The WHO’s latest alert against three Indian-made cough syrups – Coldrif, Respifresh TR, and ReLife – marks yet another grim chapter in India’s struggle with drug quality and regulatory oversight. The alert comes in the wake of 22 reported child deaths in Madhya Pradesh and Rajasthan, allegedly due to the consumption of these contaminated syrups containing diethylene glycol, a toxic industrial solvent known to cause acute kidney failure. This is not an isolated tragedy. In 2022, the WHO issued a similar warning after at least 70 children died in the African Gambia, allegedly after consuming from Indian-manufactured cough syrups contaminated with the same lethal compound.
Such repeated incidents have cast a long shadow over the credibility of India’s pharmaceutical industry, once hailed as the “pharmacy of the world.” While the country has earned global recognition for producing affordable generic medicines, these recurring lapses threaten to undo decades of goodwill. Each fatality tied to drug adulteration chips away at India’s reputation and raises serious questions about regulatory efficacy, manufacturing practices, and accountability. According to the WHO, the contaminated products failed to meet quality standards and were deemed “substandard”. Although the Central Drugs Standard Control Organisation maintains that none of these syrups were exported, the damage to India’s image is already done. The global health body has called for increased surveillance, particularly in informal and unregulated markets where these products frequently circulate undetected.
The current episode mirrors a disturbing pattern. Similar tragedies have unfolded over the years in various states – from Uttar Pradesh to Jammu and Kashmir – where cough syrups laced with toxic chemicals claimed innocent lives. Every time, authorities promise swift action: temporary factory closures, product recalls, and probes. Yet, the systemic flaws persist. The cycle of negligence, outrage, and forgetfulness continues – until the next preventable tragedy strikes. The reasons are not difficult to identify. Lax regulation, weak enforcement, and poor quality control plague large segments of India’s pharmaceutical industry. While top-tier firms adhere to international standards, numerous small and medium manufacturers operate with minimal oversight. Testing facilities are either inadequate or overstretched, and routine market surveillance is virtually non-existent.
Alarmingly, last year also, the CDSCO listed around 50 commonly used medicines as “not of standard quality”. These included well-known brand vitamin formulations. Several leading manufacturers were named. Predictably, the companies dismissed the findings as cases of “counterfeit” products – a serious allegation in itself. The mere existence of such large-scale counterfeit or substandard drugs in circulation underscores the fragility of the country’s drug surveillance system.
The consequences extend far beyond individual tragedies. Substandard or adulterated medicines erode public confidence in the healthcare system, lead to treatment failures, and exacerbate public health crises. Internationally, they risk trade restrictions, import bans, and loss of market trust. For a nation that exports nearly $25 billion worth of pharmaceuticals annually, such reputational damage can have far-reaching economic implications. Moreover, the rise of social media and global connectivity means that such incidents now attract immediate and widespread attention. The narrative of “unsafe Indian medicines” can quickly gain traction internationally, undermining not just the image of a few errant manufacturers but of the entire industry.
The time for half-measures is over. India urgently needs a comprehensive, technology-driven drug regulation framework that goes beyond reactive responses. The Government must enforce a single, nationwide drug manufacturing policy with zero tolerance for non-compliance. It should establish well-equipped, accredited laboratories capable of real-time and random drug testing across states, with results made public. Data analytics should be used to find the best-selling drugs in rural and semi-urban areas, where there is the least regulatory oversight. Random checks should also be done. Local drug inspectors and state regulators must be held criminally liable for negligence leading to public harm. Publicly naming violators, suspending licences swiftly, and imposing stringent penalties, including imprisonment for adulteration, can act as powerful deterrents.
India’s pharmaceutical sector is overshadowed by these recurring tragedies unless urgent and systemic reforms are implemented. WHO’s repeated warnings should be viewed as a much-needed alarm bell. Restoring local and global trust demands that India act decisively.
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