Mumbai: The Maharashtra Food and Drug Administration has cancelled the licences that allowed a Cipla Pharma and Life Sciences Ltd warehouse in Pune to sell and distribute medicines, citing serious allegations of improper labelling, unhygienic storage and discrepancies in inventory records.
The regulatory order concerns the company’s godown at Wadki. It was issued under the supervision of FDA Commissioner Tukaram Mundhe after the Bombay High Court directed the authority to complete the proceedings afresh.
A key ground for the cancellation was the alleged misbranding of Reactin Plus, a Schedule H medicine that requires a prescription and cannot be sold over the counter. According to the FDA, the product’s packaging carried promotional claims and images suggesting rapid relief from headaches, muscular pain, backache, joint pain, sprains, body ache and toothache, as reported by NDTV.
Inspectors also reported poor conditions inside the warehouse. Medicine cartons were allegedly kept on the floor and covered with dust, raising concerns about hygiene and the safety of the stored products.
The FDA further alleged that the facility failed to maintain a required inspection register. Expired stock was also not segregated in a separate area marked “Not for Sale,” the authority said.
Another major irregularity cited in the order was the mismatch between medicines physically available at the warehouse and entries in the company’s computerised records. The discrepancy reportedly involved antibiotics among other products.
The regulator dismissed Cipla’s contention that maintaining digital records was sufficient. It said electronic documentation could not substitute for compliance with physical storage safeguards, hygiene requirements and mandatory statutory paperwork.
After conducting a detailed hearing, the FDA passed the final cancellation order on October 1. The authority had earlier withdrawn its previous proceedings to comply with the high court’s directions.
Mundhe said the regulator’s aim went beyond enforcement and focused on protecting the quality and legality of medicines moving through the supply chain.
“In this case, the proceedings have been completed by fully respecting the directions of the Bombay High Court, following the principles of natural justice, transparency, hearing, and reasoned decisions or following all aspects,” he said in a statement.
