Critically examine the regulatory gaps in India's Drug Price Control Order (DPCO), 2013, that allow arbitrary pricing of non-scheduled essential medicines. Suggest reforms.

The DPCO, 2013, issued under the Essential Commodities Act, 1955, empowers the National Pharmaceutical Pricing Authority (NPPA) to fix ceiling prices only for formulations listed in Schedule-I [1]. The Supreme Court's September 2026 observation terming a tenfold markup on a cancer drug "broad daylight dacoity" exposes how thin that protective net is.

Strengths of the existing regime

• Ceiling pricing for scheduled drugs gives a legally enforceable price floor-ceiling for essential molecules [1].
• Trade Margin Rationalisation (TMR): a 30% margin cap on 42 non-scheduled anti-cancer medicines cut MRPs of 526 brands by about 50%, saving patients roughly ₹984 crore annually [2] — proof that distribution margins, not manufacturing cost, inflate prices.
• Alongside rising public health spending, out-of-pocket expenditure fell from 62.6% (2014-15) to 39.4% (2021-22) [3].

Persistent regulatory gaps

• No initial price fixation for non-scheduled drugs; a manufacturer's launch MRP is free, restrained only by the annual hike cap [4].
• TMR is a temporary, drug-by-drug emergency power, not a standing rule — the Standing Committee on Chemicals and Fertilisers (December 2025) sought its permanent incorporation into DPCO [4].
• Opacity: Price-to-Stockist data "remains undisclosed", so the regulator cannot measure the very gap it must police [4].
• Fixed Dose Combinations escape NPPA regulation entirely, letting firms re-package controlled molecules at free prices [4].
• Caps erode without review: stent prices rose 44% (bare-metal) and 29% (drug-eluting) between 2017 and 2024 despite control [4].

Reforms

• Amend DPCO, 2013 to make trade-margin rationalisation permanent and extend NPPA oversight to non-scheduled formulations and FDCs [4].
• Mandate PTS disclosure and periodic revision of capped prices [4].
• Cap margins, not manufacturers' prices, to protect affordability without risking supply withdrawal.

India's price control is list-based, so the leak is by design rather than by neglect. Converting episodic interventions into a permanent, transparent framework — reinforced by Jan Aushadhi and PMJAY — would make affordable medicine a substantive part of the right to life under Article 21.