The World Health Organisation (WHO) has issued a global alert against three India-made cough syrups — Coldrif, Respifresh TR, and ReLife — after they were found to be contaminated with toxic chemicals linked to multiple child deaths in Madhya Pradesh and Rajasthan. The alert follows reports that at least 22 children in Madhya Pradesh and three in Rajasthan, mostly under the age of five, died of suspected kidney failure after consuming the syrups.
According to the alert issued on Monday, the Central Drugs Standard Control Organization (CDSCO) of India confirmed the presence of diethylene glycol (DEG) — a toxic substance that can cause acute kidney injury and death — in samples of the three syrups. The contaminated batches were manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma.
Between 2019 and January 2020, supply of substandard cough syrups had led to 12 deaths in Ramnagar tehsil of Udhampur district. The contaminated drug syrups had also led to multiple complications among a number of other children. The culprit then was a Baddi-based drug manufacturer who had supplied the cough syrups which had led to these deaths. The product, Coldbest-PC, contained lethal levels of diethylene glycol (DEG), a toxic industrial chemical.
The presence of diethylene glycol was confirmed by tests conducted at the Regional Drugs Testing Laboratory in Chandigarh. The report found the Coldbest-PC syrup contained more than 34% DEG, far exceeding any safe limit and making the drug “not of standard quality”. The Coldbest-PC syrup was manufactured by Himachal Pradesh-based company named Digital Vision.
Relentless pursuit of culprits by social activist Sukesh Khajuria had led to the National Human Rights Commission (NHRC) intervening in the matter. It had then asked the Health Department of Union Territory (UT) of Jammu & Kashmir to pay some money as compensation to the victims, perhaps Rs 3 lakh for those who had died. Many children were left crippled and suffer till date due to the contaminated cough syrups. The deaths of children have been reported at a time when winter is about to start and the consumption of common cough formulations registers a sharp spike.
The National Human Rights Commission (NHRC) investigated the deaths following a complaint from the social activist. The NHRC concluded that the Jammu and Kashmir Drugs Department showed negligence and ordered the government to pay compensation. The case had then reached the Supreme Court which had upheld the NHRC order for compensation. There was one death reported from Bishnah tehsil of Jammu district at that time.
The world health body has called upon national regulatory authorities to report immediately if the products are detected in their countries. This worldwide alert has been sounded in view of the fact that some of Indian medicines are exported and these cough syrups may be among them. The chances of these drugs reaching many countries in Africa and even Latin America are there.
According to a report in The Hindu, officers of the Enforcement Directorate (ED) are conducting searches at seven locations in Tamil Nadu after the arrest of GG Ranganathan in connection with the deaths of several children in Madhya Pradesh after consuming the company’s Coldrif cough syrup. The Tamil Nadu government has also revoked the license of this pharmaceutical company.
A team from Madhya Pradesh had arrested Ranganathan, 75, who owns the Kancheepuram-based Sresan Pharmaceuticals. He was arrested last week in Kodambakkam, Chennai, by a Special Investigation Team (SIT) from Madhya Pradesh on charges of manufacturing contaminated cough syrup that led to the deaths of 22 children in the State. Two more staff members of the firm were also arrested.
Tests conducted on Batch SR-13 by Tamil Nadu’s drug testing laboratory confirmed dangerous levels of diethylene glycol (DEG), a toxic organic compound, prompting the suspension of Sresan’s manufacturing licence and the sealing of its facility in Sunguvarchatram, Kancheepuram. DEG is a dangerous contaminant and only 0.1 per cent of it is considered safe for human beings, particularlychildren who gets adversely impacted if higher dosage are there. Vital organs like kidneys, brain and heart are all affected by higher dosage and several other side effects have also been reported.
According to open source information available on the Internet, Rednex Pharmaceuticals is a drug manufacturing company based in Ahmedabad (Gujarat). Shape Pharma is another Gujarati company based in Surendranagar which is in the eye of the storm due to infant deaths. The Gujarat government has asked both Rednex and Shape Pharma to stop manufacturing cough syrups. The firms have also been directed to recall some batches they may have supplied in the recent past.
According to Gujarat Health Minister Rushikesh Patel, the firms have been asked to recall their products after some of them were found to be “Not of Standard Quality’’ (NSQ). The state government has collected 14 samples from Rednex and 11 from the Shape Pharma for investigations.
Following the findings by the Tamil Nadu government, state authorities suspended the production licences of the implicated manufacturers, halted product authorisations, and initiated recalls of the affected batches. While the CDSCO informed WHO that none of the contaminated syrups had been exported, the global health body urged all countries to maintain strict surveillance, especially in informal and unregulated drug markets.
The reason for WHO warning is that many of common cough syrups and other formulations get smuggled though officially there are no exports recorded. As such, the chances of them impacting children abroad are very real, particularly in some poorer nations.
“The contaminated oral liquid medicines pose significant risks and are unsafe for use, especially in children,” WHO warned, advising healthcare professionals to report any adverse effects and urging the public to avoid the identified products and seek immediate medical attention if exposed.
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