Sipla Pharma’s C&F Warehouse License Revoked Over Packaging Violations

Maharashtra's Food and Drug Administration has annulled the licence of the Carrying and Forwarding (C&F) warehouse operated by Sipla Pharma & Life Sciences Ltd in Wadki, Pune. The regulator highlighted alleged deficiencies in drug packaging, storage practices, stock management, and record‑keeping.

The core issue revolved around the Schedule‑H drug Reactine Plus tablets. The FDA argued that the packaging listed unapproved claims, portraying the medicine as a cure for a wide range of pains, including dental discomfort, and used images that implied muscle‑pain relief, which breached labelling norms.

The revocation follows a Bombay High Court order that instructed a fresh review of the case. After the court's direction, the state drug controller issued a new cancellation order on October 1. Previously, the FDA had initiated action on August 27, later recalling it for a revised procedural assessment.

The company received a revised show‑cause notice on September 4, submitted a written reply on September 11, and presented its arguments during a personal hearing on September 21. After a thorough examination of the reply, associated records, and the governing legal framework, the licensing authority confirmed the licence cancellation, stating that the decision was based on newly identified facts and not merely a repetition of earlier findings.