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Big Pharma Under Scrutiny as India Reports 307 Drug Pricing Violations

As of March 6, 2025, the National Pharmaceutical Pricing Authority (NPPA) has recorded 307 cases of companies breaching the permitted price limits under Paragraph 20 of the Drugs (Prices Control) Order (DPCO), 2013. The findings raise pressing concerns about the affordability of essential medicines and the enforcement of regulatory standards.

• By Newsdesk
• New Delhi
• Mar 25, 2025

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India’s pharmaceutical sector is facing heightened scrutiny after a recent report by the Parliamentary Standing Committee on Chemicals and Fertilisers revealed widespread violations of drug pricing regulations. As of March 6, 2025, the National Pharmaceutical Pricing Authority (NPPA) has recorded 307 cases of companies breaching the permitted price limits under Paragraph 20 of the Drugs (Prices Control) Order (DPCO), 2013. The findings raise pressing concerns about the affordability of essential medicines and the enforcement of regulatory standards.

Rampant Price Hikes Exposed

The DPCO, 2013, allows non-scheduled drugs—those not included in the National List of Essential Medicines (NLEM)—to undergo a maximum annual price increase of 10%. Any price adjustment exceeding this threshold constitutes a violation. Pharmaceutical giants have frequently flouted these regulations, with the NPPA imposing penalties and sanctions on the offending companies.

Notably, ANG Lifescience India Limited and Ridley Life Science Private Limited have faced blacklisting due to non-compliance with licensing conditions. Additionally, Aveo Pharmaceuticals has been served a Stop Production Order for violating manufacturing norms. The stringent actions aim to curb unethical pricing practices and restore accountability within the sector.

Big Pharma Under the Lens

The report has also cast a spotlight on major players such as Sun Pharma, Aurobindo Pharma, Dr. Reddy’s Laboratories, and Cipla. Lawmakers have demanded clarification from the Department of Pharmaceuticals (DoP) on whether these companies’ pricing policies have made essential medications unaffordable. The disproportionate pricing of life-saving drugs has drawn criticism for exacerbating healthcare inequalities, particularly affecting low-income households.

Calls for Expanding the Essential Medicines List

One of the committee’s key recommendations is to widen the scope of the NLEM to cover a greater number of essential and commonly used drugs. Currently, only 388 medicines, comprising around 1,000 formulations, are regulated under the NLEM. By broadening this list, policymakers aim to enhance price control measures and protect consumers from exorbitant costs.

“Unchecked drug price increases are a major concern. We urge the government to expand the NLEM and ensure medicines remain affordable for all,” the report emphasized.

Striking a Balance

While the NPPA asserts that stringent regulations are in place for scheduled drugs, the committee warns that the unchecked 10% annual price hike on non-scheduled drugs remains a significant issue. Even within permissible limits, cumulative increases have steadily raised the cost of essential treatments.

The report underscores the need for stronger oversight and timely interventions to safeguard public health. As the government considers the recommendations, pharmaceutical companies may face intensified monitoring to prevent further violations. For millions of patients, the outcome could mean better access to life-saving medicines at fair and regulated prices.