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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.

The Enforcement Directorate raided Sresan Pharmaceuticals and Tamil Nadu FDA officials in a money laundering probe linked to Coldrif cough syrup, blamed for child deaths in Madhya Pradesh and Rajasthan.

ED raids Coldrif manufacturer, TNFDA officials

The Enforcement Directorate raided Sresan Pharmaceuticals and Tamil Nadu FDA officials in a money laundering probe linked to Coldrif cough syrup, blamed for child deaths in Madhya Pradesh and Rajasthan.

The ED on Monday raided premises linked to Sresan Pharmaceuticals, the manufacturer of Coldrif cough syrup that allegedly caused deaths of children in Madhya Pradesh, and top officials of the Tamil Nadu FDA as part of a money laundering investigation, official sources said.
At least seven premises in Chennai are being covered by the Enforcement Directorate under the Prevention of Money Laundering Act (PMLA), they said.
The action came after the federal probe agency registered a criminal case under the anti-money laundering law, taking cognisance of police complaints filed against Sresan Pharmaceuticals in Madhya Pradesh and Tamil Nadu.
At least 22 children, mostly under the age of five, have died after being administered Coldrif in Madhya Pradesh.
Licensed in 2011 by the Tamil Nadu Food and Drug Administration (TNFDA), the Kanchipuram-based Sresan Pharmaceuticals continued operations unchecked for over a decade despite its dismal infrastructure and multiple violations of national drug safety rules, the Central Drugs Standard Control Organisation (CDSCO) has said.
The cough syrup was found to be "dangerously" adulterated with diethylene glycol (DEG), a highly poisonous substance.
The owner of Sresan Pharmaceuticals, G Ranganathan, was arrested by Madhya Pradesh Police on October 9.
Following the children's deaths, the Madhya Pradesh government suspended two drug inspectors and a deputy director of the FDA.
It also transferred the state's drug controller and ordered an investigation into the deaths, while police arrested a doctor from Chhindwara district on charges of negligence.
The Tamil Nadu government has also suspended two senior state drug inspectors and ordered the closure of Sresan Pharmaceuticals.

The Supreme Court dismissed a PIL seeking investigation and reforms over alleged toxic cough syrup deaths in Madhya Pradesh and Rajasthan, citing existing state mechanisms.

Cough syrup deaths: SC rejects PIL seeking CBI probe, nationwide drug safety review

The Supreme Court dismissed a PIL seeking investigation and reforms over alleged toxic cough syrup deaths in Madhya Pradesh and Rajasthan, citing existing state mechanisms.

The Supreme Court on Friday dismissed a PIL seeking an inquiry and systemic reform in drug safety mechanisms in the wake of deaths of children in Madhya Pradesh and Rajasthan allegedly due to consumption of toxic cough syrups.
A bench comprising Chief Justice B R Gavai and Justices Ujjal Bhuyan and K Vinod Chandran dismissed the PIL filed by lawyer Vishal Tiwari after Solicitor General Tushar Mehta objected to it.
The top law officer said the petitioner reads the newspaper and rushes to the court.
The bench, which was initially of the view that the notice should be issued, later dismissed it.
Mehta said he was not appearing for any state at the moment but the seriousness with which states like Tamil Nadu and Madhya Pradesh are taking actions cannot be undermined.
Moreover, there are proper law enforcement mechanisms in states, he added.
The bench asked Tiwari as to how many PILs he has filed so far in the top court and on being told that he has moved eight to 10 such pleas so far, the bench dismissed the instant petition.
"Dismissed," the CJI said.

Madhya Pradesh police arrested Sresan Pharma owner G Ranganathan in Chennai over the adulterated ‘Coldrif’ cough syrup case linked to multiple child deaths.

Police teams arrest TN based cough syrup pharma owner in Chennai

Madhya Pradesh police arrested Sresan Pharma owner G Ranganathan in Chennai over the adulterated &lsquo;Coldrif&rsquo; cough syrup case linked to multiple child deaths.

Tamil Nadu-based Sresan Pharma owner has been arrested by the Madhya Pradesh police with the help of Chennai police in the wee hours of Thursday, in connection with the adulterated cough syrup case, a police official said.
Teams from the Madhya Pradesh police and Chennai cops launched a hunt to trace out and nab the pharma owner Ranganathan.
'Coldrif' cough syrup manufactured by his company is attributed to the deaths of children in multiple states.
A senior police official said he was detained following a midnight operation and taken to Sunguvarchatram police station for an inquiry.
According to the police official, the police teams have been searching for G Ranganathan since October 7 after the Madhya Pradesh police team arrived, and he was finally arrested at 1.30 am today. The police also seized some documents from his Kancheepuram factory.
After being produced in the court here for obtaining the transit remand, he would be taken to Chhindwara, he said.
On October 7, the Sriperumbudur Drug Control Inspector had issued a show-cause notice to the pharma company asking it to explain the discrepancies in the quality and labelling of the medicine. Officials from the TN Directorate of Drugs Control inspected the manufacturing facility and found that the medicines were allegedly stored in &ldquo;unhygienic conditions&rdquo; on the corridors, and they noticed certain risk of contamination, he said.
The Tamil Nadu government had sealed the factory after 20 children from Madhya Pradesh died after consuming the "contaminated" cough syrup allegedly made in the unit. The government banned the cough syrup 'Coldrif' in the state from October 1 and ordered the removal of stocks of the medicine from the market.&nbsp;

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