FDA withdraws Cipla licence order after HC rap
Mumbai: The Maharashtra FDA rescinded an order to revoke Cipla Pharma & Life Sciences Ltd's Carry and Forwarding unit's drug sale licence in Pune on Saturday following the Bombay High Court's criticism of the regulator's actions. The court reprimanded the FDA for disregarding principles of natural justice and acting in a high-handed manner.
The FDA had previously cancelled the licensing of Cipla Pharma & Life Sciences's carrying and forwarding facility in Pune on August 27, 2022, citing serious irregularities in packaging, storage, and recall of Reactin Plus Tablets. Cipla Pharma & Life Sciences challenged the decision, stating that the FDA order did not raise any concerns about the safety, quality, or efficacy of the products, nor did it involve patient safety issues.
The FDA had directed the company to appear before it on August 26, a public holiday, for a hearing, but the company could not send a representative due to the holiday. The FDA proceeded with the order without granting a hearing. The high court questioned the FDA's email to the company requesting a representative for a hearing on a public holiday, stating that the regulator's actions were excessive and against natural justice principles.
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