Drugs standards body collects AMBRONOL syrup samples after WHO recommends not using it

Following the World Health Organization’s (WHO) recommendation against using two cough syrups manufactured by Noida-based Marion Biotech due to “substandard quality,” the Central Drugs Standard Control Organization collected four samples of AMBRONOL syrup for investigation on Thursday.

“The team of CDSCO has collected four samples of AMBRONOL syrup for investigation from Marion Biotech Pvt Ltd,” the Drug inspector of Gautam Buddh Nagar, Uttar Pradesh Vaibhav Babbar said. It’s a joint inspection by team of state drugs inspectors and CDSCO.

WHO on Wednesday said that two cough syrups made by Noida-based company Marion Biotech should not be used for children in Uzbekistan.

In a medical product alert on Wednesday, the WHO said the “substandard medical products”, manufactured by Marion Biotech, “are products that fail to meet quality standards or specifications and are therefore out of specification.”

“This WHO Medical Product Alert refers to two substandard (contaminated) products, identified in Uzbekistan and reported to WHO on 22 December 2022. Substandard medical products are products that fail to meet quality standards or specifications and are therefore out of specification,” the WHO said in an alert released on its website.

“The two products are AMBRONOL syrup and DOK-1 Max syrup. The stated manufacturer of both products is MARION BIOTECH PVT. LTD, (Uttar Pradesh, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,” the alert added.

Noida-based pharma Marion Biotech has come under a cloud as reports emerged about the death of children after consuming cough syrup came in from Uzbekistan.

According to WHO, laboratory analysis of samples of cough syrups, undertaken by national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan found both products contained unacceptable amounts of diethylene glycol and /or ethylene glycol as contaminants.

“Both of these products may have marketing authorizations in other countries in the region. They may also have been distributed, through informal markets, to other countries or regions,” the

WHO alert added. On December 22, Uzbekistan alleged that 18 children had died after consuming medicines manufactured by Marion Biotech company. On Tuesday, Uttar Pradesh Food Safety and Drug Administration department suspended the production licence of Marion Biotech company linked to Uzbekistan’s deaths of 18 children.

“We have suspended the production license of Marion Biotech company after not providing enough documents, a show-cause notice was also given by the state licensing authority depending upon the documents asked during the inspection which they didn’t provide,” said Gautam Buddh Nagar Drug inspector Vaibhav Babbar.