Bombay High Court: While considering a writ petition challenging orders of the Food and Drug Administration (FDA) imposing restrictions on the disposal, distribution and sale of ACILOC drug stocks, the Division Bench of Ravindra V. Ghuge, ACJ and Gautam A. Ankhad, J., recorded the statement that FDA will recall restrictions on ACILOC drug stocks and held that the notices would stand neutralised. The Court directed issuance of show-cause notices under Rule 85, Drugs Rules, 1945 (Drug Rules), wherever not already issued, and required the authorities to undertake a fresh proceedings in accordance with law.
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Background
The dispute arose when injunctions were clamped upon the petitioner at 3 locations and it was restrained from disposing of, distributing or selling the stock of the drugs identified as ACILOC 150, ACILOC 150+, ACILOC 300 and ACILOC 300+ tablets. The matter was also heard at length on 10 August 2026 and following what the Court described as a “marathon hearing”, a pass over was granted to enable the Government Pleader to obtain instructions from the FDA officials. Pursuant to such instructions, it was stated that the impugned orders would stand recalled.
It was further submitted that if any of the three locations had not been served with a show-cause notice under Rule 85, Drugs Rules, such notices would be issued within 7 working days to the said establishments. The petitioner would be granted an opportunity to submit written responses within 21 days.
The State further informed the Court that the injunctions imposed upon the establishments would stand vacated, particularly because one such injunction was imposed for 20 days under Exhibit A dated 9 July 2026 and, in the remaining cases, the injunction could not have been beyond a maximum period of 21 days.
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Analysis and Decision
The Court observed that in view of the aforesaid statement, the impugned notices would stand neutralised and would forthwith lose their efficacy. The Court directed the Assistant Commissioner, FDA, to issue notices within 7 working days and that the establishments concerned be permitted to tender written responses within 21 days from receipt of such notices.
The Court observed that, after the replies were received, the same authority issuing the notice would conduct hearings by issuing fresh intimations and ensure that the due procedure laid down in law is followed. The Court further directed that reasoned orders be passed and served on the petitioners within 24 hours through e-mail. The Court also clarified that any surviving grievance against such orders could be pursued through remedies permissible in law.
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[Cadila Pharmaceuticals Ltd. v. State of Maharashtra, Writ Petition No. 9810 of 2026, decided on 11-8-2026]
Advocates who appeared in this case:
For the Petitioner: Dr. Birendra Saraf, Senior Advocate, with Alankar Kirpekar, Shekhar Bhagat, Ashutosh Kumar, Ayush Tiwari, Anmol Saxena, Ayush Sharma and Kunal Vats, i/b Shekhar Bhagat, Advocates.
For the Respondents: Neel Helekar with Akhilesh Adhav, Neha S. Bhide, Government Pleader with P.J. Gavhane, AGP.
