Details of Regulations Post DPCO 2013


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.

Regulatory Changes Post - DPCO 2013

Regulatory Changes Details View Details
July 2014 Price Control Announced for 108 formulations of diabetes and cardiovascular drugs not part of NLEM 2011, utilizing Para 19 of DPCO 2013 for drugs outside NLEM (to be brought under regulation). Expected market impact was a reduction of Rs. 5,500 crores, with price cuts ranging from 10% to 35% (EconomicTimes 2014).
NLEM 2015 & DPCO 2015 In May 2015, around 857 formulations were brought under price control through DPCO 2015 following their inclusion in NLEM 2015. This update introduced stricter compliance for production and inventory levels (Pilla, 2019).
Formulation Additions (2015-2022) From 2015 to 2022, the NPPA continued to expand the list of regulated formulations, ensuring broader coverage of essential medicines under price control.
NLEM 2022 Introduced 34 new formulations, addressing price variations within the same company by capping prices at the lowest brand or pack size plus 10 percent. This aimed to prevent higher charges for slightly modified formulations by pharmaceutical firms (Babu, 2023).


Babu, Gireesh (2023), “NPPA Addresses the Issue of Inter Brand Price Variation in New Scheduled Drugs While Fixing Ceiling Prices,” (accessed on 18 November 2023),

EconomicTimes (2014), “Prices of 108 Diabetes, Cardiac Formulations Fixed: NPPA”, (accessed June 10 2023),

Pilla, Viswanath (2019), “How Drug Prices are Regulated in India”, (accessed on 10 June 2023),