What makes India’s cough syrups so deadly?
In a tragic reprise of headlines from a few weeks ago, news reports on 29 December, linked the death of 18 children in Uzbekistan to the use of cough syrups made in India.
According to reports, the children were given the Dok-1 Max cough syrup, made by Marion Biotech based in Noida, without a doctor’s prescription, and in a dose way higher than the standard dose.
This, just a couple of months after 4 cough syrups made in India came under fire for reportedly causing the death of over 60 children in the Gambia.
In October too, more than 130 people, mostly children, in Indonesia died of kidney failure linked to cough syrups, after which cough syrups were entirely banned in the country.
What all these incidents have in common is that they are all part of a long list of deaths of young children linked to cough syrups manufactured in India, or using raw materials from India.
So, what's going on here?
Why are cough syrups, a seemingly benign medicine sold over-the counter and used widely in the country finding themselves in the centre of health tragedies time and again?
FIT speaks to experts to find out.
India & Cough Syrups
India is a huge producer and market for cough syrups. According to a Reuters report, US-based pharmaceutical giant, Abbott Laboratories estimates roughly 60 million people suffer from dry cough in India.
Several combinations of drugs, all sold under the umbrella term of ‘cough syrups’ are widely advertised, and sold over-the-counter in this country.
According to data from, World Health Organisation (WHO), and the Association of the European Self-Medication Industry, India’s revenue in the Cold & Cough Remedies segment in 2022 alone amounts to $1.17 billion, and is only expected to grow.
But here’s the thing – "There is no evidence to suggest cough syrups even help," says Vandana Prasad, a community paediatrician and public health professional.
"I have spent decades of my career trying to convince parents that their child does not need cough syrups. But it seldom works."Vandana Prasad, Community paediatrician, Public health professional
Why, then, are they still so heavily prescribed in India?
OTC Cough Syrups: 'Irrational, Unnecessary, Dangerous'
A behind-the-scenes look at the production and sales of cough syrups in India reveals that it is a messy affair that's not always evidence-based.
Dr Prasad explains that over 75,000 combinations of irrational drugs, many of which don't even comply with guidelines.
Speaking to FIT, Amitava Guha, national co-covener of Jan Swasthya Abhiyan (People's Health Mission), further explains, "Sometimes both cough expectorants and suppressants are combined in one cough syrup," adding, "these combinations are contradicting, and don't make any sense."
Some of these combinations are also known to cause dangerous, and even fatal outcomes.
"Many of these are sedatives, which in children is not a good thing," says Dr Prasad.
"Cough suppressing cough syrups could inhibit respiratory function, especially in kids with lung issues," she says.
"Decongestants used in cough syrups such as phenylephrine and pseudoephedrine have been linked to higher risks of heart issues. And its just not needed."Vandana Prasad, Community paediatrician, Public health professional
They Can Also Cause Addiction
Codeine, a popular ingredient in cough suppressants is an addictive sedative linked to opioid addiction.
Some of the cough syrups may also contain dextromethorphan, or DXM, a cough suppressant that replaced codeine in over-the-counter cold and flu medicines in places where the latter is banned. This drug is also intoxicating and dangerous.
According to the American Addiction Centre, in 2008, the Substance Abuse and Mental Health Services Administration (SAMSHA) reported that 3 million adolescents and young adults, mainly between the ages of 12 and 25, had used cough or cold medicines to get high.
The bottom line is that "cough syrup has no therapeutic evidence. Therefore the use of cough syrups itself is irrational, unnesseray, and sometimes can be dangerous," reiterates Amitava Guha.
Even so, there continues to be a robust market for cough syrups in India says Dr Prasad, and "irrational, over-prescription by doctors reinforces it," she adds.
What of Laws and Regulations?
"The root cause of this nonsense that happens time and time again is our regulatory system and the regulators who are charged with enforcing them."Dinesh Thakur, Public Health Activist, speaking to FIT
"As far as the government regulations on allowing medicines in the market is concerned, there's absolute anomie," says Dr Guha.
"Many things including banned medicine are being allowed," he adds.
Health policy experts have been pushing for stricter regulations of over-the-counter medicines, including cough syrups. But the gaps in drug regulations in India are too many, and too wide to close.
"There is a clear nexus of the industry, and government officials in selling contaminated medicines. This kind of nexus is everywhere."Amitava Guha
According to Guha, the most constructive measure to deal with the OTC cough syrup crisis would be to ban cough syrups altogether.
But, experts say such a ban is unlikely, especially if big pharmas have a say.
According to a report in Reuters, pharma giants like Pfizer and Abbott, who control most of the $103 million market for the drug, stand to face a 'significant' increase in profits, especially if these medicines are restricted.
Speaking on a podcast on Quint FIT, lawyer Prashant Reddy said, "the larger problem is that we have a very fragmented system of regulation."
If the drug regulatory systems meant to ensure the safety and efficacy of the medicines we consume are failing us, then who do consumers turn to?
"One way is to file a complaint and fight a court case," says Guha. However, from personal experience, he adds "this is not easy."
"I fought for 12 years to get a high dose combination of estrogen, progestron banned. After 12 years of fighting, finally I was able to get it banned by the court. So, if you want to go for litigation, it is going to take you years."Amitava Guha
In the meantime, experts like Dr Prasad say, all they can do is continue to inform and educate people in the community, and dissuade them from relying on cough syrups, especially in young children.
What we need is "strict regulations, and large scale consumer awareness programmes," underscores Dr Prasad.
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