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.

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