- Cipla Pharma's Pune drug sales licences were cancelled by Maharashtra FDA from August 27
- Cancellation followed issues with storage, stock records, and unauthorised promotional claims
- Reactin Plus Tablets had unauthorised analgesic and antipyretic claims on packaging
Cipla arm has faced regulatory action in Maharashtra after the state Food and Drug Administration (FDA) cancelled the drug sales licences of Cipla Pharma & Life Sciences in Pune, citing deficiencies in drug storage, stock records and unauthorised promotional claims.
The cancellation took effect from August 27, according to the Maharashtra FDA's action against the company's Pune operations.
The regulatory action follows an investigation into Reactin Plus Tablets, a Schedule H prescription drug. The FDA found that the product packaging carried an unauthorised claim describing it as an "analgesic and antipyretic".
The Maharashtra FDA had conducted action against Reactin Plus in June and seized stock valued at Rs 11.19 lakh. According to the regulator, the promotional claim on the packaging was not authorised and could potentially encourage consumers to self-medicate with a prescription medicine.
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The FDA said such advertising could pose a public health risk by potentially influencing consumers to use the drug without appropriate medical supervision. Cipla was subsequently directed to recall Reactin Plus stock from the market.
However, the regulator found that the company had not fully complied with directions relating to the recall, contributing to the action against its drug sales licences.
The inspection also identified deficiencies in the way medicines were being stored at the company's Pune facility. The Maharashtra FDA said drug stocks were found stored directly on the floor, raising concerns over compliance with prescribed storage practices.
The inspection also found discrepancies in stock records, adding to the regulatory concerns identified during the probe. The combination of the alleged unauthorised promotional claim, incomplete compliance with recall directions, storage deficiencies and discrepancies in stock records led to the cancellation of the company's drug sales licences in Pune.
Reactin Plus is classified as a Schedule H prescription drug, meaning its sale is subject to prescription-related regulatory requirements.
The FDA's concern over the "analgesic and antipyretic" claim centres on the potential for such messaging to influence consumers to use the medicine without consulting a healthcare professional.
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