All production halted at firm linked to Uzbek syrup deaths

The suspension of Marion Biotech means that its exports will become ineligible for incentives under the Market Access Initiative Scheme.

All drug production at Marion Biotech has been halted since Thursday night in the wake of concerns that the deaths of at least 18 children in Uzbekistan could be linked to a cough syrup it exported, Union health minister Mansukh Mandaviya announced on Friday.

A police van outside the office of pharma company Marion Biotech, in Noida. (HT Photo)

Samples have been collected from the company for analysis, after Uzbek officials announced earlier this week that they had found a contaminant in the product which could prove fatal and may have been behind the deaths.

“Following inspection by @CDSCO_INDIA_INF team in view of reports of contamination in cough syrup Dok1 Max, all manufacturing activities of Marion Biotech at Noida unit have been stopped yesterday night, while further investigation is ongoing,” tweeted Mandaviya.

The company’s legal representative had said earlier on Thursday that it stopped the manufacturing of only the syrup that was mired in the controversy, which goes by the brand name Dok-1 Max and has reportedly only been exported.

Earlier this year, the World Health Organization (WHO) linked the deaths of at least 70 children in The Gambia to cough syrups manufactured by Haryana-based Maiden Pharmaceuticals, which the drugs controller general of India later said was premature, based on the investigation that India conducted.

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) on Friday said it has suspended the membership of Marion Biotech after it failed to respond to the council’s queries on the possibility of contamination of their cough syrup.

The suspension of Marion Biotech means that its exports will become ineligible for incentives under the Market Access Initiative Scheme.

The contaminant Uzbek officials said they found was ethyl glycol, often a chemical that is produced as a byproduct in the manufacturing of some syrups. If production processes are not adequately managed, these could make its way as a contaminant.

The State Security Service of the Central Asian nation announced it had started a criminal probe in the matter, reported the SSS press service on Tuesday, after it was reported that several children took Doc-1 Max tablets and syrup made by Marion Biotech.

“On the fact of death of 18 children, which occurred as a result of taking the drug Doc-1 Max, a criminal case was initiated against officials of Quramax Medical (importer of the drug) and State Center for Expertise and Standardization of Medicines... under Article 186-3 of the Criminal Code (violation of the order of retail sale of medicines containing potent substances),” the SSS said in a statement quoted by UrduPoint News / Sputnik from Tashkent.

Former president of the Indian Medical Association, Dr JA Jayalal, said that India needs to strengthen the surveillance and monitoring if the exported drugs meet the standards.

“India is one of the largest exporters of drugs and if such incidents are reported repeatedly then our country’s image and exports will be impacted. We should have better monitoring systems to make sure that the quality of drugs that are exported are up-to-mark. Countries such as US have mechanisms to thoroughly test drug quality before it enters its markets, but smaller countries do not have those and that makes it even more imperative that the quality checks are conducted here itself,” Dr Jayalal said.