Earlier this month, the World Health Organisation issued a global warning about four cough syrups that it said were substandard products and were unsafe, and their use, especially in children, could “result in serious injury or death." These four cough syrups Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, were manufactured by Maiden Pharmaceuticals Ltd, based in Haryana. The medicines have been “potentially linked” with the deaths of over 60 children in The Gambia, a West African nation. The drugs, the WHO said, contained “unacceptable amounts” of two “contaminants”—diethylene glycol and ethylene glycol, which are toxic.
Diethylene glycol, which is generally used in industrial products, is believed to be used in medicines as an adulterant in order to cut costs. This is not the first instance of deaths due to diethylene glycol—there have been several cases in India too, the latest being the deaths of 14 children in Jammu in December 2019.
India is the largest manufacturer of generic drugs in the world, and supplies a range of drugs to 200-odd countries, meeting about half of the global vaccine demand. It supplies nearly 40% of the generic drugs demand in the United States and supplies about a quarter of all medicines in the United Kingdom. The industry is growing rapidly and will is estimated to be worth about 49 billion US dollars.
The Central Drugs Standard Control Organisation (CDSCO) and the Haryana State Drugs Controller have directed a stop to all manufacting activity at Maiden Pharmaceuticals Ltd following the Gambia deaths, and an expert committee has been constituted to look into this.
But where does the responsibility for drugs lie? Who enforces our laws on spurious drugs and are they enough? Do we have enough resources to check all of the drugs manufactured in India to ensure they are safe for consumers? What is the pharma industry’s role here and what is needed to ensure that no fake or substandard drug finds its way to a patient?