Big Pharma faces heat as India records 307 drug pricing violations

Pharmaceutical companies have repeatedly violated drug pricing regulations by exceeding permitted price hikes, according to a report by the Parliamentary Standing Committee on Chemicals and Fertilisers. As of 6 March 2025, the National Pharmaceutical Pricing Authority (NPPA) recorded 307 cases of violations under Paragraph 20 of the Drugs (Prices Control) Order (DPCO), 2013, which governs price increases for non-scheduled drugs. These violations highlight growing concerns over the unchecked rise in medicine prices and their impact on affordability.
 
Under the DPCO, 2013, non-scheduled drugs—those not included in the National List of Essential Medicines (NLEM)—are allowed a maximum annual price hike of 10%. Any increase beyond this limit is considered a violation. The NPPA has taken enforcement action against multiple pharmaceutical firms for non-compliance. M/s ANG Lifescience India Limited and M/s Ridley Life Science Private Limited have been blacklisted for failing to adhere to licensing conditions, while M/s Aveo Pharmaceuticals has been issued a Stop Production Order for violating manufacturing standards, according to the report.
 
Beyond these violations, the parliamentary panel has raised concerns over the pricing strategies of major pharmaceutical companies, including Sun Pharma, Aurobindo Pharma, Dr Reddy’s Laboratories, and Cipla. It has sought a response from the Department of Pharmaceuticals (DoP) on whether these companies’ pricing and distribution practices have made essential medicines unaffordable for the public. The panel has also questioned whether the high cost of life-saving medicines has pushed them beyond the reach of lower-income patients.
 
A major recommendation in the committee’s eighth report on Demands for Grants (2025-26) is to expand the scope of the NLEM to include more essential and widely used medicines. Currently, only 388 medicines are covered under the NLEM, including around 1,000 formulations, with the NPPA regulating their prices. However, a large number of commonly prescribed medicines remain outside the price control framework, allowing manufacturers to raise prices unchecked. The panel has urged the DoP, NPPA, and the Central Drugs Standard Control Organisation (CDSCO) to regularly review and expand the NLEM to reflect evolving healthcare needs.
 
“The unchecked increase in medicine prices is a serious concern. The arbitrary exclusion of essential drugs from price control must be addressed immediately to ensure affordability,” the committee stated in its report.
 
The NPPA has informed the committee that while scheduled drugs under NLEM are strictly regulated, non-scheduled drugs are permitted annual price hikes of up to 10%. However, the committee has cautioned that even these permitted increases have led to a steady rise in drug costs, making critical treatments unaffordable for many.