The first inkling that children were dying in numbers as a result of taking a widely prescribed cough syrup called DOK-1 Max came to light in the middle of December.
The alert was not sounded by Uzbekistan’s government.
The troubling news was instead spread by means of a letter written to the chief of the Samarkand regional health department by the head of a state-run pediatric clinic in the same region. As the official wrote in the letter, which was leaked onto social media, health workers began to notice a spike of kidney ailments among children taking DOK-1 Max. The syrup began to be prescribed amid a reported surge of colds.
By the count of the authorities, which may well be far from comprehensive, although there is no way to determine this with certainty, at least 65 children lost their lives. Most of the victims were under three years old.
It is still unknown how many children who took the syrup were otherwise affected. Some parents reported that their children survived but had their health critically compromised.
Marion Biotech, the Indian company that produced the tainted drug, has said that up to 20,000 vials of DOK-1 Max “were delivered throughout Uzbekistan.” There is no information about how many of the doses were sold in pharmacies before the drug was banned.
Since August 11, a court in Tashkent has been hearing the trial of 21 people – 16 men and five women – accused of allowing all this happen. The defendants, who include one Indian national, are charged with a range of offenses, from the production and sale of substandard medicines and negligence to bribery and the forgery of documents.
Among the accused are former officials responsible for regulating the pharmaceutical industry, as well as representatives for the Uzbek company Quramax Medikal, which imported the drugs from Marion Biotech.
Although the Samarkand clinic official’s letter came to light in mid-December, the Health Ministry only moved to ban thesale of DOK-1 Max on December 22. SMS messages urging the public to refrain from buying the medicine were sent out one week after that.
The head of the Health Ministry explained at the time that the response to the crisis was so slow because local government officials were hiding the scale of the fatalities.
“The death of children … has shown the state of affairs on the ground, there is no control,” President Shavkat Mirziyoyev said in December, when he commented on the situation. “All officials who allowed for mistakes will answer before the law.”
Laboratory testing would later go on to show that the presence of the industrial compounds diethylene glycol and ethylene glycol in the Marion Biotech-produced drugs were 300 times above the norm allowed for by medical standards. The syrup should have contained propylene glycol as its base material.
Several weeks after the scandal broke in Uzbekistan, the World Health Organization, or WHO, would go on to classify DOK-1 Max and AMBRONOL, another syrup produced at Marion Biotech’s Uttar Pradesh factory, as failing “to meet quality standards or specifications.”
The “manufacturer has not provided guarantees to WHO on the safety and quality of these products,” the organization said in a January 11 statement.
In an investigation published in June, Reuters news agency found that diethylene glycol and ethylene glycol – also known as DEG and EG, respectively – were being used by companies seeking to offset the sharp rise in prices for propylene glycol.
In March, the Uttar Pradesh Drugs Controlling and Licensing Authority announced it had cancelled Marion Biotech’s manufacturing license. But Reuters reported last month that the same authorities appear to have since allowed the company to resume most of its production activities.
In June, India made it mandatory for producers of cough syrups to apply for government certification before their product qualified for export.
One of the defendants in the ongoing trial has admitted that the state pharmaceutical regulator had not conducted its own tests on DOK-1 Max before registering it. The official, who has been identified in media reports only by the initials G.S., said that since the drug had previously been registered, it was felt no further tests were needed when it came time to renew that registration. It was not clear from her remarks as reported by local media how DOK-1 Max was registered the first time around.
“We did not do any laboratory tests,” said the woman, who reportedly worked as the head of a department at the State Center for the Medical Product Standards. “Nobody ever had any complaints about this situation. We learned about all this when the investigation began.”
Legislation regulating drugs does stipulate, however, that almost all medicines in circulation in Uzbekistan need to be subjected to tests. The process is meant to take place over six stages and can last several months. The regulations do not specifically address the procedure for re-registration.
Other evidence that has come to light in the trial indicates that troubling shortcuts were taken. The head of Quramax Medikal, Raghvendra Pratar Singh, has confessed to paying a $33,000 bribe to representatives of the drug regulator to avoid an audit of Marion Biotech products.
The court also found out that Quramax Medikal made regular payments to doctors, nurses and pharmacists to prescribe or promote DOK-1 Max. Overall, the company paid Uzbek healthcare professionals more than $600,000 to fuel the syrup’s prescriptions.
Financial payments from pharmaceutical companies to doctors in Uzbekistan remains a common practice. In 2019, Prosecutor General Nigmatilla Yuldashev said that some physicians did “a certain line of business” when prescribing drugs in exchange for cash from the drug makers.
Amid all these developments, the pharma sector in Uzbekistan remains in ferment. One of the defendants in the DOK-1 Max trial is Sardor Kariyev, who was until the scandal broke the director of the state Pharmaceutical Industry Development Agency. When Kariyev resigned, he was replaced by Ulugbek Egamov, who has in turn replaced last month by Abdulla Azizov, a 42- year-old with a background in IT.