Drug Price Control Order 2013 Amendments: Ease of Doing Business and Innovation
UPSC / SSC current affairs note · Polity
Why in news
The Department of Pharmaceuticals has notified amendments to the Drug Price Control Order (DPCO) 2013 via notification S.O. 3516(E) dated 30 June 2026. These changes aim to ease doing business, encourage innovation, and address issues like manufacturer accountability for overcharging and prior approval for new drug prices. The information was shared by Minister of State for Chemicals and Fertilizers, Smt. Anupriya Patel, in a written reply in the Lok Sabha on 31 July 2026.
Background
The Drug Price Control Order (DPCO) is issued under the Essential Commodities Act, 1955, to regulate the prices of essential medicines in India. The National Pharmaceutical Pricing Authority (NPPA) is responsible for fixing and revising drug prices under this order. The 13th amendment to DPCO 2013 introduces several changes to streamline processes and reduce compliance burden.
Key facts
The Department of Pharmaceuticals notified the 13th amendment to DPCO 2013 on 30 June 2026 via notification S.O. 3516(E).
Manufacturer's liability for overcharging is now limited to the quantity of stock actually sold at the higher price by the distributor, retailer, or stockist, subject to compliance with DPCO 2013 provisions.
For new formulations of existing manufacturers (combinations or changes in strength/dosage), prior price approval is required. However, once NPPA fixes a retail price for one manufacturer, other existing manufacturers can adopt the same or lower price without prior approval for up to 12 months.
Record-keeping requirements for manufacturers/importers are now limited to the seven financial years immediately preceding the current financial year.
The government can now fix different maximum or retail prices for the same drug if justified on therapeutic grounds, to promote innovations that improve health outcomes.
These amendments aim to reduce compliance burden, eliminate prior approval for subsequent applicants, and enable faster launch of drugs in the market.
The amendments are expected to benefit both consumers and manufacturers by improving patient access to more effective, efficacious, and user-friendly drugs.
Prelims pointers
- DPCO: Drug Price Control Order, 2013
- NPPA: National Pharmaceutical Pricing Authority
- Department of Pharmaceuticals under Ministry of Chemicals and Fertilizers
- Notification S.O. 3516(E) dated 30 June 2026
- 13th amendment to DPCO 2013
- Essential Commodities Act, 1955
- Lok Sabha written reply by Minister of State Anupriya Patel
Mains angles
- GS2: Government policies and interventions for development of health sector; issues relating to pricing of essential drugs.
- GS3: Effects of liberalization on the economy; growth of pharmaceutical sector; ease of doing business.
- GS3: Science and technology- developments and their applications in health; drug pricing regulation.