Survase Rutuja Ramdas, Lad G. S, Shyamlila B. Bavage, Nandkishor B. Bavage
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 The most common categories of drugs withdrawn in the last decade were nonsteroidal anti-inflammatory drugs (28%), antidiabetics (14.28%), anti-obesity (14.28%), antihistamines (14.28%), gastroprokinetic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 in the past 3-5 years in other countries but are still available for sale in India. These adverse effects are detected though a process of regular monitoring after the drug is released called pharmacovigilance. If the adverse effects are severe or the risks of using the drug outweigh the benefits, or if the drug is ineffective, the country may ban the drug or the Drug Company may itself voluntarily withdraw the drug.
Article Details
Unique Paper ID: 152435

Publication Volume & Issue: Volume 8, Issue 3

Page(s): 410 - 412
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