Days after initiating a probe against Haryana-based pharma company Maiden Pharmaceutical Ltd., the authorities have served show-cause notices and directed the company to stop cough syrup production at its Sonipat plant. The country's drug regulator, the Central Drugs Standard Control Organisation (CDSCO), had last week started a probe against Maiden Pharma.
The probe was started after the World Health Organisation (WHO) issued a 'global alert' over the deaths of 66 children in The Gambia, an African nation. The WHO had found a relationship between the children’s deaths and the cough syrups manufactured by the company.
Teams of the central & Haryana state drug departments conducted a joint inspection at Maiden’s premises and around 12 violations were found, a news agency quoted Haryana home and health minister Anil Vij as saying. The minister said keeping these inefficiencies in mind, the Sonipat-based company was asked to stop the total production.
As per the minister, the sample report of the three cough syrups flagged by the WHO, which were sent to the central drug lab in Kolkata, is yet to come. The authorities will likely take full action following that.
On September 29, the United Nations’ public health agency informed India’s national drug regulator that it is providing technical assistance and advice to The Gambia, where children died. The contributing factor is suspected to be medicines that contain contaminated diethylene glycol or ethylene glycol. Both of them, when consumed, are ‘toxic’ to humans and can prove ‘fatal’.
Later, the global health body issued an alert that medicines such as Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup contain "unacceptable” amounts of diethylene glycol and ethylene glycol.
The WHO also warned that to date, these four products have been identified in The Gambia only but may have been distributed, through informal markets, to other countries or regions as well. However, the country’s drug regulator said the company has manufactured and exported these products only to The Gambia.
The CDSCO's preliminary probe also found that Maiden Pharma holds a manufacturer license from the State Drug Controller. The company has permission to manufacture these products for export only, and these drugs are not sold domestically. The company has manufactured and exported these products only to The Gambia, it was found.
The drug regulator has said before exporting, medical products are tested for quality and released only once they satisfy certain criteria. It has also requested the WHO to share the report on the establishment of "causal relation" to death with the medical products in question at the earliest.
The WHO had earlier warned that all batches of the products highlighted above should be considered "unsafe" until they can be analysed by the relevant National Regulatory Authorities. The Gambian government also suspended the use of all paracetamol syrups in the country and urged people to use tablets instead. The government in September revealed that dozens of kids had died, without giving the exact number.