These are murders plain and simple

Cough syrup deaths are result of wilful neglect of pharma industry oversight

Alok Tiwari

It does not take much in India to die. Dangers lurk at every step. From a neglected pothole to a religious fanatic, anything and anyone can end your life’s journey in a moment. Even then, it was shocking when it surfaced that children, 17 at last count, had died over the last couple of months after consuming cough syrup Coldrif. Several more children are battling for their life. Even if doctors can save them, they will likely suffer permanent physiological damage including in kidney and brain. These children mostly belong to Madhya Pradesh and had died in hospitals in Nagpur where they were brought for treatment.

They had all suffered renal failure. It took some weeks to link their sickness to consumption of cough syrup. It turns out that the syrup was adulterated with diethylene glycol (DEG), an industrial solvent. Coldrif is made by Sresan Pharmaceuticals based in Kancheepuram in Tamil Nadu. Following discovery of DEG in the cough syrup samples, the TN government has shut down the company. Too late for the children.

How does an extremely toxic industrial solvent end up in cough syrup? Reports say that it is used as an adulterant in glycerine. Glycerine is used as a base in many medicinal syrups. DEG has same viscosity and sweetness but is significantly cheaper. So drugmakers or their suppliers adulterate it to make a quick buck. Adults may be able to tolerate it in small quantities, but it just kills the tender kidneys of children.

This by itself is a huge scandal. What makes it worse is that India has had plenty of warning about this happening. Go back three years, there were reports of children dying in The Gambia, a tiny and poor west African country, for the same reason. Lives of close to 70 Gambian children had been snuffed out after they were given a cough syrup made in India. The substances implicated in those deaths was also DEG. The company responsible was Maiden Pharmaceuticals based in Haryana.

It became an international scandal and an embarrassment for the Indian pharma industry. Indian government at that time had denied wrongdoing saying the samples it tested did not contain DEG. But DEG was found in samples tested by the World Health Organization. The proof was clear and at that time too government halted production at Maiden.

But it does not end there. There were allegations by a Haryana lawyer probing the case that somebody in local Food and Drugs Administration had switched the samples to be tested after taking a bribe of Rs 5 crore from the company. Senior Haryana police officials had assured to probe the allegations. There is not much in public domain about what happened next. As is usual, media soon lost interest in the case. It is not clear if Maiden is now back in business or the bribery allegations led to charges against anyone.

What is unconscionable, though not entirely unexpected, is that The Gambia tragedy should have led to stricter oversight of drug companies in India, particularly with respect to possibility of DEG contamination in cough syrups. If that had happened, the ongoing Madhya Pradesh tragedy would not have occurred. However, learning from past mistakes is not our forte. We would not have learnt anything if those 70 children had died in India. How can children dying in some poor godforsaken African country be of any consequence to us? That is why this MP tragedy will not be the last.

India has one of the largest pharmaceutical industries in the world. Overall, it is something we can be proud of. Even though much of it is based on making cheap generic medicines or knockoffs of drugs others invented than any real research-based innovations, it does fulfil a need. It provides relief from the exploitative ways of global Big Pharma. It is also extremely poorly regulated. State FDAs, which have the responsibility of overseeing the sector, are in sorry state almost everywhere. They are poorly staffed, lack expertise and equipment, and are supposed to look at everything from quality issues in local dhabas to sophisticated pharma units. Hence, they escape all accountability. There is always a good enough excuse to not do things they are supposed to do. Corruption is endemic.

The big players in pharma sector who are significant suppliers to US are under the watch of US FDA and are hence on their toes. Even a minor quality lapse their means they cannot export to US. But a big chunk of industry is small units like Maiden and Sresan who either sell domestically or export to countries not so tightly regulated. They also supply to state health services that buy from lowest bidders. Since they do not have established brands and strong marketing and distribution networks of big companies, they compete on price. There is strong incentive to cut corners. Poor regulation just helps it along. This is not to say all small manufacturers supply low quality or adulterated drugs but those who do are able to get away.

Pharma is one industry there should be strongest end-to-end traceability right from initial ingredients to end products. This means there should be record of every molecule from origin to end of product life cycle. Everything used in every batch should be traceable to its origin when problems arise. I am sure rules to this effect exist in India too. But as with most other things, enforcement is a problem. Since safety is not a priority for most Indians, governments are able to get away with neglecting it everywhere from food to transportation to healthcare. Our politics is more concerned with emotive issues and votes are swayed by what immediate gratification a party can offer. Naturally, we live on the edge.

This column appeared in Lokmat Times on Oct 9, 2025