Maharashtra FDA Cancels Drug Sale Licence Of Pune Cipla Facility; Disappointing Decision, Says Firm

The Maharashtra Food and Drug Administration (FDA) on Friday said it has cancelled the drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd's carrying and forwarding (C&F) warehouse at Wadki in Pune over alleged violations, a decision the firm said was "disappointing".

The action was taken after completion of fresh proceedings in compliance with the directions of the Bombay High Court, the FDA said in a statement.

It follows an earlier FDA action taken against the facility on August 27 this year over alleged irregularities involving the packaging, storage, documentation and recall of Reactin Plus Tablets. The FDA had then cited unauthorised claims on the packaging of the Schedule H prescription drug and several deficiencies at the warehouse.

The latest order was passed on October 1 by the Assistant Commissioner (Drugs), Division 3, FDA Pune, after the department withdrew its earlier proceedings in compliance with the directions of the Bombay High Court, the FDA said.

According to the statement, the department issued a revised show-cause notice to the company on September 4. Cipla submitted its written reply on September 11 and was given a personal hearing on September 21.

The licensing authority considered the company's reply, submissions made during the hearing, inspection findings, available records and applicable legal provisions before passing the fresh order.

The FDA said the latest decision was, therefore, not merely a repetition of its earlier action but an independent regulatory decision taken after completing the entire process afresh in accordance with the court's directions.

One of the key issues involved Reactin Plus, a Schedule H medicine. During inspection of the Wadki warehouse, the FDA found the drug's packaging carrying claims describing it as an analgesic and promoting its use for conditions including headache, muscular pain, backache, joint pain, sprain, body ache and toothache.

The FDA also said the packaging carried a human figure and depicted the medicine as providing relief from muscular pain. It held that the claims, wording and illustrations on the package did not comply with applicable statutory provisions and constituted an issue of misbranding under the Drugs and Cosmetics Act, 1940.

The regulator also considered the statutory responsibilities of the establishment as a marketer of the drug, saying those responsibilities could not be avoided merely by pointing to the manufacturer's role.

The department further listed several deficiencies in storage and warehouse management. These included the absence of the prescribed Form 35 inspection book, boxes of medicines being kept directly on the floor due to inadequate pallets or racks, dust accumulation on drug stocks and shortcomings in cleanliness.

The FDA also found that expired medicines did not have a separate designated area clearly marked "Expiry-Not for Sale", while the required standard operating procedure and records relating to disposal of expired medicines were unavailable.

The food and drug safety regulator also cited deficiencies in purchase invoices, signatures on duplicate copies of sale invoices and discrepancies between computerised or SAP records and the physical stock, including antibiotics.

The FDA said it considered the explanations furnished by the company but concluded that maintaining records in SAP or another computer system did not exempt a licensed establishment from its statutory responsibilities concerning records, physical stock, safe and proper storage, cleanliness and documents required for inspection.

The earlier August 27 action had also involved the FDA's findings concerning Reactin Plus. At that time, the regulator said it had found unauthorised promotional wording on the prescription drug's packaging, seized stock and directed its withdrawal from the market.

It subsequently cited deficiencies in storage, inventory records and procedures for handling expired medicines while cancelling the licences.

FDA Commissioner Tukaram Mundhe, in the statement, said, "The objective of the Food and Drug Administration is not merely to take action but to ensure the safety and quality of medicines and statutory compliance in the drug supply chain."

He said the latest proceedings had been completed while fully respecting the Bombay High Court's directions and following principles of natural justice, transparency, an opportunity of hearing and a reasoned decision.

In a statement, Cipla said it maintains an unwavering commitment to quality and patient safety.

"We find the Maharashtra FDA’s decision regarding our Wadki C&FA in Pune disappointing. We believe our Pune C&FA warehouse operates in compliance with distribution and storage protocols and digital record-keeping standards," it said.

Cipla added it is reviewing the order and evaluating further options.

"Cipla remains fully dedicated to ensuring uninterrupted access to safe, high-quality medicines for patients and healthcare providers," the pharmaceutical major's statement added.