Propylene Glycol: Cough syrup deaths: DCGI directs drug manufacturers not to use propylene glycol supplied by Delhi firm

India’s drug regulator has directed drug producers to not use propylene glycol equipped by a Delhi-based firm which offered the ingredient to Marion Biotech, whose cough syrups had been alleged to have led to the deaths of kids in Uzbekistan. Maya Chemtech India Pvt. Ltd. equipped propylene glycol utilized in Marion Biotech’s cough syrups that had been discovered to be “not of normal high quality”, in keeping with the regulator.

Three staff of Marion Biotech had been arrested on expenses of manufacture and sale of adulterated medicine.

Additionally, the medicine inspector from the Central Medicine Commonplace Management Organisation (CDSCO) North Zone final week issued a discover to the pharmaceutical agency asking it to cease the sale and distribution of the drug involved, stating that the pattern was discovered to be “not of normal high quality”.

Uzbekistan alleged in December final 12 months that a number of kids died after consuming Marion Biotech’s cough syrups, which it claimed had been contaminated with unacceptable quantities of ethylene glycol or propylene glycol.

In keeping with a communication despatched by Drug Controller Normal of India (DCGI) Rajeev Raghuvanshi to the licensing authorities of all states and Union territories on March 7, through the course of investigation a complete of 33 samples had been drawn by medicine inspectors. The take a look at reviews of 30 drug samples have been acquired, whereby 24 samples had been declared as “not of normal high quality”.

Additionally, out of those samples, 22 fall underneath the class of adulterated/spurious underneath Sections 17A and 178 of the Medicine and Cosmetics Act, 1940.

“It’s additional knowledgeable that M/s Maya Chemtech India Pvt. Ltd…was primarily the provider of propylene glycol which has been used within the impugned batches. In view of the above, you’re requested to difficulty instructions to all producers in your jurisdiction to not use propylene glycol equipped by Maya Chemtech India Pvt,” the DCGI mentioned within the letter. Accordingly, he additionally requested them to instruct their enforcement officers to maintain strict vigil on the matter and take stringent motion as per legislation towards the offenders in public curiosity.

On January 12, the World Well being Group (WHO) had issued a “medical product alert”, referring to 2 substandard (contaminated) merchandise, recognized in Uzbekistan and reported to it on December 22, 2022.

“The 2 merchandise are AMBRONOL syrup and DOK-1 Max syrup. The acknowledged producer of each merchandise is MARION BIOTECH PVT. LTD, (Uttar Pradesh, India). So far, the acknowledged producer has not offered ensures to WHO on the security and high quality of those merchandise,” the WHO had mentioned then.

“Laboratory evaluation of samples of each merchandise, undertaken by nationwide high quality management laboratories of the Ministry of Well being of the Republic of Uzbekistan discovered each merchandise contained unacceptable quantities of diethylene glycol and/or ethylene glycol as contaminants,” it had famous.