Cough Syrup Deaths: Victims of Profits or Negligence?
S Krishnaswamy
As of 5 OctoberTwenty children (as of 8th Oct) have died in Madhya Pradesh (MP) and 3 in Rajasthan, due to diethylene glycol (DEG) contamination in cough syrup. In the Chhindwara district of MP, 16 children lost their lives after being given cough syrup Coldrif, manufactured by Sresan Pharmaceuticals. Dr Soni, a doctor posted in a Government Hospital in Chindwara, who also runs a private clinic, has been arrested for prescribing the cough syrup. In Rajasthan, 3 children died in Sikar and Bharatpur. Several others fell ill after taking a government-supplied generic cough syrup from Kayson Pharma distributed under the Chief Minister's Free Medicine Scheme. In an attempt to reassure the public, a Rajasthan doctor consumed the syrup himself but fell unconscious within hours. The Rajasthan government has halted the distribution of all 19 medicines supplied by Kayson Pharma and suspended the Drug Controller of the state.
The Union Health Ministry, in a press note citing analysis conducted by a joint team of national agencies, said there was no diethylene glycol or ethylene glycol "in the samples tested." However, they issued an advisory recommending caution in administering cough syrup to children. Contrary to these findings, Tamil Nadu's Government Drugs Testing Laboratory found DEG in samples of Coldrif syrup. The Tamil Nadu Drugs Control Department promptly ordered a halt in production by the manufacturer, Sresan Pharmaceutical Manufacturer, located in Sunguvarchathiram, Kancheepuram district. Following this, Tamil Nadu, Kerala, Rajasthan, and Madhya Pradesh all banned the sale and use of Coldrif syrup.
Two states and cough syrup from two different companies represent a more pervasive failure of the drug industry in India and its quality control measures. Even more alarming was the Union Health Ministry's what appears to be a rushed clean chit on possible contamination or even adulteration of the cough syrups, appearing to claim that the problem was not in the cough syrups but elsewhere. If the cough syrups were not the problem as claimed by the Ministry, they forgot that they then owed an explanation to us of what is killing our children.
What is Diethylene glycol or DEG?
Diethylene glycol (DEG) is a colourless and sweet-tasting industrial chemical that is mostly utilised in antifreeze and solvents. It has no legitimate use in medicines or food. When absorbed in the body, the effects of DEG can be severely toxic, damaging the kidneys and the nervous system. It is primarily responsible for acute kidney injuries and may even be deadly in children. Contamination of safe ingredients with DEG happens easily, as DEG's appearance and characteristics are similar to those of pharmaceutical-grade solvents, such as glycerin and propylene glycol (both acceptable ingredients used as solvents, or sweeteners and thickeners in medicines). DEG may be used in syrups and emulsions by manufacturers not committed to quality control or poorly regulated supply chains. Or, in the most extreme of cases, wilfully mixing the cheaper DEG or ethylene glycol with more expensive pharma-grade solvents, resulting in children and other patients suffering serious damage to their health or even death.
Past tragedies
This kind of tragedy involving the Indian pharma industry has happened before. In 2022, sixty-six children died in Gambia after ingesting pediatric syrups manufactured in Haryana by Maiden Pharmaceuticals Limited, which were later discovered to have been contaminated with diethylene glycol (DEG) and ethylene glycol. Cases of the illness were first reported in July 2022. A pediatric nephrologist contacted the Gambian Ministry of Health on this issue, and laboratory tests determined that the Maiden Pharmaceuticals Limited syrups imported from India contained DEG and ethylene glycol. The World Health Organisation later issued an alert worldwide for the medical product in October for Maiden Pharmaceuticals. The Indian response to this issue was slow. The Haryana FDA and central authorities did not start testing products until the WHO's international alert was issued.
Even before the Gambia incident, Maiden Pharmaceuticals had its drugs failing to meet drug quality testing and results year after year. When they were penalised for violations, it was only with the suspension of a handful of practice licenses for a limited time. There was no recall of any of its products, and no prosecution for violating safety: a mere slap on the knuckles. Though India was embarrassed by the global news, which made it appear that the enforcement system in India was weak and incapable of manufacturing and exporting unsafe drugs, it took no further action.
The DEG death history in India goes back several decades. Thirty-three children died in 1998 in Gurgaon, Haryana, after drinking contaminated cough syrup. Gas chromatography tests revealed the presence of DEG. Investigations identified lapses in regulatory monitoring, weak enforcement of good manufacturing practice, and insufficient testing. Previously, fourteen deaths had taken place in 1986 in Bombay's J. J. Hospital from DEG-contaminated glycerin used in medicines. The subsequent Justice Lentin Commission revealed profound corruption, interference by ministers, and fabrication of reports in Maharashtra's Food and Drug Administration. Official suspensions notwithstanding, no significant reform emerged, showing a long tradition of impunity.
In 2020, thirteen children died in Himachal Pradesh from cough syrups produced by Digital Vision, again containing DEG. Earlier, the state drug regulator had uncovered substandard drugs manufactured by Digital Vision multiple times, but only issued short-term suspensions as a response. The subsequent investigation revealed falsified records and the use of industrial-grade solvents as substitutes for medical-grade excipients. The Himachal Pradesh Drugs Control Administration received widespread criticism with regard to weak drug monitoring, delayed action and inaction, which were evidence of entrenched regulatory failures at a state level.
Regulatory weakness is not new. In 2014, the then Drug Controller General of India, G.N. Singh, stated that if the same standards as mandated in the US—namely good manufacturing practices— were applied to India, drug manufacturers in India would have to close. According to Singh, Indian people's health can be sacrificed for the profits of Indian companies or MNCs operating here.
These poisonings still happen across the globe, but mostly in countries of the global south. The 2022 Gambia poisoning was merely the most recent of a long line: in Uzbekistan (2022), Nigeria (2008), Panama (2006), Bangladesh, Haiti, India, and Argentina in the 1990s and 2000s, all the consequence of DEG contamination in syrups. They all have one thing in common—low-cost substitution of safe drug ingredients with poisonous solvents, facilitated by weak regulation and lack of transparent supply chains.
The most notorious of the epidemics is still the 1937 Massengill disaster in the US, where S. E. Massengill Company made a sulfanilamide elixir with diethylene glycol as a solvent. Over 100 people in 15 states in the US lost their lives. There was public outcry, but the firm paid only a small fine under obsolete regulations, and the lead chemist, Harold Watkins, who concocted the medication by blending DEG with raspberry flavouring, committed suicide before he could stand trial. The tragedy revealed the lack of regulation of drug safety at the time in the US and resulted in the 1938 Federal Food, Drug, and Cosmetic Act, which markedly enhanced the standards and the authority of the US Food and Drug Administration to provide drug safety in the US.
Ensure People's Safety
Nowadays, such fatalities no longer happen in Europe or the United States, due to stringent quality enforcement and robust regulatory frameworks. They are left to Asia and Africa, where they remain disconcertingly common. The cause is all too familiar: weak regulation, incompetent application, corruption between political and corporate forces, and low levels of sanctions for spurious or contaminated medicine. For avoiding further disasters, we need vigilant quality checking, thorough audits of suppliers, and transparent supply chains overseen by impartial bodies and technology-enabled tracing.
The Jan Swasthya Abhiyan (JSA) in Rajasthan stands out as a model for change in the backdrop of the recent crisis. It demanded an inquiry into the case by a truly neutral committee comprising good clinicians, pharmacologists, public health specialists, and members of civil society, conducted in an open manner, and the imposition of accountability at every level. Additionally, it also demanded sweeping structural changes, which include the improvement of quality testing through high-tech instrumentation, the batch-wise disclosure of quality test results from the Rajasthan Medical Services Corporation Limited (RMSCL), and post-supply random batch testing as an additional layer of precaution. It also demanded an adverse drug reaction-reporting system at the district level that is operational 24/7, with a priority review of each failure to identify the root cause. And a robust network of pharmacovigilance establishments within public health institutions. Additionally, it sought training for health workers to detect and report adverse events, while emphasising the importance of independent third-party audits of all RMSCL activities in restoring public confidence.
The JSA emphasised that the free medication program, which is still a lifeline to thousands of families in the state, must also be based on accountability and transparency. To prevent DEG and ethylene glycol contamination, they suggested revising pharmacopoeial standards and conducting comprehensive, risk-based factory inspections. (There has also been criticsm of the weakening of the Drugs & Cosmetics Act by the Amendment in 2023 by the Modi government, as it made a distinction between substandard drugs, which could be compounded by paying a fine, and adulterated and spurious drugs, for which criminal prosecution and jail sentence were retained. We will cover this issue later as mixing of DEG is a criminal offence even under the Amended Act).
Manufacturers must adhere to the strictest requirements, ensuring that certifications are of the highest quality, conducting comprehensive testing for impurities, and utilising only licensed suppliers. Most importantly, the unholy relationship between unscrupulous pharmaceutical firms and corrupt political authority needs to be made transparent and eliminated. Only such steps which put the people before profits will help ensure the health and safety of our people.
