India, Oct. 6 -- The death of 12 children in two states - Madhya Pradesh and Rajasthan - from a deadly toxin detected in the cough syrups prescribed to them shows what ails drug regulation in the country. In the case of the Madhya Pradesh deaths, Coldrif, the cough syrup, was found to contain 48% diethylene glycol (DEG), which is 480 times the permissible limit of 0.1%. This is not the first such instance - at home or abroad. In 2023, the WHO issued alerts on Indian cough syrups after the deaths of children in Gambia and Uzbekistan. At the time, many attempted to spin it as the failure of controls abroad on storage and transport, leading to contamination. But, even though the last such incidents at home happened decades ago - in 1986 (14 deaths) and in 1998 (33 deaths) - the latest incident shows that toxins in cough syrups could be a domestic crisis too. The root cause of the toxic content must be determined soon and pharma products at high risk of contamination must be put under special scrutiny, with existing stocks tested, and if required, recalled and destroyed. Poor communication added to the crisis. While biopsies indicated DEG poisoning, and Madhya Pradesh sent 13 suspected drugs for testing, the Centre and the state authorities erred in announcing that none of the samples contained suspected toxins while commenting on the results of just three medicines. Such communication would have contributed to false reassurances precisely when parents needed urgent warnings. It is only when testing by Tamil Nadu - where Coldrif manufacturer Sresan Pharma is based - found DEG in the cough syrup that several states moved to ban it. The incident flags safeguard failures and regulatory gaps at several levels. How thoroughly and frequently was Sresan Pharma inspected in the 20 years of its operations? Toxin content 480 times the permitted limit, after 20 years of manufacturing (in Coldrif's case), isn't merely contamination; it is industrial negligence. While the Centre is now inspecting 19 drug manufacturing units across six states, effective drug regulation calls for more than a catch-up act. India has state drug controllers and a central regulator. Between them, it seems essential quality control for medicines is falling through bureaucratic cracks. Also, while a 2023 advisory called for the drug in question not to be administered to children under the age of four years, seven of the dead were under this threshold, signalling the desperate need for a monitoring mechanism against mal-prescription and self-medication. Left unaddressed, these concerns pose serious risks for India's credibility as the pharmacy to the world....