India on Tuesday launched an inquiry into a Noida-based drugs manufacturer after deaths of 18 children in Uzbekistan were linked to a syrup the firm made, according to people familiar with the matter. 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.
According to local media reports, the chemical ethylene glycol was found in the syrup during lab tests. The same chemical, which is a common contaminant in pharma products made without adequate safeguards, is why another Indian company – Haryana-based Maiden Pharma – is under probe. Maiden’s cough syrups were linked to 70 deaths in The Gambia, but a formal conclusion has not been reached.
A senior official from the Union ministry of health and family welfare, who asked not to be named, said: “Drugs Controller General of India is in contact with the Uzbek regulator to obtain detailed information. This company it seems is supplying drugs to Uzbekistan for a long period time.”
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.
He did not offer any more details regarding the investigation.
According to people aware of the matter, who spoke on condition of anonymity, the joint inspection of Marion Biotech’s manufacturing unit in Noida had not been done till late on Tuesday night.
“Samples (including the raw material) from the batch that has been exported has been lifted and also the current batch that was there for laboratory testing. The testing will be conducted in the central government laboratory and the course of action will depend on the testing report,” said an official in the Central drugs controller’s office, requesting anonymity.
“The probe is currently on; our officers have spoken to the company representatives to get more details. It looks like this company had the same raw material supplier but we do not want to jump the gun as we have seen what happened in the earlier allegations against a manufacturer whose medicines were linked to deaths in Gambia,” said another official, requesting anonymity.
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,” added the official cited above.
