How Weak Drug Laws Are Costing Lives

Chandigarh : Monu and Monika could easily pass off as teenagers. The husband and wife are of slight build and they both speak softly, belying the fact that they are in their early twenties. Yet, Monu, a construction worker in the Himachal Pradesh town of Baddi, and Monika, a homemaker, were parents over a year ago. They had a daughter named Radhika. She was two years old when she died, after drinking an adulterated children’s cough syrup.

The couple show me an album of Radhika’s pictures, the diligent work of first-time parents. One photo has Radhika flashing a milk-toothed grin while sitting on a swing; another has her swaddled in woollens and a monkey cap, while yet another shows her posing in what looks like a woman’s dupatta. “She was a very active child,” Monika recalls. “She had just begun to walk and would go all the way up to the third floor of this building by herself”. If it weren’t for the toxic medicine, Monika is convinced her daughter would have been alive today.

The sequence of events that led to Radhika’s death began in July last year, when the toddler came down with a cold. A local healer prescribed several medicines. Among them was a cough syrup—called Cofset—manufactured by a Himachal Pradesh-based pharmaceutical manufacturer called Digital Vision. As soon as the toddler drank the syrup, she fell ill, vomiting and unable to urinate.

When she was hospitalized at the Post Graduate Institute of Medical Education and Research (PGIMER) in Chandigarh, doctors diagnosed her with acute kidney injury. The cause, the doctors said, was Cofset. Tests at the hospital had revealed that the cough syrup was tainted with a deadly chemical called diethylene glycol.

The child spent nearly a month-and-a-half in the hospital’s intensive care unit (ICU), with little impovement. A photograph from this time shows a very different toddler from the playful one in the earlier album: her eyes are closed, head swaddled in cotton, and tubes and sensors wrapped around her body. Towards the end of this period, the doctors told Radhika’s parents that she was unlikely to improve. So, Radhika was discharged. Within hours of leaving the hospital, Monika says, her daughter passed away.

Radhika was one of the 13 children, all under five years of age, who died in 2020 after drinking the adulterated cough syrup. It was an incident that brought to light how weakly the Indian pharmaceutical industry is regulated. Earlier that year, around a dozen children from Ramnagar village in Jammu had succumbed after drinking another diethylene-glycol-laden tonic, called Coldbest, also manufactured by Digital Vision.

The incident is a case study on the soft stance that Indian drug regulators take towards drug-quality problems, and the deadly consequences of this stance. In a year-long investigation, Mint found that several Indian state drug regulators had ignored dozens of red-flags on Digital Vision’s manufacturing practices for a decade. Publicly available data shows that the company’s medicines had failed to meet quality standards at least 19 times since 2009.

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