iNDICA NEWS BUREAU-
The World Health Organization (WHO) on Wednesday, October 5, issued a Medical Product Alert on four cough and cold syrups made by an Indian company. The WHO has said that the usage of these four cough syrups may be responsible for acute kidney injuries and the death of 66 children in The Gambia.
The WHO Medical Product Alert refers to four substandard products, identified in The Gambia and reported to the WHO in September 2022. A WHO release explains that substandard medical products are products that fail to meet either their quality standards or specifications and are, therefore “out of specification”.
The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup. The manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). “To date, the manufacturer has not provided guarantees to WHO on the safety and quality of these products,” a WHO release said.
Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions.
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhea, 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,” the WHO release warned.
After being alerted by WHO, the Central Drugs Standard Control Organisation (CDSCO) of India has initiated an inquiry with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of M/s Maiden Pharmaceutical Limited is located. The CDSCO has also asked the WHO to provide evidence linking the cough syrups to the deaths.
A preliminary inquiry of CDSCO has revealed that the company is a manufacturer licensed by the State Drug Controller for the products Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup, and MaGrip n Cold Syrup under reference, and holds manufacturing permission for these products only for export. The company has manufactured and exported these products only to The Gambia.
“It is a usual practice that the importing country tests the products on quality parameters before it decides to release such products for usage in the country,” said the Ministry of Health and Family Welfare.
“As per tentative results received by WHO, out of the 23 samples of the products which were tested, 4 samples have been found to contain Diethylene Glycol or Ethylene Glycol,” an official statement issued by the ministry added.
The Indian authorities are now awaiting the certificate of analysis and the exact cause behind the deaths from WHO. “CDSCO has requested the WHO to share the report on the establishment of causal relation to death with the medical products in question etc,” the ministry’s statement added.
“The samples (controlled samples of the same batch manufactured by M/s. Maiden Pharmaceuticals Limited for all the four drugs in question) have been taken and sent for testing to the Regional Drug Testing Lab, Chandigarh by CDSCO, the results of which will determine the further course of action as well as bring clarity on the inputs received from WHO,” said the Ministry of Health and Family Welfare.
The WHO, in its advice to regulatory authorities and the public, has stated that it is important to detect and remove these substandard products from circulation to prevent harm to patients. The WHO has recommended increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. “Increased surveillance of the informal or unregulated market is also advised,” the WHO has stated.
“If you have these substandard products, please do not use them. If you, or someone you know, have used these products or suffered any adverse reaction or event after use, you are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre,” the WHO release has advised. National regulatory or health authorities also have been advised to immediately notify the WHO if these substandard products are discovered in their respective country.
