The Maharashtra Food and Drug Administration (FDA) cancelled the drug sale and distribution license for Cipla Pharma & Life Sciences' Pune facility. This regulatory action becomes effective on August 27, 2026.
Inspectors identified deficiencies in drug storage and inadequate stock records. The facility also issued unauthorized promotional claims for the prescription drug Reactin Plus.
The product packaging misbranded the drug as an analgesic and antipyretic. State regulators warned that such advertising encourages self-medication and poses a public health risk.
This development follows a separate US FDA inspection at Cipla's Pithampur plant. That inspection resulted in seven regulatory observations.