Affiliations: 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 | Senior Research Fellow, Office of National Chair in Clinical Pharmacology, Indian Council of Medical Research (ICMR), Mumbai, India
Note: [] Address for correspondence: Dr. Mrs. Nilima A. Kshirsagar, National Chair in Clinical Pharmacology, Indian Council of Medical Research (ICMR), Dean, ESI-PGIMSR MGM Hospital, Govt. of India, Dr. S. S. Rao Road, Parel, Mumbai 400 012, Maharashtra, India. Tel.: +91 9821036616; Fax: 91 22 24137173; E-mail: [email protected]
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. OBJECTIVES: 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. CONCLUSION: 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.
Keywords: Benefit risk, drug withdrawal, drug regulation, nimesulide
