Drug lag for cardiovascular drug approvals in India compared with the US and EU approvals

Age-standardized burden of cardiovascular diseases is substantially higher in low and middle-income countries than in high-income countries. However, Indian patients are not getting access to the new cardiovascular drugs at the same time as patients in the developed nations. The objective of this study was to assess the drug lag for new cardiovascular drugs in India compared with that in the United States (US) or European Union (EU).

The information regarding approval of new cardiovascular drugs in the United States, European Union and India between 1999 and 2011 were obtained primarily from the online databases of regulatory agencies. The approval lag was obtained for all new cardiovascular drugs approved in each region, and the median approval lag was calculated for each region.

Of the 75 new cardiovascular drugs, 61 (81.33%) were approved in the United States, 65 (86.66%) in the European Union and 56 (74.66%) in India. The US was the first to approve 35 (56.45%) out of the 75 new cardiovascular drugs, the EU was the first to approve 24 (38.71%) and India was the first to approve 3 (4.84%). The median approval lag for India (44.14 months) was substantially higher as compared to the United States (0 month) and European Union (2.99 months).

This study confirms that there is a substantial drug lag in approval of new cardiovascular drugs in India compared with the United States and European Union. The impact of drug lag on health outcomes remains to be established.