Ajit Karn
New Delhi: The Indian drug regulator has instructed drug manufacturers not to use propylene glycol supplied by a Delhi-based company that supplied the ingredient to Marion Biotech, whose cough syrups were allegedly responsible for the fatalities of children in Uzbekistan.
According to the regulator, Maya Chemtech India Pvt. Ltd. provided propylene glycol used in Marion Biotech’s cough syrups that was “not of standard quality.”
Three Marion Biotech employees were arrested on suspicion of manufacturing and selling adulterated pharmaceuticals.
In addition, a drug inspector from the North Zone of the Central Drugs Standard Control Organisation (CDSCO) issued a notice to the pharmaceutical company requesting that it cease the sale and distribution of the drug in question, stating that the sample was “not of standard quality.”
In December of last year, Uzbekistan alleged that several children perished after consuming cough syrups from Marion Biotech that were contaminated with unacceptable levels of ethylene glycol or propylene glycol.
According to a communication sent on March 7 by Drug Controller General of India (DCGI) Rajeev Raghuvanshi to the licencing authorities of all states and Union territories, a total of 33 samples were collected by drug inspectors during the investigation. Twenty-four of the thirty drug samples for which test results were obtained were deemed “not of standard purity.”
In addition, 22 of these samples qualify as adulterated/spurious under Sections 17A and 178 of the 1940 Drugs and Cosmetics Act.
“Further information indicates that M/s Maya Chemtech India Pvt. Ltd. was the primary supplier of propylene glycol used in the contested samples. In light of the foregoing, you are requested to issue directives prohibiting the use of propylene glycol supplied by Maya Chemtech India Pvt. Ltd. by all manufacturers within your jurisdiction “stated the DCGI in the letter.
Accordingly, he also requested that they instruct their enforcement officials to maintain severe vigilance over the situation and take rigorous legal action in the public interest against the offenders.
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The World Health Organization (WHO) issued a “medical product alert” on January 12 regarding two substandard (contaminated) products discovered in Uzbekistan and reported to WHO on December 22, 2022.
“AMBRONOL syrup and DOK-1 Max syrup are the two products in question. The manufacturer listed for both items is MARION BIOTECH PVT. LTD (Uttar Pradesh, India). This manufacturer has not yet provided WHO with assurances regarding the safety and quality of these products “WHO had stated at the time.
“Laboratory analysis of samples of both products, conducted by the national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan, revealed that both products contained unacceptable levels of diethylene glycol and/or ethylene glycol as contaminants,” the report stated.
