Discuss the role of NPPA and the DPCO 2013 in balancing affordability against the availability of essential medicines.

India regulates drug prices under the Drugs (Prices Control) Order, 2013 (DPCO). The National Pharmaceutical Pricing Authority (NPPA), under the Department of Pharmaceuticals, enforces it [1]. The order has to lower prices without making it unprofitable for companies to keep medicines on the shelves.

Role in ensuring affordability

• Ceiling prices: The NLEM, notified by MoHFW, forms Schedule-I of DPCO. NPPA fixes ceiling prices for 935 scheduled formulations (Dec 2025) [2].
• Non-scheduled drugs: A company may raise MRP by no more than 10% in 12 months [3].
• Para 19 extraordinary powers: The 2019 Trade Margin Rationalisation (TMR) pilot on 42 cancer drugs cut MRPs of 526 brands by about 50% on average, saving about ₹984 crore a year [4]. In October 2026 a 30% margin cap was extended to all non-scheduled anti-cancer drugs, after NPPA found mark-ups averaging ~170% [1].

Role in safeguarding availability

• Margin cap, not price fixing: TMR limits only the supply-chain mark-up. The manufacturer's price stays free, so companies still have a reason to keep producing [1].
• Supply condition: Manufacturers must maintain current production levels under the 2026 cap [1].
• Market-based pricing: Ceiling prices are not set from production cost. Parliament has only asked the government to study bringing back cost-based pricing [5].
• Monitoring: NPPA tracks prices of both scheduled and non-scheduled drugs and acts against overcharging [3].

Gaps that upset the balance

• Weak legal footing: DPCO allows margin capping only temporarily, and there is still no permanent TMR framework [6][5].
• Opacity: Price-to-stockist (PTS) data is not public, and online pharmacies have no clear regulation [6].
• Enforcement: Monitoring misses hospital and rural sales, and large overcharged amounts are stuck in litigation [5].
• Loopholes: Companies can change a drug's strength or combination so it falls outside the scheduled list and escapes the ceiling price [5].
• Stocking risk: The supply duty binds manufacturers, not chemists. Lower margins may lead small-town chemists to stop stocking specialty drugs [1].

DPCO and NPPA have made medicines cheaper while keeping companies willing to supply them, but enforcement and legal backing lag behind. The Standing Committee has suggested amending DPCO to make TMR permanent and extending control to non-scheduled drugs and fixed-dose combinations [6]. It has also asked for a fast-track legal cell for overcharging cases [5]. NPPA should also track whether drugs are actually available in district markets. Together these steps would advance Article 47 and SDG 3.8 (Universal Health Coverage).