Last month, India called for annual audits of pharmaceutical suppliers in response to a disturbing revelation. Locally manufactured cough syrups have been linked to the tragic deaths of 141 children across the globe. What initially seemed like a recent crisis actually has roots dating back to 2019 in the Jammu and Kashmir region, according to Rutendo Kuwana, the WHO team lead for incidents involving substandard and falsified medicines.
Reuters reported that 12 children died of kidney and other organ failure, while 4 others remained severely disabled. Among the victims was two-month-old Irfan. Coughing and feverish, Irfan's father, Jafar Din purchased cough syrup called COLDBEST-PC and administered a dose to his son. After a week of vomiting and failure to pass urine, Irfan sadly succumbed to death.
The drugs responsible for these heartbreaking incidents were traced back to Digital Vision Pharma. The criminal case against Digital Vision’s owners was opened, and an investigative report by Jammu and Kashmir’s drugs regulator revealed that the drugs contained a shocking 34% concentration of the chemical diethylene glycol (DEG), far exceeding the WHO's safety limit of 0.10%. Digital Vision Founder Parshottam Goyal said, “We will challenge any case against us.” However, he speculated that someone may have “planted something", saying “Who knows what was fed to whom,” but is yet to prove otherwise.
The crisis has now taken on a global dimension, with 141 children losing their lives in countries like Gambia, Uzbekistan, and Cameroon over the past year. These incidents have been linked to high levels of DEG and a similar chemical, ethylene glycol (EG), in these cough syrups. The WHO warns that at least 15 countries may have poisonous cough syrups containing these toxic chemicals on sale.
The key issue lies in the composition of cough and cold syrups, which are typically made with propylene glycol (PG). Propylene glycol (PG) comes in two types, industrial grade and pharmaceutical grade. Prices for pharmaceutical-grade PG in India have surged due to supply chain disruptions, which may raise questions as Industrial-grade PG, which is used in products like detergents and paints, is cheaper in comparison. In fact, it must be noted that it is unsuitable for human consumption, often containing higher levels of DEG or EG that exceed the safety limits.
Initially, three companies were implicated in the poisoning cases across India, Uzbekistan, and Gambia—Digital Vision, Marion Biotech, and Maiden Pharmaceuticals. Now, Norris Medicines has also come under scrutiny and joined that list of manufacturers being investigated.
Digital Vision told Reuters that the contaminated syrup batch had been produced using pharmaceutical-grade propylene glycol (PG) sourced from Thakur Enterprises. In response, Thakur Enterprises asserted that they exclusively provide industrial-grade chemicals and had no dealings with pharmaceutical-grade PG. Furthermore, it was alleged that the industrial-grade chemicals were purchased from Manali Petrochemicals, India's sole PG manufacturer. However, there is no concrete documentation to support these claims, and Manali Petrochemicals has denied any involvement with either company.
On a different front, Maiden Pharmaceuticals faces serious allegations from the U.N. health agency, linking their cough syrups to the deaths of at least 70 children in Gambia. The propylene glycol (PG) purportedly used in their products is said to have come from the South Korean company SKC, which vehemently denies such supply. Furthermore, senior executives of Maiden Pharmaceuticals are under scrutiny for allegedly storing substandard medicines during the African poisonings.
Meanwhile, Marion Biotech stands implicated in the deaths of 65 children in Uzbekistan, according to Uzbekistan's health ministry. Indian drug controllers reported that tests conducted by an Indian government laboratory revealed 22 samples of syrups made by Marion to be "adulterated and spurious." Adding to the concern, Marion Biotech's PG supplier, Maya Chemtech, was licensed only for industrial-grade chemical sales. Additionally, Tuhin Bhattacharya, the former head of operations at the company, made a troubling statement to Reuters where he stated, "No exporter in India used to test for diethylene glycol (DEG) and ethylene glycol (EG). No one does it."
Certainly, given such a statement and the growing global concern, government action becomes imperative. However, there appear to be some inconsistencies in the approach. In a discussion with public health activist Dinesh Thakur, NPR explored government responses to this widespread issue. In March, the Indian Health Ministry requested the Department of Pharmaceuticals to compile a list of 300 widely used drug brands and affix QR codes to ensure pharmacists and customers of medication authenticity. Thakur, though, emphasises that the problem lies not in counterfeit drugs but in substandard ones.
Furthermore, there are legal loopholes that could hinder the prosecution of pharmaceutical companies. In July, the Indian parliament passed a bill that effectively decriminalises certain provisions under India's Drugs and Cosmetics Act. This change means that those manufacturing drugs "not of standard quality" may opt to pay fines, as low as $200 instead of facing jail time.
That is not to say that the Indian government has not taken positive action. In June it intensified testing requirements, mandating that all cough syrups for export undergo scrutiny in government laboratories. Health Minister Mansukh Mandaviya reported that more than 900 cough syrup samples have been cleared through these measures. Moreover, India's federal drug regulator, the Central Drugs Standard Control Organisation (CDSCO), mulled over the decision for mandatory audits for raw material and packaging material suppliers in a meeting with industry representatives last month. However, a definitive conclusion remains to be seen.
Furthermore, these stricter regulations have led to the discovery of additional contaminated medications. H.G. Koshia, the commissioner of Gujarat state's Food and Drug Control Administration, disclosed that Norris's Trimax Expectorant contained 0.118% ethylene glycol (EG), while the allergy drug Sylpro Plus Syrup had 0.171% EG and 0.243% diethylene glycol (DEG), based on tests conducted at a CDSCO laboratory. The CDSCO also identified three batches of COLD OUT syrup made by Fourrts (India) Laboratories as contaminated with DEG and EG. This cough syrup was found to have unacceptably high levels of DEG and EG in Iraq. Additionally, a glycerine batch produced by Adani Wilmar was listed, even though it contained 0.025% EG, which is well within the WHO safety limit.
And yet, despite the numerous lawsuits, criminal investigations, and heightened regulations within the medical industry, no one has been held accountable for these tragic deaths. Governments, pharmaceutical companies, and regulatory bodies must harmonise their efforts to ensure that such devastations do not occur in the future. The innocent lives lost in this crisis serve as a reminder of the urgent need for reform and transparency in the pharmaceutical supply chain.
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