The Maharashtra FDA on Saturday withdrew its order to cancel the drug sale licence of Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding unit in Pune after the Bombay High Court pulled up the regulator for going “overboard” and behaving in a “high-handed” manner.
According to the media reports, the cancellation action followed inspections that identified several alleged regulatory lapses. FDA officials are reported to have seized Reactin Plus Tablets, a Schedule H prescription medicine, after finding the unauthorised claim ‘analgesic & antipyretic’ on its packaging.
Medicines were found stored directly on the floor instead of on appropriate pallets and racks. Differences were identified between physical stock and computerized records, along with inadequate records for expired medicines.
The warehouse allegedly failed to fully comply with earlier FDA directions to recall the affected Reactin Plus batches.
