Investigation into 18 children’s deaths in Uzbekistan from cough syrup made in Noida.
According to persons with knowledge of the situation, India opened an investigation into a Noida-based pharmaceutical company on Tuesday after a syrup the company produced was implicated in the deaths of 18 infants in Uzbekistan.
The State Security Service of the Central Asian nation announced it had started a criminal probe in the matter, reported the SSS press service on Tuesday, after several children who took Doc-1 Max tablets and syrup made by Marion Biotech.
“On the fact of death of 18 children, which occurred as a result of taking the drug Doc-1 Max, a criminal case was initiated against officials of Quramax Medical (importer of the drug) and State Center for Expertise and Standardization of Medicines… under Article 186-3 of the Criminal Code (Violation of the order of retail sale of medicines containing potent substances),” the SSS said in a statement quoted by UrduPoint News / Sputnik from Tashkent.
The substance ethylene glycol was discovered in the syrup during lab tests, according to local media sources. Another Indian company, Maiden Pharma, situated in Haryana, is being investigated because of the same chemical, which is a prevalent contaminant in pharmaceutical products created without proper protections. Seventy deaths in The Gambia were attributed to Maiden’s cough syrups, although a definitive conclusion has not been made.
The Drug Controller General of India is in contact with the Uzbek regulator to gather specific details, according to a senior official from the Union Ministry of Health and Family Welfare who asked not to be identified. It appears that this company has been giving medicine to Uzbekistan for a while.
Marion Biotech did not respond to requests for a comment when HT visited its office and made phone calls.
Diethylene glycol (DEG) and ethylene glycol (EG) are highly toxic colourless and viscous liquids which have a sweetish taste. According to the Centers for Disease Control, DEG and EG are often found as contaminants in glycerin, which is used as a sweetener in formulations of many pharmaceutical syrups ingested orally.
After being alerted, the central drugs regulatory team got in touch with the Uttar Pradesh drugs licensing authority to initiate the inquiry on Tuesday.
A joint inspection was conducted by the central drugs regulatory team of north zone and state drugs regulatory team to lift samples of the drugs in question. Officials from the state drugs regulatory authority confirmed the development.
“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 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,” said AK Jain, deputy commissioner, drugs controlling and licensing authority, Uttar Pradesh.
The joint inspection of Marion Biotech’s manufacturing facility in Noida had not been completed until late on Tuesday night, according to sources with knowledge of the situation who spoke on the condition of anonymity.
“Samples (including raw material) from both the current batch and the batch that was there for laboratory testing have been removed. A central government laboratory will do the testing, and the results will determine the next step, according to a Central Drug Controller official who asked to remain anonymous.
In a briefing on October 5, WHO issued a medical product alert over four cough syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — manufactured and exported by Maiden Pharma.
WHO said in its alert that two toxic contaminants, diethylene glycol and ethylene glycol, were found in four cough syrups manufactured by Maiden and exported to The Gambia.
After thorough investigation that included testing of samples, India conveyed to WHO that all four syrup samples of Maiden pharma tested by the government were found to be complying with the specifications.
“The tests of Maiden 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.