By Susmita Roy
Copyright medicaldialogues
Mumbai: The Bombay High Court has struck down orders issued by the Maharashtra Food and Drug Administration (FDA) and the Central Drugs Standard Control Organisation (CDSCO) that had compelled two pharmaceutical companies, National Pharmaceuticals and Aveo Pharmaceuticals, to halt manufacturing medicines containing the painkillers Tapentadol and Carisoprodol.Justice Jamadar ruled that the initial stop-production directives issued by the Joint Commissioner of the FDA were a flagrant violation of the principles of natural justice and a clear breach of Rule 85(2) of the Drugs and Cosmetics Rules, 1945, as per the news reported by News18. According to Rule 85 of the Drugs and Cosmetics Rules, 1945, a licensing authority cannot suspend or revoke a licence without giving the company an opportunity to be heard.The petitions filed by the two companies National Pharmaceuticals and Aveo Pharmaceuticals, challenged sweeping stop-production orders issued in February 2025, which had effectively brought all manufacturing activities at their units to a halt. The orders were based on a DGHS advisory citing misuse of Tapentadol–Carisoprodol products, including reports of diversion to illicit markets in West Africa. Following the advisory, CDSCO and Maharashtra FDA carried out plant inspections and issued immediate halt orders on February 12, 2025.Earlier, the Medical Dialogues Team had reported that the Drugs Controller General of India (DCGI) had imposed a ban on their production and export of unapproved combination drugs containing Tapentadol and Carisoprodol.Further, it reported that a joint team from the CDSCO and Maharashtra’s Regulatory Authority had conducted a comprehensive audit of M/s. Aveo Pharmaceuticals between the 21st and 22nd of February 2025, according to a statement. The findings from the audit led to the issuance of a Stop Activity Order, halting all operations at the company’s premises.Also Read: DCGI bans production, export of all combinations of tapentadol, carisoprodolNow, in continuation, the companies contended that the regulators’ action was arbitrary and disproportionate. They highlighted that they had already surrendered licenses for Tapentadol-Carisoprodol products and submitted compliance reports. Despite this, a blanket ban was imposed on all manufacturing, effectively shutting down their operations. They also pointed out that the stop-production orders were issued before any show-cause notices, which were served only on February 14—a clear violation of the principles of natural justice.According to a copy of the judgment reviewed by News18, the court noted that the stop-production order was issued before any notice had been served, rendering the regulators’ action untenable. “The impugned actions of prohibiting the manufacture, sale and distribution of all the medicinal products were in clear violation of the statutory requirements,” the court said. “The orders are too fragile to merit countenance.”Justice NJ Jamadar emphasized that administrative authorities must follow due process, even in cases involving public health. The court observed that actions affecting fundamental rights or causing civil detriment cannot bypass principles of natural justice.The judgment noted that extending the prohibition to all manufacturing operations, when the petitioners had already surrendered licenses for the specific products, was excessive and unwarranted.The High Court quashed the February 2025 stop-production orders and the subsequent July 2025 decisions that upheld the stoppage. However, the court clarified that regulators could take fresh action provided proper procedures are followed.“The Competent Authority may pass appropriate orders in relation to the proposed action of cancellation or suspension of the manufacturing license pursuant to the show-cause notice… in accordance with law,” the ruling stated.Also Read: Licences of 2 pharma stores suspended for unethical trade practices
