The Maharashtra Food and Drug Administration (FDA) has revoked the drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd's C&F warehouse in Wadki, Pune, citing alleged lapses in drug packaging, storage, record-keeping and inventory management, the FDA said in a statement.
The FDA Pune's Division 3 Assistant Commissioner (Drugs) issued the licence-cancellation order on October 1, following a fresh regulatory review conducted in line with the Bombay High Court's directives. The latest order follows an earlier regulatory action against the facility on August 27.
In its earlier action, the regulator had raised concerns over Reactin Plus Tablets, citing unauthorised claims on the packaging of the Schedule H drug, as well as shortcomings in warehouse storage, record-keeping and procedures for handling expired medicines.
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According to the FDA, the earlier proceedings were withdrawn following the High Court's directions and the matter was reconsidered afresh. The regulator issued a revised show-cause notice to Cipla on September 4.
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The company submitted its written response on September 11 and was given a personal hearing on September 21.
The licensing authority subsequently considered Cipla's submissions, inspection findings, records and applicable legal provisions before passing the fresh order.
The FDA said the latest decision was an independent regulatory determination following completion of the proceedings and was not simply a repetition of its earlier action.
What Did FDA Find At Cipla's Pune Warehouse?
The regulator's scrutiny centred on Reactin Plus, a Schedule H prescription drug. According to the FDA, its packaging described the medicine as an analgesic and listed multiple conditions for its use, including headache, muscular pain, backache, joint pain, sprain, body ache and toothache.
The regulator also objected to the use of a human figure and an illustration depicting the medicine as providing relief from muscular pain.
The FDA said the claims, wording and illustrations did not comply with applicable statutory requirements and constituted misbranding under the Drugs and Cosmetics Act, 1940.
The regulator also examined Cipla's responsibilities as the marketer of the medicine, saying those obligations could not be avoided solely on the grounds that the product was manufactured by another entity.
The inspection also identified several warehouse-management deficiencies. These included the absence of the prescribed Form 35 inspection book, medicines being stored directly on the floor because of inadequate pallets or racks, dust accumulation on drug stocks and shortcomings in general cleanliness.
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The FDA further said expired medicines were not being kept in a separately designated area clearly marked "Expiry-Not for Sale".
It also cited the absence of the prescribed standard operating procedure and records relating to the disposal of expired medicines.
Other alleged lapses included deficiencies in purchase invoices, missing signatures on duplicate copies of sale invoices and discrepancies between computerised or SAP records and physical stock, including antibiotics.
The regulator said maintaining records through SAP or another computerised system did not absolve a licensed establishment of its statutory obligations relating to documentation, physical inventory, storage conditions, cleanliness and records required for inspection.
FDA Commissioner On Cipla Action
FDA Commissioner Tukaram Mundhe said the department's objective was not limited to enforcement action but also included ensuring the safety and quality of medicines and compliance throughout the drug supply chain.
"The objective of the Food and Drug Administration is not merely to take action but to ensure the safety and quality of medicines and statutory compliance in the drug supply chain," Mundhe said.
He added that the fresh proceedings were conducted in accordance with the Bombay High Court's directions, while following principles of natural justice, transparency, an opportunity of hearing and a reasoned decision.
The August 27 action had involved seizure and withdrawal-related directions concerning Reactin Plus, besides the FDA's findings on storage, inventory records and procedures for expired medicines.
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