According to the FDA commissioner, the aim of the FDA is not merely to take regulatory action, but to ensure the safety and quality of medicines and statutory compliance throughout the drug supply chain.
The Food and Drug Administration, Pune cancelled the wholesale drug sale license of Cipla Pharma and Life Sciences Ltd, Wadki in Pune. Tukaram Mundhe, Commissioner of Food and Drug Administration, Maharashtra, said after completing the legal and regulatory procedures, the action was taken.
“There were serious irregularities identified during the inspection of the establishment, including issues relating to the packaging and promotion of Reactin Plus Tablets, as well as deficiencies in the storage, record-keeping and management of medicines at the warehouse,” Mundhe said.
According to the FDA commissioner, the aim of the FDA is not merely to take regulatory action, but to ensure the safety and quality of medicines and statutory compliance throughout the drug supply chain. “In this case, the proceedings have been completed in accordance with the directions of the Bombay High Court and by following the principles of natural justice, transparency, opportunity of hearing and a reasoned decision,” Mundhe added.
It may be recalled that during the inspection of the Wadki warehouse, stock of Reactin Plus, a Schedule H drug, was found. The product was advertised as an ‘Analgesic and Anti-inflammatory’ providing quick relief from headache, muscular pain, backache, joint pain, pain due to sprain, body ache and toothache. The carton also carried an illustration of a human figure intended to indicate the reduction of muscular pain following use of the medicine, officials said.
Girish Hukare, Joint Commissioner (Drug), Pune said that the inspection found that the claims, text and illustration appearing on the packaging did not comply with the applicable statutory requirements. “The matter raised issues of misbranding under the Drugs and Cosmetics Act, 1940 which resulted in the regulatory action,” he added.
The inspection also identified several deficiencies relating to the storage and management of medicines. According to an official press statement, there was non-availability of the Form 35 inspection book required under the applicable rules while medicine boxes were being stored directly on the floor due to inadequate availability of pallets/racks. There was accumulation of dust on medicine stocks and deficiencies in cleanliness apart from the absence of a clearly designated area marked “Expiry – Not for Sale” for expired medicines.
Cipla in a statement said, “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. Cipla remains fully dedicated to ensuring uninterrupted access to safe, high-quality medicines for patients and healthcare providers.”
Other deficiencies related to signatures of authorized persons on duplicate copies of sales invoices and discrepancies between computer/SAP records. Earlier when the FDA had cancelled the carry and forwarding agent (CFA) drug sale license of the warehouse in Pune, Cipla Pharma had contested the Pune FDA order and in their statement had stated that FDA order had not alleged concerns related to safety quality or efficacy of their products and indicate patient safety issue. FDA officials said that the earlier proceedings were withdrawn in compliance with the directions of the High Court.
However a revised show-cause notice was issued on September 4, the organization submitted its written reply on September 11 and was given an opportunity for a personal hearing on September 21. FDA authorities said, “It is an independent regulatory decision taken afresh after completion of the prescribed process in accordance with the directions of the Bombay High Court.”
