Less than three months after Sonepat-based Maiden Pharma products were flagged as substandard and unsafe, the WHO issued a global medical alert on Wednesday night for two cough syrups manufactured by Noida-based Marion Biotech.
The firm was earlier shut down for operations by the Indian drug regulator after Uzbekistan flagged the deaths of children after consuming these drugs in excess of prescribed doses.
The latest WHO Medical Product Alert refers to two sub-standard (contaminated) products that were identified in Uzbekistan and reported to WHO on December 22, 2022.
Sub-standard medical products are products that fail to meet quality standards or specifications and are, therefore, “out of specifications”.
The two products are Ambronol Syrup and DOK-1 Max Syrup. The declared manufacturer of both the products is Marion Biotech Pvt Ltd, (Uttar Pradesh, India). Till date, the said manufacturer has not given guarantees to WHO on the safety and quality of these products. Laboratory analysis of samples of both products, carried out by the National Quality Control Laboratories of the Ministry of Health of the Republic of Uzbekistan, found that both products contained unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants,” WHO said.
It said that both these products may have marketing authorizations in other countries in the region. They may also be distributed through informal markets to other countries or regions.
Accordingly, WHO has asked nations to recall the products.
The substandard products referred to in this latest alert, WHO said, “are unsafe and their use, especially in children, can cause serious injury or death. Toxic effects include abdominal pain, vomiting, diarrhea, inability to urinate, headache, May include changes in mental status and severe kidney injury that can lead to death.
In advising regulatory authorities and the public, WHO said it is important to detect and remove these sub-standard products from circulation to prevent harm to patients.
India has taken samples of the allegedly contaminated products from the Noida-based firm and is awaiting the results of the laboratory tests.
Source – tribuneindia