The World Health Organisation (WHO) has flagged seven syrups made in India during its investigation into tainted medications and syrups linked to over 300 deaths worldwide. The WHO has also issued warnings about cough syrups produced in India that were previously associated with fatalities in the Gambia and Uzbekistan. The medications include vitamins and cough syrups produced by various pharmaceutical companies.
Recent cases in Uzbekistan, Gambia, and Nigeria have connected deaths to Indian-made medications. In response to concerns over reported deaths due to contaminated India-made cough syrups, 71 companies have received show-cause notices from the government, and 18 of them have been instructed to shut down. The closure of several factories, including Marion Biotech in Noida, Maiden Pharmaceuticals in Haryana, Global Pharma in Chennai, and QP Pharmachem in Punjab, was a result of a swift investigation by India’s drug controller.
The seven cough syrups made in India, about which the WHO has issued advisories, are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, Magrip N Cold Syrup, AMBRONOL syrup, DOK-1 Max syrup, and Guaifenesin. These cough medicines have been recalled due to contamination with diethylene glycol and ethylene glycol.
Diethylene glycol and ethylene glycol, when consumed, can cause significant harm, with toxic symptoms including abdominal discomfort, diarrhoea, headaches, acute renal injuries, vomiting, the inability to pass urine, and altered mental status, especially in children. These symptoms can potentially be fatal. The syrups have been labelled as “substandard” due to the contamination.
Union Health Minister Mansukh Mandaviya emphasised India’s zero-tolerance policy on spurious medicines. He stated, “We are the pharmacy of the world and we want to assure everyone that we are the ‘quality pharmacy of the world’.” The minister further explained that an extensive risk-based analysis is continuously conducted to ensure the production of quality medicines in the country. The government and regulators are vigilant in ensuring that no one dies due to spurious medicines.
Mandaviya revealed that a total of 24 samples were taken, of which four failed. He stated, “The question is if there was just one batch made for exports and if that fails, all samples would fail. It is not possible that 20 samples are passed and four samples fail. Still, we are alert. We are continuously doing risk-based analysis to ensure the production of quality medicines in our country.”
To address the concerns regarding the export of cough syrups, India implemented mandatory testing for cough syrups before they are shipped from June 1. Exporters are now required to provide a certificate of analysis issued by a government laboratory.
