Price notification without enforcement capacity has limited effect. Discuss the challenges NPPA faces in ensuring compliance with drug price regulation, and suggest reforms.

On 17 October 2026, NPPA notified Trade Margin Rationalisation (TMR) on 137 non-scheduled anti-cancer drugs, and the lower MRPs took effect on 9 November [1]. Patients gain only if the cut actually reaches them at the counter. That depends on enforcement more than on the notification itself.

Challenges in ensuring compliance

• Weak deterrence: As of 2025, ₹8,526 crore (85%) of overcharging demands had not been recovered. About 70% of that is under litigation, and some cases are more than 20 years old [2].
• Capacity deficit: 15 of NPPA's 48 sanctioned posts are vacant [2]. Monitoring on the ground depends on State Drug Controllers, who report through Action Taken Reports [1].
• Data blind spots: NPPA's private-agency data covers only about 70% of the market. It leaves out hospital sales, Jan Aushadhi stores and e-commerce [2]. This matters because cancer drugs are mostly dispensed in hospitals.
• Unregulated online sales: There is no mechanism to ensure fair prices on online drug platforms [3].
• Temporary legal footing: DPCO, 2013 allows margin capping only for a limited period [3], and there is no timeline for a permanent TMR framework [2].
• Opaque pricing: Non-scheduled drugs make up about 82% of the market and have no fixed launch price [2]. The price to stockist (PTS) is not disclosed, so outsiders cannot check whether an MRP is fair [3].
• Price creep: Even regulated stents became costlier, by 44% (bare-metal) and 29% (drug-eluting) between 2017 and 2024 [3].
• Low public participation: Only 30 representations came in on 1,426 draft price worksheets, and all of them were from industry [2].

Reforms

• Legal: Amend DPCO to create a permanent TMR framework with a fixed deadline [2][3].
• Recovery: Set up a fast-track dispute mechanism and a dedicated legal cell in NPPA [2].
• Institutional: Fill the vacancies [2] and strengthen the state-level monitoring that SDCs carry out [1].
• Data: Extend coverage to hospitals and e-commerce [2], and create a regulatory framework for online pharmacies [3].
• Transparency: Study and disclose the PTS–MRP gap [3], and use cost-based pricing where mark-ups are abnormal [2].
• Citizen enforcement: Publicise the Pharma Sahi Daam app and the 1800-111-255 helpline more widely [1].

TMR shows that India can lower drug prices without full price control, but each order works only as far as the enforcement behind it. A permanent legal basis, wider data and stronger institutions would turn one-off orders into lasting affordability. That would serve the health duty in Article 47 and SDG 3.8 on universal health coverage.