WHO Warns India Must Strengthen Regulations to Prevent Toxic Cough Syrup Deaths

WHO acknowledges that India has made some progress but still needs to do more to halt toxic cough syrup sales.

London:

According to a World Health Organization official, India still has significant work to do in stopping the sales of toxic cough syrup, despite showing some improvement. This comes after at least 24 children died from consuming domestically manufactured medicine.

The fatalities occurred following the consumption of Coldrif cough syrup produced by Sresan Pharma. Tests revealed the presence of diethylene glycol in the medicine, with concentrations nearly 500 times above permissible limits.

These deaths happened just two years after global commitments were made to strengthen regulations following the deaths of at least 300 children worldwide linked to similar toxins in syrup-based medications manufactured in India and Indonesia.

The WHO indicated that enforcement issues continue to persist.

"They have made some strides," stated Rutendo Kuwana, referring to India's new regulation requiring medicines to be tested for contaminants such as diethylene and ethylene glycol before export.

However, no equivalent regulation exists for syrups sold within the country—a "regulatory gap" that the WHO has highlighted.

"It's a work in progress," Kuwana 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." Kuwana leads the WHO team addressing incidents involving substandard and falsified medicines.

Reuters reported last week that India plans to eliminate its export testing requirement once companies upgrade their facilities to meet international standards by the end of the year.

India's health ministry and the Central Drugs Standard Control Organisation (CDSCO), the federal pharmaceuticals regulator, did not respond to requests for comment regarding these plans.

Representatives from Sresan Pharma did not answer repeated telephone calls.

A WHO spokesperson stated via email on Monday that the organization welcomes all measures aimed at improving quality.

However, when asked about the potential elimination of export tests, the spokesperson emphasized that medicines, including raw materials, should undergo testing throughout the entire production process, not just at the final stage.

Indian law requires drugmakers to test each batch of raw materials and the final product, but CDSCO acknowledged in October that some companies had not been complying with this requirement.

Kuwana mentioned that countries, including neighboring Pakistan, had participated in WHO training on testing for these toxins, and a new, more affordable test had been developed.

Although representatives from India did not attend, the country has confirmed to the WHO that it is implementing the testing method.

Kuwana also expressed disappointment regarding the lack of accountability for previous incidents. Despite the deaths occurring abroad, there is no record of anyone in India facing imprisonment for these violations.

"This is not just selling fake shoes," Kuwana stated. "This is a moral issue, but if you don't follow the rules, it's criminal, because it has devastating consequences."