The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd’s Carrying and Forwarding (C&F) unit in Pune, citing serious irregularities in the packaging, storage, record-keeping and recall of Reactin Plus Tablets handled at the facility.
The regulator’s action targets compliance lapses at the C&F unit rather than the manufacturing process itself, according to the details of the order. Cipla has pushed back against the decision, stating that the matter is currently sub judice and is likely to be examined further through legal proceedings.
The company has also issued a clarification distancing the issue from product integrity, asserting that the FDA’s action does not allege any concerns relating to the safety, quality or efficacy of Cipla’s products. The case adds to the scrutiny Indian pharmaceutical companies have faced recently over storage and distribution compliance, even as manufacturing standards remain unaffected.
Written by: Arundhuti Chatterjee
Graphics by: Pramit Hazra
