Maharashtra FDA has cancelled the drug sale licences of Cipla Pharma & Life Sciences’ carrying and forwarding unit in Pune, citing multiple compliance violations.
The action followed inspections that flagged irregular packaging of Reactin Plus tablets, inadequate storage arrangements, discrepancies in stock records and shortcomings in following recall directions.
The regulator also seized Reactin Plus stock worth around ₹11.19 lakh and ordered its withdrawal. Cipla has challenged the decision, saying the matter is sub judice. The company also clarified that the FDA order raises no concerns about the safety, quality or efficacy of its medicines.