India’s apex medical regulatory body, Central Drugs Standard Control Organisation (CDSCO), and state authorities have opened investigations into cough syrups manufactured by Maiden Pharmaceuticals after being alerted by the WHO. Sixty-six children have allegedly died in Gambia after consuming the medicines manufactured by the Haryana-based pharma company. The global health agency said that its laboratory analysis of samples of these syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup – revealed the presence of “unacceptable amounts of diethylene glycol and ethylene glycol”. These chemicals are toxic to humans, and can result in abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, and altered mental state. It can also lead to acute kidney injury that can prove fatal in children. In 2020, 17 children died in Jammu and Kashmir after consuming a syrup with high levels of diethylene glycol. After this tragedy, India phased out cough syrups in favour of suspensions that do not carry the risk of containing the two toxins. However, by all accounts, such dubious quality drugs continue to be manufactured, and they often find their way to Third World countries where regulations are weak.
Preliminary inquiries have revealed that Maiden Pharmaceuticals manufactured the four cough syrups only for export to Gambia. That should be no reason for relaxing regulatory scrutiny on them in the country of their manufacture. Under the Drugs and Cosmetic Act, 1940 the primary remit for monitoring the manufacture and sale of drugs is that of state authorities. The CDSCO is responsible for laying down standards and providing expert advice to regulators in the states. However, as the 2020 J&K tragedy highlighted, there is very little information sharing between authorities in the states and the Centre. Drugs that fail quality tests in one state continue to be sold in others largely because there is no binding mechanism that stipulates the nationwide recall of such medicines.
According to a CDSCO survey in 2014-2016, about five per cent of Indian drugs, several of them manufactured by large pharma companies, failed the quality test. Independent studies suggest that this figure could be much higher. The country’s pharma industry has largely been in denial over quality-related concerns expressed by national and international observers. After WHO’s alert, the pharma exporter’s body, Pharmexcil, did suspend the membership of Maiden Pharmaceuticals. Industry bodies need to do more, including setting up mechanisms for cooperation on quality control amongst firms. Adverse reports on Indian medicines, such as those from Gambia, could dent the country’s well-earned reputation of being the pharmacy of the Third World.
