HQ Team
August 7, 2023: The WHO issued a medical product alert, the fifth such on an Indian company’s syrup, terming it “substandard,” and reported by the Republic of Iraq.
“The stated manufacturer of the affected batch of the product is Fourrts Laboratories, and the product is stated to be manufactured for Dablife Pharma,” an Indian firm, according to a WHO statement.
“To date, the stated manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product.”
A sample of the Cold Out syrup was obtained from one location in Iraq and submitted for laboratory analysis.
Unacceptable amounts
The sample was found to contain unacceptable amounts of diethylene glycol (0.25%) and ethylene glycol (2.1%) as contaminants. “The acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10%.”
“The substandard batch of the product referenced in this alert is unsafe and its use, especially in children, may result in serious injury or death,” according to the WHO.
Toxic effects could include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.
Fourrts Laboratories is based in Thoraipakkam, Tamil Nadu, one of the southern states in India. It exports medicines to more than 50 countries, including Canada, Germany and the UK.
Cold Out affiliates
The Cold Out syrup may have marketing authorizations in other countries or regions. It may also have been distributed, through informal markets, to other countries, according to the WHO.
“WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal and unregulated market is also advised.”
India, last month, ordered a shutdown of Riemann Labs, a domestic pharmaceutical firm, whose cough syrup is believed to be behind the deaths of more than six children in Cameroon.
The move follows three other Indian drug companies that were told to stop manufacturing their products after 60 similar deaths occurred in the Gambia and 20 in Uzbekistan.
The Marshall Islands, and the Federated States of Micronesia, also reported cases of substandard Indian syrups being sold in those countries.
Reimann Labs
“In the case of Cameroon, a joint inspection was conducted,” by the Indian regulator Central Drugs Standard Control Organization, in the central Indian city of Indore, Bharati Pravin Pawar, the junior health minister told the parliament.
Based on the findings, “Riemann Labs., Indore…the State Drugs Controller Madhya Pradesh (state) has directed the firm to stop the manufacturing activities.”
The WHO had issued alerts and asked for various information in four cases of syrup products exported from India.
In the case of Gambia, a joint investigation was undertaken by CDSCO and the State Drug Controller, in northern Haryana state. The probe revealed a violation of Good Manufacturing Practices.
Arrests
The State Drugs Controller, Haryana issued a show cause notice to Maiden Pharma and ordered the stoppage of all the manufacturing activities at its facility in Sonipat, Haryana.
The manufacturing license of Marion Biotech, in northern Uttar Pradesh state, was suspended on January 9, 2023. Marion was linked to cough syrup deaths in Uzbekistan.
“Three persons have been arrested,” the minister said.
QP Pharmachem, linked to cases in the Marshall Islands &and the Federated States of Micronesia, was told to shut all its manufacturing facilities in northern Punjab state.
