WHO issues alert about another India-made syrup, flags ‘substandard’ quality

The World Health Organization on Monday issued an alert about a batch of India-made common cold syrup, saying that it was of substandard quality.

This was the fifth time in the past year that the global health body issued such an alert about syrup medications manufactured in India.

The World Health Organization issued the latest alert with respect to a batch of the Cold Out syrup, which was manufactured by Fourrts (India) Laboratories for an Indian firm named Dabilife Pharma. Samples from the batch that were obtained in Iraq were found to contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants, the global health body said.

Ethylene glycol and diethylene glycol can cause vomiting, convulsions, affect the circulatory system and cause acute renal failure. The World Health Organization said that the acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10%.

The health body said that neither the manufacturer nor the marketer of the common cold syrup have provided guarantees to it about the safety of the product.

However, Iraqi authorities have not yet reported any illnesses due to Cold Out, Bloomberg reported. Last week, the country’s health ministry said that the cold syrup had failed tests conducted by the authorities and that products circulating in the market were being confiscated.

Deaths due to toxic cough syrups first made headlines in October when the World Health Organization issued a global alert for four such medicines manufactured by the Haryana-based Maiden Pharmaceuticals. This was after the authorities in the West African country of The Gambia linked 66 deaths, most of them due to acute kidney failure, to the four medicines.

In December, the World Health Organization recommended not using two cough syrups made by Indian pharmaceutical firm Marion Biotech after Uzbekistan’s health ministry said that 18 children died after consuming the Dok 1 Max syrup manufactured by the company.

In April, another Indian drugmaker was also found by the World Health Organization to have exported contaminated cough syrup to the Marshall Islands and Micronesia. The manufacturer of the cough syrup was Punjab-based QP Pharmachem Limited and its marketer was Trillium Pharma in Haryana.

Last week, the Centre issued deadlines to drug manufacturers in India to adopt the World Health Organization’s good manufacturing practices.

The World Health Organization’s good manufacturing practice system is aimed at ensuring that products are “consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation”.

Health Minister Mansukh Mandaviya said that companies with a turnover of over Rs 250 crore will have to implement the 2018 guidelines within six months, while medium and small-scale enterprises with a turnover of less than Rs 250 crore will have to implement them within a year.

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