On December 27, Uzbekistan Health Ministry issued a press release stating that the children who died after taking India-made cough syrup were given the medicine without a doctor’s prescription.
In the statement, the Ministry said, “The medicine was taken without a doctor’s prescription. The main ingredient of the medicine is paracetamol, which confused the parents, and they used it incorrectly as an anti-cold medicine independently or on the recommendation of the pharmacists. “This caused the condition of patients to worsen.”
Chronology of events and statements issued by Uzbekistan authorities
Around 21 children in Samarkand, Uzbekistan, were reported to have fallen sick after taking a medicine called Dok-1 Max, a cough syrup of Indian origin. 18 of these 21 children died while getting treatment in the hospital, following the reports that children fell sick after taking the said cough syrup. Uzbekistan’s Ministry of Health issued an advisory to immediately stop the sale of the medicine in the country.
Док 1 Макс даян шамоллоша карши дорини ишлатмангла. Ножуя таъсири натижасида боллода буйрак ишламин колади акан. Самаркандда шу дорини ичиб больнисага тушган 21 болодан 15 таси улган.
(C) инсайдерлар pic.twitter.com/sw8mdRh62S
— Abbos Kh (@ibnAlisher) December 20, 2022
In a letter shared by Twitter user Abbos Kh, the Ministry of Health was informed about the incident on December 15 by the administration of Children’s Multidisciplinary Medical Centre, Samarkand. The letter noted that children took Dok-1 Max medicine during the treatment of viral disease, a popular medicine among primary care doctors. (OpIndia used Google Translator and Google Lens for the translation of the letter.)
It further noted that the medicine might cause severe side effects, including kidney damage. In two months, 21 patients were admitted to the hospital, out of which 17 had severe side effects, and 15 died. The letter further urged the Ministry to prohibit the said medicine among children.
On December 22, a press release was issued on the official Telegram Channel of Uzbekistan’s Health Ministry informing about the side effects of the medicine. Pharmaceutical Network Development Agency said in the statement that a team of experts was formed to examine the medicine Dok-1 Max manufactured by India’s Marion Biotech Pvt Ltd. The sale of the medicine was temporarily suspended till further notice. (OpIndia used Google Translator and Google Lens for the translation of the press release.)
On December 27, Uzbekistan’s Ministry of Health issued a press release saying that the results of Dok-1 Max syrup confirmed the crime and that the results were sent to law enforcement agencies. As per the press release, Marion Biotech Pvt Ltd’s Dok-1 Max tablets and syrup were registered in the country in 2012. The drug was imported to Uzbekistan by Kiramax Medical LLC. (OpIndia used Google Translator and Google Lens for the translation of the press release.)
After the death of 18 out of 21 children who reportedly got sick with acute respiratory diseases, a probe was initiated. During the investigation, the Ministry’s officials found that the children took medicine for 2-7 days up to 2.5-5 millilitres 3-4 times a day. The dose taken by the children was much more than normally prescribed for the children.
Furthermore, the medicine was taken without a doctor’s prescription. The main ingredient of the medicine is paracetamol, which confused the parents, and they used it incorrectly as an anti-cold medicine independently or on the recommendation of the pharmacists. “This caused the condition of patients to worsen,” the Ministry added.
The laboratory also found traces of ethylene glycol, a contaminant, in the syrup, which is a toxic substance, and 1-2 ml of a 95% concentration can cause severe damage to the patient’s health. Side effects of the contaminant include vomiting, lethargy, seizures, cardiovascular problems and acute kidney failure.
The Ministry took action against seven employees. A number of specialists were disciplined for their carelessness and inattention to their duties as they failed to analyse deaths on time and did not take necessary actions. The medicine was withdrawn from sale across the country. The Ministry further urged the parents not to give medicine to children without a prescription from a doctor.
On the same day, the Minister of Health, B. Musaev, expressed his condolences to the parents and relatives of 18 children who died. He also assured that the culprits involved in the case would be held accountable.
India’s action in the Uzbekistan case
Soon after the authorities in India were informed about the incident, an inquiry into the Noida-based drug manufacturer was initiated. Hindustan Times quoted an unnamed official from the Union Ministry of Health and Family Welfare (MoHFW) saying that the Drugs Controller of India and the Uzbek regulator are in contact. The information was being shared related to the matter. “Drugs Controller General of India is in contact with the Uzbek regulator to obtain detailed information. This company, it seems, has been supplying drugs to Uzbekistan for a long period of time,” he said.
On Tuesday, the Union Drug Regulatory informed the Uttar Pradesh Drug Licensing Authority to initiate an inquiry. Samples were taken from the factory by the north zone drug regulatory team of the central government and state drug regulatory teams. AK Jain, Deputy Commissioner, DCLA UP, said, “As soon as we received an email from the central drugs regulatory team that an inquiry needed to be conducted today, we immediately formed an investigating team comprising the assistant commissioner of drugs (Meerut division) and drug inspector from Gautam Buddh Nagar (Uttar Pradesh) to join the Central Drugs Standard Control Organisation (north zone) to investigate the allegations.”
Quoting Central Drugs Controller’s officers, HT noted that the samples were taken from the exported and current batches of the medicine and sent to a laboratory for testing. The action will be taken as per the report. Furthermore, another officer told HT that the company’s representatives were questioned about the raw material for the medicine. The officer added, “The tests of samples conducted in India did not find anything concrete; therefore, it will not be prudent to make any comments at this stage on Marion’s samples. Let’s wait for the test report.”
In a statement, Marion Biotech Pharma Company legal head Hasan Raza told ANI, “We regret deaths, the government is conducting the inquiry. We will take action as per the report. Samples were collected. Manufacturing of that product has been halted as of now and other processes are underway.”
There are two aspects of the report. The first ethylene glycol was present in the medicine. Secondly, it was noted by Uzbekistan’s Ministry of Health that high doses of the medicine were given to the children without a valid prescription from a doctor. As the probe into the matter is underway, it will be too soon to assert and blame the Indian drug fully for the unfortunate incident.