DCGI asks drug manufacturers not to use propylene glycol by Delhi firm

India's drug regulator has directed drug manufacturers not to use propylene glycol supplied by a Delhi-based company which provided the ingredient to Marion Biotech, whose cough syrups were alleged to have led to the deaths of children in Uzbekistan.

Maya Chemtech India Pvt. Ltd. supplied propylene glycol used in Marion Biotech's cough syrups that were found to be "not of standard quality", according to the regulator.

Three employees of Marion Biotech were arrested on charges of manufacture and sale of adulterated drugs.

Also, the drugs inspector from the Central Drugs Standard Control Organisation (CDSCO) North Zone last week issued a notice to the pharmaceutical firm asking it to stop the sale and distribution of the drug concerned, stating that the sample was found to be "not of standard quality".

 

Uzbekistan alleged in December last year that several children died after consuming Marion Biotech's cough syrups, which it claimed were contaminated with unacceptable amounts of ethylene glycol or propylene glycol.

According to a communication sent by Drug Controller General of India (DCGI) Rajeev Raghuvanshi to the licensing authorities of all states and Union territories on March 7, during the course of investigation a total of 33 samples were drawn by drugs inspectors. The test reports of 30 drug samples have been received, wherein 24 samples were declared as "not of standard quality".

Also, out of these samples, 22 fall under the category of adulterated/spurious under Sections 17A and 178 of the Drugs and Cosmetics Act, 1940.

"It is further informed that M/s Maya Chemtech India Pvt. Ltd...was mainly the supplier of propylene glycol which has been used in the impugned batches. In view of the above, you are requested to issue directions to all manufacturers in your jurisdiction not to use propylene glycol supplied by Maya Chemtech India Pvt," the DCGI said in the letter.

Accordingly, he also requested them to instruct their enforcement officials to keep strict vigil on the matter and take stringent action as per law against the offenders in public interest.

On January 12, the World Health Organization (WHO) had issued a "medical product alert", referring to two substandard (contaminated) products, identified in Uzbekistan and reported to it on December 22, 2022.

"The two products are AMBRONOL syrup and DOK-1 Max syrup. The stated manufacturer of both products is MARION BIOTECH PVT. LTD, (Uttar Pradesh, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products," the WHO had said then.

"Laboratory analysis of samples of both products, undertaken by national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan found both products contained unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants," it had noted.