The World Health Organization (WHO) on October 5 issued a medical product alert on four contaminated medicines in Gambia. It has identified that the ...
The WHO also issued a medical product alert asking regulators to remove Maiden Pharma goods from the market. The products may have been distributed ...
WHO said substandard medical products are the products that fail to meet either their quality standards or specifications. All batches of these products should be considered unsafe until they can be analysed by the relevant National Regulatory Authorities. WHO is conducting further investigation with the company and regulatory authorities in India," he said, adding that the loss of young lives due to the products is "beyond heart-breaking for their families". WHO has recommended all countries detect and remove these products from circulation to prevent further harm to patients. The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. [Gambia](/topic/gambia).
Haryana based, Maiden pharmaceuticals company was red flagged by the World Health Organisation due to its potential involvement in the deaths of children in ...
Following the death of 66 children in the Gambia, the WHO red flagged cough syrups made by Haryana-based Maiden Pharmaceuticals and urged people to not use ...
“We are trying to find out with the buyer and all that what has happened exactly. “We are trying to find out the situation because it cropped up only today morning,” Naresh Kumar Goyal told Reuters. We are not selling anything in India.”
Maiden Pharmaceuticals: The CSDCO has taken up the matter with concerned state regulatory authorities and launched a detailed investigation on the basis of ...
Sources confirmed that WHO has been requested to share at the earliest with CDSCO the report on establishment of causal relation to death with the medical products in question, photographs of labels and products etc,which is now awaited. The WHO said that the deaths of these Gambian children from acute kidney injuries may be linked to the contaminated cough and cold syrups made by Maiden Pharma. The preliminary enquiry reveals that Maiden manufactured and exported these products only to Gambia so far.
Maiden Pharmaceutical Limited is the manufacturer licensed by the State drug controller for the products under reference, and holds manufacturing permission ...
"At the same time, the exact one-to-one causal relation of death has not yet been provided by WHO, nor have the details of labels/ products been shared by WHO with CDSCO enabling it to confirm the identity/ source of the manufacturing of the products," the official source stated. It has also been informed by WHO that the certificate of analysis will be made available to it in near future and WHO will share it with India. The sources said the exact "one-to-one causal relation of death" has neither been provided by the United Nations Health Agency nor the details of labels and products been shared by it with the Central Drugs Standard Control Organisation (CDSCO), enabling it to confirm the identity or source of the manufacturing of the products.
WHO says using these medicines may result in death and that it's conducting investigations with their manufacturer, Maiden Pharmaceuticals in Haryana, ...
Maiden Pharmaceuticals' global presence has a strong concentration in Africa, including countries such as Algeria, Senegal, Nigeria, Cameroon, ...
14 mins read In a welcome message posted on its website, Maiden Pharmaceuticals Managing Director Naresh Kumar Goyal said, "In a growing world market, new challenges arise continuously and we are always prepared to face them. It manufactures a range of products such as capsules, injectables, syrups, ointments and tables across various therapeutic areas.
Child deaths in the Gambia: The four cough syrups in question are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, ...
MOST READ RECOMMENDED The deaths, WHO said, occurred due to acute kidney injuries, which are linked to Maiden Pharma’s contaminated cough and cold syrups. The medicines were made in Maiden’s Sonepat facility. Maiden Pharmaceuticals that is under investigation has indicated that it might recall the products following the government direction. This comes after the Central Drugs Standard Control Organisation (CDSCO) initiated a probe into Delhi-based Maiden Pharmaceuticals following World Health Organisation’s report linking the deaths of scores of Gambian children to consumption of the company’s cold and cough syrups.
Distributors' organisation says medicines that caused deaths in the Gambia unavailable in India, assures Central Drugs Standard Control Organisation that ...
Singhal said Indian distributors had been alerted on Thursday to the adverse effect of the drug “and have been cautioned against any possible availability or distribution of these in any part of the country”. But because of its solubility, some drug makers have inappropriately substituted it for non-toxic ingredients such as glycerine in pharmaceuticals such as cough syrups and acetaminophen. The All India Organisation of Chemists and Distributors (AIOCD) said none of the four syrups was available for sale in India. The ingredients can cause abdominal pain, vomiting, diarrhoea, headache and severe renal injury, it added. The results will guide the further course of action and bring clarity on the WHO inputs. The CDSCO has requested the WHO to share at the earliest the report on establishment of the causal relation to death with the medical products in question, the Ministry added.
This came after WHO linked the medicinal syrups to the deaths of 66 children in The Gambia.
The WHO findings, announced by Director-General Tedros Adhanom Ghebreyesus on Wednesday, came after samples of each of the four cough syrups were tested. The WHO said the children had died of kidney injuries. It said it found "unacceptable" levels of toxins in the syrups made by Maiden Pharmaceuticals.