‘They have made some strides’: WHO says India has much to do on toxic cough syrup

The World Health Organisation (WHO) has stated that although India has introduced new rules requiring export testing for contaminants in medicines, there remain critical regulatory gaps for products sold locally. This comes after the death of at least 24 children after consuming a domestically-made cough syrup found to contain diethylene glycol at nearly 500 times the permissible limit.

Two years after international pledges to improve drug safety, the agency sees progress but insists on further action to protect public health. The deaths followed previous incidents worldwide, where over 300 children were linked to similar toxic syrup-based medicines from India and Indonesia. Enforcement challenges persist, despite efforts to upgrade pharmaceutical manufacturing standards.

A WHO official emphasised the recent advancements made by Indian authorities. "They have made some strides," said the official, Rutendo Kuwana, referring to a new Indian rule requiring medicine to be tested for contaminants like diethylene and ethylene glycol before export. However, the agency stressed that no such rule exists for syrups sold locally – a "regulatory gap" the WHO has flagged.

Kuwana, who leads the WHO team handling incidents of substandard and falsified medicines, described the process as ongoing, stating, "It’s a work in progress." He added, "There’s a lot that needs to be done. It’s a big market, with tens of thousands of manufacturers and many states to deal with."

The WHO's focus on comprehensive testing was reiterated in a recent statement. A WHO spokesperson said by email on Monday the agency welcomed all steps to improve medicine quality. However, in response to a question about dropping the export tests, the spokesperson said medicines, including raw materials, should be tested throughout the production process, not just at the end.

Indian regulation currently mandates testing of each batch of raw materials and final products, but the Central Drugs Standard Control Organisation (CDSCO) noted last October that some firms had not been adhering to these requirements.

Further training and technological advances have also shaped the response to recent incidents. Kuwana said countries had attended WHO training on testing for the toxins, and a new, cheaper test had been developed. Representatives from India did not attend but it has confirmed to the WHO that it is using the method, he added. Despite this, Kuwana noted a lack of accountability regarding previous cases, which he described as a "big disappointment". He observed there was no record of jail sentences in India, even after deaths abroad.

Emphasising the gravity of the issue, Kuwana remarked, "This is not just selling fake shoes," said Kuwana. "This is a moral issue but if you don’t follow the rules, it’s criminal, because it has devastating consequences." The WHO maintains that sustained oversight and accountability are essential as India considers further regulatory changes, including proposed plans to remove export testing requirements if facilities are upgraded to international standards.