Approval of antineoplastic agents in India: comparison with the US and EU regions.

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dc.contributor.authorKataria, Bhaven C
dc.contributor.authorMehta, Dimple S
dc.contributor.authorChhaiya, Sunita B
dc.date.accessioned2014-07-30T06:58:47Z
dc.date.available2014-07-30T06:58:47Z
dc.date.issued2012-07
dc.description.abstractBackground: The antineoplastic drugs are prescribed for the treatment of cancer, which is an important cause of mortality in India; therefore, a drug lag in the availability of antineoplastic drugs is a direct threat to life. The present study was undertaken to assess the drug lag for new antineoplastic agents in India compared with that in the United States (US) or European Union (EU). Methods: The new antineoplastic agents approved in the United States, European Union and India between 1999 and 2011 were identified and information was gathered primarily from the websites of regulatory agencies of the three regions. We assessed absolute and relative drug lag for new antineoplastic agents approved in the three regions. Results: Of the 70 new antineoplastic agents, 64 (91.42%) were approved in the United States, 54 (77.14%) in the European Union and 44 (62.85%) in India. The US was the first to approve 59 (84.28%) out of the 70 new antineoplastic agents, the EU was the first to approve 9 (12.85%) and India was the first to approve 2 (2.85%). The median approval lag for India (26.35 months) was higher as compared to the United States (0 month) and European Union (7.3 months). Conclusions: This study confirms that India’s drug lag in the case of new antineoplastic agents is higher as compared to the US and EU. Further detailed analyses are necessary to find the reasons and impacts of drug lag for antineoplastic agents in India.en_US
dc.identifier.citationKataria Bhaven C, Mehta Dimple S, Chhaiya Sunita B. Approval of antineoplastic agents in India: comparison with the US and EU regions. International Journal of Basic & Clinical Pharmacology. 2012 Jul-Aug; 1(1): 13-21.en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/153369
dc.language.isoenen_US
dc.source.urihttps://www.ijbcp.com/?mno=27634en_US
dc.subjectOncologyen_US
dc.subjectanticancer drugen_US
dc.subjectmarketing approvalen_US
dc.subjectdrug lagen_US
dc.subjectnew drug developmenten_US
dc.titleApproval of antineoplastic agents in India: comparison with the US and EU regions.en_US
dc.typeArticleen_US
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