An Epidemic of Substandard drugs, Fake drugs, Pseudoscience & Counting


    A frightening scenario is emerging as there seems to be an epidemic about fake or substandard medicines, spurious drugs and heightened belief in marketed therapies by advertisements.  An epidemic of ignorance that causes people to believe in pseudoscience or merely in projected promise of cure. A hope of miracle is flashed to patients, who have been given a ‘no hope’ by scientific medicine. Such patients are an easy prey for such fraudsters. It is not uncommon that lethal substances like steroids, hormones and heavy metals are given in dangerous doses.

       In the absence of strict Government control, all kinds of dubious assertions are available about curing all types of ailments.  These alleged remedies, and the belief systems they are based on, are based on the facts that can neither be proved nor disapproved. They are dangerous to life of patients, which is why it is necessary to fight them and refute them.  But who should fight? Patients themselves are blinded by a projected faith and false belief about definite cure.

Drugs samples- declared not of standard quality

New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 50 medicine batches for failing to qualify for a random drug sample test for the month of October,2022.

These drugs samples which are declared not of standard quality include Levocetirizine tablets manufactured by Hindustan antibiotics, Onkam (ondansetron Oral solution) manufactured by Gujarat Pharmalab, Pantop-DSR (Pantoprazole Sodium Gastro-resistant & Domperidone Prolonged release Capsules IP) manufactured by Aristo pharmaceuticals, Diacowin-plus Capsules (prebiotic & probiotics capsules) manufactured by Zee Laboratories and others.

In addition, other popular drug sample that is declared not of standard quality include Montek LC (Montelukast Sodium & Levocetirizine Hydrochloride Tablets IP) manufactured by Sun pharma laboratories due to failure of Identification and assay of Montelukast.

Also Read:Drug Alert: CDSCO flags 45 formulations as not of standard quality

This came after analysis and tests conducted by the CDSCO, Drugs Control Department on 1280 samples. Out of these, 1230 samples were found to be of standard quality while 50 of them were declared as Not of Standard Quality (NSQ).

A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the disintegration test, failure of the dissolution test, failure of sterility test, etc. The samples collected were tested in five laboratories, namely CDL Kolkata, CDTL Mumbai, RDTL Chandigarh, RDTL Guwahati, and CDTL Hyderabad.

Syndicate Supplying Fake Cancer drug Busted #Spurious-Medicine

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.

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.

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.

Advantages-Disadvantage of being a doctor

     25 factors- why health care is expensive

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?

NEET- Not so Neat- percentile system

The  Myth  of  cost of  spending  on  medical  education needs to be made  transparent.

Syndicate Supplying Fake Cancer drug Busted #Spurious-Medicine


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.

     Advantages-Disadvantage of being a doctor

     25 factors- why health care is expensive

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?

NEET- Not so Neat- percentile system

The  Myth  of  cost of  spending  on  medical  education needs to be made  transparent.

India-UK FTA may tighten screws on Generic drugs. Britain doing Big Pharma Bidding?


Several international organisations working to improve people’s access to medicines have written to the UK government protesting against provisions in a proposed India-UK FTA after the chapter on intellectual property was leaked. The provisions related to pharmaceutical IP could prevent India from making affordable generics on which the National Health Service (NHS) of the UK and several other countries depend.  India’s ability to produce generics is crucial not only to the Global South but to the UK too.

Four out of five drugs used in the NHS are generics and a third of these are produced in India. So about 25% of the drugs in the NHS come from India. Between 2011 and 2016, the NHS started to experience a crisis in the amount of money it was spending on new, very expensive drugs. The amount the NHS spent rose in those years by £3.8 billion. That is more than twice the total NHS deficit at that time – £1.85 billion. The crisis was so severe that the NHS began to look for ways to save money, including importing more generics. It worked.

International non-profit calls upon calls upon India to stay vigilant and asks the U.K. to withdraw intellectual property proposals.

The proposals on intellectual property (IP) rights in the draft India-United Kingdom Free Trade Agreement (FTA) will hurt the global supply of generic medicines, Doctors Without Borders (Médecins Sans Frontières or MSF) warned on Wednesday. In a press note, the international organisation said low medicine prices help save lives in vulnerable communities across the world but the intellectual property chapter of the India-U.K. FTA contains “harmful IP provisions”. The IP-related chapter, leaked on October 31, showed that the controversial provisions tabled by the U.K. to “tighten the screws on producing, supplying and exporting affordable generic medicines from India”.

“Given the disastrous consequences, this leaked IP chapter could have on the global supply of generic medicines, the U.K. government should withdraw it completely. India should stay vigilant and not allow barriers to affordable medicines to be written into FTA negotiations,” Leena Menghaney, South Asia head of MSF’s Access Campaign, said. 

U.K.-India trade talks continuing

In a “Fact Sheet”, MSF has argued that the demand for “harmonisation” of Indian patent law with the U.K.’s laws will lead to dilution of important provisions in the Indian patent system that are necessary for manufacturing generic medicines and vaccines.

“Article E.10 of the leaked IP chapter stipulates that both parties “shall not” make patent opposition proceedings available BEFORE the grant of a patent. In effect, this provision applies only to India as the U.K. does not have a pre-grant opposition system – this goes directly against the current Indian patent law, which allows patent opposition proceedings both before and after the grant of a patent,” the MSF said in its observations on the IP provisions.

MSF pointed out that under the proposals from the U.K., even treatment providers could be subjected to legal actions for prescribing generic medicines for which India is one of the largest manufacturing hubs. MSF said that the IP provisions brought up by the U.K. opened up possibilities for “excessive enforcement” that are likely to create difficulties for both Indian pharmaceutical companies as well as the legal set-up. 

MSF highlighted that another problematic provision is Article J.11 of the leaked IP chapter. Under this provision, Customs officials could block legitimate medicines from leaving India for other developing countries if a multinational pharmaceutical corporation was to claim that their patents were being infringed upon by the Indian product. “Furthermore, Article J.5 and J.7 prescribe how courts should adjudicate IP disputes, which could impact [Indian] judicial discretion,” MSF said.

A British government spokesperson said they would not comment on the “alleged leaks” and will only sign “a deal that is fair, reciprocal, and ultimately in the best interests of the British people and the economy”.

“The U.K. and India are negotiating an ambitious Free Trade Agreement that will boost our current trading relationship, already worth more than ₤24 billion last year,” the spokesperson told The Hindu.

     Advantages-Disadvantage of being a doctor

     25 factors- why health care is expensive

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?

NEET- Not so Neat- percentile system

The  Myth  of  cost of  spending  on  medical  education needs to be made  transparent.

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

     25 factors- why health care is expensive

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? 

CCI investigates India’s largest hospital chains’ Practices


The potential penalty by India’s fair trade regulator could be steep. The CCI  (The Competition Commission of India)  investigation is the first such action against exorbitant prices of medicines and services fixed by hospitals, which have operated free of regulation so far.

A four-year investigation by India’s fair-trade regulator has concluded that some of India’s largest hospital chains abused their dominance through exorbitant pricing of medical services and products in contravention of competition laws.

The Competition Commission of India (CCI) will soon meet to weigh in on the responses by Apollo Hospitals, Max Healthcare, Fortis Healthcare, Sir Ganga Ram Hospital, Batra Hospital & Medical Research and St. Stephen’s Hospital. It will then decide whether to impose penalties, said people familiar with the matter.

The CCI can impose a penalty of up to 10 percent of the average turnover for the past three preceding financial years of an enterprise that has violated competition laws. The penalties could be steep. Apollo Hospitals posted an average turnover of Rs 12,206 crore and Fortis Rs 4,834 crore in the past three financial years.

The CCI’s director-general found that 12 super-speciality hospitals of these chains that operate in the National Capital Region abused their positions of dominance by charging “unfair and excessive prices” for renting rooms, medicines, medical tests, medical devices, and consumables, according to a copy of the summary report that Moneycontrol reviewed.

Some hospital room rents exceeded those charged by 3-star and 4-star hotels, according to the findings by the DG, who examines anti-competitive practices.

Significance of the investigation

The CCI investigation is the first such action against exorbitant prices of medicines and services fixed by hospitals, which have operated unencumbered by regulation so far. The watchdog’s action could potentially rein in the prices of medicines and healthcare equipment, or at the very least, bring transparency in the way hospitals sell these items, according to competition lawyers.

Of the 12 hospitals that faced CCI scrutiny, six belonged to Max  and two to Fortis.

The CCI and the hospital chains had no comment for this article.

Overcharging without checks

Exorbitant pricing is a common thread running through the CCI investigation report. The hospitals were found to charge more for certain medical tests as well as for X-rays, MRI and ultrasound scans than rates offered by other diagnostic centres. For consumables such as syringes and surgical blades, hospitals charged rates that were higher than those of other consumable makers, according to the CCI report.

The only exception was medicines, which hospitals sold at the maximum retail price, although they earned significant profits by procuring them at lower prices.

The CCI selected the hospitals for investigation on the basis of the number of doctors, paramedics, beds, and turnover for the period 2015-2018. The investigation found that these hospitals do not allow the use of purchase of consumables, medical devices, medicines and medical test results from outside, adding that patients use the service of in-house pharmacy and laboratories for ease of convenience.

Investigative reports pertaining to each of the hospital chains were submitted by the DG to the CCI on December 24, 2021. The CCI forwarded a copy of these reports to the hospitals on July 12, 2022, and sought their responses, according to the people, who did not want to be identified.

The CCI has been examining the pharmaceutical sector in India for years, scrutinising the pricing of medicines by healthcare companies. On April 19, 2020, it cautioned businesses, including healthcare companies, against taking advantage of Covid-19 to contravene competition laws.

     Advantages-Disadvantage of being a doctor

     25 factors- why health care is expensive

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?

Overuse of Antibiotics: Wrong analysis # Rebuttal Times of India


     The Times of India today   carries an editorial by Mr Sandeep Bansal on over prescription of antibiotics. Although there are few points which may be correct, but the article fails to highlight the basic reasons for the problem, which it was supposed to address.

    The reason for failure to find the correct reasons can be the distant analysis. Someone working in London and trying to analyse the grass root problem of India may not be a perfect idea. People need to work at ground level to identify the real issues. Otherwise the analysis remains half-baked and gives a glimpse  of the bias, which celebrities use commonly for gaining popularity by finding faults of doctors.

 

     The overall picture has to be understood to identify real reasons and hence the proper solution to the problem. The correct steps taken would settle the issue; otherwise the analytical article would   just remain a piece of paper and an matter of discussions for Arm chair preachers.

over prescription of antibiotics

   The author failed to highlight the factors like easy availability of antibiotics. People can directly approach pharmacist and get whatever antibiotic they want.  Pharmacist can sell whatever brand, doses and kind of antibiotic. The uncountable quacks, doctors of alternate medicines use all kind of antibiotics with impunity. Tons of antibiotics are consumed without any proper medical advice. Self-medication by people themselves, as it is easily available can’t be ignored as an important cause.  

       The reasons written by the author in TOI, actually constitute a minuscule fraction (5-10%), as far as use of antibiotics is concerned. By writing imperfect article, without knowing actual problems by a distant analysis, such article provides real misguidance rather than actual solutions to the problems.

         Someone to do justice to such complex and important issues, one has to work at the place and be aware about real issues and ground problems. Otherwise it just remains a method to gain cheap popularity.

   Sadly, in present era, people who do not treat patients,  are away from  truth, but they can influence the treatment of thousands of patients  just by doing an ‘On Table’ analysis.

        Wrong analysis, hence incorrect conclusions can lead to wrong decisions.

     Advantages-Disadvantage of being a doctor

     25 factors- why health care is expensive

     REEL Heroes Vs Real Heroes

     21 occupational risks to doctors and nurses

     Covid paradox: salary cut for doctors other paid at home

Immunity business in corona times


About the medicines and substances, that  are consumed by masses under a false hope of immunity enhancement. Every substance, which claims to alter human physiological functions should undergo strict international neutral trials and not allowed to be sold by mere advertisements.

Tremendous misguidance is propagated by giving a false hope to people of doing some treatment.

Every day we read in media the various pronouncements claiming to enhance the immunity especially in the  days of Covid-19. It automatically implied  or interpreted that the said product will save  the people from Corona and hence a brisk business starts. No one has studied the real effectiveness, correct  doses or side effects of preparation in real sense.

 

A myth, that any plant extracted drug is useful, free of side effects, is a belief ingrained deep in the minds of people. Such unscrupulous  advice is followed blindly without even verifying the authenticity of the source. A hope of miracle is flashed to patients who perceive  a “no hope” by scientific medicine, are an  easy prey for such fraudsters.

Another major problem  is that medicines and syrups distributed in such manner often  are without name of drug, contents and doses. It is not uncommon to get lethal substances like steroids, hormones and heavy metals in dangerous doses.   Such acts  are  real crime to society, done with an intention to cheat rather than treating them.

Any one selling  medicines in name of alternative medicines, food supplements or medical advice of any kind, has to be registered with a council, for those particular medicines. advertisement of such drugs or products should be on some scientific basis and neutral trials.

 

Most of these are not validated at all by international or national authorities, not even considered as drugs. No impartial, neutral trials conducted about effects, side effects or toxicity. Mere media or social media words, which are paid, are considered as  Gospel  Truth  and substances are consumed by masses under a false hope of immunity enhancement. Most of them marketed as herbal or alternate medicines, which are advertised as harmless but beneficial. They are sold by propagated words of benefit  and advertisements rather than a solid proof.

Slowly these medicines become part of conventional wisdom rather than  considered as drugs and chemicals or heavy metals.  In reality, being a settled medical science issue, it remains a fake news at the basis.

There is no dearth of quacks, who sell unknown and unlabelled substances, merely  to earn money, but the dangers of such products are high and unassuming consumers remain oblivious to side effects.

   Any substance is considered effective only after rigorous testing through randomised clinical trials  and additional laboratory analyses.  The substances that are merely propagated on social media or claims of company or advised by quacks will not help and merely remain as part of immunity business. They provide a false hope and thereby earn money  because of fear in the minds of masses.

Times of India carries a report about the brisk business being done, while people are looking at ways to enhance their immunity.

Any substance which claims to alter the physiology of a person or patient, cannot be consumed  without undergoing rigorous, neutral and international  safety trials. If found to be good, all  homo sapiens in the world should be benefitted. If not,   let the gullible masses not be misguided and trapped into a false hope. There has to be a strict Government  control about the products to be consumed, which claim to alter human physiology.

Balancing immunity in Corona times

 

Moral burden of poor quality PPE’s on doctor and nurses#Covid time


Medical industry has found an opportunity to do a brisk business. The norms of PPE are not well defined, from the end user’s comfort,  that is doctor and nurses. Any material is that is converted into PPE and dumped on health workers, adding enormously on their plight.  A moral burden to do their  work in every situation, is becoming difficult to carry on, while the opportunist in medical industry make merry. A sin, which  may look nonpunishable in current era, but should not be forgiven in a civilized society.

Possibly working as a doctor and nurse is going to be most difficult  profession. Working in life and death situations, excessive  documentation, unrealistic expectations from patients and administrators alike, working  under legal compulsions, prone to punishments and complaints on simple human errors,  poorly paid  and facing verbal and physical assaults. Above all despite doing all this, respect and gratitude is scant for the life savers in present era. Adding to all above issues, another problem has been added, the poor quality of PPE, which makes life of saviours a hell.

Times of India  publishes a report on the same, that brings out the plight of doctor and nurses.

‘Some PPEs feel like we’re wearing plastic rice bags  from. Trussed up inside a plastic bag in the summer heat with sweat pouring down the body but afraid to drink water as it is impossible to take a loo break. This is how a nurse described the experience of wearing a personal protective equipment (PPE) suit.

While there is no dearth of PPE any more, doctors and nurses say the quality is such that it’s like wearing a plastic bag. Doctors say hospitals are besieged by companies offering PPE kits. “The quality of most of what is offered is horrible. The fabric of many is like chawal ka thaila (RICE BAG). There is zero breathability and so health workers find it impossible to wear it for long. That reluctance could endanger them,” said a senior doctor. The WHO guidelines on PPE strike a balance between protection against infection and allowing health workers “ease, dexterity, comfort and minimal heat-associated stress”. However, the guidelines framed by the ministries of health and textiles only focus on the need to prevent blood or fluid penetration but have nothing about breathability. So, manufacturers focus on thickness of the plastic rather than the wearer’s comfort. “In the initial rush to overcome the shortage of PPE, it is understandable that the ministry did not think of all aspects. But it is unacceptable to allow people to use this opportunity to make money by supplying abysmal quality PPE and endangering the  lives of health workers.

The government should immediately issue clear-cut guidelines on quality of fabric and stitching and weed out the fake manufacturers cashing in on the sudden demand for PPE,” said a doctor in a Covid hospital. According to a manufacturer of protective wear, cheap plastic laminated fabric costs just Rs 150-200 per kilo. “So even with the cost of stitching, a poor quality PPE suit would cost only Rs 100- 200 to make but is sold for Rs 500-800. With such huge margins, getting even one small order for 10,000 PPE suits would mean a profit of at least Rs 30 lakh. This is why there is a such a huge rush of people getting into PPE making,” he explained Eight labs identified by the textile ministry to do quality checks on PPE have so far issued over 900 Unique Certification Codes (UCC), mandatory for PPE sellers, especially to land government contracts.

The government says there are 600 companies manufacturing 4.5 lakh PPE suits per day. Many with the UCC have little or no experience in making protective wear. They include chemists, lingerie and footwear manufacturers, tent or tarpaulin makers, wholesale traders of drugs, small-time pharma companies, and even a food company. “Anyone who has a garage to store the stuff can buy some fabric and organize some tailors to copy a PPE suit,” said an industry insider. “One PPE lot supplied to us had electrical insulation tapes used to seal the seams. Obviously, they started coming off when we moved around,” said a doctor in a private hospital. Another doctor in a government Covid hospital pointed out that the government only tested the coverall, but other components like face shields or goggles that came with it were substandard. Almost all hospitals seem to have PPE horror stories to narrate. The government is at pains to reiterate that its certification is only for the coverall and that only a Synthetic Blood Penetration Test (SBPT) has been conducted.

Every UCC states that the certificate is based solely on the sample submitted by the applicant. It goes on to state: “The procurement agency is advised to conduct prior due diligence before placement of supply agreement…including periodical sample tests.

 

25 factors for expensive medical treatment

Altruistic professions are not cherished in present era

21 occupational risk to doctor and nurses

Being doctor or nurse- a disadvantage in present era

plight of nurse who died reusing PPE’s

 

Price fixing by broad generic drug makers in collusion : allege 45 US states


The states said the drug makers and executives divided customers for their drugs among themselves, agreeing that each company would have a certain percentage of the market.

How large  companies  create a web of  corrupt practices, and earn   huge profits, is a common prevalent sentiment.  Tip of the Iceberg has been revealed indicating  a collusion among  generic drug makers, to jack up prices.  If these allegations are proved correct, it may expose   one  reason of exorbitant prices of pharmaceutical industry.  Whereas doctors are blamed for healthcare being expensive, the real  health industry remains hidden and  earning huge profits by dubious means.

Soaring drug prices from both branded and generic drug manufacturers have sparked outrage and investigations in the United States. President Donald Trump this year accused pharmaceutical companies of “getting away with murder” with their drug pricing.

It might be the biggest price-fixing scheme in U.S. history. On Friday, Connecticut and a coalition of more than 40 states filed a 500-page lawsuit accusing the biggest generic drug makers of a massive, systematic conspiracy to bilk consumers out of billions of dollars. It’s a more sweeping version of a similar lawsuit the states filed in 2016 that’s still being litigated. The generic industry vehemently denies the allegations.

Congress established the current generic industry in 1984 to push prices down. The idea was that once patents on brand name drugs expired, generic makers would compete to make drugs more affordable. But 1,215 generics, many of them the most prescribed drugs, jumped on average more than 400 percent in a single year.

A large group of US states accused key players in the generic drug industry of a broad price-fixing conspiracy, moving on Tuesday to widen an earlier lawsuit to add many more drug makers and medicines in an action that sent some company shares tumbling.

The lawsuit, brought by the attorneys general of 45 states and the District of Columbia, accused 18 companies and subsidiaries and named 15 medicines. It also targeted two individual executives: Rajiv Malik, president and executive director of Mylan NV, and Satish Mehta, CEO and managing director of India’s Emcure Pharmaceuticals.

Shares of Pennsylvania-based Mylan, also named as a defendant, closed down 6.6%.

The states said the drug makers and executives divided customers for their drugs among themselves, agreeing that each company would have a certain percentage of the market. The companies sometimes agreed on price increases companies sometimes agreed on price increases in advance, the states added.

The states said Malik and Mehta spoke directly to one another to agree on their companies’ shares of the market for a delayed-release version of a common antibiotic, doxycycline hyclate.

“It is our belief that price-fixing is systematic, it is pervasive, and that a culture of collusion exists in the industry,” Connecticut Attorney General George Jepsen, who is leading the case, told a news conference in Hartford.

Mylan said in a statement it had found no evidence of price-fixing by the company or any of its employees, and vowed to defend itself vigorously. Malik, the company’s second-ranking official, has received more than $50 million in compensation over the past three years, last year making more than CEO Heather Bresch.

Emcure, also a defendant in the case, did not immediately respond to a request for comment.

Two former executives of Emcure’s subsidiary Heritage Pharmaceuticals pleaded guilty in January to federal charges of conspiring to fix prices and divide up the market for doxycycline and the diabetes drug glyburide.

The two men, former Heritage president Jason Malek and former chairman and chief executive Jeffrey Glazer, reached a deal with 41 states and territories in which they each agreed to pay $25,000 and cooperate with the state probe.

Executives like Mylan’s Bresch and former Turing Pharmaceuticals CEO Martin Shkreli

have been called in front of Congress to defend the cost of their products.

MORE COMPANIES TARGETED

The original complaint, filed in December, targeted Mylan, Heritage, Aurobindo Pharma USA Inc, Citron Pharma LLC, Mayne Pharma USA Inc and Teva Pharmaceuticals USA Inc.

The states are pressing a new complaint that would add Novartis AG’s unit Sandoz, India-based Sun Pharmaceutical Industries Ltd, Endo International PLC’s unit Par Pharmaceutical, Dr

Reddy’s Laboratories, Apotex Corp, Glenmark Generics Ltd, Lannett Company Inc, Alkem Laboratories Ltd’s unit Ascend Laboratories and Cadila Healthcare Ltd’s unit Zydus Pharmaceuticals Inc.

Jepsen said the investigation is continuing, and that claims would likely be brought against more companies, and possibly executives, in the future.

The news hurt shares of companies named in the expanded suit that are traded in the United States. In addition to Mylan’s drop, Lannett lost 13.7 percent. Shares of Endo were up 7 percent, but down from their 12 percent peak before the news of the amended lawsuit.

Teva spokeswoman Denise Bradley said the company denied the allegations. Endo spokeswoman Heather Lubeski said the company would vigorously defend itself against the claims. Other companies did not immediately respond to requests for comment

The expansion of the suit requires the court’s permission.

The original lawsuit centred on just two medicines, delayed-release doxycycline and glyburide.

The price of doxycycline rose from $20 for 500 tablets to $1,849 between October 2013 and May 2014, according to US Senator Amy Klobuchar, a Minnesota Democrat who had been pressing for action on high drug prices.

The amended complaint would expand the number of drugs to include glipizide-metformin and glyburide-metformin, which are among the most commonly used diabetes treatments.

Others include: acetazolamide, which is used to treat glaucoma and epilepsy; the antibiotic doxycycline monohydrate; the blood pressure medicine fosinopril; the anti-anxiety medicine meprobamate; and the calcium channel blocking agent nimodipine.

The US Justice Department is conducting a parallel criminal investigation. On Friday, the department asked the Pennsylvania court presiding over the lawsuit to put the lawsuit’s discovery process on hold, saying it could interfere with the criminal probe.

Connecticut Assistant Attorney General Joseph Nielsen said on Tuesday the states would likely oppose that request, which could slow the lawsuit.

source

 

Bedaquiline: New anti TB drug: Govt may allow usage by private health sector


 

Bedaquiline is  a TB drug which is also known by the trade name  Sirturo. Bedaquiline works by blocking an enzyme inside the Mycobacterium tuberculosis bacteria called ATP synthase. This enzyme is used by the bacteria to generate energy. Without the ability to generate energy, the TB bacteria  are killed.

Bedaquiline is used in combination with other TB drugs to treat pulmonary TB in adults when they have multi drug resistant TB (MDR-TB

It should only be used when effective  Tb treatment cannot otherwise be provided.

It should be always be used in combination with at least 3 other TB drugs which drug susceptibility testing has shown that the patient is susceptible to. If drug susceptibility testing is not available then bedaquiline should be used with at least 4 other drugs to which the patient is likely to be susceptible.

The safety and efficacy of the drug in the treatment of HIV positive patients with MDR-TB has also not yet been established.

side effects of bedaquiline                          

The most common side effects are headache, dizziness, feeling sick, being sick, joint pain and increases in liver enzymes. Side effects can be experienced by more than one in ten people.

Another  side effect is that QTc prolongation.

The US Food and Drug Administration (FDA) on 28th December 2012 granted approval for bedaquiline to be used to treat drug resistant TB.  FDA News Release, 31st December 2012 . In October 2013 the CDC issued new federal guidelines on the use of the drug, for the treatment of multi drug resistant TB.

Government may allow private sector to use key drug used for treating tuberculosis

Around 2.1 million people have TB in India, of which an estimated 30,000 people have MDR-TB. Only 6,500 patients are on the bedaquiline-based treatment regimen, which may cause severe side effects such as heart problems and hearing impairment.

The Union health ministry (India) is considering a proposal to allow bedaquiline, a controlled-access drug used in the treatment of multi-drug resistant tuberculosis (MDR-TB), to be open for prescription in the private sector.

Being a controlled-access drug, bedaquiline is dispensed only by the government to people with MDR-TB. At least four courses of treatment are needed. The drug costs Rs 28,000 per course, which means the cost per patient is Rs 1.12 lakh on medicine alone.

Around 2.1 million people have TB in India, of which an estimated 30,000 people have MDR-TB. Only 6,500 patients are on the bedaquiline-based treatment regimen, which may cause severe side effects such as heart problems and hearing impairment. “Technical opinion is being sought as there is no consensus among experts on opening access to the private sector,” said a senior health ministry official familiar with developments.

The health ministry, in collaboration with the departments of health research, biotechnology etc, is working out an institutional mechanism to give bedaquiline to patients in the private sector. “There is a huge pharma lobby that is building an argument for putting everyone on bedaquiline, but it doesn’t work like that. Even though it is being hailed as a wonder drug, it has side effects that include hearing loss. It’s a new drug, so we don’t really have adequate data on its long-term treatment outcome,” the official quoted above said.

“People generally assume bedaquiline is safer than other drugs but they forget that compared to a 6-8 months course for other medicines, a bedaquiline-based regimen could go up to 18-24 months. The longer duration could have its effects that our experts are looking at,” he added.

The ministry has begun compiling data on treatment outcome for all oral treatment regimens among Indians, which also includes the bedaquiline-related course. “About 20 patients in the private sector in Mumbai have been given conditional bedaquiline access by the government. But the entire private sector can be given access only if they strictly adhere to the drug-compliance regimen for complete cure and to stop the patient developing extremely drug-resistant TB,” the official said.

There will be strict vigilance. “Since it is a long-term regimen, it’s verifiable. A call will be taken soon,” said a second ministry official, requesting anonymity.

The United States Agency for International Development (USAID) has provided 22,000 doses to the government. “We don’t want to deny patients newer drugs if it benefits them, so we are considering the idea,” said the first health ministry official.

The United States Agency for International Development (USAID) has provided 22,000 doses to the government. “We don’t want to deny patients newer drugs if it benefits them, so we are considering the idea,” said the first health ministry official

 

 

 

Blog at WordPress.com.

Up ↑

%d bloggers like this: