A joint inspection of the Noida facility of Marion Biotech has been carried out by a Uttar Pradesh Drug Control and CDSCO team
The Department of Chemicals and Petrochemicals with the Ministry of Chemicals and Fertilizers issued a gazette notification titled Ethylene Glycol (Quality Control) Order, 2022 on December 29.
This comes a day after Uzbekistan alleged 18 child deaths in Samarkand from consumption of a medicinal syrup manufactured by an Indian drugmaker.
Marion Biotech, the drug company in question, is based in Noida, Uttar Pradesh. The syrup it manufactured contained ethylene glycol.
Under ‘Conformity to standards and compulsory use of standard mark’, the order stated:
Specific goods or articles shall conform to the corresponding Indian Standard given in column (2) bearing the title of the Indian Standard in column (3) of the said Table and shall bear the Standard Mark under a licence from the Bureau of Indian Standards as per Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018.
The order came after the Centre consulted the Bureau of Indian Standards on the matter.
The order stated under ‘Certification and enforcement authority’: “In respect of specific goods or article, the Bureau of Indian Standards shall be the certifying and enforcing authority.”
Under ‘Penalty for contravention’, it stated that “any person who contravenes the provisions of this Order shall be punishable under the provisions of the said Act.”
“This Order shall apply to any amendment made by the Bureau of Indian Standards to the Indian Standard specified in column (2) of the said Table with effect from the date notified by the Bureau of Indian Standards in this behalf,” it added.
The Union Ministry of Health and Family welfare also released a statement December 29. It said:
There have been reports from Uzbekistan concerning contaminated cough syrup Dok1 Max made by Indian company Marion Biotech. Under directions of Union Minister of Health & Family Welfare and Chemicals & Fertilizers, Dr Mansukh Mandaviya, the Central Drugs Standard Control Organisation (CDSCO) is in regular contact with the national drug regulator of Uzbekistan regarding the matter since December 27, 2022.
The statement added that a joint inspection of the Noida facility of Marion Biotech, was carried out by a Uttar Pradesh Drug Control and Central Drugs Standard Control Organisation team on receipt of the information.
It stated that further action as appropriate would be initiated based on the inspection report.
The cough syrup samples have been taken from the manufacturing premises and sent to Regional Drugs Testing Laboratory (RDTL), Chandigarh for testing.
Marion Biotech is a licensed manufacturer and holds license for manufacturing of Dok1 Max syrup and tablet for export purposes granted by UP Drug Control, according to reports.
Its manufacture has been stopped “for now”, according to a statement by the company’s legal representative.
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, according to a report by news agency Press Trust of India.
Eighteen of 21 Uzbek children who took the syrup in question, died due to acute respiratory ailments, according to reports.
In October, the World Health Organization had sounded the alarm on four substandard India-made products typically used to treat cough symptoms in The Gambia. These syrups had caused the deaths of 66 children.
WHO sounds alarm on India-made cough syrups linked to children’s death in The Gambia
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