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Centre constitutes expert committee to look into the death of children in Gambia and the WHO reports

Our Bureau, New Delhi
Thursday, October 13, 2022, 15:45 Hrs  [IST]

The Government of India has constituted an expert committee to probe into the matters related to the death of 66 children in Gambia, according to an alert by the World Health Organisation (WHO), allegedly caused by the substandard cough and cold syrup manufactured by Haryana-based Maiden Pharmaceuticals. The Haryana State Drug Control Department has issued an order directing the company to stop manufacturing activities in the facility.
 
The Government on October 12, said that it has constituted a committee chaired by Y K Gupta, vice chairperson, Standing National Committee on Medicines, technical experts including Dr Pragya Yadav, National Institute of Virology, Pune, Dr Arti Bahl, from the Division of Epidemiology, National Centre for Disease Control, and A K Pradhan, Joint Drug Controller.
 
Reports quoting the ministry of health and family welfare, said that the committee, after examining and analysing the adverse event reports and all the related details shared by the WHO to India, will advise the Drugs Controller General (India) about the future course of action.
 
Meanwhile, the Haryana State Drug Control Department has directed the company to stop production in its facility after a joint inspection of the Central and state regulators identified 12 major flaws related to the manufacturing unit.
 
The facility, reportedly did not conduct tests for toxicities in the ingredient propylene glycol, used in the syrups.
 
The Pharmaceuticals Exports Promotion Council (Pharmexcil) has earlier suspended the Registration cum Membership Certificate (RCMC) of the company in the course of action following the World Health Organisation’s (WHO) medical product alert. The WHO alleged the company’s substandard paediatric medicines are linked with acute kidney injuries and death of 66 children in the African nation of Gambia.
 
The issue is related to four products - Promethazine oral solution, Kofexmalin baby cough syrup, Makoff Baby cough syrup and Magrip N cold syrup - exported by the company.
 
The Council said that the alleged supply which led to the death of children has brought bad reputation to the Indian pharma industry and also likely to have an impact on the trust of international agencies on India pharmaceutical exports. Maiden Pharmaceuticals has been registered with Pharmexcil since 2006 as a small scale manufacturer.
 
WHO, on October 5, has said that while the contaminated products have so far only been detected in The Gambia, they may have been distributed to other countries. WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients. It also said that the manufacturer has not provided guarantees to WHO on the safety and quality of these products.
 
The laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
 
While WHO has warned that these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions, the ministry of health and family welfare, Government of India, stated that the products had manufacturing permission only for exports and had been exported only to Gambia. The products were not sold in the domestic market of India, it added.
 
The Ministry has said that the WHO on September 29, 2022 informed the Drugs Controller General (India) that provided technical assistance and advice to Gambia.
 
WHO said that the risks involved include presence of diethylene glycol and ethylene glycol, which are toxic to humans when consumed and can prove fatal, in the product.
 
Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.
 
"All batches of these products should be considered unsafe until they can be analyzed by the relevant National Regulatory Authorities. The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death," said the WHO alert.

 

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