PremiumThe Health Ministry on 29 December said that drug regulatory body CDSCO has initiated a probe in connection with the death of 18 children in Uzbekistan and said that further action would be taken based on the inspection of the pharma company.
The Health ministry in its first statement said that the CDSCO is in regular contact with the national drug regulator of Uzbekistan since 27 December.
As per the statement issued by the Health Ministry, “immediately on receipt of the 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."
Marion Biotech is a licensed manufacturer and holds license for manufacturing of Dok1 Max syrup and Tablet for export purpose granted by Drugs Controller, Uttar Pradesh, as per the ministry.
The samples of the cough syrup have been taken from the manufacturing premises and sent to Regional Drugs Testing Laboratory (RDTL), Chandigarh for testing, the ministry said.
The update was also shared by Health Minister in a series of tweets.
Marion Biotech, does not sell the cough syrup, 'Doc-1 Max', in India and its only export has been to Uzbekistan, as per the state government official statement as reported by news agency PTI.
The health ministry of Uzbekistan claimed that the 18 children had consumed the cough syrup.
The ministry said 18 out of 21 children who took the Doc-1 Max syrup while suffering from an acute respiratory disease died after consuming it. It is marketed on the company's website as a treatment for cold and flu symptoms.
A batch of the syrup contained ethylene glycol, which the ministry said was a toxic substance. The syrup was imported into Uzbekistan by Quramax Medical LLC, the ministry said in its statement released on Tuesday.
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.
Babbar said on December 27, an inspection was carried out by a team of the Centre in which samples of five medicines were taken for testing.
“A further round of investigation is pending for which we have come here today," he said.
“The company does not have any domestic market and has only one export market which is Uzbekistan. No product (Doc-1 Max) has been sold in India," the drug inspector told news agency PTI.
The company is currently operational and they have all mandatory licenses and approvals, including certificate of pharmaceutical product (CoPP) for export which is granted by the Centre, he said.
“Now the investigation underway is to find out from where they procured the raw material and where all it has been used," he said.
The company has been operational since 2010, he added.