Lalit Garg
The recent deaths of children in Rajasthan and Madhya Pradesh linked to contaminated cough syrup raise grave questions about India’s drug regulatory system. These are not mere medical errors or tragic accidents, they are symptoms of a deeper systemic failure within the very framework meant to protect human life. When greed, negligence, and corruption infiltrate something as life-giving as medicine, even nectar turns into poison. The death of innocent children from substandard or adulterated drugs is not only the loss of families, it is the death of society’s moral conscience and public trust. Toxic substances such as diethylene glycol and ethylene glycol found in the cough syrup have caused hundreds of child deaths across several countries before. Yet the recurrence of such incidents shows that India’s drug regulatory structure suffers from chronic and structural flaws. The pressing question remains, have we learned anything from the past?
India has faced similar scrutiny before. In 2022, after the deaths of children in Gambia, the World Health Organization (WHO) issued warnings regarding an Indian-made cough syrup. Complaints followed from other nations as well. Despite being the world’s third-largest producer of medicines and exporting to nearly 200 countries, India’s pharmaceutical credibility has been tarnished by these tragic and shameful incidents. This shows an alarming lack of vigilance and quality control in a field that directly deals with human lives. Medicines meant to heal are instead turning into agents of death.
Though the government has launched investigations, recalled affected batches, and filed cases, the problem lies much deeper. From sourcing raw materials to final quality testing, negligence pervades every stage of the drug manufacturing process. Some companies use industrial-grade solvents and chemicals to cut costs, substances entirely unfit for human consumption. Meanwhile, regulatory inspections are often superficial, and oversight bodies frequently succumb to corporate influence. Both central and state-level drug control departments lack sufficient manpower, resources, and technical expertise to carry out timely inspections and testing. When audits become mere formalities and reports turn into commodities for sale, disasters like this become inevitable. In the case of Shriisan Pharmaceuticals of Tamil Nadu, laboratory tests of its Coldrif cough syrup revealed 48.6% diethylene glycol, when the international permissible limit is less than 0.10%. This is a highly toxic industrial chemical used in automotive and machine fluids. It caused kidney failure in the affected children.
These incidents have not only shattered public faith in the health administration but have also stained India’s global image. Several African nations had already imposed bans on Indian pharmaceutical products after similar deaths in past years. The fact that such tragedies are now recurring within India shows that the lessons of those episodes were never learned. As the world’s largest supplier of generic drugs, India must realize that true strength lies not in production volume but in uncompromising quality. The most painful aspect of this tragedy is that the victims were infants, their immune systems still fragile, their survival dependent on the conscience of society and the state. The moral responsibility for these deaths does not rest solely on the manufacturing companies but on the entire system that has turned a blind eye to regulation and ethics. Adulterating medicines or issuing fake quality certificates is not a mere economic offense, it is a crime against humanity. Such acts demand the severest punishment so that future offenders think a hundred times before repeating them.
India’s pharmaceutical market is worth around $60 billion, with a large share controlled by small and medium-sized enterprises. A CDSCO report from April this year revealed that a majority of these smaller firms failed to meet required quality standards, 68% of MSMEs were found non-compliant. In 2023, 65% had failed similar inspections. If these findings were known, why did the government allow their products to remain in circulation? Urgent reforms are needed: every batch must have traceable raw materials, testing reports should be made public, and quality standards must meet international benchmarks. Both central and state authorities must expand their inspection staff and laboratory capacities. License renewals should depend on past compliance and testing records, and companies violating safety norms should lose their licenses immediately. The top management of such firms must be held personally and criminally accountable.
Yet beyond government action, this crisis calls for collective introspection. Doctors must recognize the dangers of over-the-counter (OTC) medications for children. Public advisories and safety guidelines must reach grassroots levels. The media, too, must rise above sensationalism to lead an informed campaign for public health awareness. These tragedies should not fade as mere headlines, they must ignite a movement for medical integrity. India’s pharmaceutical exports are projected to exceed $30 billion this year and could touch $130 billion by 2030. But as the industry grows, so do the challenges. Testing and monitoring remain the weakest links. Regulatory agencies must operate with far greater transparency, integrity, and coordination, because this is not merely an issue of economics or global reputation, it is a matter of saving lives.
Ultimately, these events remind us that when morality is absent from the means of life protection, the entire edifice of progress collapses. The pharmaceutical sector must prioritize transparency, accountability, and human sensitivity above all else. The government and society together must ensure that no child ever dies again because of a tainted or counterfeit drug. The time has come to move from medicine to moral responsibility, from regulation to righteousness, and to deliver the harshest possible punishment to those who betray humanity for profit. Only then can life-saving medicine once again become a symbol of trust, not terror.
By
Lalit Garg
Writer, Journalist, Columnist
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