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 at the site. The facility also issued unauthorized promotional claims for the prescription drug Reactin Plus.
The regulator found Reactin Plus packaging misbranded with the claim 'analgesic and antipyretic'. Officials stated these advertisements pose a public health risk by encouraging self-medication.
This move follows a US FDA inspection of Cipla’s Pithampur plant. That inspection resulted in seven observations. These cumulative regulatory findings could negatively affect the company’s reputation and operations.