Uzbekistan Cough Syrup Deaths: Indian Government Directs Pharmaceutical Companies to Not Use Propylene Glycol from Maya Chemtech
The Central government told Parliament on Tuesday that Maya Chemtech India Pvt Ltd’s propylene glycol is not to be used by pharmaceutical companies, and that licencing authorities in all States and Union Territories are aware of this. The Delhi-based company provided the excipient to Marion Biotech, which is thought to be connected to the Uzbek cough syrup deaths of children, prompting the government’s directive.
In a written reply to the Rajya Sabha, Minister of State for Chemicals and Fertilizer Bhagwanth Khuba stated that Marion Biotech Pvt Ltd in Noida was the subject of an investigation by the Central Drugs Standard Control Organization (CDSCO) and the State Drugs Controller, Uttar Pradesh, as well as the collection of samples for testing.
The findings of 30 drug sample tests have now been made available by Chandigarh’s Regional Drugs Testing Laboratory (RDTL). Of those, 24 drug or raw material samples were deemed to be “not of standard grade”. 22 of these samples were also found to be adulterated or false in accordance with Sections 17A and 17B of the 1940 Drugs and Cosmetics Act. According to this categorization, these medications run the risk of seriously harming patients.
The minister added that three people had been detained in relation with this case, and a FIR had been filed.
The sample of excipient propylene glycol that was discovered to contain ethylene glycol (EG) is one of the drugs/raw materials that were deemed to be “not of standard grade,” the minister continued.
Based on the findings of a joint inquiry, Khuba claimed that the primary supplier of the propylene glycol used in the disputed batches was the Delhi-based Maya Chemtech India Pvt Ltd.
Accordingly, on March 7, 2023, “an alert has been issued to all State/UT licencing authorities for giving instructions to manufacturers, not to use Propylene Glycol supplied by Maya Chemtech India Pvt Ltd, Delhi in the public interest,” the official said.
The minister informed Rajya Sabha that Marion Biotech had been given permission for three products, including Ambronol Syrup (a syrup containing Ambroxol), DOK 1 Max Tablets (tablets containing paracetamol, guaiphenesin, and phenylephrine hydrochloride), and DOK 1 Max Syrup (a cough syrup containing those three ingredients).
Marion Biotech came under fire in December of last year over its cough medicine, Dok-1, which was thought to have killed 18 children in Uzbekistan who had consumed it. The CDSCO opened an investigation into the issue after this incident.
The minister also cited the committee’s findings, which was formed by the Department of Health and Family Welfare to look into child fatalities in the Gambia. He said the committee opined “that there is no causal connection that could be demonstrated between the deaths in Gambia and the products manufactured by Maiden Pharmaceuticals Ltd, Haryana”.