After Gambia incident, Uzbekistan Health Ministry has now claimed that 18 children have died after consuming cough syrup manufactured by Noida-based Marion Biotech.
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.
The laboratory tests of a batch of syrups found the presence of ethylene glycol, a toxic substance, the ministry said.
It also said the syrup was given to children at home without a doctor’s prescription, either by their parents or on the advice of pharmacists, with doses that exceeded the standard dose for children.
It was found that the children, before being hospitalised, took this syrup at home for 2-7 days, in doses of 2.5 to 5 ml three to four times a day, which exceeds the standard dose, the ministry said.
“All children were given the drug without a doctor’s prescription. Since the main component of the drug is paracetamol, Doc-1 Max syrup was incorrectly used by parents as an anti-cold remedy on their own or on the recommendation of pharmacy sellers. And this was the reason for the deterioration of the condition of patients,” it said.
In a statement, Uzbekistan Health Ministry said, “We reported the occurrence of side effects in children as a result of taking the drug Doc-1 Max in the city of Samarkand.”
“Tablets and syrup Doc-1 Max manufactured by the Indian company “Marion Biotech Pvt. Ltd” in our country were registered in 2012 and went on sale in the same year. According to the Agency for the Development of the Pharmaceutical Industry, each drug series was tested with the subsequent issuance of a certificate of conformity. This drug was imported into our country by Quramax Medical LLC,” the official statement said.
“To date, 18 out of 21 children with acute respiratory disease have died as a result of taking Doc-1 Max syrup,” it added.
It further added, “In fact, paracetamol should only be used at a body temperature of 38-38.5 C and above 1 or 2 times a day, 100-125 mg for a child under the age of one year, 200 mg for children aged 1-3 years and 250 mg – from 3 to 5 years. At normal body temperature, taking this drug is strictly prohibited.”
As per the ministry, preliminary laboratory studies have shown that this series of Doc-1 Max syrup contains ethylene glycol. This substance is toxic, and about 1-2 ml/kg of a 95% concentrated solution can cause serious changes in the patient’s health, such as vomiting, fainting, convulsions, cardiovascular problems and acute kidney failure.
It also added that, 7 responsible employees were dismissed from their positions due to the fact that they were negligent and inattentive to their duties, did not analyze child mortality in a timely manner and did not take the necessary measures, also disciplinary measures were applied to a number of specialists.
The ministry said that the collected documents were handed over to law enforcement agencies.
Furthermore it added that, currently, tablets and syrups of the drug Doc-1 Max are withdrawn from sale in all pharmacies of the country in the prescribed manner.
The shortcomings identified on the basis of the study materials, the issue of the responsibility of medical workers will be considered at a separate meeting of the Collegium of the Ministry of Health, it said.
A criminal case was initiated against officials of Quramax Medical and State Center for Expertise and Standardization of Medicines under Article 186-3 of the Criminal Code (Violation of the order of retail sale of medicines containing potent substances).
The WHO had earlier said that laboratory analysis of Maiden cough syrup had confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury.
Responding to WHO, Drugs Controller General, VG Somani, had said that tests on samples of Maiden’s products at government laboratories had “been found to be complying with specifications” and no toxic substance was detected in them.