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New Delhi- Drug regulatory body CDSCO has initiated a probe in connection with the death of 18 children in Uzbekistan allegedly linked to a cough syrup made by an Indian firm, with Health Minister Mansukh Mandaviya saying further action would be taken based on the inspection of the pharma company.
Mandaviya said the Central Drugs Standard Control Organisation (CDSCO) is in regular contact with the national drug regulator of Uzbekistan regarding the matter since December 27.
The health ministry of Uzbekistan has claimed that 18 children have died after consuming the cough syrup ‘Dok-1-Max’.
“Immediately on receipt of information, joint inspection of the NOIDA facility of the manufacturer, Marion Biotech, was carried out by UP Drug Control and CDSCO team and further action as appropriate would be initiated based on the inspection report,” Mandaviya said in a series of tweets.
Marion Biotech is a licenced manufacturer and holds licence for manufacturing of ‘Dok-1 Max’ syrup and tablet for export purpose granted by drug controller, Uttar Pradesh, the health ministry said in a statement.
The samples of the cough syrup have been taken from the manufacturing premises and sent to the Regional Drugs Testing Laboratory (RDTL), Chandigarh for testing, Mandaviya said.
Hasan Harris, legal representative of Marion Biotech, said the governments of both countries are looking into the matter and inquiring.
“There is no problem from our end and no issue in testing. We have been there for the past ten years. Once the government report will come, we will look into it. For now the manufacturing has stopped,” Harris said.
According to the ministry, chemical ethylene glycol was found in a batch of syrup during laboratory tests.
Earlier this year, death of 70 children in Gambia was linked to cough syrups manufactured by Haryana-based Maiden Pharmaceuticals following which the unit was shut for violation of manufacturing standards.
However, later the samples tested in a government laboratory in India were found to be complying with specifications.
India’s drug regulator had told the World Health Organisation (WHO) earlier this month that the global health body drew a premature link between the deaths of children in Gambia and the four India-made cough syrups which adversely impacted the image of the country’s pharmaceutical products across the globe.
In a letter to Dr Rogerio Gaspar, Director (Regulation and Prequalification) at WHO, Drugs Controller General of India (DCGI) Dr V.G. Somani had said that a statement issued by the global health body in October in the wake of the deaths “was unfortunately amplified by the global media which led to a narrative being built internationally targeting the quality of Indian pharmaceutical products”.
The DCGI had said that India has been committed to rigorous monitoring and oversight to ensure that the highest standards of manufacture are maintained in quality control of drugs and cosmetics.
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