Drug approval in India does not match the disease burden: A cross-sectional study

Abstract

Objectives: Assess the correlation between drug approval and disease burden in India

　

Design: Cross-sectional study

Data sources: Data on drug approval for last 14 years (2000-2013) was downloaded from the Central Drug Standard Control Organization website in India and the latest data on disease burden from the year 2012 was obtained the World Health Organization website.

Main Outcome measures: Mortality and disability (disease adjusted life year was were considered). Drug approval was correlated with disease burden using the Spearman correlation test.

Results: Between 2000 and 2013 a total of 1913 drugs were approved in India. Of these, 838 were fixed dose combinations and 22 were veterinary drugs, which were excluded from analysis. Due to a single drug being used for multiple indications, the final analysis was performed on 1345 indications/drugs. Overall there was a weak correlation between disease burden and drug approval for the outcomes of mortality (r=0.207, p=0.038) and disability (r=0.278, p=0.002).

Conclusion: The results from this first study assessing the correlation between drug approval and disease burden in India shows a significant mismatch and the urgent need for syncing the research output with the disease burden.