Killer cough syrup

The final phrases Afsana Khan heard from her son, Usaid, had been the strains of a nursery rhyme — “Anaar ka meetha daana (The candy seed of the pomegranate).” A drowsy and weak Usaid had tried to recite the rhyme as he lay in a hospital mattress at New Well being Metropolis Hospital in Nagpur, Maharashtra.

“I used to be attempting to cheer him up. He had began going to nursery faculty 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 wakened,” 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 result of kidney failure, after three classes of dialysis. He would have turned 4 on October 10, 2025.

Khan’s youthful son, 2-year-old Yamaan, is just too younger to grasp the tragedy. As Khan speaks, Yamaan crawls below a chair and grabs an empty bottle of cough syrup. Khan rapidly snatches it from him. “You steer clear of this,” she snaps. Hours later, a crew from the State Well being Division 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 kids 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 kids stay in a crucial situation in Nagpur. The invention of contamination within the cough syrup factors to a bigger, harmful drawback — India’s poor regulatory system.

A harmful prescription

All of the 24 kids had one factor in frequent — they developed a fever and chilly, and obtained 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. Amongst them is the hospital of Dr. Praveen Soni, a well-liked paediatrician within the space. In line with many dad and mom, Dr. Soni prescribed the Coldrif syrup, together with different medicines, for a number of sick kids. Different medical doctors on the town, together with Dr. Amit Thakur and Dr. Aman Siddiqui, additionally allegedly prescribed the identical syrup for another kids who reported comparable signs.

The dad and mom purchased the prescribed medicines and went dwelling. They started to fret when their kids complained of a abdomen ache after consuming the syrup. Quickly, fear become panic: the kids started vomiting and have become drowsy. Their small our bodies swelled up. Lastly, unable to urinate, the kids suffered extreme kidney harm and died.

Suresh Pipri, a 40-year-old farmer from Parasia’s Sethiya village, recollects the previous few days of his 5-year-old daughter’s life. “Rishika was identified with fever on August 25 and obtained remedy from Dr. Thakur,” says Pipri. “She was prescribed 5 ml of syrup twice a day. Once we gave her the primary dose, she started vomiting inexperienced fluid. She vomited a number of occasions via the evening and complained of a abdomen ache. The subsequent day, she stopped speaking and recognising anybody.”

Pipri took her once more to Dr. Thakur, who referred her to a non-public hospital in Chhindwara metropolis. Regardless of three days of remedy on the hospital, Rishika’s situation worsened and she or he 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 checks. The outcomes weren’t good. Her creatinine ranges had been extraordinarily excessive. The physician referred her to a non-public hospital in Nagpur,” he says. There, Rishika underwent 9 classes 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 cellphone and her drawings. “We did the whole lot we might, however we couldn’t save her,” he says.

A month of deaths and confusion

Whereas many of the kids in M.P. had been prescribed the syrup from mid-August onwards, the primary demise, of 3-year-old Divyansh, occurred on September 2 in a non-public hospital in Nagpur. Extra deaths of kids had been reported on September 4, 7, and 9, however authorities in Parasia and Chhindwara had been unaware of the horror.

“Because the kids had been referred to personal hospitals and had died there, the native well being division had no file of them,” says Dr. Ankit Sahlam, Block Medical Officer (BMO), Parasia.

On September 16, after 5 kids had died, well being authorities in Nagpur wrote to the Chhindwara district hospital, informing them that kids hailing from Parasia, or kids who had been referred to hospitals from Parasia block, had died in Nagpur as a result of kidney failure.

“That is after we began tracing the trigger,” says Dr. Sahlam. “Our focus was on discovering sources of an infection from water, meals, or animals. Once we discovered that the kids had been handled by native medical doctors first, we informed these medical doctors to switch all the kids with comparable signs to the Civil Hospital in Chhindwara.”

The Chhindwara authorities didn’t hint the reason for the issue. “On September 22, the medical doctors on the Authorities Medical Faculty, Nagpur, informed us that the kidney harm might have been attributable to some medication,” says the Chief Medical and Well being Officer of Chhindwara, Dr. Naresh Gonnade. The medical doctors additionally despatched the prescriptions issued to the 5 kids in Parasia.

“The Well being Commissioner in Bhopal and different State authorities instructed us to launch a marketing campaign to seek out the drugs that had prompted 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 begin gathering samples of the 2 syrups from pharmacy shops as a precautionary measure.

On September 24, groups of the Nationwide Centre for Illness Management, the Central Medication Commonplace Management Organisation (CDSCO), and the State surveillance unit of the Nationwide Well being Mission in M.P. arrived in Chhindwara to analyze the deaths and accumulate samples.

In line with a doc of the M.P. Well being Division, seen by The Hindu, the groups collected varied samples to verify for infections and ailments, together with Leptospirosis, Chandipura, and Japanese Encephalitis. Exams dominated these out. Lastly, the biopsy checks of the kidneys of 4 of the 5 kids confirmed Acute Tubular Necrosis, an acute kidney harm.

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 federal government seized batches from pharmacies and instructed medical doctors to not prescribe the syrup.

On October 1, the then Controller of the Meals 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. Whereas Coldrif had been manufactured by Sresan Prescription drugs 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 checks by the M.P. Meals and Medication Administration (MPFDA).

A excessive diploma of toxicity

With the demise toll climbing, the State Well being Ministry and the Union Well being Ministry despatched samples of assorted medicines for testing.

The Tamil Nadu authorities ordered inspection and testing of samples as properly. It discovered that one pattern of the cough syrup examined confirmed diethylene glycol (DEG) contamination at a degree of 48.6% weight/quantity. The federal government issued a ‘cease manufacturing’ order to Sresan Pharma on October 3 and the CDSCO really helpful that the corporate’s manufacturing license be cancelled.

On October 4, the Ministry of Well being and Household Welfare stated, “Nineteen medication samples which had been consumed by kids 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. Nevertheless, certainly one of 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.

In line with the CDSCO, DEG replaces pharmaceutical-grade solvents, comparable to propylene glycol and glycerin, required for protected human consumption. “DEG is cheaper and has a colourless, syrupy consistency and candy style like glycerin. It’s 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 Form Pharma (Gujarat) exhibiting 0.616% of DEG.

In its official assertion, the Tamil Nadu Medication Management Division stated the inspection crew 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 identified nephrotoxic and toxic substances,” it stated.

In India, whereas the Medication and Cosmetics Act, 1940, and the related Medication and Cosmetics Guidelines, 1945, don’t explicitly record DEG by identify, they prohibit using any substance thought-about “adulterated” or “substandard”.

Who’s accountable?

Contaminated, Indian-made cough syrup is a recurring well being hazard. In 1986, no 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, plenty of 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 kids 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. But, the issue persists.

Explaining how medicine are licensed in India, Dr. Rajeev Singh Raghuvanshi, head of CDSCO, informed The Hindu that well being is a State topic. “Because of this whereas CDSCO approves new medicine, scientific trials, and imports, the States deal with the licenses for manufacturing, sale, and distribution on the State degree,” he stated.

Because the findings, the Tamil Nadu Well being Division has suspended two senior drug inspectors in Kancheepuram for failing to hold out high quality checks and for failing to observe the medicine manufactured by Sresan Pharma during the last two years. On October 10, Tamil Nadu Well being Minister Ma. Subramanian informed reporters that whereas the State had acted towards its officers, Central drug inspectors, who’re anticipated to conduct inspections of drug manufacturing amenities throughout India as soon as each three years, haven’t performed this for six years in Tamil Nadu.

Medication are licensed in India via a course of overseen by the CDSCO and the State Drug Commonplace Management Organisations (SDSCO), following the rules of the Medication and Cosmetics Act. The method requires making purposes, submitting paperwork, and finishing up inspections to make sure that the medicine are protected, efficient, and manufactured below strict high quality requirements.

An official of the Union Well being 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 corporate wasn’t in our radar,” the official says.

A senior FDA official in Bhopal in M.P. says if a drug has been authorised by the State wherein 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. “However we had been accountable for testing random samples of the involved batch, SR-13 of Coldrif, which we didn’t do, other than not having correct sale and distribution data. Three FDA officers have been suspended for negligence.”

The aftermath

On October 9, an M.P. Particular Investigative Crew arrested G. Ranganathan, proprietor of Sresan Pharma, in Chennai. They sealed his manufacturing facility positioned alongside the Chennai-Bengaluru freeway.

The police additionally filed a prison case at Parasia police station towards Dr. Soni. They booked him and the administrators of Sresan Pharma below Sections 105 (culpable murder not amounting to homicide) and 276 (adulteration of medicine) of the Bharatiya Nyaya Sanhita, 2023, in addition to Part 27(A) of the Medication and Cosmetics Act, 1940, which prescribes penalties for the manufacture, sale, inventory, or distribution of substandard and unlawful cosmetics.

The Indian Medical Affiliation objected to Dr. Soni’s arrest. Docs say it’s tough to inform whether or not a drugs is contaminated just by taking a look at it. Many medicines which are contaminated can look, scent, or style like non-contaminated merchandise. “That is why rigorous and steady security checks on medical merchandise to detect and destroy contaminated medicines, at any time when potential, is crucial,’’ says Dr. Anil Bansal, member of the Delhi Medical Affiliation.

Additionally learn: Cough syrup contamination: Well being 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 Well being Ministry. The Chhindwara Extra Collector, Dhirendra Singh, says 543 bottles have been seized up to now.

Dr. Gonnade says no less than 1,000 ASHA employees, 3,000 Auxiliary Nurse Midwives, and a number of other Anganwadi and well being employees have been conducting door-to-door surveys since. “They’re 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 firms. It has knowledgeable the World Well being Group 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.

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 point we reached Nagpur on September 22, the medical doctors stated they had been suspicious of the syrup and had been testing it. Did he [Dr. Soni] not know that this syrup had already killed kids? What was the federal government doing,” asks Dayal. All they’re left with is a passport-sized picture of Vikas; he died on September 27.

With inputs from Serena Josephine M. in Tamil Nadu