Coldrif tests reported up to 48.6 per cent diethylene glycol, and the published limits do not agree

The World Health Organization issued Medical Product Alert No 5/2025 on 13 October 2025, naming three substandard oral liquid medicines: COLDRIF, made by Sresan Pharmaceutical, Respifresh TR, made by Rednex Pharmaceuticals, and ReLife, made by Shape Pharma. All three were found to contain diethylene glycol. The alert covers WHO's South East Asia region, refers to child fatalities in India without giving a number, and advises anyone holding the products not to use them. It lists the effects of ingestion as abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death. India's Central Drugs Standard Control Organisation confirmed the medicines had not been exported and said there was no evidence of illegal export. Production was halted, authorisations suspended and recalls initiated by state authorities.

The numbers attached to the episode do not agree, and the disagreement is not trivial. Health Policy Watch reports Coldrif as containing approximately 45 per cent diethylene glycol against a permissible limit of 0.1 per cent. The Week reports 48.6 per cent against a permissible limit of 0.01 per cent. Wikipedia's entry on the compound also gives 48.6 per cent. Whichever figure is right, the contamination is several hundred times the limit on the more permissive reading and several thousand times on the stricter one. But a public record that cannot state the applicable pharmacopoeial limit consistently is a public record with a problem, because the limit is the thing a manufacturer is supposed to test against.

The death toll diverges too. Health Policy Watch reports at least 22 children dead in October 2025. The Week reports approximately 11 deaths in the Chhindwara district of Madhya Pradesh. Wikipedia's compound entry gives at least 19 children in Madhya Pradesh. This report states the range rather than choosing within it.

What is not in dispute is the manufacturing picture. An India Today investigation cited by Health Policy Watch documented more than 350 violations at Sresan's facility, including rusted machinery, unhygienic conditions and absent quality testing. The economic driver is well understood: industrial grade solvents cost less than half the price of pharmaceutical grade ones, and substituting them raises margins.

The recurrence is the story. In 1986 patients at a Bombay hospital were given glycerin containing 18.5 per cent diethylene glycol and 21 died. In 2019 sixteen children in Jammu and Kashmir were poisoned by a syrup containing 34 per cent diethylene glycol made by Digital Vision Pharma in Himachal Pradesh; investigations that followed found violations in nearly nine of every ten of some 160 factories examined. In 2022 syrups made by Maiden Pharmaceuticals were linked to 70 child deaths in The Gambia, and further contaminated products were linked to deaths in Uzbekistan and to 99 infant deaths in Indonesia. WHO has connected contaminated cough syrups to more than 300 child deaths worldwide since 2022. The pattern predates India: the 1937 elixir sulfanilamide disaster in the United States killed 105 people across 15 states and produced the Federal Food, Drug and Cosmetic Act of 1938.

The structural explanation offered by Health Policy Watch is the split in Indian drug regulation. The Central Drugs Standard Control Organisation, operating under the Drugs and Cosmetics Act, 1940, handles new drugs, imports and clinical trials, and runs zonal offices that conduct pre licensing and post licensing inspection, surveillance and recalls. The licensing and monitoring of the thousands of small and medium manufacturers that make most of India's domestic medicines sits with state drug controllers. A central regulator issues alerts about products a state regulator licensed and was meant to inspect. Sresan is in Tamil Nadu, the 2019 manufacturer was in Himachal Pradesh, and the children died in Madhya Pradesh and Jammu and Kashmir respectively. The regulator with the strongest reason to act is in each case not the regulator that granted the licence.

The central body's own standards have been questioned from inside. A former Drugs Controller General, G. N. Singh, said in a 2015 interview that if the organisation held Indian manufacturers to American standards, most would fail.

What is not known is which of the reported contamination figures is the tested one and which is a restatement, what the applicable Indian pharmacopoeial limit for diethylene glycol in these preparations actually is, the final confirmed death toll, and whether any change to the division of licensing responsibility has followed. Three previous episodes in under three decades produced inspections and alerts. None produced a change in who holds the licence.