- The FDA had initiated action against the company for publishing unauthorised text on the packaging of its drug ‘Rectin Plus’ and for deficiencies in purchase-sale records and storage of drugs.
- The company informed the court that the FDA had sent an email on August 26, a public holiday, directing the company to appear for a hearing on the same day; the company requested an adjournment as no representative was available, but the FDA proceeded to pass the order without holding a hearing.
- The FDA cancelled licences for Cipla's carry and forwarding unit at Vadki, Pune on August 27.
- The Bombay High Court on August 29 took exception to the procedure followed by the FDA, observing violation of natural justice.
- Following the court’s remarks, the FDA informed the Bench that it would withdraw the revocation order and issue a fresh show-cause notice to the company.
- Senior counsel Abad Ponda, representing the company, submitted that the FDA’s order did not raise any question regarding the safety, quality, or efficacy of the products, nor did it involve any patient safety issue.
- Additional Government Pleader Priyabhushan Kakade, appearing for the FDA, argued that the company did not have a legal right to a hearing under the law.
- The court questioned the FDA’s decision to send an email on a public holiday, noting that this was not the first instance of such conduct from the FDA, and observed that the authority had followed an incorrect procedure and passed an order that went against the principles of natural justice.
The Bombay High Court on August 29, 2026, rebuked the Food and Drug Administration (FDA) for revoking the drug sale license of Cipla Pharma without following due process. The court emphasized that the FDA's actions violated the principles of natural justice.56
The court was hearing a petition from Cipla Pharma regarding the FDA's order dated August 27, which canceled the licenses for its carry and forwarding unit in Vadki, Pune. The FDA had taken action against Cipla for allegedly publishing unauthorized text on the packaging of its drug ‘Rectin Plus’ and for deficiencies in purchase-sale records and drug storage.14
Cipla's senior counsel, Abad Ponda, argued that the FDA's order did not question the safety, quality, or efficacy of the products, nor did it involve any patient safety issues. He pointed out that the FDA had sent an email on a public holiday, August 26, demanding the company appear for a hearing that same day. Cipla requested an adjournment due to the unavailability of a representative, but the FDA proceeded with the order without a hearing.238
The court questioned the FDA's rationale for expecting Cipla to send a representative on a public holiday, noting that the government often seeks adjournments for similar reasons. The bench remarked that this was not the first instance of such conduct from the FDA, highlighting a pattern of procedural irregularities.
“The authority had acted against the principles of natural justice,” the court stated, leading to the FDA's decision to withdraw the revocation order and issue a fresh show-cause notice to Cipla.7
“The FDA's action stemmed from unauthorized text on 'Rectin Plus' packaging and record deficiencies, but the court noted the email on a public holiday was not the first such instance. Cipla's counsel argued no safety or efficacy concerns were raised, and the FDA's counsel claimed no legal right to a hearing.”
