WHO awaits probe by Indian drug regulator to chart the fate of Marion Biotech

A day after issuing a medical product alert for two substandard cough syrups by Uttar Pradesh-based Marion Biotech, the World Health Organisation has said that it has contacted the Indian drug regulator and its investigation will decide the next course of action.

In response to a query by Moneycontrol, the United Nations health body said the Central Drugs Standard Control Organization (CDSCO) has been contacted as a standard practice.

“We await the results of their investigations that will lead us to have better understanding of the scope, potential public, and risk to the global supply chain,” said the WHO in an email response.

On January 11, the WHO had advised increased surveillance and diligence within the supply chains of countries and regions likely to be affected by Ambronol and DOK-1 Max syrups by Marion Biotech, saying that these products had failed to meet quality standards or specifications.

Read: What can the inspection of select drugmaking units hope to achieve?

“The laboratory analysis of samples of both products, undertaken by national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan found both products contained unacceptable amounts of diethylene glycol and /or ethylene glycol as contaminants,” said the WHO.

Both these products may have marketing authorisations in other countries in the region, it also said in the alert, adding that they may also have been distributed, through informal markets, to other countries or regions.

On December 27, Uzbekistan had said that 18 children may have died after consuming contaminated DOK-1 Max syrup by the Indian drug maker and had said that initial investigation had confirmed presence of toxic ethylene glycol in the drug.

India questions delay

The Indian drug regulatory authorities have cancelled the manufacturing licence of Marion Biotech after finding several violations in the Good Manufacturing Practices by the drug maker at its Noida plant but have questioned the delayed response by the WHO.

Read I Fresh inspection of Marion Biotech plant on after WHO flags 2 cough syrups

“Uzbekistan reported the matter quite a few days earlier but it is after more than two weeks that the WHO has issued the medical product alert,” said a senior CDSCO official. “Also, the alert is not based on an independent verification by the WHO but only mentions the laboratory analysis carried out in Uzbekistan.”

The official said that the test report of the drug samples of the batches in question by a central drug laboratory in India is still awaited. “There are GMP violations by the drug maker but the larger offence of contamination in the drug will only be ascertained after the test results,” he added.

India’s health ministry has not responded to the medical alert issued by the WHO so far.