Govt makes testing of cough syrups must before export

“Cough syrups shall be permitted to be exported subject to export sample being tested and production of certificate of analysis issued by any of the following laboratories,” the notification said.

Prior to this, there were no checks by the authorities for products being exported. According to officials, the checking of exported medicines will be limited to the cough syrups for now as they are the ones that have come under the scanner.

All batches of medicines sold in India are already tested by the laboratories, according to an official.

An alert for the first instance of contamination in India-manufactured syrups was raised by the World Health Organization (WHO) in October last year. The deaths of 70 children with acute kidney injury were linked to the consumption of four syrups manufactured by Indian pharmaceutical company Maiden.

The second alert from WHO came in December, with the deaths of 18 children in Uzbekistan being linked to two syrups manufactured by Marion Biotech.

In the third instance, the WHO raised an alert in April this year, with contaminated products being reported from the Western Pacific countries of Micronesia and Marshall Islands. The manufacturer, however, maintained that they did not sell their product to these countries.

In all three instances, contaminants diethylene glycol and ethylene glycol were detected in the samples tested by other countries.

The most likely source of the two contaminants is thought to be contaminated solvents that are used for the manufacturing of the syrups. While the solvents used are not harmful, both the contaminants are known to be toxic to humans. It can lead to abdominal pain, vomiting, diarrhoea, headaches, altered mental status, inability to pass urine, and acute kidney injury. The contaminants can also be fatal.

After the alerts, the Indian authorities conducted inspections of all three companies and asked them to stop manufacturing.

Earlier this year, another Indian drug manufacturer voluntarily recalled an artificial tear drops from the US market after suspicions of it being contaminated with a drug-resistant bacteria. No contamination was found by Indian authorities in samples that were preserved by the company as a quality control measure in India.