NEW DELHI: After Gambia, Uzbekistan claimed that drugs manufactured by an Indian pharma company led to the deaths of 18 children.
Mandaviya says samples collected, action based on inspection report
Union Health Minister Dr Mansukh Mandaviya said that the Central Drugs Standard Control Organisation (CDSCO), which has started the probe, has been in regular touch with the national drug regulator of Uzbekistan since December 27.
“Immediately on receipt of the information, a joint inspection of Marion Biotech’s Noida facility was carried out by UP Drug Control and the CDSCO team. Further action as appropriate would be initiated based on the inspection report,” he tweeted.
“The samples of the cough syrup have been taken from the manufacturing premises and sent to Regional Drugs Testing Laboratory, Chandigarh for testing,” he further said.
The Union Health Ministry in a statement also said that “Marion Biotech is a licensed manufacturer and holds license for manufacturing of Dok1 Max syrup and Tablet for export purposes granted by Drugs Controller, Uttar Pradesh.”
The Noida-based Marion Biotech Private Limited legal representative said that the samples of the cough syrup, said to have led to the deaths, have already been collected.
The company was registered in Uzbekistan in 2012.
"How the deaths (in Uzbekistan) occurred, the government is conducting an investigation. The report will reveal the truth," said the company's legal representative, Hasan Harris.
"There is no problem from our end and no issue in testing. We have been there for the past ten years. For now, the manufacturing has stopped," he added.
According to officials, a joint team of CDSCO and the Uttar Pradesh Drugs Controlling and Licensing Authority inspected the manufacturing unit in Noida two days back. The samples have already been sent for testing contamination. Officials are also examining for possible Good Manufacturing Practice (GMP) violations.
The action came after Uzbekistan’s Ministry of Health said 18 of 21 children took Doc-1 Max syrup, manufactured by Indian company Marion Biotech Private Limited, as they were suffering from an acute respiratory disease.
The World Health Organisation (WHO), which had issued a global alert over India-made four cough syrups linked with the deaths of 70 children in The Gambia in October, said they are ready to assist in further investigations.
According to Uzbekistan, so far, 18 out of 21 children with acute respiratory disease have died as a result of taking Doc-1 Max syrup.
"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, 2.5-5 ml, which exceeds the standard dose of the drug for children," Uzbekistan’s Health Ministry said in a press release. The deaths occurred in Samarkand.
“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 the recommendation of pharmacy sellers. And this was the reason for the deterioration of the condition of patients.”
The preliminary laboratory studies have shown that this series of Doc-1 Max syrup contains ethylene glycol.
"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,” they added.
The ministry said seven employees had been dismissed because they failed to analyse child mortality promptly and did not take necessary measures.
The ministry also said that all the tablets and syrups of the drug Doc-1 Max have been withdrawn from sale in all pharmacies of the country and asked parents to purchase medicines in pharmacies only by prescription.
The death of children in Uzbek has come in the wake of a similar one in The Gambia, where at least 70 children died allegedly after consuming cough syrups manufactured by a New Delhi-based Maiden Pharmaceuticals Ltd.
Reacting to the deaths, Congress leader Jairam Ramesh, tweeted, "Made in India cough syrups seem to be deadly. First it was the deaths of 70 kids in Gambia & now it is that of 18 children in Uzbekistan. Modi Sarkar must stop boasting about India being a pharmacy to the world & take strictest action."
India in the parliament has said that the samples collected from Maiden Pharma, linked with The Gambia children deaths, have been declared to be of standard quality. Though The Gambian government also denied any link between child deaths and the Indian cough syrups, a parliamentary committee in The Gambia has recommended the prosecution of Maiden Pharmaceutical, the manufacturer of cough syrups.
India on Tuesday announced that they had launched inspections of some drug manufacturing factories across the country to ensure high-quality standards. But they didn’t reveal the names of such manufacturing units.