Uzbekistan cough syrup deaths: Centre alerts pharma companies against Maya Chemtech's propylene
2 min read . Updated: 14 Mar 2023, 09:30 PM IST
Premium- The instruction by the government came after the Delhi-based firm supplied the excipient to Marion Biotech which was allegedly linked to the cough syrup deaths of children in Uzbekistan
The Central government on Tuesday informed Parliament that the licensing authorities of all States and Union Territories are alerted about directing pharmaceutical firms to not use propylene glycol supplied by Maya Chemtech India Pvt Ltd. The instruction by the government came after the Delhi-based firm supplied the excipient to Marion Biotech which was allegedly linked to the cough syrup deaths of children in Uzbekistan.
The Central Drugs Standard Control Organisation (CDSCO) and State Drugs Controller, Uttar Pradesh jointly conducted an investigation at Marion Biotech Pvt Ltd, Noida, and also collected samples for testing, Minister of State of Chemicals and Fertiliser Bhagwanth Khuba said in a written reply to Rajya Sabha.
The Regional Drugs Testing Laboratory (RDTL) in Chandigarh has provided the results of 30 drug sample tests thus far. Of those, 24 samples of drugs or raw materials were "not of standard quality". Additionally, 22 of these samples were deemed to be adulterated or fake, as per Section 17A and 17B of the Drugs and Cosmetics Act, of 1940. This classification indicates that these drugs could result in severe harm to patients.
The minister further reported that an FIR has been filed, and three individuals have been arrested in connection with this matter.
Among the drugs/raw materials declared "not of standard quality" include the sample of excipient propylene glycol which was found to contain ethylene glycol (EG), the minister added.
Delhi-based Maya Chemtech India Pvt Ltd was mainly the supplier of propylene glycol which has used it in impugned batches, Khuba said based on the report of a joint investigation.
"Accordingly, an alert has been issued on March 7, 2023, to all State/UTs licensing authorities for issuing directions to manufacturers, not to use Propylene Glycol supplied by Maya Chemtech India Pvt Ltd, Delhi in the public interest," he said.
Marion Biotech had received authorization for the export-only usage of three products, namely DOK 1 Max syrup (a cough syrup containing paracetamol, guaiphenesin, and phenylephrine hydrochloride), DOK 1 Max tablets (tablets comprising paracetamol, guaiphenesin, and phenylephrine hydrochloride), and Ambronol Syrup (a syrup containing Ambroxol), the minister informed Rajya Sabha.
In December of last year, Marion Biotech was placed under scrutiny due to its cough syrup called Dok-1, which was believed to have caused the death of 18 children in Uzbekistan who had ingested it. Following this incident, the CDSCO initiated an investigation into the matter.
The minister also quoted the report of the committee set up by the Department of Health and Family Welfare to investigate the death of children in Gambia. He said the committee opined "that there is no causal relationship that could be established between the deaths in Gambia and the products manufactured by Maiden Pharmaceuticals Ltd, Haryana".
(With inputs from PTI)