Abstract
BackgroundThe new drug approval in every country is closely monitored and regulated by central authorities which regulates drug development, approval, and marketing. In this study, we aim to analyze and compare the approval status of drugs that are approved for medical use in India by the Central Drugs Standard Control Organization (CDSCO) with the drug approval organizations of Western Countries. MethodsWe conducted a retrospective cross-sectional study. We queried the CDSCO website and database for new drugs and anti-cancer drugs that are approved for use in India by CDSCO during 2010–2019. We compared the approval status of those drugs in the FDA (Food and Drug Administration), EMA (European Medicines Agency), and Health Canada (HC) databases. ResultsA total of 257 new drugs (including 47 anti-cancer drugs) are approved for use in India by the CDSCO during the period 2010–2019. Out of these, only 69.6% (n = 179) new drugs were approved by the FDA, 62.65% (n = 161) were approved by EMA and 63.40% were approved by Health Canada (n = 163). Most of the anti-cancer drugs that are approved for use in India are approved by these agencies except 2 drugs that are not approved by FDA and HC. ConclusionMajority of cancer drugs approved for use in India are approved for use in the USA, Europe and Canada. However, a significant number of non-cancer drugs approved for use in India are not approved in these regions. Policy summaryWe recommend a comprehensive assessment of India’s drug regulatory processes and policies to improve patient safety.
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