The Maharashtra Food and Drug Administration (FDA) has revoked the drug sale and distribution licences for a Cipla Pharma & Life Sciences warehouse located in Pune. This decision stems from alleged breaches related to the packaging, storage, record-keeping, and handling of expired medications. The affected warehouse is Cipla’s Carrying and Forwarding (C&F) facility situated in Wadki.

This cancellation order was officially issued on October 1 after the FDA concluded its proceedings, which followed directives from the Bombay High Court. Initially, earlier proceedings were withdrawn, and a new show-cause notice was laid out before arriving at the final decision, as outlined by the regulatory body.

Allegations Regarding Reactin Plus

The case draws attention due to issues surrounding Reactin Plus, a prescription medication classified as Schedule H, which is not authorised for over-the-counter distribution. During an inspection carried out in June, FDA officials discovered that packaging for this drug included the terms “analgesic and antipyretic,” as well as claims promoting quick relief from various conditions, including headaches, muscular pain, and toothaches. Such promotional assertions were deemed impermissible for a medication that requires a prescription.

In response to these findings, the FDA had previously confiscated stock of Reactin Plus valued at approximately Rs 11.2 lakh and mandated its recall, according to reports detailing the regulatory measures taken.

Additional issues identified during the inspection highlighted storage and record-keeping inadequacies at the warehouse. Medicine boxes were reportedly found stored directly on the floor with dust accumulation, and the facility lacked a necessary inspection book. Moreover, expired drugs were allegedly not separated in a designated “Not for Sale” area.

Discrepancies in Record-Keeping

The FDA discovered inconsistencies between the actual physical stock of medicines and the records maintained in the company’s system, particularly concerning antibiotics. The regulator dismissed Cipla’s argument that its digital record system met compliance standards. It stressed that electronic records do not replace the necessity for physical inspections, adherence to hygiene protocols, and the maintenance of statutory documentation.

The decision to revoke the warehouse’s licences came after a careful review of Cipla’s response and a comprehensive hearing process. Maharashtra FDA Commissioner Tukaram Mundhe stated that the aim of these actions is to uphold safety, quality, and legal adherence throughout the pharmaceutical supply chain.

In light of the regulatory actions, Cipla has publicly contested the FDA’s decision. The company asserted its steadfast commitment to quality and patient safety, expressing disappointment over the findings related to its Wadki facility. Cipla insisted that the Pune C&F warehouse operates in compliance with established distribution and storage protocols, alongside adequate digital record-keeping practices. The firm is currently assessing the order and considering its subsequent options. Furthermore, Cipla has reiterated its dedication to providing uninterrupted access to safe, high-quality medicines for patients and healthcare providers.

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