ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has issued an immediate recall alert for a numbers of drugs following declared substandard and contaminated quality by Central Drugs Laboratory (CDL) Karachi.
In an advisory, the DRAP has directed the National Regulatory Field Force therapeutic goods industry, manufactures of oral liquid preparations and healthcare professionals to recall products, hold other batches, screen raw materials, compliance and follow set guidelines in true letter and spirit.
The DRAP issued recall alert for following drugs: (i) Substandard dexyken 300 mg tablet batch No Kf23006 Manufactured By M/s Kanel Pharma, Plot 6, Street SS-3, Rawat Industrial Estate, Islamabad; (ii) Substandard Nocox Tablets Batch No 8463 Manufactured by M/s Alfalah Pharma (Pvt) Ltd, 12-Km Lahore Road, Jamal Park, Sheikhupura; and (iii) Contaminated Propylene Glycol (Batch # YF01210911) Allegedly Manufactured by M/s Dongying Hi-Tech Spring Chemical Industry Co Ltd, China.
It said:
(i) Di-Ethylene glycol (DEG) and ethylene glycol (EG) contaminated propylene glycol (PG) when used in oral liquid preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences. Federal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis No RM-10-24-000624 dated 19-11-2024 declared the sample of propylene glycol (raw material) sent to CDL Karachi by a licensed pharmaceutical manufacturer in compliance to advisory issued by DRAP vide No 03-41/2023-QC dated 01-12-2023. The supply chain of this raw material is still under investigation.
(ii) Dexibuprofen is a non-steroidal anti-inflammatory drug (NSAID) commonly used to reduce inflammation and pain in conditions such as arthritis. The identified quality issue with these tablets may result in Reduced Efficacy, depending on the degree of substandard quality and the patient’s condition. Vulnerable populations, including elderly patients and those with existing gastrointestinal, cardiovascular, or renal conditions, may be at a higher risk.
(iii) Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) commonly used to reduce inflammation and pain in conditions such as arthritis. The identified quality issue with these tablets may result in Reduced Efficacy, depending on the degree of substandard quality and the patient’s condition. Vulnerable populations, including elderly patients and those with existing gastrointestinal, cardiovascular, or renal conditions, may be at a higher risk.
The Regulatory Field Force has directed to take increase surveillance for identification of above mentioned contaminated batch of propylene glycol in the market and is investigating the entire supply chain of this batch. The Regulatory Field Force has also been instructed to seize all oral preparations manufactured using the same batch of propylene glycol if found in the market.
Manufacturers of therapeutic goods are required to follow these instructions: (i) Recall Products: If any batch was manufactured using the same lot of propylene glycol that has been identified as contaminated, all finished products from local and export markets should be recalled.
(ii) Hold Other Batches: All finished products manufactured from the same lot of propylene glycol should be kept on hold. These products should be tested for EG/DEG contamination before releasing them into the supply chain. (iii) Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG.
(iv) Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products. (v) Follow Guidelines: 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.
The DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products. The DRAP requests 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 pharma co vigilance centres.
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 Pharma co vigilance Centre.
All therapeutic goods must be obtained from licensed pharmacies and other authorised/ 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.
Copyright Business Recorder, 2024
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