Cough syrup deaths: Noida pharma firm stops manufacturing, India begins probe

The manufacturing of Marion Biotech’s Dok-1 Max has stopped for now, the company’s legal representative said on Thursday (December 29), as the Central Drugs Standard Control Organisation (CDSO) began a probe in connection with the death of 18 children in Uzbekistan allegedly linked to the cough syrup.

Union Health Minister Mansukh Mandaviya, meanwhile, also tweeted that further action would be taken based on the inspection of the pharma company, which is currently underway, 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 by a central team and the UP drug department in Noida 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, said Mandaviya.

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 CDSO team and further action as appropriate would be initiated based on the inspection report,” Mandaviya said in a series of tweets.

Also read: Gambia cough syrup deaths expose dirty underbelly of Indian pharma

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 government teams carried out an inspection at Marion Biotech’s office in Noida Sector 67 on Thursday morning, Gautam Buddh Nagar drug inspector Vaibhav Babbar told PTI.

The company does not have any domestic market and has only one export market which is Uzbekistan. No product (Doc-1 Max) has been sold in India, the drug inspector told the media.

The company is currently operational and they have all mandatory licenses and approvals, including certificate of pharmaceutical product (CoPP) for export which is granted by the Centre, he said. Now the investigation underway is to find out from where they procured the raw material and where all it has been used, he said. The company has been operational since 2010, he added.

However, Hasan Harris, legal representative of Marion Biotech, said the governments of both countries are 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. Meanwhile, the website of Marion Biotech became inaccessible since Thursday morning.

Uzbekistan health ministry claims

The health ministry of Uzbekistan has claimed that the 18 children had consumed cough syrup, Doc-1 Max, manufactured by Noida-based Marion Biotech. According to the ministry, chemical ethylene glycol was found in a syrup batch during laboratory tests. Sources said the Drugs Controller General of India has sought more information regarding the incident from the Uzbek regulator.

In a statement released on Wednesday, the health ministry of Uzbekistan claimed that the cough syrup, Doc-1 Max, manufactured by Marion Biotech, a Noida-based company on lab testing was found to contain ethylene glycol, the chemical which could have caused the poisoning. The release said that the syrup was consumed without prescription and the children died after consuming it in a higher dose.

While preliminary laboratory examination found the presence of ethylene glycol in a certain batch of the cough syrup, the statement added to say that the component was toxic in nature and ingesting 1-2 ml/kg of 95 per cent concentrated solution can trigger severe conditions including convulsions, vomiting, dizziness, cardiovascular issues, and kidney failure.

Also read:  All you need to know about cough syrups linked to deaths in Gambia

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.

Traces of ethylene glycol were also found in the four other cough syrups manufactured in India which were linked to the deaths of 70 children in Gambia.

The statement said that the cough syrup was bought over the counter by parents at the advice of chemists as a medicine for common cold.

The affected children reportedly consumed 2.5 to 5 ml of the syrup at least thrice or four times a day for two to seven days. The statement said that while the medicine should not be taken at normal body temperature and only when the temperature is between 38 to 38.5 degrees Celsius, 100-125 mg should be administered to children under the age of one, 200 mg for children between one and three years and 250 mg for children between three and five years.

Doc-1 Max cough syrups were banned for sale after 21 cases of kidney damage and failure in children was reported over two months at the Samarkand Regional Children’s Multi-disciplinary Medical Center, while 15 of 17 children who were unable to produce urine and had to undergo dialysis, died.

Similar cough syrup deaths in Gambia

Earlier this year, similar deaths were reported in Gambia after the children allegedly consumed India-made cough syrups that had the chemicals ethylene glycol and di-ethylene glycol, produced by Maiden Pharmaceuticals.

Although a committee of the Gambian National Assembly has linked the deaths to the Indian cough syrups, the Indian government has asserted that the medicines were found to be of standard quality after being examined by the Central Drugs Standard Control Organisation and the State Drug Controller and no traces of the drugs diethylene glycol and ethylene glycol were found in the said batches.

Also read:  India-made cough syrups deaths in Gambia: Drug regulator initiates probe

DGCI statement on Gambia deaths

India’s drug regulator told the 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, 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.

Political fallout

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.”