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WHO warns against three substandard oral cough syrups in India—Coldrif, Respifresh TR, and ReLife—linked to child fatalities and urges regulatory authorities to ensure recalls and surveillance.

WHO issues alert against substandard oral cough syrups in India

WHO warns against three substandard oral cough syrups in India&mdash;Coldrif, Respifresh TR, and ReLife&mdash;linked to child fatalities and urges regulatory authorities to ensure recalls and surveillance.

The World Health Organisation (WHO) has issued an alert against three "substandard" oral cough syrups identified in India -- Coldrif, Respifresh TR and ReLife -- and urged national regulatory authorities worldwide to immediately notify it if these are detected in their country.
It has also advised healthcare professionals to report the detection of these substandard products and any incident of adverse effects, or lack of expected effects to their national regulatory authorities or National Pharmacovigilance Centre.
The alert comes after at least 22 children, mostly under the age of five, have died due to suspected kidney failure after being administered Coldrif in Madhya Pradesh. Besides, at least three children have allegedly died in Rajasthan after consuming cough syrup in different districts of the state.
The WHO has further called for increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these substandard products.
"Increased surveillance of the informal/unregulated market is also advised," the alert issued on Monday said.
The affected products are oral liquid medicines containing active ingredients commonly used to relieve symptoms of common cold, flu, or cough According to the alert, the Central Drugs Standard Control Organization (CDSCO) of India reported to WHO the presence of Diethylene Glycol (DEG) in at least three oral liquid medicines in October 8. This followed information identified by WHO on September 30 of localised clusters of acute illness and child fatalities in India.
The CDSCO informed WHO that the contaminated products were reportedly consumed by the affected children and confirmed that relevant state authorities have ordered an immediate halt to production at implicated manufacturing sites and have suspended product authorisations.
In addition, a recall of the contaminated products has been initiated by relevant state authorities.
The contaminated oral liquid medicines have been identified to be specific batches of Coldrif, Respifresh TR and ReLife, manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma, the alert said.
The alert stated the CDSCO has informed WHO that none of the contaminated medicines have been exported from India and there is currently no evidence of illegal export.
"Nevertheless, WHO encourages National Regulatory Authorities (NRAs) to consider targeted market surveillance, with particular attention to informal and unregulated supply chains where products may circulate undetected. NRAs are also advised to carefully evaluate risks associated with any oral liquid medicines originating from the same manufacturing sites- particularly those produced since December 2024," the alert stated.
The products identified in this alert are considered substandard as they fail to meet their quality standards and their specifications. These contaminated products pose significant risks to patients and can cause severe and potentially life-threatening illness, the global health agency said.
Diethylene glycol is toxic to humans when consumed and can prove fatal.The contaminated oral liquid medicines referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.
To protect patients, it is essential to detect and remove these contaminated products from circulation, the alert said.
"Healthcare professionals should report the detection of these substandard products and any incident of adverse effects, or lack of expected effects to their National Regulatory Authorities or National Pharmacovigilance Centre. The WHO advises increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these substandard products. Increased surveillance of the informal/unregulated market is also advised.
National regulatory authorities and law enforcement authorities are advised to immediately notify the WHO if these products are detected in their country," the alert stated.
"If you are in possession of any of these products, WHO recommends that you do not use them. If you, or someone you know, has, or may have, used these products, or suffered an adverse event or unexpected side-effect after use, seek immediate medical advice from a health-care professional or contact a poisons control centre.," it added.

Child deaths in Gambia linked to consumption of made-in-India cough syrups, suggests US Body

'Strong link' between child deaths in Gambia and made-in-India cough syrups: US Body report

According to the CDC, they were contacted by Gambia's Ministry of Health (MoH) to assist in characterizing the illness (multiple cases of Acute Kidney Injury and deaths in children).&nbsp;

A joint probe by the Centers for Disease Control and Prevention (CDC) of the US and the Gambian health authorities has suggested a strong link between the death of many children in Gambia and the consumption of made-in-India cough syrups that were allegedly contaminated. In October, the World Health Organization (WHO) had issued an alert stating that the four cough syrups being supplied to Gambia by the India-based Maiden Pharmaceuticals Ltd were of substandard quality and claimed that they were linked to the death of many children in Gambia.
A CDC report released on Friday stated, "This investigation strongly suggests that medications contaminated with Diethylene Glycol [DEG] or Ethylene Glycol [EG] imported into the Gambia led to this Acute Kidney Injury (AKI) cluster among children." "Patients with DEG poisoning can experience a range of signs and symptoms, including altered mental status, headache, and gastrointestinal symptoms; however, the most consistent manifestation is AKI, characterized by oliguria (low urine output) or anuria, progressing over 1-3 days to renal failure (indicated by elevated serum creatinine and blood urea nitrogen),&rdquo; read the report.
According to the CDC, they were contacted by Gambia's Ministry of Health (MoH) to assist in characterizing the illness (multiple cases of Acute Kidney Injury and deaths in children), describing the epidemiology, and identifying potential causal factors and their sources in August last year.
The report also said that in past DEG outbreaks, manufacturers have been suspected of substituting DEG in the place of more expensive, pharmaceutical-grade solvents.
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 Uzbekistan cough syrup death: 3 pharmaceutical firm employees arrested from Noida

&nbsp;Uzbekistan cough syrup death: 3 pharmaceutical firm employees arrested from Noida

The Noida Police on Friday arrested three employees of a city-based pharmaceutical firm whose cough syrup is alleged to have led to the death of 18 children in Uzbekistan last year, officials said.
The arrests come after an FIR was lodged late Thursday night against five officials of Marion Biotech, including two of its directors, over a complaint by a drugs inspector of the Central Drugs Standard Control Organization (CDSCO), they said.
The central and Uttar Pradesh state drug authorities had checked samples of Marion Biotech's drugs and found 22 of them to be "not of standard quality" (adulterated and spurious), according to the complainant drug inspector.
"Three persons named in the FIR have been arrested, while the two directors of the company are at large. Those arrested are Tuhin Bhattacharya, Head Operation; Atul Rawat, Manufacturing Chemist; and Mool Singh, Analytical Chemist," Phase 3 police station in-charge Vijay Kumar told PTI.
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Marion Biotech, which has its office in Sector 67 here, had come under the scanner in December last year for its cough syrup Dok-1 that is suspected to have led to the death of 18 children who consumed it in Uzbekistan after which the CDSCO launched a probe into the matter.&nbsp;

Cough syrup-related deaths: after WHO alert, Indian pharma's production licence suspended

On Wednesday, the WHO also issued a 'medical product alert', referring to two substandard (contaminated) products, identified in Uzbekistan and reported to it on December 22, 2022.

The production licence of Noida-based pharmaceutical firm Marion Biotech, allegedly linked with the deaths of children in Uzbekistan, has been suspended while the test results of its controversial cough syrup are awaited, an Uttar Pradesh drug official said Thursday.
A team of central agencies and the Uttar Pradesh drug department on Thursday carried out a fresh inspection at Marion Biotech's office here, a day after the World Health Organisation (WHO) issued a medical product alert on Ambronol and Dok-1 Max syrups, both manufactured by the firm.
The health ministry of Uzbekistan claimed these children had consumed the cough syrup.
On Wednesday, the WHO also issued a 'medical product alert', referring to two substandard (contaminated) products, identified in Uzbekistan and reported to it on December 22, 2022.
Also watch: <a title="Cough syrup-related deaths: after WHO alert, Indian pharma's production licence suspended" href="https://www.editorji.com/india-news/local/cough-syrup-related-deaths-after-who-alert-indian-pharma-s-production-licence-suspended-1673533332705">Cough syrup-related deaths: after WHO alert, Indian pharma's production licence suspended</a>
With PTI Inputs

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