Maharashtra FDA Cancels License of Sipla Pharma's Warehouse in Pune

The Maharashtra Food and Drug Administration (FDA) has officially withdrawn the licence authorising the carrying and forwarding (C&F) warehouse of Sipla Pharma & Life Sciences Ltd, located in Wadki, Pune. The decision came after the regulator identified several alleged shortcomings in the way medicines were packaged, stored, and recorded at the facility.

According to the FDA, earlier concerns were raised about the Schedule‑H prescription drug Reactine Plus tablets, particularly the claims printed on its packaging. The agency argued that the label suggested pain‑relief benefits that were not approved, and it also flagged the presence of human figures and muscular pain relief imagery as misleading.

The licence was revoked following a review ordered by the Bombay High Court. The court directed the state drug controller to re‑examine the case, which led to a fresh cancellation order on October 1. Earlier, on August 27, the FDA had initiated action against the warehouse, but the matter was later referred back for a revised assessment.

Sipla received a show‑cause notice on September 4, responded in writing on September 11, and presented its case during a personal hearing on September 21. After scrutinising the company’s reply, records, and the relevant legal provisions, the licensing authority confirmed the cancellation, stating that the decision was based on newly surfaced facts rather than a repeat of the earlier move.