Factual and Procedural Background Pharmaceutical companies led by Franco Indian Pharmaceuticals and the Indian Drug Manufacturers Association approached the Bombay High Court after the National Pharmaceutical Pricing Authority issued notices demanding huge sums as alleged overcharges on certain medicines. The companies had been selling sustained-release versions of drugs such as Metformin, believing these were not covered by price caps because they were not listed in the official schedule of the 2013 Drug Price Control Order. The authority insisted the price ceiling applied anyway. Interim orders from the court had already stopped any coercive recovery while the case was heard.
Dispute in Question The fight centred on whether the pricing authority could impose a ceiling price on drug formulations that were not specifically named in the First Schedule of the 2013 Drug Price Control Order. The companies argued that only the exact formulations listed in the schedule were subject to price control, while the authority claimed that any version of a listed drug fell under the same rules.
Reasoning and Decision of Court The court read the 2012 National Pharmaceutical Pricing Policy and the plain language of the 2013 Order together with official government clarifications. It found that whenever the government wanted to control a new version of a medicine it had issued separate orders to add that exact formulation to the schedule and fix its ceiling price. Since the sustained-release versions in question had never been added that way, the authority could not suddenly apply price caps to them. The court held that the authority’s demands were contrary to the law and the government’s own policy. Both writ petitions were allowed, the demand notices were quashed, and the companies were relieved of any liability for the alleged overcharges.
Title: Franco Indian Pharmaceuticals Pvt. Ltd. Vs Union of India , Order date: 10th April 2026, Case Number: Writ Petition No. 2216 of 2015 with Writ Petition No. 885 of 2015, Neutral Citation: 2026:BHC:OS:9091-DB, Name of court and Judge: Bombay High Court, Manish Pitale and Shreeram V. Shirsat JJ
Disclaimer: Donot treat this as substitute for legal advise as it may contain subjective errors. Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
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