TY - JOUR AU - Kataria, Bhaven C. AU - Panchal, Pavan J. AU - Panchasara, Ashwin K. AU - Pandya, Ashna S. AU - Parmar, Mitul R. PY - 2016/12/24 Y2 - 2024/03/28 TI - Comparison of new drug approval by regulatory agencies of US, EU and India JF - International Journal of Basic & Clinical Pharmacology JA - Int J Basic Clin Pharmacol VL - 5 IS - 1 SE - Original Research Articles DO - 10.18203/2319-2003.ijbcp20160110 UR - https://www.ijbcp.com/index.php/ijbcp/article/view/140 SP - 112-115 AB - <p><strong>Background: </strong>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.</p><p><strong>Methods:</strong> 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.</p><p><strong>Results:</strong> 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).</p><p><strong>Conclusions:</strong> 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.</p> ER -