India introduces mandatory quality checks for cough syrups meant for export

Indian authorities will ensure cough syrups are tested and approved by government-authorised laboratories before they are exported, Reuters reported Tuesday. This comes after some Indian drug companies were linked to the deaths of dozens of children in Gambia and Uzbekistan.

According to a notice dated May 22 and issued by the Indian Ministry of Health on Tuesday, any cough syrup must have a certificate of analysis issued by a government laboratory before it is exported, effective June 1. "Cough syrup shall be permitted to be exported subject to the export sample being tested and production of a certificate of analysis," the notice read.

Are tests mandatory only for syrups meant for export?

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Interestingly, the notification issued by the government of India mandates the test for cough syrups only meant for export. According to Reuters, it fails to clarify whether testing is mandatory for cough syrups meant for the domestic market.

The government has identified seven such federal government laboratories where samples could be sent for testing. Along with them, drug manufacturers can also send their samples to state laboratories certified by a national accreditation body.

Are Indian syrups causing deaths abroad?

The World Health Organization (WHO) first advised the regulators in October 2022 against the usage of cough syrups made by India-based company Maiden Pharmaceuticals and linked its products to the deathof at least 70 children in the country. This prompted the Indian authorities to launch an investigation into the allegations, but it later found out that the said company was "complying with specifications." An Indian official even said that the WHO was "presumptuous" in blaming the syrups.

Watch:Gambia cough syrup deaths: After WHO's alert, Indian govt's crackdown on Maiden Pharma

Later, Gambia’s own Medicines Control Agency, a national regulatory body, clarified that a link between the deaths of children and the Indian syrups was not confirmed. "We haven't concluded yet it is the medicine that caused it. A good number of kids died without taking any medication," a representative of the Medicines Control Agency was quoted as saying in media reports.

Toxins detected in syrups used in Uzbekistan

The debate around the usage of “substandard” Indian cough syrups heated up again when 19 children in Uzbekistan died last year after consuming products manufactured by India-based Marion Biotech. The Uzbek authorities later confirmed that contaminants were detected in many drugs manufactured by the company.

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“Laboratory analysis of samples of both products - Ambronol syrup and DOK-1 Max syrup by Marion Biotech - undertaken by national quality control laboratories of the Uzbekistan Ministry of Health found both products contained unacceptable amounts of diethylene glycol and or ethylene glycol as contaminants,” the WHO said in January this year.

Crackdown on pharma companies in India

The Indian government in March undertook a major crackdown that targeted pharma companies for manufacturing spurious medicines. A total of 76 companies were raided by India’s Drugs Controller General of India (DCGI) across 20 states, which resulted in the cancellation of licenses of 18 pharma companies.

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