What is the safe limit for toxic ingredients in medicines?

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The World Health Organization and Indonesian Health Ministry set a 0.10 per cent limit for toxic ingredients in medicines.

The World Health Organization (WHO) has established that the acceptable safe limit for known toxins such as ethylene glycol (EG) and diethylene glycol (DEG) in pharmaceutical products is no more than 0.10 per cent. This standard has also been adopted by Indonesia's Ministry of Health, as outlined in their 2020 guidelines concerning drug standards.
Maximum Toxin Concentration in Drug Batches

Prosecutors have accused Indonesian drugmaker Afi Farma of using ingredients with toxin concentrations as high as 99 per cent in 70 batches of medicine. This alleged practice occurred despite the established safety limits for these substances.
Specific Toxin Levels in Propylene Glycol

In the case of Afi Farma, two batches of propylene glycol, a common base for syrup-based medications, were found to contain between 96-99 per cent of ethylene glycol (EG). This occurred between October 2021 and February 2022, according to court documents. Ethylene glycol, commonly used in antifreeze, can cause acute kidney injury if ingested.
Economic Motivation for Using Toxins

Experts have indicated that unscrupulous producers may substitute toxic substances like EG and diethylene glycol for propylene glycol because these toxins are less than half the price. This cost-saving measure can significantly impact the affordability of raw materials for drug manufacturers.

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What is the safe limit for toxic ingredients in medicines?

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