The message in a bottle on quality from Gambia
PremiumThe likely role of Indian-made cough syrups in last week’s tragic loss of lives in Africa should spell tighter regulation of quality in India. A pharmacy to the world cannot afford any laxity
That 66 children, some under two years of age, died in Gambia after consuming contaminated cough syrup was a tragedy of particular concern to India. The World Health Organisation (WHO) linked these deaths to four brands made by a pharma company based in Haryana. This must spur our drug regulatory regime to action. The WHO found unacceptable amounts of diethylene glycol and ethylene glycol in the syrups. Both are toxic for humans and can lead to serious injury or death, especially in children. Diethylene glycol resembles propylene glycol, a solvent used for syrups. It is also cheaper, which may tempt suppliers short of scruples to use it as a dilutant. But the onus of quality control, which includes testing inputs, is on the manufacturer. It is a part of the “good manufacturing practices" that pharma companies are required to follow and regulators must enforce. Lapses can prove costly. Just two years ago, around 12 children from a village in Jammu had died after being given a cough syrup contaminated by diethylene glycol. And so, the health ministry’s statement that the four syrups made by Maiden Pharmaceuticals were meant for sale only in Gambia—and not India—is not only ethically spurious but also misleading.
While investigations are being carried out by the Central Drugs Standard Control Organisation (CDSCO) and state regulators, reports suggest a long tail of violations by the drug-maker. Maiden’s products have failed regulatory tests in several states; it was fined in Kerala for selling low-quality drugs and was blacklisted by Bihar. How then did it continue to stay in business? Why was no alert sounded over its licence to export drugs? Unfortunately, drug regulation works in silos in India, with one state’s regulator not always on the same page as the next. And so, drugs that fail quality tests in one state can keep selling in others. A similar systemic issue was highlighted in the case of the Jammu children’s deaths, where the domestic manufacturer of adulterated cough syrup had been red-flagged 19 times by various states. Those warnings went unheeded. The company faced no real consequences, a sign of an in-built leniency in regulation that critics argue was once meant to encourage the sector’s growth and now tends to favour pharma companies at the expense of patient protection. Lack of coordination among states and central regulators is worsened by the absence of a central drug recall mechanism, which would allow central drug inspectors to seize stocks of spurious drugs and keep them off the market for public safety.
There is no uncontested measure of the extent of sub-standard drugs being sold by Indian manufacturers; the CDSCO estimated it at 5% in 2016. Countries with tighter regulatory standards like the US have penalized Indian firms in the past for inferior drugs. Though Indian generic medicines have made healthcare accessible to a wide swathe of the world, it has sometimes been accused of selling poorer quality drugs to countries with weak regulatory controls. Indian authorities in general have not had a record of pro-active quality enforcement. But any compromise with medicines on standards can have devastating consequences—at home or elsewhere. Bad drugs can cost lives and such losses make global news for the apathy they reveal. The government must take urgent steps to plug all holes in our drug testing and regulatory system. More such lapses might cost the country its reputation as a ‘pharmacy of the world’, apart from keeping citizens exposed to dangers they can’t sense themselves.
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