Another Gambia-type situation? Did 18 children in Uzbekistan die after consuming cough syrup made in India?

The Uzbekistan government has claimed that 18 children have died after allegedly consuming syrup that was made in India.

This development comes months after the Gambia claimed four cough syrups made in India were responsible for the death of 69 children.

The Uzbekistan health ministry in a statement said 18 children died from the side effects of cough syrup Dok-1 Max produced an Indian pharmaceutical firm.

Let’s take a closer look at this controversy:

What happened?

AKI.com reported that the children, who died after being hospitalised with acute respiratory illnesses, had consumed ‘Dok-1 Max’ cough syrup manufactured by Noida-based Marion Biotech Limited.

As per Scroll, the Uzbekistan health ministry in its statement said the children consumed 2.5 millilitres to 5 millilitres of the cough syrup three to four times a day.

The children were given the medicine without a doctor’s prescription, as per The Quint.

“Since the main component of the drug is paracetamol, Dok 1 Max Syrup was incorrectly used by parents as an anti-cold remedy on their own or on the recommendation of pharmacy sellers,” the statement read. “And this was the reason for the deterioration of the condition of patients.”

Preliminary investigation showed that the Dok-1 Max cough syrup contains ethylene glycol, the statement added.

Ethylene glycol is one of the toxic contaminants the WHO had in October linked to the death of the children in the Gambia.

Dok-1 Max cough syrup and tablets have been withdrawn from all the country’s pharmacies, the statement added.

News18 quoted the World Health Organisation as saying: “WHO is in contact with health authorities in Uzbekistan and is ready to assist in further investigations”.

Sources at India’s health ministry told Moneycontrol that the cough syrup is not sold in India.

More details are awaited.

Deadlock over the Gambia deaths continue

This news comes days after India’s drug regulator in a letter to the WHO said test samples of cough syrups linked to the deaths in the Gambia met government standards and were not contaminated.

The test results, carried out at a government laboratory, have been forwarded to a health ministry panel of experts.

“As per the test reports received from the government laboratory, all the control samples of the four products have been found to be complying with specifications,” the letter stated, as per The Quint.

“The technical committee mentioned above has met several times. Each time the committee requested specific information from WHO on further details essential to establish the causality. Communications were sent to the WHO on 15th October, 20th October, and on 29th October 2022. Every time WHO has maintained that they are in contact with their team handling the case assessment and would get back at the earliest or that their ground partners were working on it. But no information so far has been exchanged by WHO with CDSCO,” Dr VG Somani wrote in the letter dated 13 December.

The drugs regulator also said the WHO had drawn a premature link between the deaths of children in Gambia and the four India-made cough syrups which adversely impacted the image of the country’s pharmaceutical products across the globe.

The WHO, however, has refused to back down.

“WHO’s mandate is to issue global alerts about potential risks. WHO stands by the action taken,” organisation spokesperson Tarik Jasarevic told Reuters.

“These contaminated syrups are dangerous and should not be in any medicine, ever,” Jarasevic said, adding that WHO-contracted labs in Ghana and Switzerland tested the cough syrups made by Maiden Pharma and found excess levels of ethylene glycol and diethylene glycol.

The Gambia, meanwhile, continues to hold Maiden Pharmaceuticals’ cough syrups responsible for the deaths.

“The government should pursue legal action against Maiden Pharmaceuticals for exporting contaminated drugs to The Gambia with the Atlantic brand name,” an expert panel told the country’s National Assembly, as per The Quint.

The panel is calling for the company to be blacklisted and its products banned, as per the report.

CDSCO inspecting factories across India

The news comes a day after Central Drugs Standard Control Organisation (CDSCO) started conducting inspection of identified drug manufacturing units jointly with state authorities.

The joint inspections are being conducted all over the country according to the standard operating procedures on the directions of Union Health Minister Mansukh Mandaviya, a health ministry statement said.

An action plan for the nationwide inspection of manufacturing units which are identified to be at the risk of manufacturing not of standard quality, adulterated or spurious drugs was made prior to the inspections, according to the statement.

A committee of two joint drugs controllers has been constituted at the CDSCO headquarters to monitor the process of inspection, reporting and subsequent action so as to ensure compliance with the Drugs and Cosmetics Act, 1940 and Rules, the statement said.

This will ensure high standards of quality compliance with respect to drugs manufactured in the country.

The objective of drug regulation is to ensure safety, efficacy and quality of the drugs available in the country. The drug control administration is required to ensure that manufacturing units comply with the Drugs & Cosmetics Act and Rules

Maiden eyes factory reopening

Meanwhile, Maiden Pharmaceuticals said on Friday it will seek to reopen its main factory.

The plant was closed after the World Health Organization said in October that its investigators had found “unacceptable” levels of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury, in the products.

Maiden managing director Naresh Kumar Goyal told Reuters he had full faith in Indian regulatory and judiciary processes.

“I have not done anything wrong,” he said.

“We will now try to request the authorities to reopen the factory. But I don’t know when that will happen. We are still waiting.”

India, known as the “pharmacy of the world”, supplies 45 per cent of all generic medicines to Africa. India’s pharmaceutical exports have more than doubled in the last decade to hit $24.5 billion in the last fiscal year.

Union minister Bharati Pravin Pawar told Parliament on Friday that Maiden’s manufacturing operations remain shut for now due to other violations.

The government found in October that the firm had violated rules “across its manufacturing and testing activities”.

With inputs from agencies

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