FDA Cancels License for Dera Bassi-based Cough Syrup Manufacturer QP Pharmachem
Punjab Food and Drug Administration (FDA) has cancelled the licence of QP Pharmachem Ltd for manufacturing liquid oral and injectable formulations. The company based in Dera Bassi is said to have failed to comply with hygiene norms. This comes after World Health Organisation (WHO) noted that many bottles manufactured at the factory were contaminated.
Last month, the WHO notified the public that 18,000 bottles of cough syrup exported to Cambodia by QP Pharmachem Ltd were contaminated. Central Drugs Standard Control Organisation (CDSCO) and the FDA carried out an inspection at the factory and collected samples of the cough syrup. At the time, the manufacturing of all liquid formulations at the unit was temporarily stopped and the manufacturer was issued a show-cause notice.
CDSCO confirmed that the cough syrup being manufactured by the Dera Bassi unit of QP Pharmachem was contaminated. The report found that the cough syrup contained diethylene glycol and ethylene glycol. The contaminants can cause nausea, diarrhoea, abdominal pain or even death in adverse cases.
Now, it has been reported that the FDA has cancelled the licence of QP Pharmachem Ltd for manufacturing liquid oral and injectable formulations. Furthermore, production at the tablet and capsule manufacturing unit has been stopped and will remain suspended until the manufacturer complies with the norms.
Sources have stated that the manufacturer failed to comply with hygiene norms, especially related to air, and had also failed to produce a satisfactory reply to the show-cause notice.