India’s drug regulator has advised medication producers not to use propylene glycol supplied by a Delhi-based company that sold the chemical to Marion Biotech, whose cough syrups are linked to the deaths of children in Uzbekistan.
Maya Chemtech India Pvt. Ltd. supplied propylene glycol that was found to be “not of standard quality” in Marion Biotech’s cough syrups, according to the regulator.
Three Marion Biotech employees were detained on suspicion of manufacturing and selling contaminated drugs.
Additionally, the drugs inspector from the Central Drugs Standard Control Organisation (CDSCO) North Zone last week issued a warning to the pharmaceutical firm ordering it to suspend the sale and distribution of the drug involved, noting that the sample was determined to be “not of standard quality”.
In December of last year, Uzbekistan claimed that numerous children died after consuming Marion Biotech cough syrups, which it claimed were contaminated with prohibited levels of ethylene glycol or propylene glycol.
According to a statement issued on March 7 by the Drug Controller General of India (DCGI) Rajeev Raghuvanshi to the licencing authorities of all states and union territories, 33 samples were drawn by drugs inspectors throughout the course of the investigation. The test reports of 30 drug samples have been obtained, wherein 24 samples were designated as “not of standard quality”.
Furthermore, 22 of these samples are adulterated/spurious under Sections 17A and 178 of the Drugs and Cosmetics Act of 1940.
“It is further revealed that M/s Maya Chemtech India Pvt. Ltd…was the primary source of propylene glycol utilised in the contested batches. Given the above, you are requested to direct all manufacturers in your jurisdiction not to use propylene glycol provided by Maya Chemtech India Pvt, Ltd, “according to the DCGI’s letter.
As a result, he further recommended that they tell their enforcement officials to remain vigilant on the situation and take stern legal action against offenders in the public interest.
The World Health Organization (WHO) issued a “medical product alert” on January 12, pointing to two substandard (contaminated) products discovered in Uzbekistan and submitted to it on December 22, 2022.
(With Inputs From PTI)