The manufacturing of Marion Biotech's Dok-1 Max has stopped “for now”, the company's legal representative said on Thursday as the Central Drugs Standard Control Organisation began a probe in connection with the death of 18 children in Uzbekistan allegedly linked to the cough syrup.
Union Health Minister Mansukh Mandaviya said further action would be taken based on the inspection of the pharma company, under a cloud after the Uzbekistan health ministry's allegation that the children died after consuming Dok-1 Max.
Marion Biotech does not sell Dok-1 Max in India and its only export has been to Uzbekistan, an Uttar Pradesh government official said as inspection began at the company office in Noida on the outskirts of the capital on Thursday morning.
Samples of the cough syrup have been taken from the manufacturing premises in Noida and sent to the Regional Drugs Testing Laboratory (RDTL) in Chandigarh for testing, Mandaviya said.
The CDSCO, he said, has been in regular contact with the national drug regulator of Uzbekistan regarding the matter since December 27.
"Immediately on receipt of information, joint inspection of the NOIDA facility of the manufacturer, Marion Biotech, was carried out by UP Drug Control and CDSCO team and further action as appropriate would be initiated based on the inspection report," Mandaviya said in a series of tweets.
Marion Biotech is a licensed manufacturer and holds the licence for manufacturing Dok-1 Max syrup and tablet for export purpose granted by the Drugs Controller, Uttar Pradesh, the health ministry said in a statement.
The governments of both countries are looking into the matter, said Hasan Harris, legal representative of the Noida-based Marion Biotech.
"There is no problem from our end and no issue in testing. We have been there for the past 10 years. Once the government report will come, we will look into it. For now the manufacturing has stopped," Harris told PTI.
Before Uzbekistan's claims were reports linking the deaths of 70 children in Gambia to cough syrups manufactured by Haryana-based Maiden Pharmaceuticals earlier this year. The Drugs Controller General of India claimed the WHO drew a premature link.
Sources said the DCGI has sought more information from the Uzbek regulator regarding the latest allegation.
According to the Uzbek ministry, the chemical ethylene glycol was found in a batch of Dok-1 Max syrup during laboratory tests.
The alleged role of Indian pharma companies in the deaths of children abroad had a political fallout too.
While the Congress asked the government to stop boasting about India being a pharmacy to the world and take strictest action, the ruling BJP accused it of deriding India in its "hate" for Prime Minister Narendra Modi.
"Made in India cough syrups seem to be deadly. First it was the deaths of 70 kids in Gambia & now it is that of 18 children in Uzbekistan. Modi Sarkar must stop boasting about India being a pharmacy to the world & take strictest action," Congress general secretary Jairam Ramesh said on Twitter.
The BJP hit back through its IT department in-charge Amit Malviya who said, "The death of children in Gambia had nothing to do with the consumption of cough syrup made in India. That has been clarified by the Gambian authorities and DCGI, both. But blinded in its hate for Modi, Congress continues to deride India and its entrepreneurial spirit. Shameful."
India's drug regulator told the World Health Organisation 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, DCGI Dr V G Somani said 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 the cough syrups were tested in a government laboratory in the country and found to be complying with specifications.
The DCGI had said that India has been committed to rigorous monitoring and oversight to ensure that the highest standards of manufacture are maintained in quality control of drugs and cosmetics.
