The Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers detailed India's comprehensive drug price regulation framework governed by the Drugs (Prices Control) Order 2013 (DPCO, 2013). The National Pharmaceutical Pricing Authority (NPPA) fixes ceiling prices for formulations specified in Schedule-I of DPCO 2013 based on market data and determines retail prices for new drugs as defined under section 2(1)(u). For non-scheduled formulations, manufacturers cannot increase maximum retail prices (MRP) by more than 10% of the MRP during the preceding 12 months.
Transparency measures include uploading draft price calculation sheets for proposed revised price notifications on NPPA's website for 10 working days to solicit stakeholder comments. NPPA finalizes ceiling and retail prices only after considering received comments and additional data. All price notifications are publicly available on https://nppa.gov.in. NPPA monitors compliance with DPCO 2013 provisions and takes action against overcharging and other violations based on references from Price Monitoring and Resource Units in states, State Drugs Controllers, market samples, database reports, and grievance complaints. DPCO 2013 requires manufacturers to print MRP on container labels and prohibits selling above the current price list or labeled price.
On March 12, 2024, the Department issued the Uniform Code of Pharmaceuticals Marketing Practices 2024 to prevent unethical marketing and regulate interactions between doctors/registered medical practitioners (RMPs) and pharmaceutical company representatives. The code prohibits gifts, monetary benefits, and hospitality to doctors and their family members. Pharmaceutical companies must self-declare adherence to the code and disclose expenditures related to conferences, seminars, and workshops for continuing medical education. Companies may undergo independent, random, or risk-based audits. 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/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 tax deductibility under the Income-tax Act, 1961, pharmaceutical companies' promotional expenditures must comply with the Uniform Code for Pharmaceutical Marketing Practices, 2024 and the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.
Additional government measures to improve medicine accessibility include the Pradhan Mantri Bhartiya Janaushadhi Pariyojana providing quality generic medicines through over 20,000 Janaushadhi Kendras at 50-80% cheaper rates than branded medicines. Ayushman Bharat Pradhan Mantri Jan Arogya Yojana provides ₹5 lakh health insurance cover per family per year including medicines. The Free Drugs Service Initiative under National Health Mission provides essential medicines free of charge at public health facilities. The AMRIT initiative provides affordable medicines for cancer, cardiovascular diseases, implants, and surgical disposables at up to 50% discount through AMRIT Pharmacy stores. Financial assistance is provided to below-poverty-line patients through Rashtriya Arogya Nidhi and Health Minister's Discretionary Grant.