India’s Marion Biotech halts manufacturing, CDSCO initiates probe, Health News, ET HealthWorld

Uzbekistan cough syrup deaths: India's Marion Biotech halts manufacturing, CDSCO initiates probe

New Delhi: Marion Biotech Pharma Company, an Indian firm based in Noida on Thursday said that it regrets the deaths allegedly caused to its cough syrup and that the manufacturing of the product has been halted. Further, the Central Drugs Standard Control Organisation (CDSCO) has initiated a probe, sources told the news agency PTI.

In a statement, the Uzbek Health Ministry on Wednesday said that “18 out of 21 children with acute respiratory disease have died as a result of taking Doc-1 Max syrup manufactured by the Indian company Marion Biotech Pvt Ltd”.

Hasan Harris, legal representative of Marion Biotech, said the governments of both countries is looking into the matter and inquiring. “There is no problem from our end and no issue in testing. We have been there for the past ten years. Once the government report will come, we will look into it. For now the manufacturing has stopped,” Harris said. According to the ministry, chemical ethylene glycol was found in a batch of syrup during laboratory tests.

Sources said the Drugs Controller General of India has sought more information regarding the incident from the Uzbek regulator. An inspection jointly conducted by the central drugs regulatory team of north zone and state drugs regulatory team was also taken during which samples of the drugs were also lifted.

The Ministry further alleged that the victims “took this drug at home for 2-7 days 3-4 times a day, 2.5-5 ml, which exceeds the standard dose of the drug for children” before they were hospitalised.

In October, the World Health Organization (WHO) had issued an alert for four “contaminated” India-made medicines, chiefly for paediatric use, identified in the west African nation of The Gambia and found to contain chemicals that were toxic and potentially fatal after 66 child deaths.

The four medicines cough and cold syrups were produced by the Haryana-based Maiden Pharmaceuticals Limited.

However, later the samples tested in a government laboratory in India were found to be complying with specifications. India’s drug regulator had told the World Health Organisation (WHO) earlier this month that the global health body drew a premature link between the deaths of children in Gambia and the four India-made cough syrups which adversely impacted the image of the country’s pharmaceutical products across the globe.

In a letter to Dr Rogerio Gaspar, Director (Regulation and Prequalification) at WHO, Drugs Controller General of India (DCGI) Dr V G Somani had said that a statement issued by the global health body in October in the wake of the deaths “was unfortunately amplified by the global media which led to a narrative being built internationally targeting the quality of Indian pharmaceutical products”.

In the letter, Somani said the samples of four made-in-India cough syrups linked to the deaths of 66 children in Gambia, which were tested in a government laboratory in the country, were found to be complying with specifications.

India had on Tuesday launched an inspection of some drug factories across the country to ensure high quality standards. India is known as the “pharmacy of the world” and its pharmaceuticals exports have more than doubled over the past decade to $24.5 billion in the past fiscal year.

The Uzbek health ministry said it had dismissed seven employees for negligence for not analysing the deaths in a timely manner and not taking the necessary measures. It said it had taken disciplinary measures against some “specialists”, without specifying what role the specialists had. It is also withdrawing the Doc-1 Max tablets and syrups from all pharmacies.

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