Bombay High Court pulls up drug regulatory body over Cipla licence cancellation

The Food and Drug Administration informed the court that the "impugned order would stand withdrawn forthwith" and fresh notices would be served on Cipla Pharma before September 4.

3 min readMumbaiUpdated: Aug 29, 2026 07:48 PM IST

The authority informed the court that the impugned order would be withdrawn immediately.

The Bombay High Court on Saturday pulled up the Maharashtra Food and Drug Administration (FDA) for “going overboard” and questioned its transparency while hearing a plea by Cipla Pharma regarding an order cancelling its licence. The authority informed the court that the impugned order would be withdrawn immediately.

The FDA officers, during an inspection conducted on Cipla Pharma premises in June, allegedly found irregularities involving packaging and advertising material related to certain tablets, following which the authority cancelled its licence.

“Notice of hearing was given on August 26 on a state holiday, and your office was not open. How is it appropriate, fair and transparent? This is what we keep on telling you. You are doing a laudable job, an appreciable job, but working overboard. And this is not the first time this has happened,” Acting Chief Justice Ravindra V Ghuge orally questioned FDA.

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“As you normally say, justice must not only be done, but must appear to be done. Show us that you had given them sufficient time for hearing. You have followed a wrong procedure and set it aside. We are giving you a chance. You have done something high-handedly,” the judge added.

After the government lawyer claimed that a hearing for the company was contemplated under Section 66 of the Food Safety and Standards (FSS) Act, the bench, also comprising Justice Gautam A Ankhad, questioned why the department then issued notice to the petitioner. “How is your order sustainable considering violation of natural justice?” Justice Ankhad orally questioned.

Fresh notice before September 4

Thereafter, the state lawyer, on instructions from the FDA officers, informed the bench that the “impugned order would stand withdrawn forthwith” and fresh notices would be served on Cipla Pharma before September 4.

The High Court noted that whenever the petitioners desired, a hearing would be arranged by issuing them a specific show-cause notice based on previous communications between the petitioner company and the FDA, along with the additional material and detailed reply to be given by the company in response to the notice by September 11.

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The court also said that if the department, without laying down any precedent, deemed it appropriate to arrange a personal hearing with five-day prior notice, the petitioner shall not seek any excuse of its representative falling ill or any other reason.

“Since some actions of the department impugned by the petitioners in this petition fell on a non-working day / State holiday, we would advise the department, unless there is a dire urgency or an emergency situation, not to hold such hearings on holidays,” the High Court noted and disposed of the plea.

Omkar Gokhale

Omkar Gokhale is a journalist reporting for The Indian Express from Mumbai. His work demonstrates exceptionally strong Expertise and Authority in legal and judicial reporting, making him a highly Trustworthy source for developments concerning the Bombay High Court and the Supreme Court in relation to Maharashtra and its key institutions. Expertise & Authority Affiliation: Reports for The Indian Express, a national newspaper known for its rigorous journalistic standards, lending significant Trustworthiness to his legal coverage. Core Authority & Specialization: Omkar Gokhale's work is almost exclusively dedicated to the complex field of legal affairs and jurisprudence, specializing in: Bombay High Court Coverage: He provides detailed, real-time reports on the orders, observations, and decisions of the Bombay High Court's principal and regional benches. Key subjects include: Fundamental Rights & Environment: Cases on air pollution, the right to life of residents affected by dumping sites, and judicial intervention on critical infrastructure (e.g., Ghodbunder Road potholes). Civil & Criminal Law: Reporting on significant bail orders (e.g., Elgaar Parishad case), compensation for rail-related deaths, and disputes involving high-profile individuals (e.g., Raj Kundra and Shilpa Shetty). Constitutional and Supreme Court Matters: Reports and analysis on key legal principles and Supreme Court warnings concerning Maharashtra, such as those related to local body elections, reservations, and the creamy layer verdict. Governance and Institution Oversight: Covers court rulings impacting public bodies like the BMC (regularisation of illegal structures) and the State Election Commission (postponement of polls), showcasing a focus on judicial accountability. Legal Interpretation: Reports on public speeches and observations by prominent judicial figures (e.g., former Chief Justice B. R. Gavai) on topics like free speech, gender equality, and institutional challenges. Omkar Gokhale's consistent, focused reporting on the judiciary establishes him as a definitive and authoritative voice for legal developments originating from Mumbai and impacting the entire state of Maharashtra. ... Read More

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