Testing onus on drug maker, but buck stops with regulator: Experts

Chandigarh, October 8

With the death of 66 Gambian children suspected to have been caused by diethylene glycol (DEG) and ethylene glycol impurities in propylene glycol, used in four paediatric cough syrups produced by Maiden Pharmaceuticals in Sonepat, former state drug controllers have said the drug manufacturer has to ensure testing of propylene glycol while the state regulator has to keep a check on its certification.

The WHO, in its alert, has said the toxic effects of the adulterant DEG and ethylene glycol can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury, which may lead to death.

No testing facility in The Gambia

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• Officials of the Food and Drugs Administration, Haryana, say it was for the Gambian authorities to have tested the imported cough syrups
• The Gambian health services director, Mustapha Bittay, told a news channel the country did not have a laboratory capable of testing medicines’ safety

Faridabad companies under scanner too

• As per the Central Drugs Standard Control Organisation website, Faridabad-based firms are under the scanner for seven drugs failing the test from April to August 2022 in Jharkhand and Assam
• The drugs included telmisartan, ibuprofen, paracetamol, iron and folic acid tablets. Some firms are repeat offenders

Propylene glycol is used as a solvent in pharmaceutical drugs like syrups, injectables and even topical formulations. “After water, propylene glycol is the most widely used solvent in drug manufacturing,” says an ex-State Drug Controller, GL Singhal.

Most drug manufacturers purchase propylene glycol from outside, but they are supposed to test every batch before using it. Even suppliers have to test it before sending it to the drug manufacturers. “The testing has to be done at the supplier end and also at the drug manufacturing place before using,” says another former State Drug Controller, Narender Ahuja Vivek.

“The gas chromatography test is required to test the purity of propylene glycol. Small-scale units get it tested by private laboratories. Most of the time, the certification is not proper,” says Singhal.

“Propylene glycol has industrial use too. A drug maker is required to buy it from a certified pharma-grade supplier, which didn’t happen in the case of Digital Vision Pharma whose Coldbest-PC syrup caused 12 deaths in Udhampur in 2020,” says Vivek.

“Propylene glycol is three times more expensive than the DEG and ethylene glycol. So, the DEG and ethylene glycol could have been mixed with propylene glycol to save cost. There will be no problem in industrial applications, but in the case of the supply for drug manufacturing, the mixing can be fatal,” said Singhal.

Earlier, there was no test to detect the DEG in propylene glycol in Indian Pharmacopoeia (IP) that first came in 1955 and then in 1966. Following the death of 15 children due to kidney failure in 1973 in Chennai, it was added to conduct a pre-manufacturing test on propylene glycol to rule out the presence of the DEG before using it as a solvent, said Singhal.

Later, 21 patients died in Mumbai in 1986 due to the DEG in administered glycerine, a routine drug used to combat swellings. In 1998, 33 children died in Gurugram because of the DEG in syrups.

Experts say despite regulations, the buck stops with the state regulator. “It is the duty of the state regulator (FDA) to inspect whether propylene glycol used in the formulations has been tested at the supplier end and also at end of the drug manufacturers,” said Singhal.