Cough syrup deaths: Production on hold as Central, UP drug dept teams inspect firm

Following reports of deaths of 18 children in Uzbekistan after consuming a made-in-India cough and cold syrup, Indian drug regulators inspected the Noida premises of its manufacturer Marion Biotech and picked up samples for testing, while its production has been put on hold.

Though there is no formal complaint from the central Asian country, the Ministry of External Affairs has taken up the matter with the authorities in Tashkent, seeking details of an ongoing internal investigation besides providing consular assistance to individuals facing legal action as part of the probe.

Union Health Minister Mansukh Mandaviya on Thursday said a joint inspection of the Noida facility of Marion Biotech was carried out by UP Drug Control and Central Drug Standards and Control Organisation teams. Any further action would be initiated based on the inspection report.

Also Read | Marion Biotech stops producing cough syrup after Uzbekistan deaths

The ministry was informed by Uzbekistan about the unfortunate incident on December 27.

Marion Biotech holds licence for manufacturing Dok1 Max syrup — believed to be the causative agent behind the deaths — and tablet for export purpose granted by the Drugs Controller, Uttar Pradesh.

The cough syrup samples have been sent to the Regional Drugs Testing Laboratory, Chandigarh.

The syrup is a cocktail of three medicines — paracetamol, guaifenesin and phenylephrine hydrochloride — and is being sold as a product intended for the treatment of blocked nose, sore throat, productive cough, headache and fever associated with cold and flu.

Also Read | Uzbekistan cough syrup-linked deaths: Mandaviya says inspection carried out at Noida facility

A legal representative of Marion Biotech said the Indian maker of pharmaceuticals and cosmetics regretted the deaths and the company halted production of Dok-1 Max syrup.

A December 27 press statement from the Uzbekistan Health Ministry identified two factors behind the tragedy — excess doses of the medicine in kids who don't require the drug and presence of ethylene glycol — a toxic chemical — as a contaminant in the syrup.

The Uzbekistan incident comes two months after 70 children died in The Gambia reportedly after drinking contaminated cough syrups made by Haryana-based Maiden Pharmaceuticals. The World Health Organisation (WHO) issued a global alert in the wake of the tragedy as tests revealed presence of diethylene glycol and ethylene glycol — two toxic contaminants — in some of the cough syrup samples.

Subsequent testing of Maiden products by Indian officials didn't find the contaminants in any of the four syrups that were sent to The Gambia, but the government is yet to restart production at the Haryana unit. The causality report from the WHO is yet to come.

Maiden Pharma and Marion Biotech are not two isolated cases of DEG and EG contamination as there were several such cases in the past, leading to the death of Indian children. Earlier this week, the Centre launched a country-wide inspection of medicine production units.