In a development with significant regulatory implications, Madhya Pradesh Drug Controller Dinesh Srivastava revealed that, until recently, there was no legal requirement to test finished pharmaceutical products for toxic diethylene glycol (DEG). Notably, Aaj Tak had highlighted this gap on October 9, reporting the absence of mandatory DEG testing in finished medicines.
Acting on Srivastava’s recommendation, the Union government has amended rules so that both DEG and ethylene glycol (EG) must now be tested in raw materials and finished drug formulations before reaching the market. The move aims to prevent tragedies like the one caused by Coldrif cough syrup, which claimed the lives of at least 22 children in Madhya Pradesh.
The syrup, manufactured by Sresan Pharmaceutical in Tamil Nadu in May 2025, was found to contain 46.28% w/v DEG, a toxic chemical harmful to human health. Investigations by the Central Drugs Standard Control Organisation (CDSCO) revealed multiple lapses by the Tamil Nadu Food and Drug Administration (TNFDA). Although licensed in 2011, Sresan Pharma continued operations despite poor infrastructure and repeated violations of national drug safety rules.
The deaths primarily occurred in MP’s Chhindwara and neighbouring districts, prompting national attention. India’s drug regulator issued directives instructing all states to ensure rigorous batch testing of raw materials and finished products, and to source medicines only from approved suppliers. Several states, including Delhi and West Bengal, banned or froze stocks of the syrup as a precaution, even where contaminated batches were not confirmed to have reached the market.
WHO has also highlighted the regulatory gap: while exported drugs undergo stricter testing, domestic medicines were not uniformly screened for DEG and EG, leaving a critical safety loophole.
A ground investigation by Aaj Tak exposed serious delays and infrastructure failures in Madhya Pradesh’s drug testing labs: samples were sent via ordinary mail, labs were understaffed, and mobile testing vans remained unused.
NEW NORMS AND THE ROAD AHEAD
Under the new norms, manufacturers will have to conduct DEG and EG testing not only at raw-material stage but also for finished batches before releasing them to the market. The inclusion of these tests in the Indian Pharmacopoeia monograph gives them statutory backing.
Experts say this marks a significant shift in India’s pharmaceutical oversight. However, implementation will be key. Many states, including MP, suffer from chronic staff shortages, lab backlogs, and neglected infrastructure (as shown in MP’s long testing delays).
Questions are also being raised about prior warning signs. Tamil Nadu, for instance, claimed it alerted Madhya Pradesh and the Union government about contamination in the Coldrif batch early on. But authorities allegedly failed to act until the deaths became public.
Meanwhile, the pharmaceutical industry faces fresh scrutiny and pressure. Already, multiple states have banned or frozen stocks of Coldrif and related products.
The focus will now turn to enforcement: sampling, lab capacity, regulatory oversight — and ensuring that this tragedy prompts durable change, not just swift headlines.
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