Overview

Following the implementation of the DPCO 2013, the Indian government introduced several regulatory changes to further regulate the prices of essential medicines and ensure their affordability. Evidently, the Government has introduced back-to-back changes in terms of DPCO 2015 and changes to NLEM, to address the issue of declining sales volumes of regulated drugs. These changes, aimed at addressing the declining sales volumes of regulated drugs and enhancing access to crucial medications, encompassed additional formulations and stricter compliance requirements. In the Table below, we outline the significant regulatory updates introduced post-DPCO 2013, highlighting their scope and intended impact on the pharmaceutical industry.