Draft:2025 India cough syrup crisis: Difference between revisions

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The [[Tamil Nadu]] state drug control department cancelled all manufacturing licenses of Sresan Pharma.<ref name=”g405″>{{cite web |author=The Hindu Bureau |date=13 October 2025 |title=Cough syrup deaths: T.N. government cancels drug licences of Sresan Pharma, shuts down company |url=https://www.thehindu.com/sci-tech/health/tamil-nadu-government-completely-revokes-licence-of-adulterated-cough-syrup-firm-shuts-down-company/article70157787.ece#:~:text=The%20Tamil%20Nadu%20Drugs%20Control%20Department%20has%20cancelled%20all%20manufacturing,one%20of%20its%20paediatric%20syrups. |access-date=15 October 2025 |website=The Hindu}}</ref> The company’s owner was formally arrested and will face life imprisonment if convicted.<ref name=”w392″>{{cite web |last=Kannan |first=Sindhu |date=9 October 2025 |title=MP Cough Syrup Death Case: G Ranganathan, owner of pharma company that supplied ‘poisonous’ Coldrif, arrested; MP toll rises to 21 |url=https://timesofindia.indiatimes.com/city/chennai/cough-syrup-row-owner-of-pharma-company-that-supplied-poisonous-coldrif-arrested-mp-toll-rises-to-21/articleshow/124402535.cms |access-date=15 October 2025 |website=The Times of India}}</ref> Production of all medicines at Sresan’s facility was halted, and a nationwide ban on Coldrif was enforced.<ref name=”r363″>{{cite web |last=Bajwa |first=Harpreet |date=7 October 2025 |title=Cough syrup deaths: Punjab and HP governments ban Coldrif |url=https://www.newindianexpress.com/nation/2025/Oct/07/cough-syrup-deaths-punjab-and-hp-governments-ban-coldrif |access-date=15 October 2025 |website=The New Indian Express}}</ref><ref name=”u548″>{{cite web |date=11 October 2025 |title=Cough syrup deaths: Delhi govt bans sale, distribution of Coldrif |url=https://www.thehindu.com/news/cities/Delhi/cough-syrup-deaths-delhi-govt-bans-sale-distribution-of-coldrif/article70151023.ece |access-date=15 October 2025 |website=The Hindu}}</ref> In [[Gujarat]], authorities recalled Respifresh TR and ReLife and ordered the manufacturers to suspend production of all drugs.<ref name=”a141″>{{cite web |last1=Costigan |first1=Amelia |last2=Mackintosh |first2=Angus |date=10 October 2025 |title=More Indian cough syrups recalled after 19 children die by poisoning |url=https://www.abc.net.au/news/2025-10-10/more-indian-cough-syrups-recalled-19-children-die/105876056 |access-date=15 October 2025 |website=ABC News}}</ref>

The [[Tamil Nadu]] state drug control department cancelled all manufacturing licenses of Sresan Pharma.<ref name=”g405″>{{cite web |author=The Hindu Bureau |date=13 October 2025 |title=Cough syrup deaths: T.N. government cancels drug licences of Sresan Pharma, shuts down company |url=https://www.thehindu.com/sci-tech/health/tamil-nadu-government-completely-revokes-licence-of-adulterated-cough-syrup-firm-shuts-down-company/article70157787.ece#:~:text=The%20Tamil%20Nadu%20Drugs%20Control%20Department%20has%20cancelled%20all%20manufacturing,one%20of%20its%20paediatric%20syrups. |access-date=15 October 2025 |website=The Hindu}}</ref> The company’s owner was formally arrested and will face life imprisonment if convicted.<ref name=”w392″>{{cite web |last=Kannan |first=Sindhu |date=9 October 2025 |title=MP Cough Syrup Death Case: G Ranganathan, owner of pharma company that supplied ‘poisonous’ Coldrif, arrested; MP toll rises to 21 |url=https://timesofindia.indiatimes.com/city/chennai/cough-syrup-row-owner-of-pharma-company-that-supplied-poisonous-coldrif-arrested-mp-toll-rises-to-21/articleshow/124402535.cms |access-date=15 October 2025 |website=The Times of India}}</ref> Production of all medicines at Sresan’s facility was halted, and a nationwide ban on Coldrif was enforced.<ref name=”r363″>{{cite web |last=Bajwa |first=Harpreet |date=7 October 2025 |title=Cough syrup deaths: Punjab and HP governments ban Coldrif |url=https://www.newindianexpress.com/nation/2025/Oct/07/cough-syrup-deaths-punjab-and-hp-governments-ban-coldrif |access-date=15 October 2025 |website=The New Indian Express}}</ref><ref name=”u548″>{{cite web |date=11 October 2025 |title=Cough syrup deaths: Delhi govt bans sale, distribution of Coldrif |url=https://www.thehindu.com/news/cities/Delhi/cough-syrup-deaths-delhi-govt-bans-sale-distribution-of-coldrif/article70151023.ece |access-date=15 October 2025 |website=The Hindu}}</ref> In [[Gujarat]], authorities recalled Respifresh TR and ReLife and ordered the manufacturers to suspend production of all drugs.<ref name=”a141″>{{cite web |last1=Costigan |first1=Amelia |last2=Mackintosh |first2=Angus |date=10 October 2025 |title=More Indian cough syrups recalled after 19 children die by poisoning |url=https://www.abc.net.au/news/2025-10-10/more-indian-cough-syrups-recalled-19-children-die/105876056 |access-date=15 October 2025 |website=ABC News}}</ref>

In [[Rajasthan]], the state government suspended the distribution of all Kayson Pharma products under its free medicine scheme and also suspended the state drug controller.<ref name=”r978″>{{cite web |last=Kumar |first=Sharat |date=4 October 2025 |title=Rajasthan suspends drug controller, cracks down on key cough syrup supplier |url=https://www.indiatoday.in/india/story/rajasthan-suspends-drug-controller-cracks-down-on-key-cough-syrup-supplier-2797553-2025-10-04 |access-date=15 October 2025 |website=India Today}}</ref> An expert committee was appointed to investigate the deaths, and the prescribing doctor involved in the [[Sikar]] cases was suspended.<ref name=”x084″>{{cite web |last=Ali |first=Syed Intishab |date=3 October 2025 |title=Sikar doc, pharmacist suspended; new guidelines for syrup issued |url=https://timesofindia.indiatimes.com/city/jaipur/sikar-doc-pharmacist-suspended-new-guidelines-for-syrup-issued/articleshow/124278722.cms |access-date=15 October 2025 |website=The Times of India}}</ref> Across India, health ministries reissued guidelines recommending that cough and cold medicines be administered only to children over five years of age and avoided in infants under two unless absolutely necessary.<ref name=”x660″>{{cite web |date=3 October 2025 |title=Health Ministry issues advisory on cough syrups among kids: Do not prescribe such medication for children under two |url=https://indianexpress.com/article/health-wellness/cough-syrup-kids-health-ministry-advisory-prescribe-10286014/ |access-date=15 October 2025 |website=The Indian Express}}</ref> Warning labels for pediatric safety were mandated, and the [[Directorate General of Health Services (India)|Directorate General of Health Services]] advised physicians to exercise careful clinical evaluation and strict dosing when prescribing syrups to older children.<ref name=”s406″>{{cite web |last=Desk |first=Online |date=3 October 2025 |title=Centre warns against cough syrups for children under 2 years after deaths in two states |url=https://www.newindianexpress.com/nation/2025/Oct/03/centre-warns-against-cough-syrups-for-children-under-2-years-after-deaths-in-two-states |access-date=15 October 2025 |website=The New Indian Express}}</ref>

In [[Rajasthan]], the state government suspended the distribution of all Kayson Pharma products under its free medicine scheme and also suspended the state drug controller.<ref name=”r978″>{{cite web |last=Kumar |first=Sharat |date=4 October 2025 |title=Rajasthan suspends drug controller, cracks down on key cough syrup supplier |url=https://www.indiatoday.in/india/story/rajasthan-suspends-drug-controller-cracks-down-on-key-cough-syrup-supplier-2797553-2025-10-04 |access-date=15 October 2025 |website=India Today}}</ref> An expert committee was appointed to investigate the deaths, and the prescribing doctor involved in the [[Sikar]] cases was suspended.<ref name=”x084″>{{cite web |last=Ali |first=Syed Intishab |date=3 October 2025 |title=Sikar doc, pharmacist suspended; new guidelines for syrup issued |url=https://timesofindia.indiatimes.com/city/jaipur/sikar-doc-pharmacist-suspended-new-guidelines-for-syrup-issued/articleshow/124278722.cms |access-date=15 October 2025 |website=The Times of India}}</ref> Across India, health ministries reissued guidelines recommending that cough and cold medicines be administered only to children over five years of age and avoided in infants under two unless absolutely necessary.<ref name=”x660″>{{cite web |date=3 October 2025 |title=Health Ministry issues advisory on cough syrups among kids: Do not prescribe such medication for children under two |url=https://indianexpress.com/article/health-wellness/cough-syrup-kids-health-ministry-advisory-prescribe-10286014/ |access-date=15 October 2025 |website=The Indian Express}}</ref> Warning labels for pediatric safety were mandated, and the [[Directorate General of Health Services (India)|Directorate General of Health Services]] advised physicians to exercise careful clinical evaluation and strict dosing when prescribing syrups to older children.<ref name=”s406″>{{cite web |last= |first= |date=3 October 2025 |title=Centre warns against cough syrups for children under 2 years after deaths in two states |url=https://www.newindianexpress.com/nation/2025/Oct/03/centre-warns-against-cough-syrups-for-children-under-2-years-after-deaths-in-two-states |access-date=15 October 2025 |website=The New Indian Express}}</ref>

In addition to bans and arrests, regulatory agencies carried out broader crackdowns. The [[Enforcement Directorate]] conducted raids on Sresan Pharma headquarters in connection with alleged financial irregularities.<ref name=”g405″ />

In addition to bans and arrests, regulatory agencies carried out broader crackdowns. The [[Enforcement Directorate]] conducted raids on Sresan Pharma headquarters in connection with alleged financial irregularities.<ref name=”g405″ />

In late 2025, India experienced a deadly outbreak of cough syrup poisoning that primarily struck children in the central state of Madhya Pradesh and the neighbouring state of Rajasthan. Dozens of young children fell ill and many died after taking locally sold cough medicines. Investigations showed that at least one of the implicated syrups, Coldrif, produced by Sresan Pharmaceuticals, contained extremely high levels of the industrial solvent diethylene glycol (DEG).[1] Another incident in Rajasthan involved a government-distributed cough syrup containing the active ingredient dextromethorphan hydrobromide made by Kayson Pharma.[2][3] The World Health Organization also issued global alerts about the contaminated syrups.[4]

Background

India is a leading global drug producer, but the quality of some locally marketed medicines has been questioned after previous tragedies. In 2022–2023, dozens of children in Uzbekistan, the Gambia and Cameroon died after taking Indian-made syrups contaminated with ethylene glycol or diethylene glycol.[5] For example, 18 children in Uzbekistan died after ingesting Dok-1 Max, and WHO later found toxic glycols in syrups from India’s Marion Biotech.[6] Similarly, a WHO investigation attributed dozens of child deaths in the Gambia to four Indian cough syrups contaminated with ethylene glycol or diethylene glycol. After those incidents, India tightened export controls, but domestic oversight gaps remained a concern.[4]

Outbreak

Madhya Pradesh

The first fatalities emerged in early October 2025 in Chhindwara district of Madhya Pradesh. Local health officials reported that infants and toddlers with common cold symptoms rapidly developed severe dehydration and acute kidney injury after receiving a cough syrup. By mid-October, at least 17 children under age five from Chhindwara and nearby areas had died of renal failure after consuming the syrup.[7][8] A state government investigation traced all the cases to Coldrif syrup, manufactured by Sresan pharmaceuticals in Tamil Nadu. The Madhya Pradesh government banned Coldrif on 2 October 2025, after its laboratory tests confirmed diethylene glycol contamination.[9] The death toll continued to rise, and on 15 October, officials reported that 24 children (mostly under five) had died in connection with Coldrif poisoning, and several more were hospitalized.[10] In these cases, children initially had symptoms of mild respiratory illness but then suffered persistent vomiting, abdominal pain and difficulty urinating.[11]

Rajasthan

In early October, three children (aged 2–5) died in the districts of Sikar and Bharatpur after taking a government-dispensed cough syrup.[12][13] The offending product was a generic cough syrup containing dextromethorphan hydrobromide, manufactured by Kayson Pharma in Jaipur. Unlike the Madhya Pradesh cases, this syrup did not test positive for diethylene glycol (the active ingredient dextromethorphan is a standard cough suppressant),[14] but the timing of the deaths prompted authorities to suspect contamination or overdose. The Rajasthan government immediately suspended distribution of all Kayson Pharma medicines and stopped dispensing any cough syrups containing dextromethorphan.[15]

Contaminated syrups

The outbreak in Madhya Pradesh was primarily linked to Coldrif, produced by Sresan Pharmaceuticals, which contained approximately 48.6% diethylene glycol (DEG), far exceeding permissible limits and causing multiple child fatalities. Two additional syrups, Respifresh TR and ReLife, manufactured in Gujarat—also tested positive for DEG but were not associated with reported deaths.[16] In Rajasthan, a separate incident involved a dextromethorphan hydrobromide syrup produced by Kayson Pharma, which was implicated in child deaths and hospitalizations due to improper use and suspected contamination.[17]

Investigation and WHO alert

Indian health authorities, in coordination with international agencies, initiated urgent investigations in early October 2025. The Central Drugs Standard Control Organisation (CDSCO) and state regulators collected numerous samples of cough syrups, antipyretics, and antibiotics from six states to test for contamination.[3] Most randomly sampled syrups from general pharmacies tested negative for diethylene glycol (DEG), indicating that the problem was confined to specific batches. Following requests from Madhya Pradesh authorities, Tamil Nadu drug inspectors obtained samples of Coldrif directly from the Sresan Pharma factory; tests released on 3 October confirmed extremely high levels of DEG.[18][1] The Sresan pharma plant was subsequently sealed, with inspectors reporting unsafe and abandoned conditions on site.[19]

A multi-disciplinary team—including CDSCO, ICMR, AIIMS Nagpur, and NEERI—began analyzing clinical data and drug samples to identify the source of contamination. Police filed a criminal complaint, naming Sresan’s owner, G. Ranganathan, in a manslaughter case, and arrested a prescribing doctor, Praveen Soni, for negligent prescribing.[5][20] The charge sheet cited violations of the Drugs & Cosmetics Act, including adulteration of drugs and culpable homicide not amounting to murder.[21]

Internationally, the World Health Organization (WHO) was notified on 8 October and issued a Medical Product Alert on 13 October, confirming that specific batches of Coldrif, Respifresh TR, and ReLife contained toxic DEG.[22][23] The alert noted that Indian authorities had ordered immediate production halts and product recalls. WHO advised healthcare professionals worldwide to report any cases involving these products and to avoid their use in children. The U.S. Food and Drug Administration (FDA) reported that none of the contaminated syrups had been exported to the United States but recommended vigilance in other markets.[24][25]

Government actions

The Tamil Nadu state drug control department cancelled all manufacturing licenses of Sresan Pharma.[26] The company’s owner was formally arrested and will face life imprisonment if convicted.[27] Production of all medicines at Sresan’s facility was halted, and a nationwide ban on Coldrif was enforced.[28][29] In Gujarat, authorities recalled Respifresh TR and ReLife and ordered the manufacturers to suspend production of all drugs.[30]

In Rajasthan, the state government suspended the distribution of all Kayson Pharma products under its free medicine scheme and also suspended the state drug controller.[31] An expert committee was appointed to investigate the deaths, and the prescribing doctor involved in the Sikar cases was suspended.[32] Across India, health ministries reissued guidelines recommending that cough and cold medicines be administered only to children over five years of age and avoided in infants under two unless absolutely necessary.[33] Warning labels for pediatric safety were mandated, and the Directorate General of Health Services advised physicians to exercise careful clinical evaluation and strict dosing when prescribing syrups to older children.[34]

In addition to bans and arrests, regulatory agencies carried out broader crackdowns. The Enforcement Directorate conducted raids on Sresan Pharma headquarters in connection with alleged financial irregularities.[26]

References

  1. ^ a b “India declares three cough syrups toxic after child deaths”. Reuters. 9 October 2025. Retrieved 15 October 2025.
  2. ^ Singh, Harsha Kumari; Chowdhury, Shatabdi (3 October 2025). “Firm Behind Cough Syrup Linked To Child Deaths Under Scanner In Rajasthan”. www.ndtv.com. Retrieved 15 October 2025.
  3. ^ a b “CDSCO launches inspections of drug manufacturing units in six states after cough syrup deaths”. The New Indian Express. 4 October 2025. Retrieved 15 October 2025.
  4. ^ a b Das, Krishna N.; Paramasivam, Praveen; Rigby, Jennifer (9 October 2025). “WHO calls out gap in India’s cough syrup testing after deaths”. Reuters. Retrieved 15 October 2025.
  5. ^ a b Rishika Sadam, Krishna N. Das (6 October 2025). “Police launch manslaughter probe into India’s cough syrup deaths”. Reuters. Retrieved 15 October 2025.
  6. ^ “Toxic Cough Syrup, Weak Oversight: India’s Unending Drug Safety Crisis”. Health Policy Watch. 15 October 2025. Retrieved 15 October 2025.
  7. ^ Malpani, Mehul (7 October 2025). “Cough syrup death toll rises to 20 in Madhya Pradesh”. The Hindu. Retrieved 15 October 2025.
  8. ^ Kumar, Sanjay; Kumar, Sanjay; Broadwith, Phillip; Kumar, Sanjay (14 October 2025). “23 Indian children’s deaths linked to contaminated cough syrup”. Chemistry World. Retrieved 15 October 2025.
  9. ^ Malpani, Mehul (10 October 2025). “Cough syrup deaths: Tamil Nadu’s Sresan Pharma owner brought to M.P.’s Chhindwara, sent to 10-day police custody”. The Hindu. Retrieved 15 October 2025.
  10. ^ “MP cough syrup tragedy: Child death toll rises to 24 after three year-old girl dies in Nagpur”. The New Indian Express. 15 October 2025. Retrieved 15 October 2025.
  11. ^ “Medical Product Alert N°5/2025: Substandard (contaminated) oral liquid medicines”. World Health Organization (WHO). 13 October 2025. Retrieved 15 October 2025.
  12. ^ Singh, Harsha Kumari; Chowdhury, Shatabdi (3 October 2025). “Firm Behind Cough Syrup Linked To Child Deaths Under Scanner In Rajasthan”. www.ndtv.com. Retrieved 15 October 2025.
  13. ^ “CDSCO launches inspections of drug manufacturing units in six states after cough syrup deaths”. The New Indian Express. 4 October 2025. Retrieved 15 October 2025.
  14. ^ “Cough Syrup Samples Tested in MP Were Negative For Two Major Contaminants: Health Ministry”. The Wire. 3 October 2025. Retrieved 15 October 2025.
  15. ^ “Cough syrup row: Rajasthan government suspends drug controller, halts distribution of Kaysons Pharma drugs”. The Hindu. 4 October 2025. Retrieved 15 October 2025.
  16. ^ Vats, Varsha (14 October 2025). “Coldrif, Respifresh TR And ReLife: WHO Issues Global Warning Against These Three Indian Cough Syrups”. www.ndtv.com. Retrieved 15 October 2025.
  17. ^ Ali, Syed Intishab (3 October 2025). “Govt rejects family’s claim of cough syrup given to boy by Chirana hosp”. The Times of India. Retrieved 15 October 2025.
  18. ^ Dutta, Tanushka (4 October 2025). “Explained: What Is Diethylene Glycol Found In ‘Coldrif’ Cough Syrup At Tamil Nadu Unit”. www.ndtv.com. Retrieved 15 October 2025.
  19. ^ The Hindu Bureau (13 October 2025). “Cough syrup deaths: T.N. government cancels drug licences of Sresan Pharma, shuts down company”. The Hindu. Retrieved 15 October 2025.
  20. ^ Singh, Ravish Pal (14 October 2025). “Doctor arrested over cough syrup deaths admitted to getting commission: Police”. India Today. Retrieved 15 October 2025.
  21. ^ Shwenk, Martin; Murthy, Narayana; Poonawalla, Adar; Jain, Manu; Kamath, Nitin (5 October 2025). “Cough syrup row: FIR filed against arrested doctor, manufacturer”. The Economic Times. Retrieved 15 October 2025.
  22. ^ “WHO alert on cough syrups ‘alarming’; there are missing links that need to be probed: Expert”. The Hindu. 8 October 2022. Retrieved 15 October 2025.
  23. ^ Bhirani, Garvit (14 October 2025). “WHO issues alert! Coldrif named among 3 ‘substandard’ cough syrups in India after 22 children die in Madhya Pradesh”. mint. Retrieved 15 October 2025.
  24. ^ “FDA’s actions to protect children from contaminated cough medicine”. U.S. Food and Drug Administration. 10 October 2025. Retrieved 15 October 2025.
  25. ^ India, U.S. Mission (14 October 2025). “Health Alert: Recall of Specific Children’s Cough and Cold Medicines in India”. U.S. Embassy & Consulates in India. Retrieved 15 October 2025.
  26. ^ a b The Hindu Bureau (13 October 2025). “Cough syrup deaths: T.N. government cancels drug licences of Sresan Pharma, shuts down company”. The Hindu. Retrieved 15 October 2025.
  27. ^ Kannan, Sindhu (9 October 2025). “MP Cough Syrup Death Case: G Ranganathan, owner of pharma company that supplied ‘poisonous’ Coldrif, arrested; MP toll rises to 21”. The Times of India. Retrieved 15 October 2025.
  28. ^ Bajwa, Harpreet (7 October 2025). “Cough syrup deaths: Punjab and HP governments ban Coldrif”. The New Indian Express. Retrieved 15 October 2025.
  29. ^ “Cough syrup deaths: Delhi govt bans sale, distribution of Coldrif”. The Hindu. 11 October 2025. Retrieved 15 October 2025.
  30. ^ Costigan, Amelia; Mackintosh, Angus (10 October 2025). “More Indian cough syrups recalled after 19 children die by poisoning”. ABC News. Retrieved 15 October 2025.
  31. ^ Kumar, Sharat (4 October 2025). “Rajasthan suspends drug controller, cracks down on key cough syrup supplier”. India Today. Retrieved 15 October 2025.
  32. ^ Ali, Syed Intishab (3 October 2025). “Sikar doc, pharmacist suspended; new guidelines for syrup issued”. The Times of India. Retrieved 15 October 2025.
  33. ^ “Health Ministry issues advisory on cough syrups among kids: Do not prescribe such medication for children under two”. The Indian Express. 3 October 2025. Retrieved 15 October 2025.
  34. ^ “Centre warns against cough syrups for children under 2 years after deaths in two states”. The New Indian Express. 3 October 2025. Retrieved 15 October 2025.

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