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'Substandard...': WHO warns against use of cough syrups linked to Uzbek deaths
The syrups were administered in doses higher than prescribed for children, either by parents who mistook it for an anti-cold remedy or on the advice of pharmacists, according to an analysis.
The World Health Organization has warned against prescribing two India-made cough syrups for children after they were linked to the death of 19 children in that country last month. The WHO said the 'substandard medical products' - both made by Noida-based Marion Biotech - 'are products that fail to meet quality standards or specifications and are therefore out of specification'.
In a 'medical product alert' issued Wednesday, the 'substandard medical products' were identified as 'AMBRONOL and DOK-1 Max'. The WHO said, "The stated manufacturer of both is Marion Biotech Pvt Ltd… To date, manufacturer has not provided guarantees to WHO on safety and quality of these products."
Marion Biotech has been battling controversy since news of the deaths emerged and did not immediately respond to Reuters' request for a comment.
On Monday Uttar Pradesh's drugs licensing and controlling authority suspended its manufacturing licence, people in the know told Hindustan Times.
Officials said the company had failed to respond to a 'show cause' notice served on December 30; they had been given seven days to reply.
READ | Uzbekistan cough syrup deaths: UP suspends licence of Noida company
Production of all medicines at the plant had already been stopped per a directive by union health minister Mansukh Mandaviya.
READ | Marion Biotech, cough syrup makers linked to Uzbek deaths, halts production
The minister said a report by a Central Drugs Standard Control Organisation (CDSCO) team revealed 'reports of contamination in cough syrup DOK-1'.
The Dok-1 Max and AMBRONOL syrups contain a toxic substance - ethylene glycol - and was administered in doses higher than prescribed.
It is unclear who authorised the high dosages. The medication - tablet and syrup - have been withdrawn from all pharmacies in Uzbekistan.
Watch: India-made cough syrup 'toxic' for 18 Uzbekistan kids | Details
Last week Uzbek authorities arrested four people as part of their investigations; this was after seven employees of the Uzbek health ministry were sacked.
Neither Dok-1 Max or AMBRONOL is understood to be for sale in India.
This is the second-such controversy surrounding India's pharma exports; the first involved the export of a cough syrup to The Gambia where 70 kids died.
That syrup was made by New Delhi-based Maiden Pharmaceuticals Ltd. However, in that case the government and company denied any wrongdoing.
READ | 'Compliant with norms': India to WHO on Gambia kids' deaths
Known as the 'pharmacy of the world', India has doubled pharma exports over the last decade, touching $24.5 billion in the last fiscal year.
With input from ANI, Reuters
