The World Health Organization on Tuesday said that contaminated cough syrup made by an Indian company has been found in the Marshall Islands and Micronesia in the Oceania region.
In a medical product alert issued on Tuesday, the global health body said that samples of Guaifenesin syrup TG syrup were contaminated with “unacceptable amounts” of diethylene glycol and ethylene glycol. The two chemical compounds are impurities that are fatal and can attack the nervous system.
The manufacturer of the cough syrup is Punjab-based QP Pharmachem Limited and its marketer is Trillium Pharma in Haryana.
“The substandard product referenced in this alert is unsafe and its use, especially in children, may result in serious injury or death,” the World Health Organization said. “Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.”
The alert did not mention whether any children in Marshall Islands or Micronesia had fallen ill after consuming the syrup.
Australia’s regulatory authority, the Therapeutic Goods Administration, had analysed samples from a batch of the syrup and sent a report to the World Health Organization on April 6.
Neither QP Pharmachem nor Trillium have provided guarantees about the safety and quality of the syrup, the global health body said.
“The product referenced in this alert may have marketing authorisations in other countries in the Western Pacific region,” the agency added. “It may have also been distributed, through informal markets, to other countries or regions.”
QP Pharmachem’s Managing Director Sudhir Pathak told ANI that the Food And Drug Administration of Punjab has doubts about whether someone had duplicated the syrup sent to Cambodia and then sold the product in the Marshall Islands and Micronesia to defame the Indian government.
“The FDA department has taken samples of cough syrup sent to Cambodia for testing,” he added. “A total of 18,336 bottles of cough syrup were sent.”
Trillium Pharma has not yet responded to the global health body’s alert.
Cloud over Indian drugs
India’s image of being the “pharmacy of the world” has been dented after the deaths of the children in the Gambia and Uzbekistan.
Earlier this month, the United States Food and Drug Administration had flagged a series of violations by an Indian manufacturer of eye drops that have been linked to vision loss and deaths.
Tamil Nadu-based Global Pharma recalled its Artificial Tears eye drops early in February after it allegedly led to 68 cases of eye infection in America, including eight cases of vision loss and three deaths.
In March, Central and state drug regulators in India had cancelled or suspended licences of 18 companies as part of action taken against pharmaceutical firms for producing spurious or adulterated medicines.