Source : INDIA TODAY NEWS
The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale and distribution licences of a Cipla Pharma & Life Sciences warehouse in Pune after finding alleged violations involving the packaging of a prescription medicine, storage practices, record-keeping and handling of expired drugs.
The action relates to the company’s Carrying and Forwarding (C&F) warehouse at Wadki in Pune. The final cancellation order was issued on October 1 after the FDA completed proceedings following directions from the Bombay High Court. The earlier proceedings were withdrawn and a fresh show-cause notice was issued before the final order, according to the regulator.
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The case centres partly on Reactin Plus, a Schedule H prescription medicine that is not meant for over-the-counter sale. During an inspection in June, FDA officials found packaging carrying the words “analgesic and antipyretic”, along with promotional claims relating to quick relief from ailments including headache, muscular pain, backache, joint pain, sprain, body ache and toothache. The regulator considered these claims impermissible for the prescription drug.
The FDA had earlier seized Reactin Plus stock worth around Rs 11.2 lakh and directed its recall, according to reports on the regulatory action.
Storage, records under scanner
The inspection also flagged problems at the warehouse beyond the product packaging. FDA officials found medicine boxes stored directly on the floor, with dust accumulation, and said the facility did not have a mandatory inspection book. Expired medicines were allegedly not segregated in a designated “Not for Sale” area.
The regulator also found discrepancies between physical stocks and computerised records, including in the case of medicines such as antibiotics. The FDA rejected the company’s explanation that its digital record-keeping met the requirements, saying electronic records did not replace mandatory physical checks, hygiene standards and statutory documentation.
The FDA said the action was taken after considering Cipla’s response and following a detailed hearing process. Maharashtra FDA Commissioner Tukaram Mundhe said the objective was to ensure safety, quality and legal compliance across the drug supply chain.
Cipla, however, has contested the action. In a statement, the company said it maintains an “unwavering commitment to quality and patient safety” and described the FDA’s decision regarding its Wadki C&F facility as disappointing.
“Cipla believes” the Pune C&F warehouse operates in compliance with distribution and storage protocols as well as digital record-keeping standards, the company said. It added that it was reviewing the order and evaluating further options.
Cipla also said it remains committed to ensuring uninterrupted access to safe, high-quality medicines for patients and healthcare providers.
The regulatory action concerns the licences of the Pune C&F facility and the violations identified there. Cipla has maintained that the matter requires further review and is evaluating its options against the FDA order.
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SOURCE :- TIMES OF INDIA
