India has long held the mantle of the “Pharmacy of the World”. Its pharmaceutical industry, valued at over $50 billion, commands global respect for providing affordable, life-saving medicines to more than 200 countries.
From generic drugs that make HIV treatment accessible in Africa to vaccines that protected millions during the pandemic, India’s pharmaceutical strength has served the world.
Yet, a spate of tragedies has begun to expose fissures in that reputation. Once hailed as a global saviour, India’s drug manufacturing sector now finds itself under intense scrutiny for lapses that have cost children their lives and shaken the country’s moral standing in global health.
The recent deaths of children in Madhya Pradesh and Rajasthan after consuming the Coldrif cough syrup is a reminder of India’s regulatory frailty. Tests revealed Diethylene Glycol (DEG), a deadly industrial solvent used in brake fluid and antifreeze, at 48 per cent concentration - 480 times the legal limit. DEG kills, silently and quickly attacking kidneys, liver and nervous systems. That this syrup could circulate for nearly 20 years before being pulled from the shelves is not just corporate negligence, but regulatory inertia that has lethal consequences.
And this is not new. In 2022, over 70 children in Gambia died after taking Indian-made syrups exported by Maiden Pharmaceuticals. The WHO found “unacceptable amounts of Diethylene Glycol and Ethylene Glycol” in the syrups. Uzbekistan, in the same year, witnessed 65 children perish from Indian based Marion Biotech’s Dok-1 Max and Ambronol syrups, again linked to DEG contamination.
By 2023, another export Guaifensin TG syrup sent to the Marshall Islands and Micronesia was flagged by WHO for the same toxic contaminants. India has seen this horror before: Mumbai in 1986, Gurgaon in 1998, Jammu in 2020. Every time, outrage follows promises of reform are made, and then the system drifts back to business as usual.
Also read: WHO asks India if Coldrif cough syrup was exported abroad
Why does this keep happening? Because India’s pharmaceutical governance is fractured and underpowered. The Central Drugs Standard Control Organisation (CDSCO) and state drug controllers operate in silos, often stepping on each other’s toes frequently failing to step up.
One inspector can be responsible for more than 200 manufacturing units, leaving quality checks sporadic and largely symbolic. The lack of a transparent, centralised database allows shoddy products to circulate freely.
Many smaller companies depend on unverified raw materials, some industrial-grade, not pharmaceutical. DEG slips into the supply chain not by accident, but because of systemic negligence and a culture that relies on self-certification rather than accountability.
The WHO has not minced words. Its 2023 alert warned that these substandard products are unsafe and can kill children, and that the failure lies as much regulators as with manufacturers. WHO Director-General Dr Tedros Adhanom Ghebreyesus put it plainly: “When medicines meant to save children’s lives instead take them, it is a tragedy that demands accountability.”
India must lead by example, he said, ensuring its exports meet the same standards expected domestically.
The fallout is visible. Several African and Asian nations have tightened rules for Indian pharmaceutical imports. Eighteen companies had their licenses suspended or cancelled in 2023 for poor manufacturing practices. In recent years, there have been talks of QR codes, online inspection portals and traceability. However, rebuilding trust takes more than technology; it requires a culture of accountability, clear systems and ruthless enforcement.
The Coldrif case is not about one ‘bad actor.’ It is about a chain of weak links, from suppliers to inspectors to company boards that allow deadly negligence to persist.
Every paediatric batch must be rigorously tested, results made public and violators criminally prosecuted. Lifetime bans, independent audits, verified raw material suppliers, and public awareness campaigns are not optional. They are the bare minimum.
India’s pharmaceutical miracle was built on the promise that no one should be denied medicine because of cost. But moral leadership now demands more than affordability.
The question now is urgent, uncomfortable and unavoidable: can the ‘pharmacy of the world’ reform itself before it loses the world’s faith entirely?
If India aspires to be a global health leader, it must choose to act with humility, transparency and uncompromising standards. Because public health is the true wealth of a nation and each contaminated syrup is a withdrawal from that account.
By Shyna Gupta
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