Maharashtra FDA cancels Cipla warehouse's drug sale licences in Pune

Amid the statewide crackdown the Maharashtra Food and Drug Administration FDA has cancelled the wholesale drug sale licences of Cipla Pharma amp Life Sciences Ltds CampF warehouse in Wadki Pune As per the official press note shared by FDA an inspection revealed alleged misbranding of a prescription medicine and several irregularities in storage and recordkeepingFDA action against Cipla follows Bombay High Court directionsAccording to the FDA the earlier proceedings against the establishment were withdrawn in compliance with the Bombay High Courts directions following which a revised showcause notice was issued on September 4 2026Cipla submitted its written response on September 11 and was subsequently granted an opportunity for a personal hearing on September 21Furthermore the licensing authority examined the companys explanations alongside the inspection findings and available records before passing the cancellation orderFDA further clarified that the decision was an independent regulatory order issued after completing the entire procedure afresh rather than a repetition of the earlier actionFDA in the press note added ldquoThe action was taken by the FDAs Pune office after completing the prescribed legal procedure in compliance with the directions of the Bombay High CourtrdquoReactin Plus packaging raises misbranding concernsOne of the key issues identified during the inspection concerned the packaging and advertising claims of Reactin Plus a Schedule H prescription medicineMaharashtra FDA found that the medicine was advertised as an analgesic and antiinflammatory drug claiming quick relief from headaches muscular pain backache joint pain sprainrelated pain body aches and toothachesFurthermore the medicines carton also featured a human figure suggesting that its use could reduce muscular painAs per FDA the claims text and illustrations on the packaging did not comply with applicable statutory provisions raising concerns of misbranding under the Drugs and Cosmetics Act 1940FDA further highlighted that the responsibility of the marketer placing the medicine on the market was also examinedThe licensing authority observed that an establishment could not avoid its statutory obligations as a marketer merely by attributing responsibility to the manufacturerFDA identifies multiple storage and recordkeeping violationsThe inspection of the Wadki warehouse also revealed several deficiencies in the storage and management of medicinesThe FDA listed the following irregularitiesThe prescribed Form 35 inspection book was unavailableMedicine boxes were stored directly on the floor due to inadequate pallets and racksDust had accumulated on medicine stocks indicating deficiencies in cleanlinessThere was no separate area clearly marked Expiry ndash Not for Sale for expired medicinesStandard Operating Procedures SOPs and records required for the disposal of expired medicines were unavailablePurchase invoices lacked the required serial numbersCopies of sales invoices had deficiencies concerning the signatures of authorised personnelDiscrepancies were found between computerisedSAP records and actual medicine stocks including antibioticsFDA rejects reliance on digital records as an exemptionThe FDA said ldquoCipla submitted explanations in its written response and during the personal hearing which were independently examined by the licensing authorityrdquoHowever the order clarified that maintaining records in SAP or other computerised systems does not exempt a licensed establishment from its statutory responsibilities concerning documentation actual stock safe storage cleanliness and the availability of records required during inspectionsThe department emphasised that every licensed establishment involved in the sale and distribution of medicines must ensure compliance with its legal obligationsCipla issues clarification statementIssuing an official statement about the incident Cipla said Cipla maintains an unwavering commitment to quality and patient safety and we find the Maharashtra FDArsquos decision regarding our Wadki CampFA in Pune disappointingWe believe our Pune CampFA warehouse operates in compliance with distribution and storage protocols and digital recordkeeping standards We are reviewing the order and evaluating further options they addedThe pharmaceutical further added Cipla remains fully dedicated to ensuring uninterrupted access to safe highquality medicines for patients and healthcare providersTukaram Mundhe reiterates focus on drug safetyFDA Commissioner Tukaram Mundhe while hailing the action taken by the FDA said ldquoThe objective of the Food and Drug Administration is not only to take action but also to ensure compliance with the legal provisions in the drug supply chain regarding the quality safety etc of drugsrdquoMundhe added ldquoIn this case the action has been taken by keeping in full respect the directions of the Honble Bombay High Court and following all the aspects of natural justice transparency due process of law etc The Food and Drug Administration Maharashtra State strictly follows the legal provisions related to the quality and safety of drugsrdquo