Investigation into Indian cough syrup causing deaths in Gambia and Uzbekistan.
The Indian government was caught off guard by a scandal involving the deaths of 66 children in Gambia and a similar case in Uzbekistan, both allegedly caused by Indian cough syrup. Uzbekistan’s Ministry of Health reported 18 deaths out of 21 children who had taken Marion Biotech Pvt Ltd’s Dok-1 Max syrup.
The Uzbek incident
A special working group formed by the Uzbekistan Health Ministry investigated the incident in which children in Samarkand reported side effects after consuming cough syrup. The syrup was used as an anti-cold remedy by parents themselves or on the advice of pharmacists. The working group found that the dosage was slightly higher than recommended for children and laboratory tests revealed the presence of ethylene glycol in the cough syrup samples.
Ethylene glycol, the press note said, was poisonous, and 1.2 ml/kg of a 95 per cent solution could cause serious changes in a patient’s health, including vomiting, fainting, seizures, cardiovascular problems and acute kidney failure.
The working group dismissed seven officials for neglecting their duties, failing to analyse the deaths on time, and for not taking necessary precautions. Disciplinary action was taken against specialists too. Dok-1 tablets and medicines have been withdrawn from all pharmacies in Uzbekistan. Other issues, such as the question of accountability of medical personnel, are to be taken up at a board meeting of the Ministry, the press note said.
It was a scandal the Indian government was least prepared for. Just two months ago, a controversy erupted involving the death of 66 children in the Gambia allegedly after taking cough syrup imported from India. Last month, a similar case came to light in Uzbekistan. In a press release at the end of December 2022, Uzbekistan’s Ministry of Health stated that 18 of 21 children with acute respiratory diseases died after ingesting Dok-1 Max syrup manufactured by Marion Biotech Pvt Ltd, a company based in Noida, Uttar Pradesh.
The firm Quaramax Medical LLC had imported the syrup. Marion Biotech had a licence from the Food Safety and Drug Administration department in Uttar Pradesh to manufacture the cough syrup and tablets for export.
The Central government has been quick to deny any causal connection between the medicine and the deaths in the Gambian case, and results of the investigations in the Uzbek case are pending. All manufacturing activities in the two pharmaceutical companies have been stopped until further notice. Frontline’s email to Marion Biotech got no response until the magazine went to print.
The Uzbek incident
According to the Uzbekistan Health Ministry’s press note, a special working group it constituted began an inspection after children in Samarkhand who had consumed the syrup reported side effects. The main substance in the drug is paracetamol, and parents used it as an anti-cold remedy on their own or on the recommendation of pharmacists.
The working group concluded that the dosage—2.5-5 millilitres three to four times a day for up to seven days—was a “little above the norm for a child”. However, there were other problems too. Preliminary laboratory tests of a series of cough syrup samples detected ethylene glycol in them.
Ethylene glycol, the press note said, was poisonous, and 1.2 ml/kg of a 95 per cent solution could cause serious changes in a patient’s health, including vomiting, fainting, seizures, cardiovascular problems and acute kidney failure.
The working group dismissed seven officials for neglecting their duties, failing to analyse the deaths on time, and for not taking necessary precautions. Disciplinary action was taken against specialists too. Dok-1 tablets and medicines have been withdrawn from all pharmacies in Uzbekistan. Other issues, such as the question of accountability of medical personnel, are to be taken up at a board meeting of the Ministry, the press note said.
Indian response
India’s Health Ministry, responding to the Uzbek incident, stated on December 29 that the Central Drugs Standard Control Organisation (CDSCO) and the FSDA of UP had “immediately on receipt of the information” conducted a joint inspection of the Marion Biotech facility. Samples were sent to the Regional Drug Testing Laboratory in Chandigarh.
The results are awaited. The FSDA of UP told Frontline that the testing was in progress but they were unsure when it would be completed.
Union Health Minister Mansukh Mandaviya instructed CDSCO and State Drug Control authorities to carry out joint inspections of certain drug manufacturing units on December 27. The specific units and selection criteria were not disclosed. Two joint drug controllers were designated to oversee the inspections and verify compliance with the Drugs and Cosmetics Act, 1940, and its regulations.
