A relatively unknown Indian pharmaceutical firm is in the eye of an international storm after World Health Organization (WHO) director-general Tedros Adhanom Ghebreyesus told reporters that the agency was investigating whether deaths of 66 children in The Gambia from acute kidney injuries were linked to cough syrup manufacturer Maiden Pharmaceuticals. The agency said laboratory analysis of the cough syrup confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury. The Indian
A relatively unknown Indian pharmaceutical firm is in the eye of an international storm after World Health Organization (WHO) director-general Tedros Adhanom Ghebreyesus told reporters that the agency was investigating whether deaths of 66 children in The Gambia from acute kidney injuries were linked to cough syrup manufacturer Maiden Pharmaceuticals. The agency said laboratory analysis of the cough syrup confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury. The Indian drug regulator has launched its own probe into the manufacturing processes of the company that claims to sell its products to countries in Asia, Africa, and Latin America. Though some aspects of the case remain unclear — for example, confusion reigns on whether samples were tested in The Gambia before administering the cough syrup — this much is clear: The case mars India’s ambition to emerge as a pharmacy to the world and exposes several infirmities with its drug regulatory system, especially monitoring and inspection of manufacturing processes.
Adulterated cough syrups have caused havoc in the developing world for three decades. Typically, glycerine used in cough syrup is diluted or replaced with diethylene glycol (DEG), a cheaper compound used to make industrial solvents and polymers, but one that can cause multiple organ failure, especially in children. Adulteration is a common practice across the world and finds a way in the good manufacturing practices (GMP) framework of many countries and the WHO (which asks for a specific test to check for the presence of DEG in cough syrups). Failure to pass this test has led to strict censure from the Food and Drug Administration in the United States.
It is now clear that no such test was performed on at least the batch of cough syrup given to children in The Gambia. Authorities will now have to determine whether this was the result of a deliberate misstep, a lack of robust monitoring of the manufacturing process and supply chains, or shoddy testing. India has been here before. Nearly three years ago, 14 children died in the Jammu region of acute kidney failure after they ingested a cough syrup allegedly adulterated with DEG. The batch of syrup was then pulled from the market, its production halted, and the company penalised. But it didn’t lead to any long-term changes, such as implementing a stringent nationwide GMP framework. Drug regulation continues to be ad hoc and poorly staffed and functioning under laws that need to be updated. India needs to learn fast.
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