National Pharmaceuticals' Manufacturing Halted Without Due Process
Bombay High Court Quashes Orders Halting Pharmaceutical Production Over Procedural Violations
In a landmark judgment delivered on September 22, 2025, the Bombay High Court has set aside orders from the Food and Drug Administration halting the production of medicines by National Pharmaceuticals, citing violations of statutory provisions and principles of natural justice. The company, a reputed pharmaceutical manufacturer, was directed to stop production without a prior show cause notice or hearing, a move which the court deemed unlawful.
The case revolves around the orders dated February 22 and 26, 2025, where the Joint Commissioner (K.D.) Food and Drug Administration directed National Pharmaceuticals to cease production across its manufacturing facilities. This decision was upheld by the Minister, Department of Food and Drugs, Government of Maharashtra, dismissing the company's appeals.
National Pharmaceuticals challenged the orders through writ petitions, arguing the breach of Rule 85(2) of the Drugs and Cosmetics Rules, 1945. This rule mandates the issuance of a show cause notice and providing an opportunity for hearing before suspending or canceling a license. The court found that the FDA's actions were in violation of these statutory requirements.
Justice N. J. Jamadar underscored the necessity of adhering to principles of natural justice, highlighting that administrative actions affecting fundamental rights must follow due process. He noted that the stop production orders were passed before any show cause notice was issued, rendering them void ab initio.
The judgment also addressed the broader implications of the orders, which halted the manufacturing of all medicines beyond the contentious combinations of Tapentadol and Carisoprodol. The court criticized this blanket prohibition as excessive and injurious to stakeholders' rights.
The case gained significance following a circular by the Directorate General of Health Services, which cited potential drug abuse of Tapentadol and Carisoprodol combinations. While National Pharmaceuticals complied by surrendering licenses for these drugs, the FDA's subsequent actions lacked procedural fairness, leading to the current legal proceedings.
Justice Jamadar's decision reiterates the importance of statutory compliance and procedural fairness in administrative actions. The court's ruling allows the competent authority to reconsider its decisions, provided they are in line with legal protocols.
The judgment serves as a reminder to regulatory bodies about the necessity of following legal frameworks and respecting the rights of entities under their jurisdiction. It also highlights the judiciary's role in safeguarding procedural integrity against administrative excesses.
Bottom Line:
An order directing the cessation of production of all medicines under a valid manufacturing license without prior issuance of a show cause notice or providing an opportunity for hearing is in violation of Rule 85(2) of the Drugs and Cosmetics Rules, 1945, and principles of natural justice.
Statutory provision(s): Drugs and Cosmetics Act, 1940, Rule 85(2) of Drugs and Cosmetics Rules, 1945, Section 22(1)(cca), Section 18-B
