ISLAMABAD: Following the detection of “poisonous impurities,” the Drug Regulatory Authority of Pakistan (DRAP) has recalled a cough syrup and imported raw material used in it, says an alert issued here on Thursday.
According to the DRAP alert, Ethylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid preparations, can lead to serious health risks due to EG’s toxicity. When ingested, EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal.
The DRAP advisory said that the regulatory field force identified a batch of PG that was used as a solvent in the manufacturing of oral liquid preparations. The batch was labelled as manufactured by Dow Chemical, Thailand. However, on analysis of a sample by the Central Drug Laboratory in Karachi, an unacceptable level of EG was found, therefore, the authority took the action.
Owing to the aforementioned reasons, the Regulatory Field Force has taken possession of a contaminated batch of PG and is investigating the entire supply chain of this batch. The therapeutic goods manufacturer has been instructed to recall any finished products that were manufactured using the same lot of propylene glycol. The Regulatory Field Force has also been instructed to seize all oral preparations that were made using the same batch of propylene glycol if found in the market. The DRAP has directed the therapeutic industry to hold finished products manufactured from any other lot of propylene glycol of Dow Chemical Thailand and ensure testing of finished products for EG/DEG contamination before releasing them into the supply chain.
The regulator has advised manufacturers of therapeutic goods to follow these instructions: (i) If any batch was manufactured using the same lot (C815N30R41) of propylene glycol that has been identified as contaminated, all finished products from local and export markets should be recalled.
(ii) All finished products manufactured from any other lot of propylene glycol of Dow Chemical Thailand should be held. These products should be tested for EG/DEG contamination before releasing them into the supply chain.
(iii) Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG.
(iv) Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.
(v) Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.
(vi) Adhere to the pharmacopoeia monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products.
DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products.
DRAP requested healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres.
Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products must be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.
Consumers should stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately and report the incident to the Drug Regulatory Authority of Pakistan/National Pharmacovigilance Centre.
All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.
When contacted a top official of DRAP, said every pharmaceutical company was supposed to test all the active as well as non-active raw materials for impurities for the safety of patients, adding that DRAP was also starting “risk-based sampling and testing” of raw materials being imported in the country. Asked why criminal proceedings were not being launched against the manufacturers and importers, the DRAP official said some of the companies would be prosecuted as they were found involved in criminal activities.
“Here in this fresh case, we suspect that some middle man imported raw material from an authentic source in Thailand but later added industrial grade material in it to increase its quantity and provided it to the manufacturers. We are not only recalling the raw material imported by this middle man but are also going to lodge a criminal case if any wrongdoing was proved after investigations,” the official added.
Copyright Business Recorder, 2024
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