Drug lag for antineoplastic and immunomodulating agent approvals in India compared with the US and EU approvals
Keywords:Drug lag, Oncology, Anticancer drug, European medicines agency (EMA), Drug development
Background: There is a tremendous amount of research being conducted on development of new drugs for cancer therapies. The drug development of cancer therapies has dramatically increased over the past few decades. The present study was undertaken to assess the drug lag for new antineoplastic and immunomodulating agents in India compared with that in the United States (US) or European Union (EU).
Methods: The new drugs approved in the US, EU and India between 2011 and 2015 were identified and information was gathered primarily from the websites of regulatory agencies of the three regions. For the drug products identified, the drugs were classified into fourteen main Anatomical Therapeutic Chemical (ATC) groups, review classification and approval date. We assessed the absolute and relative drug lag for new antineoplastic and immunomodulating agents approved in the three regions (with the ATC code L).
Results: Of the 67 new antineoplastic and immunomodulating agents, 63 (94.02%) were approved in the United States, 58 (86.56%) in the European Union and 18 (26.86%) in India. The US was the first to approve 59 (88.05%) out of the 67 new antineoplastic and immunomodulating agents, the EU was the first to approve 7 (10.44%) and India was the first to approve 1 (1.49%). The median approval lag for India (18.36 months) was higher as compared to the United States (0 month) and European Union (6.02 months).
Conclusions: This study confirms that India lag behind the US and EU regions in terms of total number of new drug approvals for antineoplastic and immunomodulating agents. There is a substantial approval delay in India compared to the US and EU regions. Further detailed analyses are necessary to find the reasons and impacts of drug lag for new antineoplastic and immunomodulating agents in India.
Bai L, Smith DC, Wang S. Small-molecule SMAC mimetics as new cancer therapeutics. Pharmacol Ther. 2014;144(1):82-95.
Bai L, Wang S. Targeting apoptosis pathways for new cancer therapeutics. Annu Rev Med. 2014;65:139-55.
Kataria BC, Panchasara AK, Pandya AS, Panchal PJ, Parmar MR. Contemplation on new drug approvals by U.S. FDA, 2011-2015. Int J Basic Clin Pharmacol. 2016;5(1):55-9.
Kataria BC, Panchal PJ, Panchasara AK, Pandya AS, Parmar MR. Comparison of new drug approval by regulatory agencies of US, EU and India. Int J Basic Clin Pharmacol. 2016;5(1):112-5.
Clinton W, Gore A. Reinventing the regulation of cancer drugs: National performance review, 1996. Available at http://www.fda.gov/ ohrms/dockets/ac/05/ briefing/2005-4191B1_01_03-Reinvent-Cancer-Drugs.pdf. Accessed 9 January 2016.
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.
U.S. Food and Drug Administration. Drug approval reports. Available at www.accessdata.fda.gov/ scripts/cder/drugsatfda/index.cfm?fuseaction= Reports. ReportsMenu. Accessed 9 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 9 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 9 January 2016.
WHO Collaborating Centre for Drug Statistics Methodology, ATC/DDD Index 2016. Available at www.whocc.no/atc_ddd_index/. Accessed 25 January 2016.
European Medicines Agency. Xeljanz. Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002542/smops/Negative/human_smop_000501.jsp&mid=WC0b01ac058001d127. Accessed 12 January 2016.