- The National Pharmaceutical Pricing Authority (NPPA) regulates the prices of scheduled formulations in India under the Drug Prices Control Order (DPCO). - Medicines included in the National List of Essential Medicines (NLEM) are subject to price caps fixed by the government to ensure affordability and public health access. - For non-scheduled drugs, manufacturers are legally permitted to increase prices by up to 10% annually, while price control violations attract statutory penalties under the Essential Commodities Act. - Balancing pharmaceutical industry innovation and commercial viability with affordable healthcare access remains a key regulatory challenge in India. - **Drug Prices Control Order:** An order issued by the government under the Essential Commodities Act to regulate and fix the prices of essential medicines in India to ensure affordability. - **National List of Essential Medicines:** A curated list of medicines considered vital for public healthcare needs, prioritizing safety, efficacy, and affordability, which forms the basis for price caps under the DPCO. - **National Pharmaceutical Pricing Authority:** An expert regulatory body under the Ministry of Chemicals and Fertilizers responsible for fixing and revising drug prices and enforcing the DPCO in India. **Introduction** The article details the institutional mechanisms governing medicine pricing in India, highlighting the role of the National Pharmaceutical Pricing Authority (NPPA), the Drug Prices Control Order (DPCO), and the National List of Essential Medicines (NLEM). It explains how essential and non-scheduled drug prices are regulated, monitored, and capped to balance public health priorities with pharmaceutical sector growth. **Core Issue and Detailed Points** - The National Pharmaceutical Pricing Authority (NPPA) regulates the prices of scheduled formulations in India under the Drug Prices Control Order (DPCO). - Medicines included in the National List of Essential Medicines (NLEM) are subject to price caps fixed by the government to ensure affordability and public health access. - For non-scheduled drugs, manufacturers are legally permitted to increase prices by up to 10% annually, while price control violations attract statutory penalties under the Essential Commodities Act. - Balancing pharmaceutical industry innovation and commercial viability with affordable healthcare access remains a key regulatory challenge in India. **Key Statutory Bodies, Acts & Concepts** - **Drug Prices Control Order:** An order issued by the government under the Essential Commodities Act to regulate and fix the prices of essential medicines in India to ensure affordability. - **National List of Essential Medicines:** A curated list of medicines considered vital for public healthcare needs, prioritizing safety, efficacy, and affordability, which forms the basis for price caps under the DPCO. - **National Pharmaceutical Pricing Authority:** An expert regulatory body under the Ministry of Chemicals and Fertilizers responsible for fixing and revising drug prices and enforcing the DPCO in India.