As part of the investigation into reported high levels of diethylene glycol, SAHPRA conducted tests on samples from the two affected batches of Benylin Paediatric syrup using an independent laboratory and a method recommended by the World Health Organization.
The World Health Organization suggests a broader warning will be issued regarding the contaminated Johnson and Johnson-made children's cough syrup discovered in Nigeria. The cough syrup, known as Benylin Paediatric, underwent laboratory tests conducted by Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC).
“Benylin Paediatric syrup is indicated for the relief of cough and its congestive symptoms and for the treatment of hay fever and other allergic conditions in children aged 2 to 12 years.
“Diethylene glycol is toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death,” NAFDAC In a statement published on its website.
The batch currently under recall was manufactured in South Africa in May 2021 and has an expiration date of April 2024. The regulatory body advised individuals in possession of bottles from this batch to cease usage or sale and deliver them to the nearest office.
Following Nigeria's recall, five other African nations have also removed the product from their shelves - Rwanda, Kenya, Tanzania, Zimbabwe, and South Africa, where the medication was produced.
An extra batch of the syrup has been recalled by South Africa's regulatory authority. SAHPRA, the national regulatory authority for health products in South Africa, enforces health product recalls to address safety concerns or quality issues in the interest of public health.
As part of the investigation into reported high levels of diethylene glycol, SAHPRA conducted tests on samples from the two affected batches of Benylin Paediatric syrup using an independent laboratory and a method recommended by the World Health Organization. The results showed no presence of diethylene glycol in the recalled batches, indicating that units from batches 329303 and 329304 stored at the correct temperature would not have unacceptable levels of diethylene glycol.
“SAHPRA will continue to closely monitor medical products that have the potential of containing unacceptable levels of diethylene glycol. And we will continue to address safety concerns or quality issues so that the health of the public is protected,” says SAHPRA CEO, Dr Boitumelo Semete-Makokotlela
In 2022, the World Health Organization connected Indian-manufactured cough syrup to the occurrence of acute kidney failure, resulting in the tragic deaths of nearly 70 children in West Africa. As a response, Indian authorities took action by closing down a factory near Delhi, where these medicines were produced. However, it took them a whole week to do so. The suspension of the plant's manufacturing operations only came about after a thorough investigation conducted jointly by the state and federal drug regulatory authorities, which uncovered 12 violations.
According to laboratory analysis conducted by the WHO, the cough syrups contained "unacceptable amounts of diethylene glycol and ethylene glycol," chemicals that are typically used in industrial settings. In defense of their manufacturing process, the company responsible for the cough syrup has issued a response, while India's federal drug regulator has disputed the findings presented by the WHO. This is not an isolated incident, as cough syrups have previously been associated with other instances of mass poisonings among children in India and other countries.
Activists argue that the root of the problem lies in the longstanding lack of stringent regulation within India's thriving pharmaceutical industry. India is a major exporter of medicines to more than 200 countries and plays a significant role in the generic market in the United States. With a current turnover of $50 billion, its pharmaceutical industry ranks among the largest in terms of volume. However, critics contend that the government's oversight is severely deficient; creating an environment that fosters dangerous violations.
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