Recall of locally manufactured cough syrup ordered after DRAP alarm

Drug Regulatory Authority of Pakistan found 'out of specification presence' of Pseudoephedrine, a controlled substance

By
Khawar Khan

KARACHI: The Pakistani branch of global pharmaceutical and healthcare company Novartis has ordered complete recall of their locally manufactured cough and cold syrup Sancos due to out of specification composition of the controlled substances in the product. 

The Drug Regulatory Authority of Pakistan (DRAP) had raised the issue after Drug Inspectors during a routine check found Sancos Syrup for cough and cold to contain more than the required normal levels of Pseudoephedrine, a controlled substance.

A controlled substance is generally a drug or chemical whose manufacture, possession, or use is regulated by the government which provides the substance to the manufacturer according to their required quota.

Pseudoephedrine, a decongestant, is mostly used in the manufacture of medicine for relief from cold, flu, hay fever, allergies, bronchitis and even insomnia. 

In light of the alarm raised by DRAP the the Inspector of Drugs governing the Islamabad Capital Territory ordered the immediate recall of the medicine from pharmacies in February. 

Following the order Novartis Pharmaceuticals issued a notification informing all doctors, caregivers, patients and those involved in medical practices and sale of medicines to return all stock of the syrup. 

In a notice widely published Novartis Pharma Pakistan Limited stated that the said medicine was manufactured under license by a third party pharmaceutical company and issued directives that all stocks of the medicine be returned. However in its advertisements Novartis did not state why it had ordered a product recall.