By Ghulam Haider
The Indian drug regulator carried out inspection of the Noida-based Marion Biotech’s production facility on Thursday, and promised more action based on the probe report after the company’s cough syrup was linked to death of atleast 19 children in Uzbekistan.
Uzbekistan’s health ministry has said that 19 children have died after drinking a cough syrup manufactured by Indian drug maker Marion Biotech, with preliminary tests showing a batch of the medicine contained ethylene glycol, a toxic substance.
The children were given the Dok-1 Max syrup without a doctor’s prescription, Uzbekistan’s health ministry said, adding that the amount children consumed also exceeded the standard dose for children.
India’s health ministry said in a statement that its officials have been “in regular contact with the national drug regulator of Uzbekistan regarding the matter” since 27 December.
The Drugs Controller General of India (DCGI) said that it inspected Marion Biotech’s production facility in Noida, near India’s national capital Delhi, and promised more action based on the investigation report on the children’s deaths in Uzbekistan allegedly by the company’s cough syrup.
It added that health officials have conducted an inspection of Marion Biotech’s facility in Noida in Uttar Pradesh state. “The samples of the cough syrup have been taken from the manufacturing premises and sent to Regional Drugs Testing Laboratory, Chandigarh for testing,” the statement added. It further said that the Central Drugs Standard Control Organisation (CDSCO) has initiated a probe into the matter.
The incident follows another similar nature that took place in Gambia, where deaths of at least 70 children had been linked to cough and cold syrups manufactured by New Delhi-based Maiden Pharmaceuticals Ltd. The Indian government and also the company, however, have since denied the allegations.
Last week, a parliamentary committee in The Gambia recommended prosecution of Maiden Pharmaceuticals after weeks of investigation. The committee also recommended banning all products by the firm in the country.
The drug regulator reviewed the company’s Noida facility and is in regular touch with its Uzbekistan counterpart, the Indian health ministry said in a statement. “The samples of the cough syrup have been taken from the manufacturing premises and sent to Regional Drugs Testing Laboratory, Chandigarh for testing,” the ministry said.
The Indian maker of the cough syrup which is being probed for the deaths of 18 children in Uzbekistan have said that it regrets the casualties. A legal representative of Marion Biotech said the Indian maker of pharmaceuticals and cosmetics regretted the deaths and the company has halted production of the Dok-1 Max syrup.
Uzbekistan’s health ministry said on Wednesday that at least 18 children in Samarkand city died after consuming the syrup manufactured by the Indian drugmaker. Another child, a one-year-old, died after being given the syrup for five days, Uzbek news website report.uz said on Thursday, citing the Qashqadaryo regional prosecutor’s office.
Officials in the Samarkand region had initially not reported the deaths to the ministry, the report added, citing Health Minister Bekhzod Musayevand.
Seven employees were dismissed by the Uzbek ministry following a probe into the matter, and “disciplinary measures” were taken against some specialists. The Doc-1 Max tablets and syrups have also been withdrawn from all pharmacies, the Uzbek ministry added in its statement on Wednesday.
The syrup contained a toxic substance, ethylene glycol, and was administered in doses higher than the standard dose for children either by their parents, who mistook it for an anti-cold remedy or on the advice of pharmacists, the Uzbekistan ministry said.
Marion Biotech website is currently down, but the company’s LinkedIn page says it was founded in 1999 and that its products are “household names in Central Asian countries, Central and Latin America, South East Asia and Africa”.
Producing a third of the world’s medicines, mostly in the form of generic drugs, India is known as the ‘pharmacy of the world’, and has doubled its pharmaceutical exports over the last decade, touching $24.5 billion in the last fiscal year.
The country, home to some of the fastest-growing pharmaceutical companies, is known as the “world’s pharmacy” and meets much of the medical needs of developing countries.
The Uzbek ministry statement, dated 27 December, says that Dok-1 Max tablets and syrup have been sold in the country since 2012.
“It was found that the deceased children, before admission to hospital treatment, took this drug at home for 2-7 days, 3-4 times a day, 2.5-5ml, which exceeds the standard dose of the drug for children,” the ministry said.
The statement did not specify over what time period the deaths occurred. Uzbek authorities were investigating “claims that 15 children died in central Samarkand region over the past two months after taking a cough syrup made in India”.
On 26 December, Podrobno.uz news website reported that 21 children – 15 of them under the age of three – were treated for acute kidney failure “allegedly caused by the India-made cough syrup Dok-1 Max between September and December”. Three of the patients recovered.
The ministry also said that “preliminary laboratory studies have shown that this series of Dok-1 Max syrup contains ethylene glycol”.
In October, the World Health Organization (WHO) had sounded a global alert and linked four India-made cough syrups to the deaths of 66 children from kidney injuries in The Gambia. It said tests on samples of the syrup showed that they contained unacceptable amounts of toxic substances diethylene glycol and ethylene glycol.