The Maharashtra Food and Drug Administration cancelled the drug sale licences of Cipla Pharma and Life Sciences Ltd for its carrying and forwarding facility in Wadki, Pune, following an inspection that revealed storage deficiencies, inventory discrepancies, and illegal labelling, according to state regulatory officials. The regulatory action took effect on August 27, after authorities seized stock worth 11.2 lakh rupees and reviewed the company’s response to an official show-cause notice.
Regulatory Inspection and Licence Cancellation at Pune Facility
State FDA joint commissioner for drugs Ganesh Rokade stated that the enforcement action stemmed from a follow-up investigation into the packaging and recall of the Schedule H prescription drug Reactin Plus, according to reports by The Times of India. During an initial inspection of Cipla’s main warehouse in June, officials discovered that the pain relief medication carried the words “analgesic and antipyretic” on its outer packaging. Drug regulators concluded that such descriptive labelling on a prescription medication encourages self-medication and creates potential public health risks.
Following the initial seizure of the misbranded products, a subsequent inspection of the Wadki carrying and forwarding facility uncovered multiple statutory violations. According to state drug authorities, inspectors found discrepancies between physical inventories and computerized stock records, along with missing purchase and sale documentation. Officials also documented severe storage deficiencies, including inadequate pallets and racks, improper record-keeping procedures for expired medicines, and drugs stored directly on the facility floor.
Legal Proceedings and Company Response
The Maharashtra FDA cancelled the facility’s permits under the provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, after examining the company’s reply to the issued show-cause notice. A spokesperson for Cipla Pharma and Life Sciences stated that the firm contested the Pune FDA’s order through legal channels. According to the company’s official statement, judicial consideration of the matter precludes further comment on active proceedings at this stage.
Cipla maintained that the regulatory enforcement order does not allege any concerns regarding the safety, quality, or therapeutic efficacy of its manufactured products. The company emphasized that the regulatory dispute involves administrative and storage infractions rather than any confirmed patient safety incidents or product defects.
Broader Regulatory Scrutiny in Maharashtra
The ongoing judicial proceedings in the Bombay High Court continue to examine the procedural validity of state regulatory actions as legal teams navigate the contested administrative orders.
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