program of India: Data reliability will be under question

Rajiv Mahajan.


Pharmacovigilance or Adverse Drug Reactions (ADRs) monitoring is the pharmacological science related to the collection, detection, assessment, monitoring, and prevention of adverse effects or any other drug-related problem. India is fast growing as a hub of clinical trials. This is reflected in the fact that the total number of applications received and processed at Central Drug Standard Control Organization (CDSCO) New Delhi has doubled from around 10,000 in the Year 2005 to 22,806 in Year 2009; with increase in New Drug Applications, global clinical trials, and market authorization of vaccine and biotech products from 1200, 100, and 10 in Year 2005 to 1753, 262, and 137 in the Year 2009 respectively.

Key words: Pharmacovigilance, India, Private Players

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