Post MP kids' deaths, pharma panel make glycol test must for all syrup formulations

In the wake of 24 deaths of children in Madhya Pradesh allegedly due to cough syrups adulterated with diethylene glycol (DEG), the Indian Pharmacopoeia Commission has amended norms and made it mandatory for all oral liquid formulations to be tested for impurities of DEG and ethylene glycol (EG).

The Indian Pharmacopoeia Commission is an autonomous institution under the Ministry of Health and Family Welfare. Commission Secretary-cum-Scientific Director Dr V Kalaisevlan has written to all state drug controllers stressing amendments to some monographs of the Indian Pharmacopeia (IP) 2022, for effective implementation.

Deadly concoction

Maiden Pharmaceuticals’ four cough syrups, manufactured in Sonepat, Haryana, were linked to 70 children's deaths in The Gambia in 2022. In 2023, Marion Biotech’s two formulations, manufactured in UP, were connected to 18 deaths in Uzbekistan

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As many as 12 children died in Udhampur in December 2019 and January 2020 due to adulterated syrups of Digital Vision. The first documented case of cough syrup adulteration with diethylene glycol in India was detected in 1972 when 15 kids died in Chennai (then Madras), followed by 14 deaths in Mumbai in 1986, 11 in Bihar in 1988, and 33 in Gurugram in 1998

“As per the amendment, now, all liquid orals must be tested for DEG and EG impurities, irrespective of whether propylene glycol (PG) was added to the formulation,” said Haryana’s State Drug Controller Lalit Goel.

In a letter issued to all senior drug control officers of Haryana today, Goel instructed, “You are hereby requested to bring this mandatory requirement to all manufacturing units under your jurisdiction for strict compliance. This amendment is effective immediately.”

Sresan Pharma’s Coldrif syrup is under scanner for children's deaths in Madhya Pradesh, and the testing by the Tamil Nadu drug controller revealed 48.6% DEG in the sample, a toxic substance.

Meanwhile, two more formulations, Rednex Pharmaceuticals’ Respifresh and Shape Pharma’s Relife, both made in Gujarat, are being investigated for DEG adulteration. Respifresh testing revealed 1.342% DEG, while Relife sampling found 0.616 percent DEG against the permissible limit of 0.1%.

Propylene glycol (PG) is widely used in the preparation of pediatric liquid oral formulations, particularly cough syrups and analgesic syrups. Both the Indian Pharmacopoeia and the United States Pharmacopeia provide tests for the absence of impurities in PG. The two critical impurities, DEG and EG, are toxic and potentially fatal.

But now, all oral formulations need to be tested for DEG and EG, regardless of whether PG is added, using a gas chromatography test.

However, former State Drug Controller of Haryana, GL Singal, said, “The addendum implies that not just PG but even if water is used a solvent in oral liquid formulations, the manufacturer has to go for gas chromatography for testing EG and DEG. It will impact small scale sector pharma industry as gas chromatography equipment is expensive.”