Unhealthy practices: Regulatory vigilance on pharma needs a relook

India’s reputation as “pharmacy to the world” has taken a knock with the death of 14 children who consumed a cough syrup contaminated with industrial solvents typically used in paint, ink, and brake fluid. True to form, the state and central government apparatus has been galvanised into action after the tragedy, arresting the doctor who prescribed the cough syrup, launching a police investigation of the manufacturers of the cough syrup, instructing state health authorities not to prescribe cough syrups to children below the age of two years even as state governments started banning the sale of the offending medication. This flurry of action does not disguise the fact that this was a wholly avoidable tragedy, which points to a wilful application of inadequate regulatory vigilance, for which some infants have paid the price. 

 

By rights, the presence of the toxic chemicals diethylene glycol (DEG) and ethylene glycol (EG) in the cough syrup should have been a thing of the past. In 2022, the deaths of nearly 70 children in The Gambia and 18 in Uzbekistan were linked to Indian-made cough syrups. A World Health Organization (WHO) investigation revealed “unacceptable amounts” of DEG and EG in the syrups. DEG and EG are cheaper substitutes for propylene glycol, which is a standard base for medicinal syrups, enabling manufacturers to maximise margins. In 2023, besides cancelling the licence of the manufacturers concerned, the government made it mandatory for cough-syrup manufacturers to get samples tested and certified at a government-certified laboratory before being exported. As a swift response to a crisis that impacts India’s reputation overseas, the move was unexceptional.

 

But then, as now, few questions seemed to have been asked of the Central Drugs Standard Control Organisation (CDSCO), which oversees manufacturing practices in the pharma sector, as to how such contamination escaped its scrutiny. In the latest tragedy, initial tests by the CDSCO found the cough syrups to be DEG- and EG-free; it was a laboratory in Tamil Nadu that revealed the presence of both chemicals beyond permissible limits. In the spotlight again for the wrong reasons, the CDSCO has launched risk-based inspections of manufacturing units of 19 drugs, including cough syrup and antibiotics. The aim, the CDSCO said, was to identify gaps that caused such quality failures and suggest process improvements to avoid such incidents in the future.

 

Such belated action begs two questions from the government. First, why were such inspections not launched in 2022, following the deaths of the Gambian and Uzbek children? Second, why did the government limit itself to imposing more stringent testing standards for cough syrups made for export and exclude those made for domestic sale? After all, deaths from ingesting contaminated cough syrups in India have occurred with distressing frequency for decades.  In 1973, 14 children died in Chennai; in 1986, 14 people died in Mumbai; in Delhi, 33 children died; and in 2020, 12 children in Jammu died — all from DEG poisoning. Taken together with the country’s flourishing market in fake drugs, this latest tragedy is unlikely to enhance India’s case as it seeks to defend its global market share in pharmaceuticals. India supplies 40 per cent of the generic medicine used in the United States, 25 per cent in the United Kingdom, and 90 per cent in Africa. Uneven and lax regulation is hardly the right prescription for dishonest manufacturers.