India Pharma Outlook Team | Wednesday, 26 March 2025
A recent report by the Parliamentary Standing Committee on Chemicals and Fertilizers claimed that pharmaceutical companies repeatedly flout drug pricing regulations by exceeding the allocated annual price hikes. So far, up to 6th March 2025, 307 drugs have been found through Paragraph 20 of the Drugs (Prices Control) Order (DPCO) 2013 to be violative, which is the law that regulates the price increase of non-scheduled drugs making it applicable from time to time.
Non-scheduled drugs can only be increased by up to 10%, which implies that the annual hike should not exceed the maximum limit specified in the NLEM. Any excess hike is treated as wrong and it is viewed as committing a violation. The NPPA has already used strict enforcement, one of which includes the pointless approval or licensing refusal to M/s ANG Lifescience India and M/s Ridley Life Science. M/s Aveo Pharmaceuticals is to be stopped from producing for its misconduct.
It has been pointed out by the parliamentary committee other than this that the pricing policies of the four major pharmaceutical companies in the country are Sun Pharma, Aurobindo Pharma, Dr Reddy’s Laboratories, and Cipla. The latter has even questioned the Department of Pharmaceuticals (DoP) whether these companies will still be able to have affordable public access to essential drugs due to their pricing and distribution modus operandi. The committee has also stressed on the point that the high cost of life-saving drugs has excluded the poor patients from purchasing and using these drugs.
The eighth report from the committee on Demands for Grants (2025-26) tasks the NLEM with the inclusion of more commonly prescribed medicines. At present, only 388 drugs are covered by price regulation, meaning that many major drugs will remain outside the regulation framework. The expert committee has called for the DoP, NPPA, and CDSCO to conduct periodic reviews and expand the NLEM to keep the costs and the availability of essential treatment under control.
In its report, the committee stated, "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."