“I used to be making an attempt to cheer him up. He had began going to nursery college simply two months in the past, so I requested him to recite the rhyme. He fell unconscious after saying these strains and by no means awakened,” says Khan, sitting in her two-room home in Parasia city in Chhindwara district of Madhya Pradesh (M.P.), about 150 km away.
On September 13, 2025, Usaid died as a consequence of kidney failure, after three periods of dialysis. He would have turned 4 on October 10, 2025.
Khan’s youthful son, 2-year-old Yamaan, is simply too younger to grasp the tragedy. As Khan speaks, Yamaan crawls underneath a chair and grabs an empty bottle of cough syrup. Khan shortly snatches it from him. “You steer clear of this,” she snaps. Hours later, a workforce from the State Health Department arrives to grab the bottle.
The 60-millilitre bottle of the cough syrup, Coldrif, has been linked to an unfolding tragedy in M.P. Since September, 24 youngsters from the State have died. Most of them had been from Chhindwara, whereas some had been from the neighbouring Betul and Pandhurna districts. Three extra youngsters stay in a crucial situation in Nagpur. The discovery of contamination within the cough syrup factors to a bigger, harmful downside — India’s poor regulatory system.
Afsana Khan sits along with her son Yamaan. Khan’s 3-year-old son, Usaid, died as a consequence of kidney failure after ingesting the cough syrup prescribed by an area physician. | Photo Credit: A.M. Faruqui
A harmful prescription
All the 24 youngsters had one factor in frequent — they developed a fever and chilly, and acquired remedy in Parasia, a bustling city 30 km from the district headquarters.
Parasia is surrounded by the scenic Satpura mountain ranges and coal mines and is lined with rows of hospitals, clinics, and pharmacies. Among them is the hospital of Dr. Praveen Soni, a well-liked paediatrician within the space. According to many dad and mom, Dr. Soni prescribed the Coldrif syrup, together with different medicines, for a number of sick youngsters. Other docs on the town, together with Dr. Amit Thakur and Dr. Aman Siddiqui, additionally allegedly prescribed the identical syrup for another youngsters who reported comparable signs.
The dad and mom purchased the prescribed medicines and went residence. They started to fret when their youngsters complained of a abdomen ache after ingesting the syrup. Soon, fear was panic: the kids started vomiting and have become drowsy. Their small our bodies swelled up. Finally, unable to urinate, the kids suffered extreme kidney injury and died.
Suresh Pipri, a 40-year-old farmer from Parasia’s Sethiya village, recollects the previous couple of days of his 5-year-old daughter’s life. “Rishika was identified with fever on August 25 and acquired remedy from Dr. Thakur,” says Pipri. “She was prescribed 5 ml of syrup twice a day. When we gave her the primary dose, she started vomiting inexperienced fluid. She vomited a number of instances via the evening and complained of a abdomen ache. The subsequent day, she stopped speaking and recognising anybody.”
Suresh Pipri, a 40-year-old farmer from Parasia’s Sethiya village, recollects the previous couple of days of his 5-year-old daughter Rishika’s life. | Photo Credit: A.M. Faruqui
Pipri took her once more to Dr. Thakur, who referred her to a personal hospital in Chhindwara metropolis. Despite three days of remedy on the hospital, Rishika’s situation worsened and he or she was not in a position to urinate in any respect, he says.
“On September 2, the physician carried out a sonography and another kidney-related exams. The outcomes weren’t good. Her creatinine ranges had been extraordinarily excessive. The physician referred her to a personal hospital in Nagpur,” he says. There, Rishika underwent 9 periods of dialysis. When her situation worsened, she was placed on a ventilator for 4-5 days. She died on September 16.
Pipri stares at Rishika’s dance movies on his telephone and her drawings. “We did all the pieces we may, however we couldn’t save her,” he says.
A month of deaths and confusion
While many of the youngsters in M.P. had been prescribed the syrup from mid-August onwards, the primary loss of life, of 3-year-old Divyansh, occurred on September 2 in a personal hospital in Nagpur. More deaths of youngsters had been reported on September 4, 7, and 9, however authorities in Parasia and Chhindwara had been unaware of the horror.
“Since the kids had been referred to personal hospitals and had died there, the native well being division had no report of them,” says Dr. Ankit Sahlam, Block Medical Officer (BMO), Parasia.
On September 16, after 5 youngsters had died, well being authorities in Nagpur wrote to the Chhindwara district hospital, informing them that youngsters hailing from Parasia, or youngsters who had been referred to hospitals from Parasia block, had died in Nagpur as a consequence of kidney failure.
“This is once we began tracing the trigger,” says Dr. Sahlam. “Our focus was on discovering sources of an infection from water, meals, or animals. When we discovered that the kids had been handled by native docs first, we advised these docs to switch all the kids with comparable signs to the Civil Hospital in Chhindwara.”
The hospital of Dr. Praveen Soni, who prescribed the cough syrup to a number of youngsters in Parasia city of Chhindwara district in M.P. | Photo Credit: A.M. Faruqui
The Chhindwara authorities did not hint the reason for the issue. “On September 22, the docs on the Government Medical College, Nagpur, advised us that the kidney injury may have been attributable to some drugs,” says the Chief Medical and Health Officer of Chhindwara, Dr. Naresh Gonnade. The docs additionally despatched the prescriptions issued to the 5 youngsters in Parasia.
“The Health Commissioner in Bhopal and different State authorities instructed us to launch a marketing campaign to seek out the drugs that had brought on the deaths,” Dr. Gonnade says. The search led to 2 frequent cough syrups within the prescriptions — Coldrif and Nastro-DS. Dr. Gonnade says the Drug Inspector of Chhindwara was requested to start out accumulating samples of the 2 syrups from pharmacy shops as a precautionary measure.
On September 24, groups of the National Centre for Disease Control, the Central Drugs Standard Control Organisation (CDSCO), and the State surveillance unit of the National Health Mission in M.P. arrived in Chhindwara to analyze the deaths and acquire samples.
According to a doc of the M.P. Health Department, seen by The Hindu, the groups collected numerous samples to test for infections and ailments, together with Leptospirosis, Chandipura, and Japanese Encephalitis. Tests dominated these out. Finally, the biopsy exams of the kidneys of 4 of the 5 youngsters confirmed Acute Tubular Necrosis, an acute kidney damage.
Dr. Sahlam, the BMO of Parasia, says that it was solely on September 26 that the authorities suspected Coldrif to be a possible trigger. The authorities seized batches from pharmacies and instructed docs to not prescribe the syrup.
On October 1, the then Controller of the Food and Drug Administration, Dinesh Kumar Maurya, wrote to the drug management authorities in Tamil Nadu and Himachal Pradesh, asking them to take motion within the matter. While Coldrif had been manufactured by Sresan Pharmaceuticals in Kancheepuram in Tamil Nadu, Nastro-DS had been manufactured by Aqunova Pharma, in Himachal’s Solan district. Nastro-DS has since been cleared following exams by the M.P. Food and Drugs Administration (MPFDA).
A excessive diploma of toxicity
With the loss of life toll climbing, the State Health Ministry and the Union Health Ministry despatched samples of assorted medicines for testing.
The Tamil Nadu authorities ordered inspection and testing of samples as nicely. It discovered that one pattern of the cough syrup examined confirmed diethylene glycol (DEG) contamination at a stage of 48.6% weight/quantity. The authorities issued a ‘cease manufacturing’ order to Sresan Pharma on October 3 and the CDSCO advisable that the corporate’s manufacturing license be cancelled.
On October 4, the Ministry of Health and Family Welfare mentioned, “Nineteen drugs samples which had been consumed by youngsters had been collected from personal practitioners and close by retail shops… Out of the preliminary 10 samples analysed within the first batch, 9 met high quality requirements. However, one among them, viz. cough syrup Coldrif, contained DEG past permissible limits.’’
DEG is a poisonous chemical substance usually utilized in antifreeze options for air-conditioners, fridges, and freezers, and as a solvent for merchandise, together with cosmetics, at very low concentrations.
According to the CDSCO, DEG replaces pharmaceutical-grade solvents, comparable to propylene glycol and glycerin, required for secure human consumption. “DEG is cheaper and has a colourless, syrupy consistency and candy style like glycerin. It is utilized by producers to chop prices,’’ says a senior official at CDSCO.
Upon additional investigation, the CDSCO recognized three merchandise which had been contaminated — Coldrif from Sresan Pharma (Tamil Nadu) exhibiting 48.6% DEG; Respifresh TR from Rednex Pharma (Gujarat) exhibiting 1.342% DEG; and ReLife from Shape Pharma (Gujarat) exhibiting 0.616% of DEG.
In its official assertion, the Tamil Nadu Drugs Control Department mentioned the inspection workforce discovered a number of non-compliances at Sresan Pharma. They seen 39 crucial observations and 325 main observations. “It was discovered that the alleged batch was manufactured utilizing non-pharmacopoeial grade Propylene Glycol as an excipient, which could have been contaminated with DEG and Ethylene Glycol (EG), that are recognized nephrotoxic and toxic substances,” it mentioned.
In India, whereas the Drugs and Cosmetics Act, 1940, and the related Drugs and Cosmetics Rules, 1945, don’t explicitly record DEG by title, they prohibit the usage of any substance thought of “adulterated” or “substandard”.
Who is accountable?
Contaminated, Indian-made cough syrup is a recurring well being hazard. In 1986, not less than 14 sufferers, together with a baby, died of acute renal failure after being administered glycerol syrup laced with DEG at Mumbai’s J.J. Hospital. In 2022, quite a few nations reported that over-the-counter cough syrups for youngsters had been contaminated with DEG and EG. These resulted within the deaths of greater than 300 youngsters in Gambia, Indonesia, and Uzbekistan. A lab evaluation in Gambia revealed that the product samples contained unacceptable quantities of DEG and EG and that the bottles of syrup had been imported from India. Yet, the issue persists.
Explaining how medicine are licensed in India, Dr. Rajeev Singh Raghuvanshi, head of CDSCO, advised The Hindu that well being is a State topic. “This signifies that whereas CDSCO approves new medicine, medical trials, and imports, the States deal with the licenses for manufacturing, sale, and distribution on the State stage,” he mentioned.
Since the findings, the Tamil Nadu Health Department has suspended two senior drug inspectors in Kancheepuram for failing to hold out high quality checks and for failing to watch the medicine manufactured by Sresan Pharma during the last two years. On October 10, Tamil Nadu Health Minister Ma. Subramanian advised reporters that whereas the State had acted towards its officers, Central drug inspectors, who’re anticipated to conduct inspections of drug manufacturing services throughout India as soon as each three years, haven’t completed this for six years in Tamil Nadu.
Drugs are licensed in India via a course of overseen by the CDSCO and the State Drug Standard Control Organisations (SDSCO), following the rules of the Drugs and Cosmetics Act. The course of requires making purposes, submitting paperwork, and finishing up inspections to make sure that the medicine are secure, efficient, and manufactured underneath strict high quality requirements.
An official of the Union Health Ministry says that within the case of Coldrif, the corporate, Sresan Pharma, obtained its license from the State authorities in 2011; this was renewed in 2016. “The firm wasn’t in our radar,” the official says.
A senior FDA official in Bhopal in M.P. says if a drug has been authorized by the State by which it’s manufactured, the maker doesn’t want separate approval to promote it in one other State. “No approval was granted to this syrup by the MPFDA,” he says. “But we had been accountable for testing random samples of the involved batch, SR-13 of Coldrif, which we didn’t do, aside from not having correct sale and distribution information. Three FDA officers have been suspended for negligence.”
The aftermath
On October 9, an M.P. Special Investigative Team arrested G. Ranganathan, proprietor of Sresan Pharma, in Chennai. They sealed his manufacturing facility positioned alongside the Chennai-Bengaluru freeway.
G. Ranganathan, proprietor of Sresan Pharma, which manufactured the Coldrif cough syrup linked to the deaths of a number of youngsters in Madhya Pradesh, being produced in Saidapet Court for remand in Chennai. | Photo Credit: B. Velankanni Raj
The police additionally filed a legal case at Parasia police station towards Dr. Soni. They booked him and the administrators of Sresan Pharma underneath Sections 105 (culpable murder not amounting to homicide) and 276 (adulteration of medicine) of the Bharatiya Nyaya Sanhita, 2023, in addition to Section 27(A) of the Drugs and Cosmetics Act, 1940, which prescribes penalties for the manufacture, sale, inventory, or distribution of substandard and unlawful cosmetics.
The Indian Medical Association objected to Dr. Soni’s arrest. Doctors say it’s troublesome to inform whether or not a drugs is contaminated just by taking a look at it. Many medicines which can be contaminated can look, scent, or style like non-contaminated merchandise. “This is why rigorous and steady security checks on medical merchandise to detect and destroy contaminated medicines, every time potential, is crucial,’’ says Dr. Anil Bansal, member of the Delhi Medical Association.
Also learn: Cough syrup contamination: Health Ministry directs strict compliance with revised Schedule M norms
The M.P. authorities is now probing how a big batch of contaminated cough syrup landed in Parasia. “Over 600 bottles of contaminated cough syrup had been dispatched from Jabalpur to Chhindwara, with a big batch despatched to Parasia,’’ says a supply within the Union Health Ministry. The Chhindwara Additional Collector, Dhirendra Singh, says 543 bottles have been seized to this point.
Dr. Gonnade says not less than 1,000 ASHA staff, 3,000 Auxiliary Nurse Midwives, and several other Anganwadi and well being staff have been conducting door-to-door surveys since. “They are all trying to find these bottles,” he says.
The CDSCO has requested all of the State governments to submit an inventory of cough syrup producers of their States and has initiated a joint audit of those corporations. It has knowledgeable the World Health Organization that it has recognized and recalled three contaminated cough syrups — Coldrif, Respifresh TR, and ReLife — and halted their manufacturing. It has additionally clarified that none of those merchandise had been exported.
Prabhu Dayal Yaduvanshi and Kunti Yaduvanshi sit with their elder son Jitendra at their residence in Dighavani village in Madhya Pradesh’s Chhindwara. Their youthful son, Vikas, died after having Coldrif. | Photo Credit: A.M. Faruqui
In Dighavani village, about 15 km from Parasia, Prabhu Dayal and Kunti Yaduvanshi sit in darkness. Their youthful son, Vikas, caught a fever on September 19 and was prescribed Coldrif by Dr. Soni. “By the time we reached Nagpur on September 22, the docs mentioned they had been suspicious of the syrup and had been testing it. Did he [Dr. Soni] not know that this syrup had already killed youngsters? What was the federal government doing,” asks Dayal. All they’re left with is a passport-sized photograph of Vikas; he died on September 27.
With inputs from Serena Josephine M. in Tamil Nadu
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