Publication:

An overview of drugs approved in India from 1999 through 2015

Background The drug approval regulations in India have changed since 2005 with new regulations for the conduct of clinical trials from 2013 onward. The present study was planned to see the number of drugs approved by Drugs Controller General of India (DCGI) and their trend over the last 16 years in view of new regulatory guidelines.

Methods Data obtained from website of the regulatory authority, i.e., Central Drugs Standard Control Organizationregarding DGCI approval of drugs in India from 1999 until May 2015 was noted for analysis.

Results We identified 1716 drug approvals by the DCGI from 1999 to 2015, with a mean of 100.94±83.80 (standard deviation) approvals per year (median approvals per year: 57; range: 3-270). There is a rising trend for approval of drugs as a single agent, as well as in combination from 2004 showing a peak in 2008 with a decline from 2010 onward. Thus, very few drugs have been approved in last 3 years.

Conclusions Thus, the present study highlights the changing scenario of drug approval, with few drugs being approved for clinical practice in the last 3 years.