title: A study on drug safety monitoring program in India.
abstract: Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers.
authors.affiliation: Department of Pharmacy Practice, Annamalai University, Annamalai Nagar-608 002, India.
authors.forename: A
authors.initials: A
authors.lastname: Ahmad
authors.affiliation: Clinical, Social and Administrative Sciences, College of Pharmacy, University of Michigan at Ann Arbor, 428 Church Street, Ann Arbor, MI 48109-1065, USA.
authors.forename: Isha
authors.initials: I
authors.lastname: Patel
authors.affiliation: Walmart Pharmacy, 150 Barnum Ave Cutoff, Stratford, CT-06510, USA.
authors.forename: Sudeepa
authors.initials: S
authors.lastname: Sanyal
authors.affiliation: Clinical, Social and Administrative Sciences, College of Pharmacy, University of Michigan at Ann Arbor, 428 Church Street, Ann Arbor, MI 48109-1065, USA.
authors.forename: R
authors.initials: R
authors.lastname: Balkrishnan
authors.affiliation: Department of Pharmacy Practice, Annamalai University, Annamalai Nagar-608 002, India.
authors.forename: G P
authors.initials: GP
authors.lastname: Mohanta
keywords: Adverse drug reaction; banned drugs; drug safety; pharmacovigilance