With the Union Health Ministry urging doctors to mandatorily mention indications and reasons for justification while prescribing antibiotics, infectious disease specialists say the initiative can help in rationalising antimicrobial usage and avoid indiscriminate consumption. The practice could also help further an evidence-based approach in medicine, along with improving patient outcomes, and curbing treatment costs and unwarranted side effects, they said. "Prescribers have to think and document the rationale before prescribing antimicrobials... This will help in the rational prescribing of antimicrobials and avoiding injudicious, indiscriminate usage," infectious disease specialist and senior consultant at the Yashoda Super Speciality Hospital in Kaushambi Dr Chhavi Gupta told PTI. In a letter to all doctors in medical colleges and medical associations on January 1, Director General of Health Services Dr Atul Goel urged them to make it a mandatory practice to write indications, ...
DGHS Atul Goel appealed to all pharmacists to strictly implement Schedules H and H1 of the Drugs and Cosmetics Rules, 1945, with regards to selling antibiotics
The Union Health Ministry has urged all doctors in medical colleges and medical associations to make it a mandatory practice to mention indication, reason for justification while prescribing antibiotics. Director General of Health Services Dr Atul Goel has also appealed to all pharmacists to strictly implement schedule H and H1 of the Drugs and Cosmetics Rules and stop over-the-counter sale of antibiotics and sell them only on the prescription of a qualified doctor. Misuse and overuse of antimicrobials are one of the main drivers in the development of drug-resistant pathogens, Goel said in a letter dated January 1. "With few new antibiotics in the research and development pipeline, prudent antibiotic use is the only option to delay the development of resistance," he stated. Antimicrobial resistance (AMR) is one of the top global public health threats facing humanity, the letter addressed to all doctors of medical colleges and to all medical associations said. It is estimated that
US health officials plan to endorse a common antibiotic as a morning-after pill that gay and bisexual men can use to try to avoid some increasingly common sexually transmitted diseases. The proposed CDC guideline was released Monday, and officials will move to finalise it after a 45-day public comment period. With STD rates rising to record levels, more tools are desperately needed, said Dr. Jonathan Mermin of the Centers for Disease Control and Prevention. The proposal comes after studies found some people who took the antibiotic doxycycline within three days of unprotected sex were far less likely to get chlamydia, syphilis, or gonorrhoea compared with people who did not take the pills after sex. The guideline is specific to the group that has been most studied gay and bisexual men and transgender women who had an STD in the previous 12 months and were at high risk of getting infected again. There's less evidence that the approach works for other people, including heterosexual m
Pharma major Lupin Ltd on Monday said it has received approval from the US health regulator to market its generic antibiotic Doxycycline Hyclate delayed-release tablets used to treat bacterial infections. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Doxycycline Hyclate delayed-release tablets of strengths 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg, Lupin said in a regulatory filing. This product will be manufactured at Lupin's Pithampur facility in India, it added. Doxycycline Hyclate Delayed-Release tablets had estimated annual sales of USD 9 million in the US, the company said citing IQVIA MAT June 2023 data.
While global trials are on, doctors have started using one of company's antibiotics against superbugs to save lives
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
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Antibiotics should not be used in Covid cases unless there is clinical suspicion of bacterial infection, according to a revised guideline for the treatment of adult coronavirus patients issued by the Centre. The revised guidelines, issued on Sunday amid an uptick in coronavirus cases, stated that drugs such as Lopinavir-ritonavir, hydroxychloroquine, Ivermectin, Molnupiravir, Favipiravir, Azithromycin and Doxycycline should not be used for the treatment of adult COVID-19 patients in India. The AIIMS/ICMR-COVID-19 National Task Force met on January 5 to revise the clinical guidance protocol. It has also advised doctors not to use convalescent plasma therapy. "Antibiotics should not be used unless there is clinical suspicion of bacterial infection. Possibility of co-infection of COVID-19 with other endemic infections must be considered," the guidelines said. Additionally, in moderate or severe diseases at high risk of progression, Remdesivir may be considered for up to five days. It
Glenmark Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic antibiotic drug. The company has received final approval from the US Food & Drug Administration (USFDA) for Clindamycin Hydrochloride Capsules, a generic version of Pfizer's Cleocin capsules, Glenmark Pharma said in a statement. Glenmark's Clindamycin Hydrochloride Capsules in strengths of 75 mg, 150 mg, and 300 mg, will be distributed in the US by Glenmark Pharmaceuticals Inc, it added. According to IQVIA sales data for the 12-month period ending January 2023, the Cleocin Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg achieved annual sales of around USD 33.6 million. Glenmark shares were trading 0.12 per cent up at Rs 426.10 apiece on the BSE.
"Whenever there will be a real use of antibiotics, they will not work due to the resistance," the IMA wrote
The formulation, to be sold under the Zidavi brans for Rs 2,700 a vial, has been approved by US FDA, European Medicines Agency, and CDSCO
Countries with lower rates of testing, mostly low- and middle-income countries, are more likely to report significantly higher AMR rates
The Indian Council of Medical Research has issued guidelines warning against the use of antibiotics for conditions such as low-grade fever and viral bronchitis while advising doctors to follow a timeline while prescribing them. The ICMR guidelines stated that antibiotics should be prescribed for a duration of five days for skin and soft tissue infections, five days in case of community-acquired pneumonia and eight days for hospital-acquired pneumonia. "A clinical diagnosis most often helps us predict causative pathogens fitting into a clinical syndrome which would tailor the correct antibiotic rather than blindly relying on fever, procalcitonin levels, WBC counts, cultures or radiology to make a diagnosis of infection," the guidelines said. It stated limiting empiric antibiotic therapy to seriously ill patients. Generally, empiric antibiotic therapy is only recommended for a select group of patients suffering from severe sepsis and septic shock, community-acquired pneumonia, ...
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Thirty-four drugs, including some anti-infectives such as Ivermectin, Mupirocin and Nicotine Replacement Therapy, have been added to the National List of Essential Medicines taking the total drugs under it to 384. Several antibiotics, vaccines and anti-cancer drugs will become more affordable by their addition to the list. However, 26 drugs such as Ranitidine, Sucralfate, white petrolatum, Atenolol and Methyldopa have been deleted from the revised list. The deletion has been done based on the parameters of cost effectiveness and availability of better drugs. Union Health Minister Mansukh Mandaviya, who released the list on Tuesday, 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." Endocrine medicines and contraceptives Fludrocortisone, Ormeloxifene, Insulin Glargine and
According to a new study by researchers at Emory University in Atlanta, the use of broad-spectrum antibiotics in mice with malignant melanoma, an aggressive form of skin cancer
More than 47 per cent 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 per cent 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. However, these data did not include the drugs dispensed through public facilities, though this is less than 1520 per cent of all drug sales in the country as per studies and national health accounts estimates. The researchers found a lower consumption rate of
Pharmaceutical firm Wockhardt Ltd on Tuesday said it has initiated a global Phase III clinical study of its new antibiotic candidate WCK 5222, which will be completed in 18 months