WHO issues alert for another India-made cough syrup: Why are these drugs so deadly?

Another India-made cough syrup has come under scrutiny. The World Health Organization (WHO) has sounded alert on a batch of contaminated India-manufactured cough syrup that was found in the Marshall Islands and Micronesia. This is the third such alert issued for contaminated cough syrups produced in India within seven months. The United Nations health agency said that Guaifenesin TG syrup, manufactured by Punjab-based QP Pharmachem Ltd, showed “unacceptable amounts of diethylene glycol and ethylene glycol”. What has the WHO said about the India-made syrup, why is it spurious and when was such an alert notified before? Let’s take a closer look. Spotlight on another India-made cough syrup The WHO has urged people not to use Guaifenesin syrup, which is used to relieve congestion and cough symptoms. But the statement does not reveal if anyone had fallen sick after consuming the contaminated drug. As per the alert issued on Tuesday (25 April), these contaminants were found in a batch of the syrup with an expiry date of October 2023. The contamination was flagged to the WHO on 6 April. The statement said the syrup was tested by Australia’s drug regulator, the Therapeutic Goods Administration. The Punjab-manufactured drug was marketed by Haryana-based Trillium Pharma. “To date, neither the stated manufacturer nor the marketer have provided guarantees to WHO on the safety and quality of these products,” the health agency said in its statement. Speaking to BBC, Sudhir Pathak, managing director of QP Pharmachem, said the company exported 18,346 bottles to Cambodia after “getting all due regulatory permissions”. He also said he “did not know” how the drugs reached Marshall Islands and Micronesia.

Dera Bassi, Punjab | Food And Drug Administration of Punjab doubts that someone has duplicated the product (cough syrup) sent to Cambodia and then sold it in the Marshall Islands and Micronesia to defame the Government of India. The FDA department has taken samples of cough syrup… pic.twitter.com/t5H483Hc1Z

— ANI (@ANI) April 26, 2023

“We did not send these bottles to the Pacific region, and they were not certified for use there. We don’t know under what circumstances and conditions these bottles reached the Marshall Islands and Micronesia,” Pathak was quoted as saying by BBC. How bad are these contaminants? Sweet-tasting ethylene glycol is a colourless and odourless alcoholic compound. It is a syrupy or viscous liquid at room temperature, as per Pediaa.Com. Diethylene glycol is an industrial solvent used for making paints, ink and brake fluids. Diethylene glycol and ethylene glycol are adulterants that are sometimes illegally used as solvents in liquid drugs. According to The Hindu, diethylene glycol and ethylene glycol may be used by pharma companies as an alternative to non-toxic solvents such as glycerine or propylene glycol to cut costs. Consuming these substances can cause abdominal pain, vomiting, diarrhoea, inability to pass urine, headache and severe renal injury. These toxic compounds could also be fatal for humans. “The typical reason these chemicals end up in medicine is because pharmaceutical manufacturers do not adequately test industrial solvents purchased from chemical traders and used to manufacture cough syrups despite the fact that the law mandates such testing for contaminants,” Dinesh Thakur and Prashant Reddy T, co-authors of The Truth Pill: The Myth of Drug Regulation in India, wrote for Indian Express last December. ALSO READ: A look at the big problem of spurious drugs in India Recent alerts by WHO In January, the WHO warned against using two Indian cough syrups that were linked to the deaths of 18 children in Uzbekistan. On 28 December, Uzbekistan’s health ministry said that these children had consumed cough syrup Doc-1 Max, manufactured by Noida-based Marion Biotech. As per the UN health agency, the analysis of Ambronol and Dok-1 Max found “unacceptable amounts” of two contaminants - diethylene glycol and/or ethylene glycol. This incident came to light months after similar claims were made in The Gambia where the death of at least 70 children from kidney injuries was attributed to the consumption of cough and cold syrups made by Indian pharma firm Maiden Pharmaceuticals Ltd. As per the WHO, even these cough syrups had “unacceptable” amounts of diethylene glycol and ethylene glycol. However, the Indian government and Maiden Pharmaceuticals, had rejected the allegations. Last October, the WHO had issued an alert against four cough and cold syrups – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – made by Maiden Pharmaceuticals following The Gambia tragedy. In March, the Central government cancelled the manufacturing licence of Marion Biotech after raw material collected from the company were found contaminated. In a separate incident, the United States warned in February that an eye drop manufactured by a Tamil Nadu-based firm caused an outbreak of a drug-resistant bacteria, causing three deaths and serious infections in the country. Earlier this month, the US Food and Drug Administration (FDA) said the eye drop maker, Chennai-based company Global Pharma Healthcare Private Limited, had violated several safety norms. Rows haunt Indian pharma India is the world’s largest exporter of generic drugs and the leading manufacturer of vaccines globally. These recent controversies have put India’s pharmaceutical industry under scanner. [caption id=“attachment_12511722” align=“alignnone” width=“640”] India is the world’s largest exporter of generic drugs and the leading manufacturer of vaccines globally. Wikimedia Commons (Representational Image)[/caption] Prashant Reddy, a public health activist in India, told Al Jazeera last December that “the main problem is that there is no transparency about how the drug regulator works”. “It obviously doesn’t bode too well for India that there have been two such incidents in a matter of few months,” Reddy had said after the Uzbekistan tragedy. Speaking to BBC, Thakur, also a former Indian drug executive-turned-public health expert, said he is worried that many Indian firms are not adhering to “good manufacturing practices”. A pharmaceutical industry leader, on condition of anonymity, told BBC in October 2022 that “although some countries do have very rigid quality standards”, India’s drugs were “completely safe”. “We are not defending the mishaps, but these are aberrations”, he added. To this, Thakur countered: “An aberration should only happen once. You can’t play with people’s lives”. Since these recent controversies, India has launched “risk-based inspections” of drug manufacturers and cancelled the licences of 18 companies, while permissions for specific products at three companies also been withdrawn, reported Indian Express.  With inputs from agencies Read all the  Latest News,  Trending News,  Cricket News,  Bollywood News, India News and  Entertainment News here. Follow us on  Facebook,  Twitter and  Instagram.