Tukaram Mundhe led Maharashtra FDA revokes drug license of Cipla unit due to irregularities Reactin Plus | Today’s news
The Food and Drug Administration (FDA) in Maharashtra has revoked the drug sales licenses of the Carry and Forwarding (C&F) unit of Cipla Pharma & Life Sciences Ltd in Pune over irregularities related to packaging, storage and recall of Reactin Plus tablets, PTI reported.
The cancellation took effect on August 27 following an inspection of the company’s main warehouse at Wadki in Pune district, the FDA said in a statement on Friday.
During a June inspection, FDA officials found that the packaging of Reactin Plus Tablets, a Schedule H prescription drug, contained an unauthorized claim describing it as an “analgesic and antipyretic.”
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Stock value ₹11.19 crore seized
The regulator seized the value of the shares ₹11.19 lakh, saying the claim violates provisions of the Drugs and Cosmetics Act, 1940 and the Anti-Narcotics Rules, 1945.
The FDA subsequently ordered the company to recall the misbranded tablets. However, the regulator said the company did not fully comply with the recall guidelines and related requirements.
A follow-up inspection of the C&F department’s drug sales and distribution system also found several deficiencies. These were discrepancies between purchase and sales records and computerized inventory, as well as differences between physical and recorded inventory.
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However, Cipla challenged the FDA’s order, saying the matter is currently under litigation.
Cipla Pharma & Life Sciences said in a statement that the order relates to the operation of a C&F warehouse operated on its behalf and that as the matter is pending in court, it is not appropriate to comment further on the proceedings.
The company also clarified that the order does not raise any concerns about the safety, quality or efficacy of its products, nor does it involve or imply any patient safety issue.
“Cipla has been a trusted healthcare organization for nine decades and continues to uphold the highest standards of quality, compliance and patient safety,” the company said.
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Medicines were stored directly on the floor
The FDA also found that drugs were stored directly on the floor with inadequate pallet and shelving arrangements. She drew attention to deficiencies in the storage of medicines and in the records and procedures for dealing with expired medicines.
The regulator issued a show-cause notice to the licensee and examined the company’s response. After a review, the FDA stated that the deficiencies and guidance related to the recall of Reactin Plus tablets were not adequately addressed.
FDA Commissioner Tukaram Mundhe said the department will show no leniency in matters related to drug safety and public health, especially when it comes to the advertisement, sale, storage and distribution of Schedule H prescription drugs.
“Any violation of the rules by any entity involved in the manufacturing and distribution of drugs will attract strict action under the law,” he said.
