The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licences of a Cipla Pharma & Life Sciences Ltd Carry and Forwarding (C&F) facility in Pune district after inspections uncovered multiple regulatory lapses involving the storage, distribution and recall of medicines. The cancellation, effective from August 27, follows regulatory scrutiny of the company’s main warehouse at Wadki. The FDA said its action was taken after the licence holder’s response to a show-cause notice failed to satisfactorily address the deficiencies detected at the facility. The violations included problems with the handling of Reactin Plus Tablets, a Schedule H prescription medicine, as well as discrepancies in inventory records and shortcomings in warehouse storage practices.
Reactin Plus stocks seized
The regulator’s scrutiny intensified following an inspection around June, when officials examined the packaging of Reactin Plus Tablets. According to the FDA, the medicine’s packaging carried an unauthorised description presenting it as an “analgesic and antipyretic”. The regulator concluded that the claim did not comply with requirements under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
Officials subsequently seized stocks of the medicine valued at Rs 11.19 lakh. The FDA also ordered the company to recall the affected Reactin Plus Tablets already supplied to the market. It later found that the recall instructions had not been implemented to its satisfaction.
Warehouse lapses detected
A wider examination of operations at the C&F facility subsequently revealed several shortcomings in the system used to store and distribute medicines. Inspectors found differences between the physical quantity of medicines at the warehouse and stock reflected in computerised records. Purchase and sales records also did not fully correspond with the inventory found during inspection.
The regulator further observed that some medicines had been kept directly on the floor instead of being stored using appropriate pallets and racks. Procedures and documentation for dealing with expired medicines were also found deficient.
Recall compliance questioned
The FDA issued a show-cause notice after recording the alleged violations and gave the licence holder an opportunity to explain its position. After considering the response, the regulator concluded that the identified deficiencies had not been adequately rectified. It also remained dissatisfied with compliance relating to its instructions for recalling Reactin Plus Tablets. The drug sale licences of the Pune C&F unit were consequently cancelled.
FDA warns of strict action
FDA Commissioner Tukaram Mundhe said the regulator would take a strict approach to violations that could affect medicine safety and public health. He stressed that entities involved in manufacturing and distributing medicines must comply with regulations covering advertising, storage, sale and distribution, particularly in the case of Schedule H prescription drugs. The FDA said breaches of statutory requirements by companies operating anywhere in the medicine supply chain would attract action under applicable law.