In a major regulatory development, the Maharashtra Food and Drug Administration (FDA) has withdrawn its order cancelingthe drug sale license of Cipla Pharma & Life Sciences Ltd’sCarrying and Forwarding (C&F) unit in Wadki, Pune. The decision follows sharp reprimands from the Bombay High Court, which ruled that the state regulator acted in a “high-handed” manner and in direct violation of the principles of natural justice.
The division bench, comprising Acting Chief Justice RavindraGhuge and Justice Gautam Ankhad, intervened after Ciplachallenged the FDA’s sudden cancellation. The court observed that the regulatory authority had gone “overboard” in enforcing punitive measures without adhering to the required statutory procedures and fair hearing norms.
The initial cancellation order, slated to take effect from August 27, was issued by the Maharashtra FDA citing alleged irregularities regarding the packaging, storage, and recall protocol of Reactin Plus Tablets handled at the Wadkidistribution facility.
Following the High Court’s intervention and strong rebuke, the FDA consented to withdraw the cancellation order forthwith. The regulator has stated that it will issue a fresh show-cause notice to Cipla Pharma & Life Sciences Ltd, allowing the company due opportunity to respond before any formal, reasoned order is passed.
This judicial intervention safeguards the distribution operations of essential pharmaceutical supplies while reinforcing the necessity for statutory authorities to uphold due process. Ciplacontinues to maintain that it adheres strictly to standard regulatory compliance and quality assurance protocols across its supply chain network.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
