India's drug regulator probing Uzbekistan cough syrup death allegations

Union health minister Mansukh Mandaviya has said that Indian drug regulatory agency Central Drugs Standard Control Organisation (CDSCO) is in regular touch with the national drug regulator of Uzbekistan after that country said 18 children with acute respiratory disease died in the city of Samarkand after consuming cough syrup manufactured by an Indian company Marion Biotech Pvt Ltd.

In a series of tweets, health minister said CDSCO along with UP Drug Control Administration had carried out a joint inspection of Marion's Noida facility immediately on receipt of the information. Further action as appropriate would be initiated based on the inspection report, he said.

The sample cough syrup have been taken from the manufacturing premises and sent to Regional Drugs Testing Laboratory, Chandigarh for testing, the minister said.

Uzbekistan is the second country after Gambia to link child deaths to India-made cough syrups. In the case of Gambia, the CDSCO had said the test results of sample did not show any evidence of contamination of the medicinal product.

A press release issued by the Ministry of Health of Uzbekistan on December 27 had said that an internal inquiry conducted by the regulatory agencies of that country found that the deceased children, before admission to hospital treatment, took Doc-1 Max syrup manufactured by Marion Biotech for 2-7 days 3-4 times a day, 2.5-5 ml, which exceeds the standard dose of the drug for children. The preliminary laboratory studies conducted by the agencies of that country also found that the particular series of Doc-1 Max syrup contained ethylene glycol, a substance that is toxic.

Uzbekistan has withdrawn the tablets and syrups of the drug Doc-1 Max from sale in all pharmacies of the country.

Noida-based Marion Biotech had got tablets and syrup Doc-1 Max registered in Uzbekistan in 2012. The drug was imported into Uzbekistan by a local company Quramax Medical LLC.

Incidentally, CDSCO and state drug control authorities have commenced joint inspections of India's drug manufacturing facilities all over the country from December 27. The government had stated that the joint inspections were on the basis of an action plan prepared in advance for nationwide inspection of manufacturing units which are identified to be at the risk of manufacturing Not of Standard Quality (NSG), adulterated or spurious drugs.