The Ministry of Chemicals and Fertilizers, through the Department of Pharmaceuticals, has detailed India's comprehensive framework for drug price regulation and pharmaceutical marketing practices. Drug prices are regulated under the Drugs (Prices Control) Order 2013 (DPCO, 2013), which is based on the principles of the National Pharmaceutical Pricing Policy, 2012. The National Pharmaceutical Pricing Authority (NPPA) fixes ceiling prices for formulations specified in Schedule-I to DPCO, 2013 using market data, and determines retail prices for new drugs as defined under section 2(1)(u) of DPCO, 2013. For non-scheduled formulations, manufacturers cannot increase the Maximum Retail Price (MRP) by more than 10% of the MRP during the preceding 12 months.
NPPA ensures transparency in price fixation by uploading draft versions of price calculation sheets for proposed revised price notifications on its website for 10 working days to invite stakeholder comments. Final ceiling and retail prices are determined only after considering all received comments and additional data. All price notifications are publicly available on the NPPA website (https://nppa.gov.in). The authority monitors compliance with DPCO, 2013 provisions and takes appropriate action against overcharging and other violations based on references from various sources including Price Monitoring and Resource Units in States, State Drugs Controllers, market samples, market database reports, and public complaints. DPCO 2013 requires manufacturers to print MRP on drug labels, and no person can sell formulations at prices exceeding the current price list or labeled price.
To prevent unethical marketing practices, the Department of Pharmaceuticals issued the Uniform Code of Pharmaceuticals Marketing Practices 2024 on March 12, 2024. This code regulates interactions between doctors/registered medical practitioners (RMPs) and pharmaceutical company representatives by prohibiting gifts, monetary benefits, and hospitality to doctors and their family members. Pharmaceutical companies are accountable for their medical representatives' actions and must self-declare adherence to the code while disclosing expenditures related to conferences, seminars, and workshops for continuing medical education. Companies may undergo independent, random, or risk-based audits, and the code establishes a two-layer complaint adjudication process with appeals handled by the Department of Pharmaceuticals. Penalties include reprimand and publication of details, recovery of money or items given in violation, issuance of corrective statements in media for non-compliant promotional material, and potential action under existing laws by relevant government departments.
For promotional expenditures to be tax deductible under the Income-tax Act, 1961, pharmaceutical companies must comply with both the Uniform Code for Pharmaceutical Marketing Practices, 2024 and the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.
Beyond price regulation, the government has implemented several initiatives to improve medicine accessibility, including the Pradhan Mantri Bhartiya Janaushadhi Pariyojana scheme providing quality generic medicines through over 20,000 Janaushadhi Kendras at 50-80% cheaper rates than branded medicines. The Ayushman Bharat Pradhan Mantri Jan Arogya Yojana provides health insurance cover of ₹5 lakh per family per year for secondary/tertiary care hospitalization including medicines. The Free Drugs Service Initiative under National Health Mission provides essential medicines free of charge at public health facilities from Primary Health Centres to district hospitals. The AMRIT initiative offers affordable medicines for cancer, cardiovascular diseases, implants, and surgical disposables at up to 50% discount through AMRIT Pharmacy stores. Financial assistance is also provided to below-poverty-line patients through Rashtriya Arogya Nidhi and Health Minister's Discretionary Grant for major life-threatening diseases including cancer.
This information was provided by Minister of State for Chemicals and Fertilizers, Smt. Anupriya Patel, in a written reply to the Lok Sabha on August 7, 2026.