Prices of drugs in India are regulated as per the provisions of the Drugs (Prices Control) Order, 2013 (“DPCO, 2013”)

Ministry of Chemicals and Fertilizers Prices of drugs in India are regulated as per the provisions of the Drugs (Prices Control) Order, 2013 (“DPCO, 2013”) National Pharmaceutical Pricing Authority (NPPA) fixes ceiling prices of scheduled medicines specified in the First Schedule to DPCO, 2013; NPPA has fixed the ceiling prices for 930 scheduled formulations, including 131 anti-cancer, 11 anti- diabetic and 66 cardiovascular formulations Retail prices of 3,482 such new drugs also stand fixed as on 14.7.2025, of which 1,924 are in the anti- diabetic, anti-cancer and cardiovascular categories Posted On: 08 AUG 2025 5:13PM by PIB Delhi Prices of drugs in India are regulated as per the provisions of the Drugs (Prices Control) Order, 2013 (“DPCO, 2013”). The National Pharmaceutical Pricing Authority (NPPA) fixes ceiling prices of scheduled medicines specified in the First Schedule to DPCO, 2013. Further, as per the provisions of DPCO, 2013, the ceiling prices of scheduled medicines are revised annually based on Wholesale Price Index (All commodities) for the preceding calendar year, on or before the 1st of April of every year. All manufacturers, importers and marketers of scheduled medicines are required to sell their products within the ceiling price plus applicable local taxes. NPPA also fixes retail prices of “new drugs”, that is, formulations launched by existing manufacturers of a medicine listed in NLEM by combining it with another drug, or by changing the strength or dosage or both of such medicine. Further, DPCO, 2013 also provides for fixation of prices of drugs in public interest under extraordinary circumstances and monitoring of price increase of non-scheduled drugs. Accordingly, prices of drugs, particularly drugs for diseases such as cancer, diabetes and cardiovascular conditions are regulated in the following manner: i. NPPA has fixed the ceiling prices for 930 scheduled formulations, including 131 anti-cancer, 11 anti- diabetic and 66 cardiovascular formulations. All manufacturers, importers and marketers of scheduled medicines are required to sell their products within the ceiling price plus applicable local taxes. The average price reduction due to fixation or refixation of prices under NLEM, 2022 was about 17%, resulting in estimated annual savings of approximately ₹3,788 crore to patients. ii. Retail prices of 3,482 such new drugs also stand fixed as on 14.7.2025, of which 1,924 are in the anti- diabetic, anti-cancer and cardiovascular categories. The applicant manufacturers and marketing companies are required to sell these drugs within the said retail price.iii. Besides the above, the maximum retail price (MRP) of 22 diabetic and 84 cardiovascular non-scheduled medicines has been capped, resulting in estimated annual savings of about ₹350 crore to patients. iv. Trade margin of 42 non-scheduled anti-cancer medicines have been capped, resulting in reduction in prices of 526 brands of medicines by an average of about 50%, resulting in estimated annual savings of about ₹984 crore to patients. v. For non-scheduled formulations, including for non-scheduled anti-diabetic, anti-cancer and cardiovascular formulations, manufacturers are required to not increase MRP of drugs launched by them by more than 10% during the preceding 12 months. Details of prices fixed by NPPA are available on its website (www.nppa.gov.in). The Standing National Committee on Medicines (SNCM), consisting of all stakeholders and experts, carefully evaluates the relative safety, efficacy, availability and affordability of medicines from each therapeutic class, consults all stakeholders and considers WHO’s Essential Medicines List, drugs used in national health programmes, Indian Pharmacopoeia, National Formulary, etc., to recommend drugs for inclusion in NLEM. Based on the said recommendations, the Ministry of Health and Family Welfare publishes NLEM, which is notified as the First Schedule to DPCO, 2013. SNCM reviews and revises NLEM from time to time to address the issues of changing disease prevalence, treatment modalities, introduction of newer medicines and identification of unacceptable risk-benefit profile as well as therapeutic profile of medicine. Drugs under NLEM are categorised under therapeutic groups and no categorisation of drugs as life-saving drugs is made. Under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana scheme product basket, 2,110 medicines and 315 surgical, medical consumables and devices are available, covering all major therapeutic groups, such as cardiovascular, anti-cancers, anti-diabetic, anti-infective, anti-allergic and gastro-intestinal medicines and nutraceuticals. Almost all generic medicines included in NLEM, except lab reagents and vaccines, are included in the scheme product basket. To spread awareness about the scheme throughout the country, including in the State of Tamil Nadu, the Pharmaceuticals and Medical Devices Bureau of India, which is the scheme implementing agency, regularly undertakes number of activities, including issuance of advertisements in various modes, such as the print media, radio, television, mobile application, cinema, hoardings, branding of bus queue shelters and buses, auto wrapping and television screens at Common Service Centres, outreach through social media platforms and celebration of Jan Aushadhi Diwas on the 7th of March every year. As on 30.6.2025, 16,912 Jan Aushadhi Kendras (JAKs) have been opened across the country under the scheme, of which 1,432 JAKs have been opened in the State of Tamil Nadu, including 20 JAKs in Karur district, 40 in Dindigul district, 71 in Tiruchirappalli district and 32 in Pudukottai district. During last five years, that is, during the period from 1.4.2020 to 31.3.2025, 436 cases of overcharging have been initiated by NPPA and an amount of ₹133.19 crore has been recovered from the companies concerned during the same period. Detailed list of overcharging cases where demand notices have been issued is available on the website of NPPA (www.nppa.gov.in ). This information was given by the Union Minister of State for Chemicals and Fertilizers Smt Anupriya Patel in Lok Sabha in a written reply to a question today. ***** MV/GS (Release ID: 2154217)