Comparison of new drug approval by regulatory agencies of US, EU and India
Keywords:Priority review, CDSCO, EMA, FDA, ATC group
Background: As per World Trade Organisation (WTO), from the year 2005, India granted product patent recognition to all new chemical entities (NCEs). This may affect the new drug approvals in India. The purpose of this study was to compare the new drug approvals in India with the United States (US) and the European Union (EU) regions.
Methods: We obtained information about regulatory approval of new drugs in the US, EU, or India of last 5 years (from 2011 through 2015) from the publicly accessible databases of three regulatory agencies. For the drug products identified, the drugs were classified into fourteen main Anatomical Therapeutic Chemical (ATC) groups, review classification and approval date.
Results: There were 509 new drugs approved from 2011 through 2015 by one or more of the three regulatory agencies. Total 182 new drugs were approved in US during the period of 2011 to 2015, with an average of 36.4 new drugs approved per year. For the same period a total of 257 new drugs were approved in the EU, with an average of 51.4 new drugs approved per year and in India a total of 70 new drugs were approved, with an average of 14 new drugs approved per year. There were more number of new drug approvals in antineoplastic and immunomodulating agents (L) ATC group in all the three regions (US= 66; EU= 61 and India= 17).
Conclusions: For new drugs approved between 2011 and 2015, India has lagged behind the US and the EU in approval of new drugs. There was no difference in the patterns of new drug approvals with respect to the therapeutic areas.
The European Medicines Agency (EMA). Available at www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000235.jsp&mid=. Accessed 2 January 2016.
U.S. Food and Drug Administration. The history of drug regulation in the United States. Available at www.fda.gov/downloads/AboutFDA/WhatWeDo/History/ProductRegulation/PromotingSafeandEffectiveDrugsfor100Years/UCM114468.pdf. Accessed 2 January 2016.
Kataria BC, Bhavsar VH, Donga BN. Contemplation on approved drugs in India from 1999 through 2011. Asian J Pharm Clin Res. 2012;5(3):25-9.
U.S. Food and Drug Administration. New molecular entity and new therapeutic biological product approvals for 2015. Available at www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM481709.pdf. Accessed 3 January 2016.
U.S. Food and Drug Administration. Drug approval reports. Available at www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.ReportsMenu. Accessed 1 January 2016.
European Medicines Agency. The European Public Assessment Report. Available at www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&jsenabled=true. Accessed 1 January 2016.
The Central Drugs Standard Control Organization (CDSCO). List of approved drug. Available at www.cdsco.nic.in/forms/SearchMore.aspx?Id=11. Accessed 3 January 2016.
WHO Collaborating Centre for Drug Statistics Methodology, ATC/DDD Index 2016. Available at www.whocc.no/atc_ddd_index/. Accessed 3 January 2016.
Kataria BC, Mehta DS, Chhaiya SB. Drug lag for cardiovascular drug approvals in India compared with the US and EU approvals. Indian Heart J. 2013;65(1):24-9.
Kataria BC, Mehta DS, Chhaiya SB. Approval of antineoplastic agents in India: comparison with the US and EU regions. Int J Basic Clin Pharmacol. 2012;1(1):13-21.
Kataria BC, Mehta DS, Mehta SJ. Drug lag for antimicrobial agents: comparison of the US, EU and India approvals. Natl J Med Res. 2012;2(3):264-8.
Cadila Healthcare Ltd. Lipaglyn. Available at www.lipaglyn.com/about_lipaglyn.html. Accessed 3 January 2016.