DRUG LAG FOR ANTIMICROBIAL AGENTS: COMPARISON OF THE US, EU AND INDIA APPROVALS

Abstract

Background: Antimicrobial resistance is a global problem and the need for new antimicrobial agents is greater in both developed and developing nations. However, there is a difference in timing of introduction of new antimicrobial agents between India and developed markets. Aim: Assess the drug lag for new antimicrobial agents approved in the United States, European Union and India. Materials and Methods: The new antimicrobial agents approved in the United States, European Union and India between 1999 and 2011 were identified and information was gathered primarily from the websites of regulatory agencies of the three regions. We assessed absolute and relative drug lag for new antimicrobial agents approved in the three regions. Results: Of the 70 new antimicrobial agents, 59 (84.28%) were approved in the United States, 59 (84.28%) in the European Union and 58 (82.85%) in India. The median approval lag for India (39.7 months) was substantially high as compared to the United States (0 month) and European Union (6.5 months). Conclusion: This study confirms that India’s drug lag in the case of new antimicrobial agents is quite substantial. Further detailed analyses are necessary to find the background factors and impacts of drug lag for antimicrobial agents in India.

Keywords

• Drug approval
• Drug lag
• Regulatory authority
• New drug development