New Delhi: Following Uzbekistan’s claiming that at least 18 children in the country have died after allegedly consuming an India-manufactured cough syrup, the Ministry of Health has stated that the samples of the syrup have been sent for laboratory testing and further action will be initiated based on the inspection report
The health ministry of Uzbekistan, in a statement, said that the children who died had consumed cough syrup Doc-1 Max – manufactured by Noida-based Marion Biotech.
India has launched a probe into the matter and the manufacturing of the cough syrup has been halted until the samples are tested.
Health Minister Mansukh Mandaviya said samples have been sent to Regional Drugs Testing Laboratory in Chandigarh for testing and that the government would “initiate further action based on the inspection report. The Centre is in touch with Uzbekistan since December 27.
According to the Uzbekistan’s health ministry, the laboratory tests of a batch of syrups found “the presence of ethylene glycol”, a toxic substance. It also said the syrup was given to children at home without a doctor’s prescription, either by their parents or on the advice of pharmacists, with doses that exceeded the standard dose for children.
It was found that the children, before being hospitalised, took this syrup at home for 2-7 days, in doses of 2.5 to 5 ml three to four times a day, which exceeds the standard dose, the ministry said.
The syrup was used by the parents as an anti-cold remedy.
After the deaths of 18 children, Doc-1 Max tablets and syrups have been withdrawn from all pharmacies in the country, the statement said, adding that seven employees were sacked because they failed to analyse the situation in time and take steps.
A joint inquiry is being conducted by the teams of Central Drugs Standard Control Organisation (CDSCO – north zone) and Uttar Pradesh Drugs Controlling and Licensing Authority.
A casualty assessment report has also been sought from Uzbekistan.Marion Biotech said samples of the cough syrup have been collected from its manufacturing unit and that they are now waiting for the test report.
“The government is conducting an inquiry. We will take action as per their report, for now, the manufacturing has stopped,” said Hasan Raza, the company’s legal head.
This is the second time in a year that India-manufactured cough syrups have come under the scanner.
Earlier this year, deaths of 70 children in Gambia were linked to cough syrups manufactured by Haryana-based Maiden Pharmaceuticals.
The Central Drugs Standard Control Organisation had in October shut its unit in Sonepat for violation of manufacturing standards.
The WHO had earlier said that laboratory analysis of Maiden cough syrup had confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury.
Responding to WHO, Drugs Controller General, VG Somani, had said that tests on samples of Maiden’s products at government laboratories had “been found to be complying with specifications” and no toxic substance was detected in them.
