NEW DELHI: The New Delhi-based Maiden Pharmaceuticals Limited, which is in the eye of a storm after the World Health Organisation (WHO) issued a global alert on four of its cough syrups linked to 66 child deaths in The Gambia, said on Saturday that they are “shocked and deeply saddened” about the incident. They also said that they are “not selling anything” in India.
The company, which has two manufacturing units in Haryana, broke its silence after WHO on October 5 flagged four of their cough syrups as "contaminated" and "substandard", said in a media statement, that they are in “the field of medicines for over three decades and have been diligently following the protocols of the health authorities including Drugs Controller General of India and the state drugs Controller, Haryana.”
“We have valid drug approvals for the export of the products in question, and we are not selling anything in the domestic market, so it is for export only,” the statement of its Director Vivek Goyal said. Soon after the alert was issued, the company’s website was unavailable, and its phones were not reachable.
The company said they had obtained raw materials from certified and reputed companies.
“We are shocked to hear media reports regarding the deaths and deeply saddened by this incident, but we received the official information from our agent at The Gambia on October 5, and on the subsequent date, the World Health Organisation alert was issued against us,” the statement said.
It further said that government agencies visited their factory on October 1, 3, 6 and 7.
They noted that the CDSO took samples of the medicines along with all relevant documents in question in the presence of its directors.
The company said that they are “awaiting results” and “since the matter is already pending investigations and subjudice, we cannot comment on any other issues and shall update you in future as and when we receive the information.”
The world body had also said syrups have been "potentially linked with acute kidney injuries and 66 deaths among children.”
The four cough and cold syrups are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
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, the WHO said.
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. Harmful effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury, which may lead to death.
Soon after the alert, India's CDSO launched an urgent investigation and said that the company had manufactured and exported these products only to The Gambia.