Mumbai: The Maharashtra Food and Drug Administration (FDA) has revoked the drug sale licences of the Carry and Forwarding (C&F) facility operated by Cipla Pharma & Life Sciences Ltd. at Wadki in Pune, citing multiple regulatory breaches, including improper packaging of a Schedule H medicine, non-compliance with a product recall and major lapses in storage and documentation.
The cancellation took effect immediately on August 27, according to an order issued by the FDA on Thursday.
Packaging Breach
The action followed an inspection of the company’s principal warehouse at Wadki conducted around June. During the inspection, FDA officials found that packs of Reactin Plus Tablets, a Schedule H drug, carried the unauthorised description “analgesic and antipyretic”.
The department seized stock valued at Rs 11.19 lakh and classified the medicine as misbranded under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.
An analgesic is a medicine used to relieve pain, while an antipyretic is intended to bring down fever. The FDA took objection to the inclusion of the therapeutic description on the packaging of a prescription medicine, stating that the label could lead consumers to believe that the drug was meant to treat pain or fever.
According to the department, such labelling could encourage people to use the medicine without consulting a doctor. It said the unauthorised promotion of a prescription drug raised concerns over its improper use and posed a potential risk to public health.
The company was thereafter instructed to withdraw the affected batches from the market, as reported by The Free Press Journal.
Recall, Storage Lapses
A later inspection of the C&F facility found that the recall instructions had not been implemented completely, the FDA said.
Officials found a mismatch between the stock at the warehouse and the quantities listed in the computer system. They also noted gaps in purchase and sales records and improper storage of medicines
Several medicines had reportedly been placed directly on the floor instead of being kept on pallets or racks. The warehouse also lacked an adequate number of pallets and racks needed to ensure proper storage of pharmaceutical products.
The inspection further pointed to deficiencies in the upkeep of records and procedures concerning medicines that had expired.
Licences Revoked
The FDA subsequently served a show-cause notice on the licence holder, seeking an explanation for the violations. After reviewing the company’s reply and the findings recorded during the inspections, the department determined that the breaches justified cancellation of the drug sale licences.
An email was sent to Cipla’s corporate communications team requesting its response to the FDA’s observations and the licence cancellation. No reply had been received until the time of going to press.
Cipla Challenges FDA Order
Cipla Pharma & Life Sciences (CPLS), however, has challenged the Pune FDA’s order and said that the matter is sub-judice. The company also said the order did not raise any issue concerning the safety, quality or efficacy of its products and did not involve or point to any patient safety concern.
In a statement, Cipla Pharma & Life Sciences said: “Cipla Pharma & Life Sciences (CPLS) has contested the Pune FDA’s order pertaining to the operations of a C&F warehouse operated on behalf of CPLS and the matter is currently sub judice. As the issue is under judicial consideration, it would not be appropriate to comment further on the proceedings at this stage. We would, however, like to clarify that the order does not allege any concerns relating to the safety, quality, or efficacy of our products, nor does it involve or indicate any patient safety issue.Cipla has been a trusted healthcare organization for nine decades and continues to uphold the highest standards of quality, regulatory compliance, and patient safety.”
The company’s statement followed the FDA’s decision to cancel the licences with immediate effect from August 27. Cipla reiterated that, since the matter is before the judiciary, it would not be appropriate for it to make further comments on the proceedings at this stage.
FDA Warning
FDA Commissioner Tukaram Mundhe said the department would take a strict view of any breach involving the safety of medicines and public health, especially when prescription drugs classified as Schedule H medicines were concerned.
“Strict compliance with legal provisions governing the advertising, sale, storage and distribution of medicines is essential. Any violation by entities involved in the drug supply chain will invite strict action as per law,” Mundhe said.