Article · Volume 9, Issue 1 · pp. 6–10

Drug Approval in India Does not Match the Disease Burden: A Cross‑sectional Study

Jaykaran Charan¹, Jatin V. Dhanani², Maulik Sumantbhai Doshi³, Tea Reljic⁴, Athanasios Tsalatsanis⁴, Ambuj Kumar⁴

¹Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan.
²Department of Pharmacology, GMERS Medical College, Valsad, Gujarat.
³Department of Clinical Pharmacology, KEM Hospital, Mumbai, Maharashtra, India.
⁴USF Health Program for Comparative Effectiveness Research and Evidence Based Medicine, University of South Florida, Tampa, Florida, USA.

Abstract

Objectives: To assess the correlation between drug approval and disease burden in India.Materials and Methods: A cross sectional study was conducted and data on drug approval for the past 14 years (2000–2013) were downloaded from the central drug standard control organization website in India and the latest data on disease burden from the year 2012 were obtained the World Health Organization website. Mortality and disability (disease adjusted life year) were considered. Drug approval was correlated with disease burden using the Spearman’s 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 the 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.

Keywords: Drug approval; disease‑adjusted life years; disease burden; India

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