Cough syrup-related adverse events and deaths among children across several states over the past few weeks have been widely reported. The law has begun to take its own course with tests, bans and arrests. Sadly, this is not the first such instance. Similar tragedies were reported during the winter of 2019-20 from Jammu. In 2022-23, Indian cough syrup brands were linked to deaths in Cameroon, The Gambia and Uzbekistan. The World Health Organisation has expressed “deep concern over these developments and emphasises… the regulatory gap in DEG/EG screening for domestically marketed medicines in India.” Leading drug regulators such as the US Food and Drug Administration have put out public advisories about Indian cough syrup brands that are “contaminated with DEG/EG as identified by India’s Central Drugs Standard Control Organisation. These products have been recalled in India.”
Medicine manufacturers in other countries have also been incriminated for similar adverse events. Three hundred and twenty-three cases of Acute Kidney Injury (AKI) and 190 deaths were reported in Indonesia as recently as 2023, and six pharmaceutical companies were prosecuted for negligence. The WHO reported similar cases from at least seven countries in 2022 and alerted Pakistan’s drug regulators in April and September 2024; earlier this year, the Drug Regulatory Authority of Pakistan published advisories for the drug manufacturers and the federal and provincial testing laboratories to this effect.
The adverse events are on account of diethylene glycol (DEG) and ethylene glycol (EG) contamination of the cough syrup. The symptoms are initially insidious, such as low energy, abdominal pain, vomiting and diarrhoea. As the pathology progresses, there is shortness of breath, rapid breathing and may progress to a coma. DEG/EG poisoning can lead to kidney failure (AKI), liver damage, brain or nervous system injury and death within a space of a few days.
The discourse around these series of tragedies have focused principally on (unfortunately) well-known regulatory inadequacies. State and central level policies have led to a high concentration of pharmaceutical manufacturing units in Maharashtra, Gujarat, Telangana, Andhra Pradesh, Karnataka, Tamil Nadu, Himachal Pradesh, and Uttarakhand. There are an estimated 10,500 pharmaceutical manufacturing units with 8,500 classified as Micro, Small, and Medium Enterprises (MSMEs). A key challenge is shortfalls of regulatory staff in the Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services and the state-level Food and Drug Administration establishments. The benchmark is: One drug inspector for every 50 manufacturing units, and one inspector for every 200 sales units. CDSCO has a 40 per cent vacancy of drug inspectors against the sanctioned positions. A member of the Parliamentary Standing Committee on chemicals and fertilisers was quoted as flagging the extent of shortage as “one officer for nearly 1.5 districts”. Maharashtra reportedly has a vacancy of 77 per cent. What needs to be understood is that the regulatory personnel must maintain scrutiny not just over drug manufacturing units but also an enormous number of pharmacies, wholesalers, and blood banks.
There is an urgent need to expand the gaze from these proximate regulatory factors to a little acknowledged elephant in the room: The commercial determinants of health (CDoH) which the WHO defines as a key social determinant and includes “conditions, actions and omissions by commercial actors that affect health. Commercial determinants arise in the context of the provision of goods or services for payment and include commercial activities, as well as the environment in which commerce takes place. They can have beneficial or detrimental impacts on health.”
Which brings us to the point: What exactly is diethylene glycol (DEG) and ethylene glycol (EG) and how do they adulterate cough syrups? These are industrial solvents that are highly toxic and can be fatal for children even in small amounts. Its “inadvertent” use in the pharmaceutical industry and consequent poisoning and deaths go back nearly a 100 years now (the earliest report was in 1937). Glycerol refers to the pure chemical compound while glycerine is a commercial term for a commercial-grade, less-pure form that often contains water or other impurities. It is a frequently used component in most cough syrups for its multiple properties — solvent or thickening agent and for its properties such as lubrication, demulcency, sweetness, and ability to act as a humectant. DEG and EG are used as adulterants or contaminants in commercial glycerine.
A key element in the background is the supply and price dynamics of glycerine. The prices in India have risen upwards of about 45 per cent in the last 15 months or so. While these reflect global trends, Southeast Asian markets have witnessed volatility in this regard during July-August this year and are expected to be so through the last quarter this year. The drivers are high demand in the end-use markets that include pharmaceuticals, food additives, fuel blending, and cosmetics. The price of glycerine (extracted from palm oil) is in sync with the palm oil market, the major producers being Malaysia and Indonesia. Indonesia’s B40 policy mandates 40 per cent palm oil mix with 60 per cent diesel (referred to as B40) currently and a 50 per cent mix by 2026 — leading to reduced availability of palm oil in the export market. At the same time, El niño related droughts have led to reduced production of palm fruits and a consequent rise in palm oil prices. Its price rise has been attributed to increased domestic production and import restrictions. Palm oil prices in Malaysia and Indonesia rose to $1,023.5 and $961.5 per metric ton respectively in March. For the two highest importers, the prices in China and India (the highest) were $1,345 and $1,578 per metric ton. At the same time, the prices for DEG have been declining in the Indian domestic markets recently.
What also needs to be factored in as a commercial determinant is the cough syrup — more appropriately, the cough and cold medicines (CCM) — market. The global market in 2025 was upwards of $6 billion and the compound annual growth rate is estimated at 3.65 per cent for 2025-33. Another estimate puts it at 4.1 per cent. Over the counter availability and e-commerce home deliveries are driving demand in the backdrop of increasing upper respiratory infections, with the Asia-Pacific region leading the market share.
At the same time, around the world (including in India), professionals are being sensitised regarding the rational prescription of CCMs, particularly among children; more advocacy is needed about avoiding self-prescription though. In case you hadn’t guessed it, placebo effects of cough syrups have been variously estimated to range from 40 to 85 per cent.
The writer is chairperson, Centre of Social Medicine and Community Health, JNU. Views are personal
