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Fifteen deaths, and counting. In yet another tragic incident, which may once again prompt the world to raise its eyebrows over the quality standards of Indian made cough syrups, at least 15 children were reported dead in Chhindwara district of Madhya Pradesh following complications after use of Coldrif cough syrup, manufactured by Tamil Nadu-based Sresan Pharmaceuticals. The cough syrup contained diethylene glycol (DEG) above permissible limits. What is surprising is that both the regulators and industry experts know that DEG is an industrial chemical most commonly used in making products like brake fluids, antifreeze, paints, plastics, and some household items. It is a cheap and colourless liquid, which is used in medicines as a substitute for a safer substance called propylene glycol, a solvent that helps dissolve drugs into liquid form. The problem is that while propylene glycol is safe in regulated amounts, DEG is highly toxic for humans. When consumed, even in small quantities, these chemicals can cause severe poisoning. There can be no doubt that the incidents like the one occurred in MP recently are absolutely human-made tragedies as the regulators, experts and even doctors are well aware that DEG can damage the kidneys, liver, and nervous system. They all know that children are especially vulnerable because their organs are still developing and they have smaller body weight, which means even a tiny dose can become fatal. When this is the reality, the billion dollar question that arises in everybody’s mind is, why DEG is after all allowed in medicines even in permissible limits. The drug regulators at the Centre and States and the Union Health Ministry should come out with a convincing answer.
Obviously, there were knee-jerk reactions from the drug regulatory authorities and the government. The Central Drugs Standard Control Organisation (CDSCO) as well as the drug control departments in concerned States conducted testing of the controversial cough syrup. Interestingly, there were contradictory test reports from different States and the CDSCO. Even as the CDSCO found the cough syrup samples it tested from Madhya Pradesh free from DEG, samples of a cough syrup tested by the drug regulator of Tamil Nadu turned out to contain DEG beyond the permissible limits. The crisis over the confirmed contamination of Coldrif cough syrup has now triggered a swift and wide-ranging regulatory response across multiple States, as authorities are working to pull the lethal medicine from circulation. All said and done, the recent reports of death of 15 children in Madhya Pradesh have once again put the spotlight on the safety of cough syrups produced in India. It is a rude reminder to Indian drug authorities to maintain quality of pharmaceutical products. Repeated incidents like this will prove to be a thorn in the flesh of the country’s reputation as ‘the pharmacy of the world’ which exports pharmaceutical products to around 200 countries in the world, including the regulated markets like the US and EU. It is a fact that the Indian pharmaceutical industry’s image was severely beaten when the World Health Organisation some time back issued alert against four contaminated medicines - Promethazine oral solution, Kofexmalin baby cough syrup, Makoff baby cough syrup and Magrip N cold syrup - all manufactured by the Haryana-based Maiden Pharmaceuticals that resulted in the death of 66 children in Gambia. Later, such incidents were reported from Uzbekistan also. Now, the Union Health Ministry should fix responsibilities for such tragic incidents and take exemplary actions against those responsible, be it regulators, industry, or even doctors.
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