Maharashtra FDA cancels Pune pharma firm's licence after June raid

The Maharashtra FDA has cancelled the drug sale licence of a Pune-based pharma firm for multiple violations, including unauthorised advertising on prescription drugs, failure to follow recall directions, and poor storage conditions.

The Food and Drugs Administration (FDA) of Maharashtra on Friday cancelled the Carry and Forwarding (C&F) drug sale licences of a prominent pharmaceutical firm located in Wadki, Pune, with effect from August 27, citing multiple regulatory violations. The action came after an FDA raid conducted in June this year at the firm's warehouse, where a Schedule H prescription drug stock worth Rs 11.19 lakh was seized.

Multiple Violations Cited

According to the Maharashtra FDA, the packaging of the prescription medicine carried unauthorised advertising text promoting it as an "analgesic & antipyretic". The FDA said such unauthorised promotion of prescription medicines could encourage self-medication and pose a risk to public health.

The firm was also found to have failed to properly implement subsequent drug recall directions. A follow-up inspection revealed several other critical regulatory compliance failures, including discrepancies between physical stock and computerised purchase and sales records. The inspection also found failure to comply with drug recall instructions, substandard storage conditions, including drugs being stored directly on the floor and inadequate pallet and rack arrangements, as well as deficiencies in record-keeping and procedures for managing expired medicines.

Licence Cancelled After Unsatisfactory Response

Following the issuance of a Show-Cause Notice and after the explanations submitted by the firm were found unsatisfactory, the FDA cancelled the licences with immediate effect.

FDA Vows Strict Action on Non-Compliance

"There will be no compromise on drug safety and public health. Strict compliance with legal provisions regarding the advertising, sale, storage, and distribution of prescription drugs is mandatory. Stringent action will be taken against any violator in the supply chain," said Tukaram Mundhe, Commissioner, FDA Maharashtra.

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