India on Tuesday conducting an investigation into a Noida-based drugmaker after the deaths of 18 children in Uzbekistan were linked to a syrup the firm made, according to people familiar with the matter. The Central Asian nation’s state security has announced that it has launched a criminal investigation into the matter after several children took Marion Biotech’s Doc-1 Max tablets and syrup.
“On the basis of the fact of the death of 18 children, which occurred as a result of the use of the drug Doc-1 Max, criminal proceedings were initiated against the officials of Quramax Medical (importer of the drug) and the State Center for Expertise and Standardization of Medicines. .. under Article 186-3 of the Criminal Code (Violation of the Regulation on the Retail Sale of Medicines Containing Active Substances),” in a statement quoted.
According to local media reports, the chemical ethylene glycol was found in the syrup during laboratory tests. The same chemical, which is a common contaminant in pharmaceutical products manufactured without adequate safeguards, is the reason another Indian company – Haryana-based Maiden Pharma – is under investigation. Maiden’s cough syrups have been linked to 70 deaths in Gambia, but no formal conclusion has been reached.
A senior official from the Union Ministry of Health and Family Welfare, who did not wish to be named, said, “The Drug Controller General of India is in touch with the Uzbek regulator to get detailed information. It appears that this company has been supplying drugs to Uzbekistan for a long time.
Marion Biotech did not respond to requests for comment when HT visited its office and telephoned. Diethylene glycol (DEG) and ethylene glycol (EG) are highly toxic colorless and viscous liquids with a sweet 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 the formulations of many pharmaceutical syrups taken orally.
After being alerted, the Central Drug Regulatory Team contacted the Uttar Pradesh Drug Licensing Authority on Tuesday to initiate an investigation. The North Zone Central Drug Regulatory Team and the State Drug Regulatory Team conducted a joint inspection to collect samples of the drugs in question. Officials from the State Medicines Regulatory Agency confirmed the development.
“As soon as we received an email from the Central Drug Control Team that an investigation was required today, we immediately constituted an investigation team comprising Assistant Drug Commissioner (Meerut Division) and Drug Inspector from Gautam Buddh Nagar (Uttar Pradesh). join the Central Drugs Standard Control Organization (North Zone) to investigate the allegations,” said AK Jain, Deputy Commissioner of Drug Control and Licensing Authority, Uttar Pradesh.
He did not release any further details about the investigation. According to people familiar with the matter, who spoke on condition of anonymity, the joint inspection of Marion Biotech’s manufacturing unit in Noida was not done until late Tuesday evening. “Samples (including raw material) were taken from the batch that was exported as well as the current batch that was there for laboratory testing. The testing will be done at a central government laboratory and action will depend on the test report,” said an official from the office of the central drug controller, requesting anonymity.
“The probe is currently on; our officials spoke with company representatives to get more details. It looks like this company had the same raw material supplier, but we don’t want to jump the gun because we saw what happened in earlier allegations against a manufacturer whose drugs were linked to deaths in Gambia,” another official said, requesting anonymity.
At a briefing on 5 October, the WHO issued a drug alert for four cough syrups – Promethazine Oral Solution, Kofexmaline Children’s Cough Syrup, Makoff Children’s Cough Syrup and Magrip N Cold Syrup – manufactured and exported by Maiden Pharma.
In its warning, the WHO said two toxic contaminants, diethylene glycol and ethylene glycol, were found in four cough syrups manufactured by Maiden and exported to Gambia. After a thorough investigation that included testing of samples, India told the WHO that all four samples of Maiden pharma syrup tested by the government were found to meet specifications. “Tests of Maiden samples conducted in India found nothing specific; therefore, it will not be prudent to comment on Marion’s samples at this stage. Let’s wait for the test report,” the official quoted above added.
By: Vaishali Verma
