WHO Issues Medical Product Alert on India-Made Cough Syrup: What Does It Mean?

Yet another cough syrup manufactured in India has come under fire by the World Health Organization for being 'contaminated'.A 'substandard' batch of the drug in question, Guaifenesin Syrup, identified in the Marshall Islands and Micronesia (Australia), was issued a medical product alert by the WHO.What does medical product alert mean? How will it impact this cough syrup? Read on to find out.Cough Syrup Deaths: India Must Focus On Systemic Gaps Over Pharma ReputationWhat happened: In a statement released on 25 April, WHO said that samples of Guaifenesin Syrup from the Marshall Islands were tested by the Therapeutic Goods Administration (TGA) of Australia. The analysis found that the product contained unacceptable amounts of diethylene glycol (DEG) and ethylene glycol in the products.The WHO traced the manufacturer of the affected product to QP Pharmachem Ltd, based in Punjab. The product is marketed by Harya-based Trillium Pharma.The WHO, in its statement, also said, "neither the stated manufacturer, nor the marketer have provided guarantees to WHO on the safety and quality of these products."Why it matters: WHO warns that the product mentioned in the Alert is unsafe and its use, especially in children, may result in serious injury or death.Diethylene glycol and ethylene glycol, in particular, can be very toxic to humans if consumed, and can lead to abdominal pain, vomiting, diarrhoea, headache, acute kidney injury, and even death.The big picture: This is not the first time cough syrup manufactured in India has been pulled up for DEG poisoning. In fact, just months ago, DEG contaminated cough syrups from India were linked to the death of over 60 children in the Gambia and around 18 children in Uzbekistan.‘No Evidence That Cough Syrups Work’: Why Are They So Widely Used in India?A 'medical product alert' is essentially the WHO's response to substandard medical products that could potentially cause a significant threat to International public health.According to the WHO, a Medical Product Alert is issued when a drug or medical product is tested, and the following criteria are met.The report been validated (e.g. through laboratory analysis)It poses a genuine and significant threat to public healthThe risk extends beyond the country where the product was discoveredIf prior warnings or alerts have already been issued concerning the medical productAdequate steps have not been taken to remove the product from the supply chainIt is a recent report and the SF product is likely still in circulationAction to be taken: The alert is meant to warn stakeholders of the development so that surveillance and diligence within the supply chains of countries and regions likely to be affected by these products may be increased.Health authorities of other nations have also been advised to notify WHO is the flagged products are found in their respective country.It does not, however, mean the WHO, or any health authority, is taking direct action against the manufacturing company. That is for the health authorities of the home country to do.Gambia, Uzbekistan Cough Syrup Deaths: How Safe Are Made-In-India Drugs?

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WHO Issues Medical Product Alert on India-Made Cough Syrup: What Does It Mean?

The affected product is a batch of Guaifenesin Syrup TG Syrup made by a pharma company in Punjab, said WHO.

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Topics: Cough Syrup What We Know