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Pulls Up Maharashtra FDA over Cipla Licence Cancellation for Violating
The on Saturday delivered a stinging rebuke to the , pulling up the regulator for acting in a "" manner and violating fundamental when it cancelled the wholesale drug sale licence of ’s carrying and forwarding facility at Wadki, Pune. The court’s sharp observations, made by a division bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad, forced the FDA to withdraw its —issued effective —and to issue a , guaranteeing the pharmaceutical giant a proper before any final decision is taken.
The case is the latest in a series of instances where the has scrutinised the enforcement actions of the Maharashtra FDA, examining whether the regulator’s approach is proportionate, follows , and respects the . The court’s intervention in the Cipla matter highlights a growing judicial concern over , particularly when the consequences for businesses—including the disruption of supply chains for life-saving medicines—are severe.
Background: The Cipla Case and the FDA’s Alleged Violations
The FDA’s troubles began with an inspection of Cipla’s Pune facility in June, during which officials claimed to have found irregularities related to the packaging, storage, and recall of Reactin Plus tablets, a Schedule H prescription medicine. According to the regulator, the packaging bore the promotional words "analgesic and antipyretic," which, in the case of a prescription-only drug, could encourage self-medication and pose a risk to public health. Further inspections revealed discrepancies between physical and computerised stock records, gaps in purchase and sale records, and alleged non-compliance with recall directions.
Based on these findings, the FDA issued a to Cipla on . The company responded on , and a was scheduled for . However, was a public holiday declared by the state government. Cipla sought an adjournment, but the FDA proceeded with the hearing—after receiving the adjournment request through a non-executive staff member—and passed the on the same day.
Cipla immediately challenged the order before the , arguing that it had not been given an adequate and that the cancellation would disrupt the supply of critical medicines to patients. The company also clarified that the FDA’s order did not allege any safety, quality, or efficacy concerns regarding its products, nor did it involve any patient safety issue.
Court’s Observations and FDA’s U-turn
During the hearing on Saturday, , appearing for Cipla, highlighted the procedural flaws in the FDA’s actions. He pointed out that the FDA had emailed the company asking it to send a representative for the hearing on a public holiday. When the company sought time, the regulator heard an unauthorised employee and passed the without granting a proper hearing.
The bench was visibly displeased.
"You (FDA) are doing a laudable and appreciative job, but now you are going overboard. This is not the first time this is happening. You have wronged, and now you have to resolve the issue,"
the court remarked. The judges further questioned the regulator’s fairness:
"If the court does the same thing, will it be fair? The government refuses or seeks adjournments claiming they cannot work on holidays; then how has the state’s department passed an order like this on a public holiday?"
The court also noted that the FDA had acted with "
" without properly examining the law, and described the
as
"against the
."
The bench advised the FDA to avoid scheduling hearings on public holidays unless there is a genuine emergency.
Faced with the court’s ire, , appearing for the FDA, initially argued that the law does not provide the company a right to a hearing. However, the bench was unconvinced, and the FDA ultimately agreed to withdraw the forthwith. It will now issue a and pass a after giving Cipla a full opportunity to present its case.
Broader Scrutiny of FDA Enforcement Actions
The Cipla case is not an isolated instance. In recent months, the has widened its scrutiny of the Maharashtra FDA’s enforcement actions, examining whether the regulator’s decisions are proportionate and follow . The court has intervened in cases involving restaurants, hotels, sweet shops, milk vendors, and other pharmaceutical companies.
For example, in the case of five restaurants operating on the ’s premises in Bandra-Kurla Complex, the court set aside the FDA’s after finding that the regulator had taken a "" approach. The restaurants were found to be 88% compliant with food safety rules, yet the FDA had continued the suspension over a contractual arrangement issue. The court warned of possible against officials.
Similarly, in the case of in Pune, the court quashed a licence suspension following a food-poisoning incident, directing the FDA to pay ₹5 lakh in compensation to the business after a subsequent inspection showed 98% compliance. In another instance, the court restored the licence of in Navi Mumbai, questioning whether the deficiencies justified the continued suspension.
The also stayed FDA action against milk vendors and suppliers, raising questions about whether the —including and an opportunity for hearing—was followed before suspension. In the case, the court examined whether the FDA had exercised its powers appropriately in stopping the sale and distribution of certain medicines.
These cases demonstrate that the is not opposed to the FDA’s enforcement of food and drug safety standards; rather, it insists that such enforcement must be lawful, reasonable, and procedurally fair. The court’s interventions have highlighted several recurring issues: whether businesses were given an to respond, whether the alleged violation justified immediate suspension or cancellation, whether subsequent was considered, and whether the regulator gave sufficient reasons for its decision.
Legal Implications for Regulatory Practice
The Cipla judgment reinforces the well-settled principle that administrative authorities must follow the rules of before taking adverse actions. A and a are mandatory, and scheduling hearings on public holidays without the consent of the party is improper. The court’s observation that the FDA’s actions were "" sends a clear message that regulators cannot bypass , even in matters involving public health.
Moreover, the court’s emphasis on
—echoed in the remark
"
"
—suggests that regulatory action must be commensurate with the gravity of the alleged violation. Cancellation or suspension of a licence, especially for a company that distributes critical medicines, should not be a first resort. The availability of less drastic measures, such as
or corrective directions, must be considered.
For businesses, this judgment provides a strong precedent to challenge regulatory actions that are or disproportionate. It also places the onus on regulators to document their reasoning and to ensure that any hearing is conducted fairly and on a working day, unless an emergency justifies otherwise.
Conclusion: A Warning to Regulators
The Maharashtra FDA’s quick U-turn in the Cipla case—withdrawing its to avoid further judicial censure—demonstrates the power of in safeguarding procedural rights. However, the ’s warnings are clear: continued failures to follow could lead to against individual officers.
The court’s broader scrutiny of FDA enforcement actions is a reminder that regulators, while performing a laudable function, are not above the law. The
and
are not mere technicalities but essential safeguards that protect businesses from arbitrary state action. As the court has repeatedly asked:
"How many times should we try to convince and
? Do you feel you are a lord and you can do anything?"
For legal professionals, the Cipla case and the accompanying series of judgments offer valuable insights into the evolving standards of administrative law in India. The message is unequivocal: is non-negotiable, and even the most well-intentioned regulatory action must respect it.
