Quick Summary: The Bombay High Court overturned orders that stopped two pharmaceutical companies from making medicines. These orders were initially issued by the Food and Drug Administration (FDA) and supported by the Maharashtra government. The court found that the companies weren't given a fair chance to explain themselves.
Two pharmaceutical companies, National Pharmaceuticals and AVEO Pharmaceuticals, were involved in a legal fight with the Food and Drug Administration (FDA) over making certain drugs. The issue began when the Directorate General of Health Services sent out a notice on February 21, 2025, taking back permission to make combinations of Tapentadol and Carisoprodol because they could be misused.
Both companies quickly followed the directive. National Pharmaceuticals, led by its director Nutan Tiwari, gave up its product license on February 23, 2025, and AVEO Pharmaceuticals did the same. The FDA accepted these surrenders the next day.
Despite following the rules, the FDA, along with the Central Drugs Standard Control Organization (CDSCO), conducted inspections on February 25, 2025. The very next day, the FDA ordered the companies to stop all production without giving them a chance to explain or defend themselves.
"The stop production orders were passed without any opportunity of hearing," argued Mr. Arsiwala, the companies' lawyer.
Both companies appealed to the Maharashtra government, hoping to start production again. However, on July 10, 2025, the Minister of Food and Drug Department dismissed these appeals, once again without checking if the FDA's orders were legal.
Judge N. J. Jamadar looked at the case and found that the FDA had acted too soon. According to Rule 85 of the Drugs and Cosmetics Rules, 1945, the companies should have been given a chance to explain their side before production was stopped.
"The impugned actions of prohibiting manufacture were in clear violation of statutory requirements," the court noted.
The court canceled the orders from both the FDA and the Maharashtra government, allowing the companies to start making medicines again. However, it clarified that the authorities could still take action if they follow the proper legal procedures.
This judgment highlights the importance of giving people a fair chance to explain themselves, especially when their businesses and jobs are involved.
