Pune: Cipla has expressed disappointment over the Maharashtra Food and Drug Administration’s decision to cancel the drug sale and distribution licences of its carrying and forwarding (C&F) warehouse at Wadki in Pune, maintaining that the facility complies with prescribed storage, distribution and digital record-keeping protocols.

The pharmaceutical company said it is reviewing the FDA’s latest order and assessing the options available to it. Cipla also reiterated its commitment to quality and patient safety, saying it would continue working to ensure uninterrupted access to medicines for patients and healthcare providers.

The development follows fresh proceedings by the Maharashtra FDA after an earlier regulatory action against the Pune facility was withdrawn following directions from the Bombay High Court. The latest order was issued on October 1 by the Assistant Commissioner (Drugs), Division 3, FDA Pune.

Cipla says warehouse follows prescribed protocols

In its response, Cipla said the Maharashtra FDA’s decision concerning its Wadki C&FA facility was disappointing.

The company maintained that the Pune warehouse operates in compliance with applicable drug storage and distribution protocols and follows standards for digital record-keeping.

Cipla said it was reviewing the order and evaluating further options. It also stressed that quality and patient safety remain its priorities.

The company’s response comes amid regulatory action over alleged irregularities identified during inspections of the facility and issues connected with the handling and distribution of Reactin Plus tablets.

FDA cites Reactin Plus packaging claims

The Maharashtra FDA’s action centres partly on Reactin Plus Tablets, a Schedule H prescription medicine.

According to the regulator, the packaging carried unauthorised claims describing Reactin Plus as an analgesic and promoting its use for conditions including headache, muscular pain, backache, joint pain, sprain, body ache and toothache.

The packaging also contained illustrations and claims relating to relief from muscular pain. The FDA treated these claims as misbranding under provisions of the Drugs and Cosmetics Act, 1940.

The regulator had earlier raised concerns over the packaging and seized stock of Reactin Plus in connection with the alleged violation. Earlier reports said the FDA had also directed the company to recall affected stock from the market.

Storage and record-keeping deficiencies flagged

Apart from the packaging issue, the FDA cited several deficiencies relating to the warehouse’s storage and documentation practices.

The regulator said medicines were found stored directly on the floor, with inadequate pallets or racks. Dust accumulation on stocks and shortcomings in cleanliness were also flagged during inspections.

The FDA further alleged that expired medicines were not adequately segregated in a clearly marked area and that records and standard operating procedures relating to their disposal were not available.

The regulator also pointed to discrepancies between computerised or SAP inventory records and physical stock, as well as deficiencies in purchase and sale invoice records.

These findings formed part of the basis for the latest licensing action against the Wadki facility.

Fresh proceedings followed Bombay High Court directions

The latest cancellation followed a fresh regulatory process after the FDA withdrew its earlier proceedings in compliance with directions from the Bombay High Court.

The Maharashtra FDA issued a revised show-cause notice to Cipla on September 4. The company submitted its written response on September 11 and was subsequently given an opportunity for a personal hearing on September 21.

The licensing authority then considered Cipla’s response, submissions made during the hearing, inspection findings, records and applicable legal provisions before issuing its fresh order on October 1.

The process is therefore separate from simply extending the earlier order, with the regulator conducting fresh proceedings after the court-directed withdrawal of the previous action.

Cipla maintains commitment to patient safety

Cipla has continued to emphasise that it remains committed to quality, regulatory compliance and patient safety.

The company said it would work to ensure uninterrupted access to safe and high-quality medicines for patients and healthcare providers.

Its latest statement focuses on the company’s position that the Pune C&FA warehouse complies with applicable storage, distribution and digital record-keeping protocols, while also indicating that Cipla is examining the regulatory order and its available options.

The latest action concerns the sale and distribution licences of the specific C&F warehouse at Wadki, rather than a blanket cancellation of Cipla’s pharmaceutical manufacturing operations.

Regulatory scrutiny continues

The case highlights the importance of compliance across the pharmaceutical supply chain, including not only manufacturing standards but also the storage, documentation, inventory management and distribution of medicines.

The Maharashtra FDA has said its action is aimed at enforcing statutory requirements governing drug storage and distribution and ensuring that medicines are handled in accordance with applicable standards.

For Cipla, the immediate focus is on reviewing the October 1 order and determining its next course of action. The company has not accepted the regulator’s assessment of its Pune warehouse and has maintained that the facility operates according to prescribed protocols.

The dispute is therefore continuing, with the FDA’s findings and Cipla’s response representing the two positions in the matter.