Discuss how DPCO 2013 balances patients' affordability against the pharmaceutical industry's need for innovation, especially for patented medicines.

The Drugs (Prices Control) Order, 2013 is issued under the Essential Commodities Act to put the National Pharmaceutical Pricing Policy, 2012 into effect. Its aim is to prevent profiteering while leaving the market enough freedom to sustain investment [1]. NPPA's October 2026 cap on 137 anti-cancer drugs, including patented ones, puts this balance to the test [2].

Tools favouring affordability

• Ceiling prices apply to Schedule-I drugs, which are the NLEM 2022 list. This list includes 63 anti-cancer medicines [1][3].
• Paragraph 19 gives NPPA an extraordinary public-interest power. It used this power to cap trade margins at 30% of MRP on 137 non-scheduled cancer drugs [2]. In the 2019 pilot, MRPs of 526 brands fell by up to 90% [4].
• Anti-evasion safeguards: companies must repay overcharged amounts with interest, and must give 6 months' notice before stopping a medicine [1].

Space preserved for industry and innovation

• Light-touch control of non-scheduled drugs: companies set their own launch prices. Paragraph 20 only limits MRP increases to 10% in 12 months [1].
• TMR targets the middleman: it caps the gap between the distributor price and the MRP. The manufacturer's own price, which funds R&D returns, is left alone [1].
• Patented drugs: they are covered only through margins. Their patent-linked price premium survives, while the right to health under Article 21 is still served.

Gaps in the balance

• High base price: a 30% margin on an expensive patented drug still gives a high MRP. The Standing Committee on Chemicals and Fertilizers suggested cost-based pricing where markups are abnormal [5].
• Ad-hoc approach: Paragraph 19 orders are issued drug by drug, and there is no permanent TMR framework [5]. Retail margins on cancer drugs are still 50–60% [6].
• Weak enforcement: Rs 8,526 crore (85%) of overcharging dues was still unrecovered as of 2025, and about 70% of it is stuck in litigation [5].

DPCO 2013 uses ceiling prices, margin caps and supply safeguards to keep cancer care affordable. It tries to leave innovation alone by not touching the manufacturer's price. The way forward is to write TMR into a permanent statutory framework, set up fast-track recovery through a dedicated legal cell [5], and expand National Cancer Grid–style pooled procurement [7]. Together these would protect both patients and innovation, in line with Article 21 and the universal health coverage goal of SDG 3.8.