Pharmaceutical companies have come under fire for repeatedly breaching drug pricing regulations by exceeding permitted price hikes, according to a report by the Parliamentary Standing Committee on Chemicals and Fertilisers. As of March 6, 2025, the National Pharmaceutical Pricing Authority (NPPA) has recorded 307 instances of violations under Paragraph 20 of the Drugs (Prices Control) Order (DPCO), 2013, which regulates price increases for non-scheduled drugs. These violations have intensified concerns about the uncontrolled rise in medicine costs and its impact on affordability.
Under the DPCO, 2013, manufacturers of non-scheduled drugs—those not included in the National List of Essential Medicines (NLEM)—can raise prices by up to 10% annually. Any price increase beyond this limit is 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 comply with licensing conditions, while M/s Aveo Pharmaceuticals has received a Stop Production Order due to breaches of manufacturing standards, the report states.
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 policies have made essential medicines inaccessible to the public. Additionally, the panel is investigating whether the high costs of life-saving drugs have pushed them beyond the reach of lower-income patients.
One of the key recommendations 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 commonly used medicines. At present, the NLEM regulates the prices of 388 medicines, covering nearly 1,000 formulations, under NPPA oversight. However, many widely prescribed medications remain outside this 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 conduct regular reviews and expand the NLEM to better address evolving healthcare needs.
“The unchecked rise in medicine prices is a serious issue. The arbitrary exclusion of essential drugs from price control must be tackled immediately to ensure affordability,” the committee emphasized in its report.
The NPPA has informed the committee that while the prices of scheduled drugs under the NLEM are strictly regulated, non-scheduled drugs are allowed to increase in price by up to 10% annually. However, the panel cautioned that even these permitted hikes have resulted in a gradual rise in drug costs, making critical treatments increasingly unaffordable for many patients.
