Madhya Pradesh, Rajasthan probe child deaths linked to cough syrup

Drug authorities in Madhya Pradesh and Rajasthan are probing child deaths linked to cough syrup supplied to government hospitals, with testing of samples and quality concerns

Cough syrup deaths have resurfaced, with two children dying and others falling ill in Rajasthan, and at least six children reported dead in Madhya Pradesh. Industry insiders believe more state governments may have procured the syrup from Jaipur-based Kayson Pharma through tenders, and the full extent of the problem is yet to emerge.

 

The State Drug Authorities of Rajasthan and Madhya Pradesh are conducting investigations and testing in the affected regions, according to officials. This follows reports that a generic cough syrup supplied to Rajasthan government hospitals was linked to the deaths of two children and several cases of illness in the state over the past two weeks, prompting authorities to ban 22 batches of the drug and order an inquiry.

 

 

“Our drug inspector has collected samples from Sikar, Jhunjhunu and Bharatpur, and the test reports are expected within three days. The syrup should not be administered to children below five years of age,” Rajasthan Drug Controller Ajay Phatak said, according to PTI.

 

In Chhindwara district of Madhya Pradesh, at least six children reportedly died of kidney failure allegedly after consuming the cough syrup.

 

As a consequence, the government’s nodal agency for disease surveillance, the National Centre for Disease Control (NCDC), has collected water and entomological and drug samples from hospitals and other sites in both states.

 

The samples will be tested to rule out possible infectious diseases, and results will be shared with the state drug authorities, officials said.

 

However, officials told Business Standard that the cough syrup in question was not “contaminated”, contrary to initial suspicion. They said the syrup does not contain propylene glycol, which has the potential to generate contaminants such as diethylene glycol (DEG) and ethylene glycol (EG). 

 

Propylene glycol is commonly used as a liquid base solvent in medications to dissolve and carry otherwise insoluble ingredients.

 

Similar cases have been reported earlier, including with Haryana-based Maiden Pharma in 2022. State drug administrations had tested samples across brands nationwide at that time. Industry insiders said such issues typically arise when manufacturers fail to adequately test propylene glycol or other solvents.

 

“Most cases happen when solvents meant for chemical industries or even textile-grade chemicals make their way into the pharma ingredient supply chain. The manufacturer needs robust quality assurance and control systems to detect this,” said a senior executive of an Ahmedabad-based firm.

 

A state Food and Drug Administration (FDA) commissioner, speaking on condition of anonymity, said many state FDAs lack adequate facilities to test for adulteration, except in producing states such as Maharashtra and Gujarat. However, in this case, it remains unclear why the syrup caused sickness and deaths.