A study on drug safety monitoring program in India.

作者: R Balkrishnan , GP Mohanta , Isha Patel , Sudeepa Sanyal , A Ahmad

DOI: 10.4103/0250-474X.143070

关键词:

摘要: Pharmacovigilance is useful in assuring the safety of medicines and protecting consumers from their harmful effects. A number single drugs as well fixed dose combinations have been banned manufacturing, marketing distribution India. An important issue about availability over counter India that sufficient adverse drug reactions data these not reported. The most common categories withdrawn last decade were nonsteroidal antiinflammatory (28%), antidiabetics (14.28%), antiobesity antihistamines gastroprokinetic (7.14%), breast cancer infertility irritable bowel syndrome constipation (7.14%) antibiotics (7.14%). Drug withdrawals market made mainly due to issues involving cardiovascular events (57.14%) liver damage (14.28%). Majority since 3-5 years other countries but are still available for sale present study compares monitoring systems developed such USA UK provides implications developing a system can ensure efficacy Absence gold standard surveillance system, variations culture clinical practice across makes it difficult completely adopt another country's practices. There should be multidisciplinary approach towards implemented throughout entire duration spanning discovery usage by consumers.

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