India’s National Pharmaceuticals Pricing Policy, 2012 (NPPP, 2012) establishes the regulatory framework for drug pricing in the country. The Ministry of Chemicals and Fertilizers has issued a press release on the policy on February 4, 2025.
The policy emphasizes several key principles, including regulating prices based on the essentiality of drugs, focusing price controls on consumer-level formulations (medicines) rather than bulk drugs or intermediates, and using market-based pricing mechanisms instead of cost-based pricing, which was the approach under the previous Drugs (Prices Control) Order, 1995.
International Regulatory Cooperation
Additionally, the Department of Health and Family Welfare has announced that the Central Drugs Standard Control Organisation (CDSCO) has established regulatory cooperation agreements or memoranda of understanding with several international agencies. These collaborations aim to strengthen cooperation in drug regulation and oversight. The CDSCO has partnered with agencies in the following countries and regions:
- Afghanistan
- Argentina
- Brazil
- Denmark
- Dominican Republic
- Ecuador
- Germany
- Guyana
- Japan
- Netherlands
- Russian Federation
- Suriname
- Sweden
- Ukraine
- United Kingdom
- United States of America
- BRICS Drug Regulatory Authority
These international partnerships are expected to facilitate information sharing, improve regulatory standards, and promote greater harmonization in drug regulation, ultimately benefiting public health.
