Drug Regulatory Reforms

Almost half of health-related expenses incurred by households in India are on medicines. However, consumers lack the technical expertise to ascertain the safety, quality or efficacy of these medicines. Hence, there is critical need to regulate this sector. While policymakers have quite successfully promoted India’s health care industry, in particular the pharmaceutical sector, not enough attention has been paid to strengthening the drug regulatory framework and processes. The recent exercise by the Central Drug Standard Control Organisation to revisit India’s Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, is, therefore, a step in the right direction.

The Research Program on Drug Regulatory Reforms in India seeks to address key challenges around drug regulation and evolution of pharmaceutical industry in the country – while leveraging the potential of the pharmaceutical industry to address India’s evolving disease burden as well as continue to contribute to overall economic growth. So far, we have produced policy research on administrative structure and functions of drug regulatory authorities, quality and safety, clinical trials and registration of medicines.