The death of 66 children, some of whom were under the age of two, in The Gambia from consuming contaminated cough syrups was of particular concern to India. The World Health Organization (WHO) has linked these deaths to four brands made by a Haryana-based pharma company. This should prompt our drug regulatory system to act. WHO found unacceptable amounts of diethylene glycol and ethylene glycol in the syrup. Both are toxic to humans and can cause serious injury or death, especially in children. Diethylene glycol resembles propylene glycol, the solvent used for syrups. It is also cheap, which may prompt suppliers to scrutinize its use as a diluent. But the responsibility for quality control, including testing inputs, rests on the manufacturer. It is a part of “good manufacturing practices” that pharma companies are required to follow and regulators must enforce. Mistakes can prove costly. Just two years ago, around 12 children from a village in Jammu died after being contaminated with cough syrup. by diethylene glycol. And so, the health ministry’s statement that the four syrups made by Maiden Pharmaceuticals were for sale only in The Gambia – not in India – is not only morally counterfeit but also misleading.
While investigations are under way by the Central Drugs Standard Control Organization (CDSCO) and state regulators, the report suggests a long tail of violations by the drugmaker. Maiden’s products have failed regulatory tests in several states; He was fined and blacklisted by Bihar for selling low-quality medicines in Kerala. Then how did it stay in business? Why was no alert issued regarding license to export drugs? Unfortunately, drug regulation in India works in silos, the regulator of one state is not always on the same page as the next. And therefore, drugs that fail the quality test in one state may continue to be sold in another state. A similar systemic issue was highlighted in the case of children’s deaths in Jammu, where a domestic manufacturer of adulterated cough syrup was red flagged 19 times by different states. Those warnings were ignored. The company faced no real consequences, critics argue, indicating an inherent leniency in regulation that was once meant to encourage growth in the sector and now favors pharma companies at the expense of patient safety. The lack of coordination between states and central regulators is worsened by the absence of a central drug recall mechanism that would allow central drug inspectors to seize stocks of counterfeit drugs and keep them off the market for public safety.
There is no uncontested measure of the quantity of substandard drugs being sold by Indian manufacturers; CDSCO had estimated it to be 5% in 2016. Countries with strict regulatory standards like the US have penalized Indian firms for substandard drugs in the past. Although Indian generic drugs have made healthcare accessible to a large part of the world, it has sometimes been accused of selling poor quality drugs to countries with weak regulatory controls. Indian authorities in general do not have a record of proactive quality enforcement. But any compromise with medicines on standards can have disastrous consequences at home or elsewhere. Bad drugs can kill people and such damages make global news for the apathy they manifest. The government must take immediate steps to plug all the loopholes in our drug testing and regulatory system. More such lapses could lead to the loss of the country’s reputation as the ‘pharmacy of the world’, apart from making citizens aware of the dangers they may not realize themselves.
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