title: Nimesulide controversy: a comparison of EU and Indian scenario.
abstract: BACKGROUND
  Regulatory decision for withdrawal of a drug from market in European Union (EU) or other developed countries poses a challenge to authorities in developing countries specially when decision varies from different countries, such as for nimesulide.
  
  
  OBJECTIVE
  To compare and evaluate, benefit and risk data for regulatory action, of nimesulide in India and EU.
  
  
  METHODS
  Data on Nimesulide from EU available from Report on EMA website and Indian data from published literature (SCOPUS data base), WHO Vigibase and International Medicines Statistics (IMS) was compared.
  
  
  RESULTS
  Publications from India on Adverse drug reactions (ADRs) are case reports (10) and case series (14). Drug Utilization Research (DUR) studies (17) are mostly from tertiary centres. Data in the WHO Vigibase is meagre, data from IMS is not easily available and there is regional variation in prescriptions. Thus incidence of ADRs per sale, prescription or defined daily does (DDD) cannot be calculated, as has been done for EU.
  
  
  CONCLUSIONS
  Limited and varying data in post marketing studies on ADRs and drug utilization for nimesulide from India made regulatory decision difficult. India and other similar countries could contribute to post marketing data for local and global regulatory decisions by systematically planned studies and networking within country and across countries in region.
authors.affiliation: National Chair in Clinical Pharmacology, Indian Council of Medical Research (ICMR), Government of India; Dean, ESI-PGIMSR MGM Hospital, Government of India, Parel, Mumbai, India.
authors.forename: Nilima A
authors.initials: NA
authors.lastname: Kshirsagar
authors.forename: Sagar S
authors.initials: SS
authors.lastname: Bachhav
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D004335:Drug and Narcotic Control / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D006801:Humans; D007194:India; D060735:Pharmacovigilance; D013449:Sulfonamides / Q000009:adverse effects*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D013449:Sulfonamides; C012655:nimesulide
keywords: Benefit risk; drug regulation; drug withdrawal; nimesulide