Spurious drugs: Punjab FDA cancels Dera Bassi cough syrup manufacturer’s licence
Vishav Bharti
Chandigarh, May 17
Coming down heavily on the manufacturer in the recent contaminated cough syrup case, the Punjab Food and Drug Administration (FDA) today cancelled the licence of Dera Bassi-based QP Pharmachem Ltd for manufacturing liquid oral and injectable formulations.
Besides, production at the tablet and capsule manufacturing unit has also been stopped and will remain suspended until the manufacturer complies with the norms. Earlier, the manufacturing of all liquid formulations at the unit was temporarily stopped and the manufacturer was issued a show-cause notice.
Unit based in Dera Bassi
- The WHO had issued an alert after 18,000 bottles of cough syrup exported to Cambodia by QP Pharmachem Limited were found contaminated
- On April 18, a joint team of the CDSCO and the FDA inspected the unit and collected samples, which were found contaminated
According to sources, the manufacturer failed to comply with the hygiene norms, especially related to air, and also failed to furnish a satisfactory reply to the show-cause notice.
Exercising its powers under Rule 85 of the Drugs and Cosmetics Act, 1940, the FDA cancelled the licence of the manufacturer. Last month, the World Health Organisation (WHO) had issued an alert after 18,000 bottles of cough syrup exported to Cambodia by QP Pharmachem Ltd were found contaminated. On April 18, a joint team of the Central Drugs Standard Control Organisation (CDSCO) and the FDA carried out an inspection at the unit and also collected samples of the cough syrup.
A report of the CDSCO confirmed that the cough syrup being manufactured by the Dera Bassi unit was contaminated. The CDSCO report found that the cough syrup was contaminated with diethylene glycol and ethylene glycol. The contaminants can cause nausea, diarrhoea, abdominal pain or even death in adverse cases.
