Affiliations: National Chair in Clinical Pharmacology, Indian Council of Medical Research (ICMR), ESI-PGIMSR MGM Hospital, 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: +9122 24137173; E-mail: [email protected]
Abstract: BACKGROUND: With globalization and signing of WTO GATT treaty, the market in India has expanded. This has necessitated important regulatory decisions. OBJECTIVE: This study aims to determine the gap in introduction and withdrawal of drugs in India and EU. METHODS: For drugs prohibited for manufacture and sale(withdrawn) in India during 1983–1998 and 1999–2012 periods, data on year of introduction and withdrawal in India and EU/internationally was extracted from Central Drugs Standard Control Organization (CDSCO), European Medical Agency (EMA) websites and Google search engine and compared. RESULTS: The gap in introduction of drug in India compared to EU/internationally during 1999–2012 period is shorter than 1983–1998 period, while the gap in withdrawal has not changed much. CONCLUSION: Regulatory authority in India has approved drugs in recent year more quickly than the past but gap in withdrawal has not shortened, indicating need for strengthening postmarketing studies and review process.
Keywords: Drug approval, drug withdrawal, CDSCO, EMA
