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FDA cancels Cipla’s wholesale drug licence at Pune warehouse
FDA cancels wholesale drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd’s C&F warehouse at Wadki in Pune, citing alleged regulatory and storage-related irregularities
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Pune: The Maharashtra Food and Drug Administration (FDA) has cancelled the wholesale drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding (C&F) warehouse at Wadki in Pune, citing alleged regulatory and storage-related irregularities.
Assistant commissioner (drugs), circle-3 and licensing authority, FDA Pune, issued the order on October 1 in accordance with the directions of Bombay High Court, officials said on Saturday.
The administration had earlier cancelled the licences of the facility with effect from August 27 after allegedly finding irregularities involving the packaging, storage and recall of Reactin Plus Tablets. The proceedings were subsequently withdrawn in compliance with the high court’s directions, following which FDA issued a revised show-cause notice to the company on September 4, officials said.
Cipla submitted its written response on September 11 and was given a personal hearing on September 21. The authority considered the company’s response, inspection findings, records and applicable legal provisions before passing the order, officials said.
During an inspection, officials allegedly found stocks of Reactin Plus Tablets, a Schedule H drug. The authority said the packaging described the medicine as an “Analgesic & Anti-inflammatory” and made claims of quick relief from headaches, muscular pain, backache, joint pain, sprain-related pain, body aches and toothaches.
Officials said the carton also carried a human figure illustration depicting reduction in muscular pain. FDA alleged that the claims, text and illustration violated provisions of the Drugs and Cosmetics Act, 1940, raising concerns of misbranding.
The inspection also allegedly found medicines stored directly on the floor because of inadequate pallets or racks, dust and cleanliness issues, and no clearly marked separate area for expired medicines. Officials said records and standard operating procedures for disposal of expired medicines were also inadequate.
FDA found discrepancies between SAP/computer records and physical stock, including antibiotics. Other alleged deficiencies included missing Form 35 inspection records and shortcomings in purchase and sales documentation.
“The proceedings have been completed by fully respecting the directions of the high court.” said FDA commissioner Tukaram Mundhe.
Cipla said it was disappointed with the decision.
“Cipla maintains an unwavering commitment to quality and patient safety, and 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. We are reviewing the order and evaluating further options,” the company said.
