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Minister to Rajya Sabha: Indiscreet prescribing of antibiotics causes microbial resistance

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

Indiscreet prescribing of antibiotics is one of the major causes of microbial resistance in the country, Minister of State for Health S P Singh Baghel told Rajya Sabha on Tuesday.

Indiscreet prescribing of antibiotics is one of the major causes of microbial resistance in the country, Minister of State for Health SP Singh Baghel told Rajya Sabha on Tuesday.

The National Centre for Disease Control (NCDC) conducted a point prevalence survey (PPS) on antibiotic use at 20 tertiary care government hospitals (NAC-NET sites).

This study was conducted amongst 9,653 eligible patients admitted to these 20 hospitals, Baghel said in a written reply.

The survey found that 71.9 per cent of the patients received antibiotics.

Of those who were prescribed antibiotics, 54.8 per cent received antibiotics for prophylactic indications (surgical prophylaxis 37.3 per cent and medical prophylaxis 17.5 per cent).

”Indiscreet prescribing of antibiotics is one of the major causes of microbial resistance in the country,” he said.

Also read: Doctors must mention reason while prescribing antibiotics, says Health Ministry

The Union health ministry has initiated several initiatives to promote judicious use of antimicrobials.

The ministry launched the Red Line awareness campaign on antimicrobial resistance, urging people not to use medicines marked with a red vertical line, including antibiotics, without a doctor’s prescription.

The Indian Council of Medical Research (ICMR) has released treatment guidelines for antimicrobial use in common syndromes in which guidelines for the use of antibiotics for viral bronchitis and low-grade fever antibiotics are included in Schedule H and H1 of the Drugs Rules, 1945.

These drugs have specific caution labelling requirements and are sold only under the prescription of a registered medical practitioner.

The supply of a drug specified in Schedule H1 is recorded in a separate register and such records, which are maintained for three years, are open for inspection.

The Central Drugs Standard Control Organisation (CDSCO) has placed 24 hi-end antimicrobials under schedule H1 by issuing notification, Baghel stated.

Also read: India may consider restricting fluoroquinolone antibiotics just like the UK did

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Infant deaths rising due to inefficacy of antibiotics against sepsis: research

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

The study found high mortality rate in infants infected with sepsis and significant burden of antibiotic resistance. Sepsis is a life-threatening bloodstream infection which affects up to 3 million babies a year globally.

Many newborns are dying because the antibiotics used to treat sepsis are losing their effectiveness, according to a global observational study which involved over 3,200 newborn babies suffering from the infection in 11 countries, including India.

The study, conducted from 2018 to 2020 and co-authored by a team of over 80 researchers, found there was high mortality among infants with culture-positive sepsis (almost 1 in 5 across the hospital sites), and a significant burden of antibiotic resistance.

The research, published on Friday in the journal PLOS Medicine, provides a wealth of high-quality data aimed at improving the treatment of newborn babies with sepsis.

“It was very important to undertake this study to get a better understanding of the kind of infections we are seeing in newborns in hospitals, the bugs causing them, the treatments that are being used and why we are seeing more deaths,” said Manica Balasegaram, Executive Director of Global Antibiotic Research and Development Partnership (GARDP).

“The study has given us vital information which will help us to better design clinical trials and ultimately improve the care and outcome of babies with neonatal sepsis,” Balasegaram said.

Sepsis is a life-threatening bloodstream infection which affects up to 3 million babies a year globally. Every year, 214,000 newborn babies, mostly in low- and middle-income countries (LMICs), die of sepsis that has become resistant to antibiotics.

Newborn babies are particularly at risk of severe infection because of their underdeveloped immune systems.

“One of the study’s most striking findings is the wide disparity in deaths from neonatal sepsis, depending on where people live,” said Nishad Plakkal, Additional Professor of Neonatology and Associate Dean (Research) at JIPMER, Puducherry.

“It’s not unusual in my unit for one nurse to take care of five or six very ill babies at one time. This makes it easier for infections to spread,” Plakkal said.

There was extensive variation in mortality between the 19 hospitals in the study, ranging from 1.6 per cent to 27.3 per cent, with markedly higher rates in LMICs, the researchers said.

“The study exposed the glaring reality of antibiotic-resistant infections, especially in hospitals in LMICs, where we are often faced with a shortage of nurses, beds and space,” said Sithembiso Velaphi, head of paediatrics at Chris Hani Baragwanath Academic Hospital in Johannesburg, South Africa.

“The risk of infections is very high and most infections are resistant to antibiotics. If an antibiotic doesn’t work, the baby often dies. This urgently needs to change. We need antibiotics that will cover all bacterial infections,” said Velaphi, More than 200 different antibiotic combinations were used by hospitals in the study, with frequent switching of antibiotics due to high resistance to treatments.

Many physicians were forced to use antibiotics such as carbapenems due to the high degree of antibiotic resistance to the recommended treatments in their units. These are classified by the World Health Organization as “Watch” antibiotics.

They are recommended only for specific, limited indications as they need to be preserved. However, these were often the only antibiotics available to treat the infection.

Last-line antibiotics were prescribed to 15 per cent of babies with neonatal sepsis enrolled in the study.

Using the data collected, the team developed two tools that could be used in clinical trials and in any neonatal intensive care unit worldwide.

ALSO READ: India soon to achieve SDG goals for reduction in newborn deaths: Top WHO official

The NeoSep Severity Score, based on 10 clinical signs and symptoms, could be used by clinicians to identify newborns who have a high risk of dying, and ensure they get special attention more quickly, the researchers said.

The NeoSep Recovery Score uses many of the same clinical signs and symptoms and could provide clinicians with key information on whether to escalate treatment, they said.

“The observational study has been instrumental in providing the high-quality data that we need to design trials of appropriate treatments for sepsis in newborn babies. It has been a huge collaborative effort by researchers and clinicians in Africa, Asia, Latin America and Europe,” said Neal Russell, Principal Investigator for the neonatal sepsis study at St George’s, University of London (SGUL), UK.

The study also aims to inform WHO guidelines on treatment for newborn babies with sepsis.

ALSO READ: New study reveals possible causes of Sudden Infant Death Syndrome

The results of the study have been used to design a pivotal strategic public health clinical trial to find better treatments for newborn infections in the context of increasing resistance to existing treatments.

The trial will also look at appropriate formulations and dosages for newborn babies. It will be expanded to other countries and regions from 2024, with a target of recruiting up to 3,000 newborns overall.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Blood pressure, cardiac, antibiotics, multivitamins, probiotics and more — 48 drugs fail latest quality test

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

The monthly list, issued by the Central Drugs Standard Control Organisation (CDSCO), has flagged 48 medicine batches failing the quality parameters in the month of March out of the total 1,497 samples tested.

Several commonly used medicines — including calcium, folic acid, multivitamins, antibiotics, anti-diabetic, and cardiovascular — have been flagged for failing quality tests in the latest drug safety alert issued by the country’s apex health regulator in March.

The monthly list, issued by the Central Drugs Standard Control Organisation (CDSCO) on its website, has flagged 48 medicine batches failing the quality parameters in the month of March out of the total 1,497 samples tested — reflecting a failure rate of over three per cent.

The list includes medicines, medical devices or cosmetics which are either not of standard quality or spurious, adulterated or misbranded. However, the flagged products were declared not of standard quality or NSQ.

Top-selling medicines such as epilepsy drug Gabapentin, hypertension drug Telmisartan, anti-diabetes drug combination Glimepiride and Metformin and HIV drug Ritonavir are part of the drug alert. It also includes the popular hypertension drug Telma — which includes Telmisartan and Amlodipine.

Other commonly used medicines flagged include iron and folic acid tablets, probiotics and several multivitamin pills. It also includes Vitamin C, Vitamin B12, Folic Acid and Niacinamide injections.

These drugs are manufactured by private as well as public drug makers, including PSU Karnataka Antibiotics & Pharmaceuticals, Uttarakhand-based Synokem Pharmaceuticals, Haryana-based Nestor Pharmaceuticals, Uttar Pradesh-based JBJM Parenterals, Solan-based Ronam Healthcare and Mumbai based Glenmark Pharmaceuticals.

Reacting to the development, a Glenmark spokesperson said: “We have investigated the matter and found that the TELMA AM Tablets (Telmisartan 40 mg and Amlodipine 5 mg Tablets IP) batch number 18220076 from the NSQ list of “March 2023 Month Drugs Alert” are counterfeit medicines and have not been manufactured by Glenmark.

“We have requested the CDSCO to take action on this and also made an appeal for removal of the product from the drug alert list. As a responsible manufacturer, we have provided proactive information and leads to all concerned regulatory officials from time to time. Additionally, we have taken the necessary measures, which include engaging an external agency to investigate the presence of counterfeit drugs across the country,” the spokesperson added.

According to industry experts, once the drug features in the list — along with the batch number, manufacturing date and expiry date — the company recalls the entire batch. “After the recall, the entire batch has to be destroyed,” an industry veteran said.

Not-of-standard quality (NSQ) drugs can adversely impact the quality of treatment and cause harm to patients, besides contributing to the emergence of drug resistance and spread of the disease.

The alerts are used by the government to seek cues and conduct investigations at manufacturing units which are frequently failing quality checks.

The Ministry of Health and Family Welfare is already conducting massive nation-wide audits and raids at several drug manufacturing units to fix the gaps in good manufacturing practices.

In another move, in March, the central government cracked the whip on more than 70 drug makers for manufacturing spurious or lower-quality medicines in India, cancelling the licenses of 18 manufacturers. The government raided drug makers in 20 states across India after identifying 203 pharmaceutical companies.

Both the moves have been driven by multiple allegations levelled by importers of Indian medicines, including Uzbekistan, Gambia and the United States. Since October last year, India has been facing allegations of exporting spurious quality drugs, raising concerns of denting the decades-old reputation of “pharmacy to the world”.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Indian Medical Association advises against indiscriminate use of antibiotics

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

Viral cases have also surged due to air pollution, the Indian Medical Association (IMA) said, adding that it mostly occurs in people aged below 15 and above 50 and causes upper respiratory infections along with fever. The association also asked doctors to prescribe only symptomatic treatment and not antibiotics. “It is necessary to diagnose whether the infection is bacterial or not before prescribing antibiotics,” it said.

A persistent cough, sometimes accompanied by fever, running through India for the past two-three months is due to Influenza A subtype H3N2, ICMR experts said. The H3N2, which has been in wide circulation for the past two-three months, causes more hospitalisations than other subtypes, said Indian Council of Medical Research (ICMR) scientists who keep a close watch on ailments caused by respiratory viruses through the Virus Research and Diagnostic Laboratories network.

They have also suggested a list of Dos and Don’ts for people to follow to protect themselves from contracting the virus.

The Indian Medical Association (IMA), on the other hand, has advised against the indiscriminate use of antibiotics amid rising cases of cough, cold and nausea across the country.

Also Read: India may issue alert on Marion cough syrup exports after toxins found

Seasonal fever will last five to seven days, it said. The fever goes away at the end of three days but the cough can persist for up to three weeks, the IMA’s Standing Committee for Anti-Microbial Resistance said.

Viral cases have also surged due to air pollution, it said, adding that it mostly occurs in people aged below 15 and above 50 and causes upper respiratory infections along with fever.

The association also asked doctors to prescribe only symptomatic treatment and not antibiotics.

“Right now, people start taking antibiotics like Azithromycin and Amoxiclav etc, that too without caring for done and frequency and stop it once start feeling better. This needs to be stopped as it leads to antibiotic resistance. Whenever there will be a real use of antibiotics, they will not work due to the resistance,” the IMA said in a statement.

Also Read: India Fat Alert: Child obesity set to rise 9 percent by 2035

The most misused antibiotics are Amoxicillin, Norfloxacin, Oprofloxacin, Ofloxacin and Levofloxacin. These are being used for the treatment of diarrhoea and UTI, it said.

“We have already seen widespread use of Azithromycin and Ivermectin during Covid and this too has led to resistance. It is necessary to diagnose whether the infection is bacterial or not before prescribing antibiotics,” it said.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Antibiotics, anti-cancer drugs to become more affordable as govt adds 34 drugs in essential medicines list

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

Antibiotics and Anti-cancer drugs would now be more affordable as the government has added 34 new drugs to the National List of Essential Medicines 2022.

Several anti-cancer drugs, antibiotics and vaccines will now become more affordable as they are among 34 new additions to the National List of Essential Medicines, with the government saying this will reduce ”patients’ out-of-pocket expenditure”.

Anti-infectives like Ivermectin, Mupirocin and Meropenem have been added to the list, taking the total drugs under it to 384.

Four major anti-cancer drugs — Bendamustine Hydrochloride, Irinotecan HCI Trihydrate, Lenalidomide and Leuprolide acetate which are effective in various types of cancers — and psychotherapeutic medicines — Nicotine Replacement Therapy and Buprenorphine — have been added to the list.

However, 26 drugs such as Ranitidine, Sucralfate, white petrolatum, Atenolol and Methyldopa have been dropped from the previous list of total 376 drugs.

Also read: National List of Essential Medicines 2022 launched — Bleaching powder out, Nicotine replacement therapy in

The deletion has been done based on the parameters of cost effectiveness and availability of better drugs.

The criteria for deletion from NLEM include — banned in India, reports of concerns on the safety profile, the disease burden for which a medicine is indicated is no longer a national health concern and in case of antimicrobials, if the resistance pattern has rendered an antimicrobial ineffective.

After launching the list on Tuesday, Union Health Minister Mansukh Mandaviya tweeted, “Released the National List of Essential Medicines 2022. It comprises 384 drugs across 27 categories. Several antibiotics, vaccines, anti-cancer drugs and many other important drugs will become more affordable & reduce patients’ out-of-pocket expenditure.”

The drugs in NLEM are included in scheduled category and their price is regulated by the National Pharmaceutical Pricing Authority. Speaking on the occasion, Mandaviya said his ministry is taking various steps under the vision of Prime Minister Narendra Modi towards “Sabko Dawai, Sasti Dawai”.

“In this direction, National List of Essential Medicines (NLEM) plays an important role in ensuring accessibility of affordable quality medicines at all levels of healthcare. This will give boost to cost-effective, quality medicines and contribute towards reduction in Out of Pocket Expenditure on healthcare for the citizens,” he said.

The primary purpose of NLEM is to promote rational use of medicines considering the three important aspects — cost, safety and efficacy, Mandaviya said.

He said the NLEM is a dynamic document and is revised on a regular basis considering the changing public health priorities as well as advancement in pharmaceutical knowledge. The NLEM was formulated in 1996 and it was revised thrice earlier in 2003, 2011, and 2015.

Revision of NLEM 2022 has been done after constant consultation with stakeholders spanning from academia, industrialists and public policy experts etc., and crucial documents like WHO EML 2021. In the revised list, endocrine medicines and contraceptives Fludrocortisone, Ormeloxifene, Insulin Glargine and Teneliglitin have been added.

Also read: Make organ donation mandatory after death; by living minors only under exceptional cases: Doctors

Montelukast, which acts on the respiratory track, and ophthalmological drug Latanoprost also figure in the list. Besides, cardiovascular medicines Dabigatran and Tenecteplase too find place in the list besides medicines used in palliative care.

“Antinfectives such as Ivermectin, Meropenem, Cefuroxime, Amikacin, Bedaquiline, Delamanid, Itraconazole ABC Dolutegravir have been added to the NLM,” Dr Y K Gupta, Vice Chairman of the Standing National Committee on Medicines, said. Rotavirus vaccine has also been added in the list.

The drugs in NLEM are included in scheduled category and their price is regulated by the National Pharmaceutical Pricing Authority, Dr Gupta said.

He said that the Covid drugs and vaccines have not been added in the list as they have been granted emergency use authorisations and the data is still not conclusive and complete from the regulatory perspective.

The committee considered the essentiality of medicines for COVID-19. Conditional approval/ emergency use approval was granted to some new medicines for COVID-19, keeping in mind the risk of growing pandemic vs the potential benefit (risk-benefit ratio) on the basis of the available in vitro, non-clinical and clinical trial data, Dr Gupta stated.

“The committee also put great emphasis on rational use of antimicrobial agents by all stakeholders including manufacturers, doctors, patients and veterinary experts,” he said.

A revised list of 399 formulations was submitted by an expert committee under the Indian Council of Medical Research (ICMR) last year. After detailed analysis of Indian requirements, major changes were sought by Mandaviya.

The criteria for inclusion of drugs in NLEM are that they are useful in diseases which is a public health problem in India, licensed/ approved by Drugs Controller General of India (DCGI), have proven efficacy and safety profile based on scientific evidence.

These are comparatively cost effective and have to be aligned with the current treatment guidelines and recommended under National Health Programs of India. (e.g. Ivermectin part of Accelerated Plan for Elimination of Lymphatic Filariasis 2018).

Also read: Twice-daily nasal saline flushing may reduce COVID-19 severity, reveals study

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

 Daily Newsletter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Over 47% antibiotic formulations used in India in 2019 unapproved: Lancet study

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

More than 47 percent of antibiotic formulations used in India’s private sector in 2019 were not approved by the central drug regulator, according to a study published in The Lancet Regional Health-Southeast Asia. The research also found that azithromycin 500mg tablet was the most consumed antibiotic formulation (7.6 per cent) in India, followed by cefixime …

More than 47 percent of antibiotic formulations used in India’s private sector in 2019 were not approved by the central drug regulator, according to a study published in The Lancet Regional Health-Southeast Asia.

The research also found that azithromycin 500mg tablet was the most consumed antibiotic formulation (7.6 per cent) in India, followed by cefixime 200 mg tablet (6.5 per cent) during the year.

The researchers at Boston University, US and Public Health Foundation of India, New Delhi, examined the private sector antibiotic use, which contributes to 8590 percent of the total consumption in India. The data were gathered from a panel of 9,000 stockists who store products from approximately 5,000 pharmaceutical companies.

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However, these data did not include the drugs dispensed through public facilities, though this is less than 1520 percent of all drug sales in the country as per studies and national health accounts estimates.

The researchers found a lower consumption rate of antibiotics compared to previous estimates but very high relative consumption of broad-spectrum antibiotics, which act against a wide range of disease-causing bacteria.

“The total defined daily dose (DDD) — the assumed average maintenance dose per day for a drug in adults — consumed in 2019 was 5,071 million (10.4 DDD/1,000/day),” they said.

The study shows that formulations listed in the national list of essential medicines (NLEM) contributed 49 percent while fixed-dose combinations (FDC) contributed 34 percent, and unapproved formulations were 47.1 percent.

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FDCs are the combinations of two or more active drugs in a single dosage form. “Centrally unapproved formulations accounted for 47.1 per cent (2,408 million) of total DDDs,” the authors of the study noted. “Cephalosporins, macrolides, and penicillins were the top three antibiotic classes among unapproved formulations,” they said.

The Watch group of antibiotics constituted 72.7 per cent of unapproved products and combinations discouraged by the World Health Organization (WHO) constituted 48.7 per cent of FDCs. Watch includes broad-spectrum antibiotics with a high chance of resistance to be used only for specific indications.

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“We do not have proper surveillance systems monitoring antibiotic usage in our country and irrational antibiotic usage is rampant,” said Dr. Hari Kishan Boorugu, Consultant Physician & Diabetologist, Yashoda Hospitals Hyderabad.

“Problem lies at multiple levels — antibiotic usage by patients without prescription, irrational usage of antibiotics by quacks and even by many qualified doctors,” Boorugu told PTI. Inappropriate use of antibiotics is a significant driver of antibiotic resistance in India, the authors of the study noted in the journal.

“Largely unrestricted over-the-counter sales of most antibiotics, manufacturing and marketing of many FDC and overlap in regulatory powers between national and state-level agencies complicate antibiotics availability, sales, and consumption in the country,” they said.

The authors acknowledge some limitations to their study, including the fact that the dataset covers only the private sector sales of antibiotics and will not reflect the antibiotics dispensed through the public system.

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Also, the data do not differentiate between community and hospital use as the data are collected at the stockist level, they said. “Prevalence of multidrug resistant bacterial infection is high in many countries including India and irrational usage of antibiotics is a major driving factor for this menace,” Booruge explained.

“Unless we act now, soon we will be in a situation like pre-antibiotic era without effective antibiotics for treating most bacterial infections,” he added.

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Coronavirus fallout: Prices of paracetamol, raw materials for key antibiotics soar in India

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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According to industry heads, raw materials of key drugs used to manufacture painkiller paracetamol and common antibiotics such as Azithromycin and Amoxicillin have seen prices spike anywhere between 20 percent to over 50 percent since the outbreak.

Prices of raw materials of key drugs such as paracetamol and antibiotics have seen a spike owing to the Coronavirus outbreak. The viral outbreak that began in China has infected more than 71,000 people globally.

According to industry heads, raw materials of key drugs used to manufacture painkiller paracetamol and common antibiotics such as Azithromycin and Amoxicillin have seen prices spike anywhere between 20 percent to over 50 percent since the outbreak. Prices of paracetamol raw material has moved up to Rs 450 per kg versus Rs 250 kg earlier, Azithromycin has risen to Rs 12,500 per kg versus Rs 7,800 per kg earlier and Amoxicillin prices have moved to Rs 1,800 per kg versus Rs 1,500 per kg earlier, industry sources say.

One of the key reasons for this increase is that many of the starting materials or raw materials to manufacture these drugs are sourced from China. For example, most fermentation-based active pharmaceutical ingredients (APIs) such as cephalosporin, penicillin and erythromycin are imported from China, with the country being either the largest or the only source globally for these supplies. Wuhan, the capital of Central China’s Hubei province, the epicentre of the outbreak and a hub for API supplies, has not seen manufacturing restart and supplies from other regions in China are also slow, says the head of an API manufacturing company on condition of anonymity. Supplies from other regions in China are mainly impacted by logistic issues such as slow government clearances.

One of India’s largest manufacturers of paracetamol on condition of anonymity has said shortages have risen. For example, there is currently a 20-30 percent shortage of a key raw material used to manufacture paracetamol. In this case, alternate supplies are unusually tough, according to the company head, as China provides 80 percent of supplies for it. Traders are also taking advantage of the situation and hiking prices of inventory, says Zydus Cadila Chairman Pankaj Patel.

While prices of these key raw materials have surged, the industry doesn’t expect it to filter down to the finished product, as many of these drugs are under price control. Any decision on a hike in prices will have to be taken by the Centre.

Looking for secondary sources

However, the manufacturers remain worried. Most companies currently have inventory for 1 or 2.5 months only. A few have raw materials to meet their needs until Q1FY21 as most companies stocked up on inventory ahead of the Chinese New Year, which is a normal industry practice. But if the current situation lasts beyond April, the raw material shortage will become an issue, Patel noted.

Furthermore, the industry could brace itself for further price hikes. Many companies are already looking for secondary sources of API supplies, buying at higher prices in the spot market and trying to backward integrate as much and as quickly as possible.

While the spike in prices of key raw materials is negative for most pharmaceutical companies, it is an opportunity for some. IOL Chemicals, which manufacturers APIs for pain drug ibuprofen and exports 50 percent of it, says they are receiving more queries from Latin America and countries such as Vietnam. Currently, around 30 percent of global ibuprofen supplies are impacted, as per the company, because one of the key suppliers of ibuprofen API is Hubei Biocause, which is impacted as it is based in Wuhan region.

On the other hand, US-based chemical company BASF is currently facing technical issues and expected to restart supplies only in March. The impact is already seen on ibuprofen API prices. From around $15 the prices have moved up to $18 and expected to rise to $20 as per IOL Chemicals. The company expects its capacity utilization, which is currently at 80 percent, to increase due to the expectant incremental order inflows.

But are incremental supplies an opportunity for the rest of the industry? The likes of Glenmark believe so. In their Q3 earnings conference call, Glenmark said the developments in China are a significant opportunity and it expects flows to come to India from China. Biocon chief Kiran Mazumdar Shaw and Patel also echoed this view, saying that the time is ripe to ramp up API supplies irrespective of the price as the shortage of APIs is a long term opportunity for India if the government offers support.

According to Patel, to combat the present shortage, in the near term the industry must ramp up indigenous API capacity whilst for the long term, fresh investments are imperative.

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Coronavirus: No plans regarding ban on exports of active pharmaceutical ingredients, says Indian Pharmaceutical Alliance

There is no plan regarding a ban on the exports of active pharmaceutical ingredients (APIs) at the moment, clarified Sudarshan Jain, secretary-general of Indian Pharmaceutical Alliance, after reports indicated that a high-level committee constituted by the Department of Pharmaceuticals of the government is contemplating a restriction on exports.

“We are closely monitoring the situation, taking stock of the inventory, how we can service the patients’ needs and I don’t think there is any decision at this particular moment regarding exports. The critical task at the moment is to take the inventory of the situation, evaluate alternate sources and then keep on monitoring the situation. At this moment, there are no suggestions to stop the exports of Active Pharmaceutical Ingredients (APIs),” said Jain.

The reports claimed that restrictions may be put on crucial antibiotics and vitamins in the light of the coronavirus outbreak.

“The biggest hit will be taken up by cephalosporin or Penicillin G manufacturer because almost most of the companies in India have shut down their shops and they source it from China because they are cheapest there,” Surajit Pal, pharma analyst at Prabhudas Lilladher, said.

Reacting to the news, Vijay Garg, joint MD of IOL Chemicals, said, “If the export ban is there then problems definitely will come but as far as IOL is concerned, we are majorly into pain management. Our flagship product is Ibuprofen. So we are very minimal dependent on China and moreover the product which we are importing from China is not in the epicentre of the outbreak. We are covered for six months plus we have an alternative. Definitely the problem will come only in antibiotics or in diabetics where the dependence is much more.”

 5 Minutes Read

Kids in low income countries prescribed excess antibiotics

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

Antimicrobial resistance is one of today’s biggest threats to global health and development, according to the World Health Organization.

Kids in low and middle-income countries (LMICs) are receiving an excessive amount of antibiotic prescriptions that could harm the children’s ability to fight pathogens as well as increase antibiotic resistance worldwide, warns a new study.

Children in these countries received 25 antibiotic prescriptions through age five – a “remarkable” estimate, given that two antibiotic prescriptions per year are considered excessive in many high-income settings, said the study published in the journal The Lancet Infectious Diseases.

“We knew children in LMICs are sick more often, and we knew antibiotic prescription rates are high in many countries. What we did not know was how these elements translate into actual antibiotic exposure – and the results are rather alarming,” said lead author of the study Gunther Fink from Swiss Tropical and Public Health Institute (Swiss TPH), Basel, Switzerland.

Antimicrobial resistance is one of today’s biggest threats to global health and development, according to the World Health Organization.

One factor contributing to this global health threat is the excessive use of antibiotics worldwide.

The research team from Swiss TPH and Harvard T.H. Chan School of Public Health in the US analysed data from 2007-2017 from health facilities and household surveys from eight countries: Haiti, Kenya, Malawi, Namibia, Nepal, Senegal, Tanzania, and Uganda.

Results showed that antibiotics were administered in 81 percent of cases for children with a respiratory illness, in 50 percent for children with diarrhoea, and in 28 percent for children with malaria.

The researchers found that the number of antibiotic prescriptions in early childhood varied from country to country.

While a child in Senegal received approximately one antibiotic prescription per year in the first five years of life, a child in Uganda was prescribed up to 12.

In comparison, a prior study showed that children under five in Europe receive less than one antibiotic prescription per year on average.

“This number is still high given that the vast majority of infections in this age group are of viral origin,” said study co-author Valerie D’Acremont from Swiss TPH.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Common toothpaste ingredient making antibiotics less effective, says study

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

Triclosan is the active ingredient responsible for the “antibacterial” property which is added to toothpaste, mouthwash, cosmetics.

A common ingredient found in toothpaste and handwashes could make antibiotics less effective in treating conditions like urinary tract infections (UTIs), which, if left untreated, can become life-threatening, say researchers.

Triclosan is the active ingredient responsible for the “antibacterial” property which is added to toothpaste, mouthwash, cosmetics. It is even added to clothing, baby toys and credit cards with the intention of reducing or preventing bacterial growth.

According to the study, led by researchers at the Washington University in St. Louis, triclosan exposure may inadvertently drive bacteria into a state in which they are able to tolerate normally lethal concentrations of antibiotics, including those that are commonly used to treat UTIs.

UTIs occur when bacteria, primarily Escherichia coli (E. coli), enter and infect the urinary tract. Antibiotics such as Cipro are commonly used to kill the bacteria and treat the infection.

UTIs are common, so is exposure to triclosan. About 10 per cent of adults have levels high enough to prevent E. coli from growing.

In the study, published in the journal Antimicrobial Agents and Chemotherapy, the team examined whether triclosan’s presence in the body interferes with treating UTIs.

They found that mice which drink triclosan-spiked water have urine triclosan levels similar to those reported in humans.

“This result meant we could actually test the impact that human urine levels of triclosan have during antibiotic treatment of UTIs in mice,” said Petra Levin, Professor at the varsity.

After antibiotic treatment, mice with triclosan exposure had a large number of bacteria in their urine and stuck to the bladder, but mice without exposure had significantly lower bacterial counts.

They found 100 times more bacteria in the urine of triclosan-treated mice, suggesting that antibiotics are less effective at treating UTIs when triclosan is around.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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Oil Fluctuates as Traders Assess China’s Vow, Unrest in Libya

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index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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