Cough syrup tragedy. Responsible:  doctor-pharma-drug regulator?


A doctor has been arrested in Madhya Pradesh’s Chhindwara after a toxic batch of Coldrif cough syrup allegedly caused the deaths of 18 children across two states, exposing alarming lapses in drug quality control. Of the total deaths, 14 were reported from Chhindwara alone,    A special team from Kotwali police arrested Dr Soni from Rajpal Chowk in Chhindwara late Saturday night after the FIR was registered against him, the SP said.

      The doctor has been booked for negligence and prescribing the medicine even after its adverse effects on children for nearly a month. The manufacturer had been charged as it was supplying contaminated syrup, as per the test report, Pandey told PTI.

        Here doctor who prescribed was arrested, whereas who manufactured the cough syrup is primarily responsible.

 What is the role of ‘Drug regulator’ and ‘drug quality regulator’ in such cases?

Do they carry any accountability or responsibility?  

Strangely doctors are invariably the easy scape-goats.  It is time to treat pharmaceutical malaise. The rise in “falsified and substandard medicines” has become a “public health emergency.” A surge in counterfeit and poor-quality medicines means that thousands of patients a year are thought to die after receiving shoddy or outright fake drugs intended to treat ailments. Most of the deaths are in countries where a high demand for drugs combines with poor surveillance, quality control, and regulations to make it easy for criminal gangs and cartels to infiltrate the market.

   If deep investigations are not done in such cases, poor quality medicines will continue to be marketed and doctors would be held responsible for the adverse reactions and deaths. Strict regulations for quality of pharmaceutical agents are need of the hour.

    Usually, every problem related to health is called medical malaise, but that is a misnomer.  In fact, health care comprises tens of different industries.  Complex interplay of various industries like pharmaceutical, consumable industry and other businesses associated with health care remain invisible to patients. Various important components for example pharma industry, suppliers, biomedical, equipment, consumables remain largely unregulated. Collective malaise of all these is conveniently projected as medical problems as blame is conveniently passed on to doctors, as they are only visible component of mammoth health business.  Rest all remain invisible, earn money and doctors are blamed for the poor outcome of the patient, as doctor is the only universal link that is visible with patient. By an average application of wisdom, it is easier to blame doctors for everything that goes wrong with patient.

     In routine, if patient gets fake or low-quality medicines and does not get well, gets side effects, doctor will face harassment. Whereas people involved and industry will be sitting pretty and make money.

The government on Sunday also suspended Dr Soni from service. He has been attached to the health department regional officer in Jabalpur, as per an order.

MP Chief Minister Mohan Yadav on Saturday said strict action will be taken against those responsible.

The Tamil Nadu drug control authorities, in their report dated October 2, declared the Coldrif syrup sample (Batch No SR-13; Mfg: May 2025; Exp: April 2027) manufactured by Sresan Pharmaceuticals, Kancheepuram, as adulterated because it contained diethylene glycol (48.6% w/v), a poisonous substance “which may render the contents injurious to health”.

Following the report, the Madhya Pradesh Food and Drug Administration issued instructions to stop further sale and distribution of Coldrif statewide and immediately seize any available stock for investigation under the Drugs and Cosmetics Act, 1940. It also ordered that other products manufactured by Sresan Pharmaceuticals be removed from sale pending testing.

The Tamil Nadu government on Friday banned Coldrif following reports of deaths in Madhya Pradesh and at least three similar fatalities in Rajasthan due to suspected kidney infections.

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The rise in “falsified and substandard medicines” has become a “public health emergency”. A surge in counterfeit and poor quality medicines means that thousands of patient  a year are thought to die after receiving shoddy or outright fake drugs intended to treat ailments. Most of the deaths are in countries where a high demand for drugs combines with poor surveillance, quality control and regulations to make it easy for criminal gangs and cartels to infiltrate the market.

There is an  urgent  need for  effort to combat a “pandemic of bad drugs” that is thought to kill hundreds of thousands of people globally every year.

More are thought to die from poor or counterfeit vaccines and antibiotics used to treat or prevent acute infections and diseases. Beyond the fakes that are made and sold by criminal gangs are poor-quality medicines that lack sufficient active ingredients to work properly, or fail to dissolve correctly when taken. Sloppy manufacturing is often to blame, but others are sold past their shelf life or have degraded in poor storage conditions.

    Governments and pharmaceutical companies had to improve the security of the drug supply chain in all countries from the point of manufacture to the patient. Regarding online pharmacies, there is poor public understanding of how to differentiate between a legitimate online pharmacy and an illegal one. Illegal online pharmacies and the sale of medicines via social media platforms pose the greatest risk to the  public.

Deadly Cocktail: to Make  Fake Cancer Drugs- Syndicate Manufacturing & supplying over 21 Spurious Medicines

To make big money, Pradhan got his cousin Shubham Manna and Ram Kumar involved in his plan and started making spurious cancer drugs. “He had been providing spurious medicines at a discounted 50% of market prices. He was manufacturing and supplying more than 21 spurious cancer medicines of various companies of different countries,” special commissioner (crime) Ravindra Yadav said. The syndicate comprised highly-qualified and well-earning individuals. Manna had completed his BTech and served in MNCs before joining hands with Pradhan. Police said his job was to generate barcodes, emboss batch numbers and expiry dates on medicines. He also looked after overall packaging of the spurious medicines. International syndicate used to procure capsules and manufactured fake medicines by filling them with starch.

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Deaths due to Low Quality Medicine- Pharma Industry Needs Strict Regulation


It is  time to treat Pharmaceutical malaise.

    Take example for cough syrup related  66 deaths at Gambia or  Injection Propofol related deaths at PGI Chandigarh. If deep investigations are not done, poor quality medicines will continue to be marketed and doctors would be held responsible for the adverse reactions and deaths. Strict regulations for quality of pharmaceutical agents is need of the hour.

    Usually every problem related to health is called medical malaise, but that is a misnomer.  In fact health care comprises tens of different industries.  Complex interplay of various industries  like pharmaceutical, consumable industry and other businesses associated with  health care  remain invisible to patients. Various important components for example pharma industry, suppliers, biomedical, equipment, consumables remain largely unregulated. Collective malaise of all these is conveniently projected as medical problems  as blame is conveniently passed on to doctors, as they are only visible component of mammoth health business.  Rest all remain invisible, earn money and  doctors are blamed for the poor outcome of the patient, as doctor is the only universal link that is visible with patient. By an average application of wisdom, it is easier to blame doctors for everything that goes wrong with patient.

      Cough syrup related deaths at Gambia or  Injection Propofol related deaths at PGI Chandigarh – two examples are only a tip of the iceberg.  In routine, if patient gets fake or low quality medicines and does not get well, gets side effects, doctor will face harassment. Whereas people involved and industry will be sitting pretty and  make money.

Therefore strict administration and quality check  is required   to correct Pharma malaise. It may be a complex issue because of complexity involved in implementation and execution of policies. But recognition and beginning to think of the problem is also an important step.

Red alert over deaths after Propofol injection- PGI CHANDIGARH

WHO warns over deaths of 66 children in The Gambia (Indian Pharmaceutical Cough syrup).

WHO warns over deaths of 66 children in The Gambia (Indian Pharmaceutical Cough syrup)

The WHO has issued an alert over four cough and cold syrups made by Maiden Pharmaceuticals in India, warning they could be linked to the deaths of 66 children in The Gambia

The World Health Organization (WHO) on Wednesday issued a warning over four cough and cold syrups made by an Indian company, saying that they could be linked to the deaths of 66 children in The Gambia. The WHO said that the cough and cold syrups, made by Maiden Pharmaceuticals in Haryana, could be the reason for serious kidney injuries. “Please do not use them,” the WHO said in its advisory.

The four cough and cold syrups that have been linked to the deaths of 66 children in The Gambia are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. In a release, the WHO has said that the Indian company has not yet provided guarantees on the safety and quality of these products.

“Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” the WHO said in a medical product alert. The WHO also warned that while the products had so far been found in The Gambia, they could have been distributed to other countries.

According to the WHO, diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death, the WHO said.

New Delhi-based Maiden Pharmaceuticals declined to comment on the matter.

The World Health Organization also said that it was conducting further investigation with the company and regulatory authorities in India regarding the cough syrup linked to deaths of 66 children.

Last month, Gambia’s government said that it has also been investigating the deaths. The government statement came as a spike in cases of acute kidney injury among children under the age of five was detected in late July.

“While the contaminated products have so far only been detected in the Gambia they may have been distributed to other countries,” WHO Director General Tedros Adhanom Ghebreyesus said at a press conference on Wednesday.

The WHO Director General added that WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients.

Meanwhile, the DSCO has already taken up an urgent investigation into the matter with the regulatory authorities in Haryana.

Red alert  over  deaths after Propofol injection- PGI  CHANDIGARH

CHANDIGARH: Five patients had died after they were sedated before surgeries on a single day last week at PGI, prompting doctors to sound a red alert to Central Drugs Standard Control Organisation (CDSCO)on Propofol injection – an anesthetic given before any major surgery. In this case, the drug was taken from the chemist shop in the hospital emergency. “Following a complaint from PGI doctors, we came with a CDSCO team to collect samples. The samples have been sent to Central Drugs Laboratory, Kolkata,” said Sunil Chaudhary, senior drug control officer, UT. He said, “The suspected batch of drugs has been stopped for supply till reports are received.” Sources said test analysis will take around two-three weeks and final report will be submitted by the CDSCO team. The five patients had to undergo orthopaedic and neurosurgeries. On deliberating the cause of deaths, doctors found Propofol injection as the common thread.

Advantages-Disadvantage of being a doctor

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REEL Heroes Vs Real Heroes        

 21 occupational risks to doctors and nurses

Covid paradox: salary cut for doctors other paid at home

   Medical-Consumer protection Act- Pros and Cons              

Expensive Medical College  seat- Is it worth it? 

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