Manufacture and distribution of two Gujarat-based cough syrup brands were halted on Wednesday after inspections revealed serious lapses. The development came even as the Tamil Nadu government initiated criminal action against a pharmaceutical company for sale of adulterated Coldrif cough syrup that led to the death of numerous children. The Drugs Controller General of India has also flagged serious lapses after conducting checks at factories across India, while state authorities issued advisories.
According to officials, cough syrups produced by Shape Pharma and Rednex Pharmaceuticals in Gujarat were found to be of dubious quality during inspections. State and federal inspectors have reportedly identified unspecified deficiencies and ordered an immediate halt to all production and distribution. Gujarat Health Minister Rishikesh Patel also confirmed in a statement that multiple samples had been “sent to government laboratories for further testing”.
At least 20 children in Madhya Pradesh have died recently while undergoing treatment for kidney failure. They had fallen ill after drinking contaminated cough syrup produced by Sresan Pharmaceuticals. The Tamil Nadu government had subsequently banned the sales of Coldrif cough syrup from October 1 and ordered the removal of stock from the market.
Several states have also issued advisories and put numerous medicines from the brand on hold. The Telangana government also advised the public on Wednesday to immediately stop using Relife cough syrup by Shape and and Respifresh TR manufactured by Rednex.
“The cause of the deaths in MP was Diethylene Glycol found in the cough syrup. After speaking with the Drug Controller of Tamil Nadu, we learned that Coldrif has not entered Rajasthan. A detailed guideline has been issued at the central level regarding which children should receive which type of medicine. All doctors have been trained… We are telling the parental population that you should not give any medicine to children without consulting a doctor. You should not give it to anyone… So, we have the report from the drug testing lab. In this, there are no abnormalities found in this particular brand. RMSA has put 19 different medicines from this brand on hold,” the Rajasthan Drug Commissioner told ANI.
Diethylene Glycol contamination
According to the notice issued by Telangana authorities, samples from both brands were found to be “adulterated” with a highly toxic chemical known as diethylene glycol. The same substance was also found in the contaminated Coldrif samples produced by Sresan Pharmaceuticals in Tamil Nadu. Diethylene glycol or DEG is a colorless, odorless, hygroscopic liquid that can cause severe poisoning when ingested.
Officials indicated that the contaminated Coldrif samples had contained nearly 500 times the permissible limit of DEG. The Tamil Nadu Health Minister cited findings from the State Drug Control department to reveal that Sresan Pharma had been making the cough syrup with 48.6% of the ‘poisonous substance’.
Pharma firm to face criminal action, factory sealed
The Tamil Nadu government announced on Wednesday that it would be taking criminal action against the drug manufacturer. The government has issued its second notice against the drug manufacturer for the alleged presence of diethylene glycol in the cough syrup Coldrif, asking why criminal action should not be taken, the health and family welfare minister informed.
