State govt asks M/S Pharma to stop manufacturing saline

Kolkata: The state Health department has asked a saline manufacturing unit to stop manufacturing the product after a joint inspection team from Central Drugs Standard Control Organisation (CDSCO) and the state Drug Control Directorate found the unit was not conforming to certain standards of manufacturing.

A joint team from the two organisations carried out an inspection at the unit of M/S Pharma Impex Laboratories Pvt Ltd (Pharma Impex) in Baruipur on Jan 21 and 23. The teams found gross deficiencies in Good Manufacturing Practice (GMP) that covers areas including quality, pest-free environment, quality raw material, standard equipment, proper storage and trained manpower. After the Midnapore Medical College incident, the state banned Paschim Banga

Pharmaceuticals from producing and supplying Ringer’s lactate and other drugs. After this, the majority of the saline in government hospitals was supplied by Pharma Impex.

The drug control licensing authority has also issued a show-cause notice to M/S Pharma Impex Laboratories Pvt Ltd (Pharma Impex) asking why its licence should not be cancelled for violation of Drugs and Cosmetic Rules 1945.

The Health department has not however stated clearly whether to recall all saline bottles by this particular company, which are already in circulation in govt hospitals.