Gambia Children Death Case: What Ails India's Drug Regulatory System

How could this tragedy unfold? Who's to blame? The manufacturer, the drug regulators in Haryana or the central regulator?

<div class="paragraphs"><p>Bottles of cough syrup. (Photo:&nbsp;Towfiqu barbhuiya/Unsplash)</p></div>
Bottles of cough syrup. (Photo: Towfiqu barbhuiya/Unsplash)

The tragic death of 70 children in The Gambia, likely caused by substandard cough syrup manufactured in a facility in Haryana, has put the spotlight on India's drug regulatory system.

In a flurry of steps taken weeks after the incident, production of all drugs at Median Pharmaceuticals Ltd., the manufacturer of the syrups, was halted by the government, and Indian central and state regulators have stepped in. 

The questions though being asked are, what took so long? And how could this tragedy unfold? Who's to blame -- the manufacturer, the drug regulators in Haryana or the central regulator? 

BQ Prime spoke with Dinesh Thakur, pharma activist and whistleblower in the Ranbaxy saga; and T Prashant Reddy, an activist and a lawyer, on their new book 'The Truth Pill: The Myth of Drug Regulation in India'. 

The World Health Organization had issued an alert saying the cough syrups were contaminated with diethylene glycol or ethylene glycol. But this is not the first case linked to DEG poisoning in India. Five such tragedies have taken place, with the last one in 2019 in Ramnagar, Jammu, where 12 children died in similar manner.

Thakur says it took the Gambian tragedy to shine a light on the Jammu deaths, where an FIR is yet to be filed three years after the incident. 

Where does the buck stop for such tragedies? Thakur and Reddy point to the 'federal drug regulatory system' helmed at the very top by the Central Drugs Standards Control Organisation or CDSCO. The duo received a notice from the CDSCO on Saturday for suggesting that it's the central regulator that issues the certificate of pharmaceutical products. The CDSCO, however, claimed that the certificate is issued by the state regulators. Thakur and Reddy have filed a response.

The buck must stop at the central drug regulator, Thakur told BQ Prime. "At the end of the day, the company's job is to make money. The regulator's interest should be to protect public health... The challenge we have in India is that our regulator speaks more for ease of doing business than protecting the public health of the people of India.''   

Reddy highlighted the relatively lenient punishment that "not of standard quality" drugs attract in India, citing cases after cases where the punishment to pharma companies has not exceeded a few thousand rupees and minimal or no jail time. He points to lack of political will that prevents drug inspectors form asking for a more stringent punishment. 

The duo demand more transparency, better education for drug inspectors and the need to formulate laws that put the interests of Indian consumers first to fix the regulatory system. 

Watch the full interview here: