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Repeated deadly cough syrup scandals pose hard questions for India’s drug regulators (www.straitstimes.com)

submitted 4 days ago by schizoidman@lemmy.zip to c/world@lemmy.world

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cross-posted from: https://lemmy.zip/post/50737089

Diethylene glycol (DEG) is an organic compound that is commonly used as an industrial solvent in antifreeze mixtures and brake fluids. But, in India, DEG is ending up with worrying frequency where it should never be – in cough syrups for children.

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[–] tal@olio.cafe 4 points 4 days ago* (last edited 4 days ago) (2 children)

The pharmaceutical variant has a strictly controlled presence of DEG, if any, unlike the cheaper commercial kind, which has far higher levels of the compound, making it unfit for human consumption. Manufacturers, knowingly or unknowingly, use commercial-grade PG when making cough syrups to cut costs.

Known as the “pharmacy of the world”, India accounted for 3 per cent of the world’s total pharmaceutical exports in 2023. It is particularly known for exporting affordable drugs, especially to Africa and other developing regions.

In May 2023, following the scandals abroad, the CDSCO mandated a testing protocol for cough syrups in designated Indian laboratories before export.

But no such testing was mandated for the domestic market, which has many small manufacturers producing low-cost medicines. It has now asked all state governments to submit a list of cough syrup manufacturers, while initiating a joint audit of these companies.

The failure to prevent repeated cough syrup scandals has also brought up a whiff of alleged corruption. Mr Sukesh Khajuria, a public health activist who has been helping families of the 2019-20 victims in and around Jammu seek justice, alleged that the Indian government had failed to rein in corruption within the country’s drug regulatory set-up.

“Pharma companies have hidden partnerships with the party in power,” he claimed.

A 2024 report published on Scroll, an Indian online news website, said that 35 pharmaceutical companies in India had contributed nearly 10 billion rupees (S$146.4 million) to political parties. Of these, at least seven companies were being investigated for poor-quality drugs when they made their contributions.

Well. If the state doesn't fix it from a licensing side, I guess it'd be possible for a company to fill the gap. Like, certify drug manufacturers.

The difference between certification and licensing is that a certifier can't prohibit a company from doing business if it isn't certified. But...it does mean that a purchaser, at least as long as they know what certification to look for, can look for a given certification.

You can make a certification company that places any restrictions it wants to certify a product or company, so that eliminates roadblocks to getting that side of things moving. 'course, the certifier has to build reputation for the certification to mean much.

[–] fullsquare@awful.systems 2 points 4 days ago* (last edited 4 days ago)

Manufacturers, knowingly or unknowingly, use commercial-grade PG when making cough syrups to cut costs.

i'd note that there's zero technical reason why DEG would end up in PG. reaction of water with ethylene oxide gives you ethylene glycol, diethylene glycol and higher analogues and these are then separated by distillation. propylene glycol is made from propylene oxide instead, and it's more expensive than ethylene oxide. diethylene glycol has little use on its own, at least compared to other glycols

however,

The physical properties of diethylene glycol make it an excellent counterfeit for pharmaceutical-grade glycerine (also called glycerol) or propylene glycol

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