Sunday May 28, 2023

Pharma firm section sealed for exporting substandard cough syrup to Gambia: NHS

February 26, 2023

ISLAMABAD: The syrup section of a local pharmaceutical firm has been sealed by the Drug Regulatory Authority of Pakistan (DRAP) after the Medicines Control Agency (MCA) Gambia reported that a cough syrup manufactured by the said pharmaceutical company found to be contaminated with toxic chemicals, health authorities in Islamabad said on Sunday.

“The DRAP has sealed the syrup section of the pharmaceutical compnay after medical control agency of Gambia reported that cough syrup manufactured and exported by the company to Zambia contained unacceptable levels of Diethylene Glycol (DEG) or Ethylene Glycol (EG), which can cause immediate death by causing kidney failure”, an official of the National Health Services, Regulations and Coordination (NHS,R&C) told The News on Sunday.

According to World Health Organization (WHO), hundreds of children and adults have died in several countries in Africa and Asia which reported several incidents of over-the-counter cough syrups for children with confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol (EG). The cases are from at least seven countries, associated with more than 300 fatalities in three of these countries.

Most are young children under the age of five and in majority of cases, cough syrups produced in India contained contaminants, which are toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even taken in small amounts, and should never be found in medicines.

Following the alert issued by the MCA Gambia regarding substandard cough syrup produced in Pakistan by the Davis Pharmaceutical Laboratories, Islamabad, the DRAP officials also issued a recall alert and asked the manufacturing company and all the drug inspectors and officials to confiscate all the seven suspected products of the Davis Pharma in the country.

“Fortunately, not a single product of this company has been found at the pharmacies in the country. The batch which reportedly contained the toxic chemicals beyond permissible levels was manufactured only for export”, the NHS official said and added that samples of the syrups produced by the company have been send to chemical analysis at Drug Testing Lab (DTL) of DRAP.

The official said instructions have been issued to the DRAP to take stern action against the manufacturer including cancellation of production license and arrest of the owners of the company if they were found involved in the criminal negligence, saying at a time when Pakistani authorities were trying to increase the medicine imports, such reports were extremely damaging for the image and security of the country. “We have also directed the DRAP to take action against all the pharmaceutical companies which are not following Good Manufacturing Practices (GMP) and producing substandard medicines. We only need companies that follow international standards of medicines’ manufacturing”, the official added.

An official of the DRAP said immediately after the Gambian authorities issued the red alert, they investigated the matter and also issued a recall alert in the country but added that no suspected products of the said company were found at pharmacies in the country. “The said batch which reportedly contained the unacceptable levels of toxic compound was manufactured in 2021 and it was not supplied in the country. We have sealed their syrup section and initiated inquiry after sending the samples for the chemical analysis at DTL. If they are found contaminated, strict action would be initiated against the culprits”, the DRAP official added.

The official informed that in order to prevent children from falling sick by consuming syrup medicines, the Drug Regulatory Authority of Pakistan (DRAP) had directed all the pharmaceutical companies of Pakistan back in October 2022 to ensure the use of ‘pharmaceutical grade solvents (ingredients)’ purchased from qualified vendors and keep a close eye on the presence of toxic materials, which should not be present in the medicines’ raw materials.

Hundreds of children have already died in Gambia and Indonesia during last six to eight months by consuming syrup medicines containing ingredients linked to acute kidney injuries (AKI), DRAP official said. “But no such case has been reported in Pakistan yet due to enhanced surveillance and strict monitoring of the therapeutic goods’ manufacturing process,” the official added.