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Medical Voice 6th November 2019

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Dr KK Aggarwal    06 November 2019

A new open access journal on integrated care from BMJ

Leading healthcare knowledge provider BMJ has added a new title to its expanding portfolio of more than 70 specialist journals, with the launch of the Integrated Healthcare Journal.

Integrated Healthcare Journalis a new online only Open Access journal co-owned by the Royal Pharmaceutical Society (RPS) and edited by Dr Paresh Dawda, a general medical practitioner, academic and researcher based in Australia.

The journal aims to support a joined-up and connected approach for healthcare design and delivery in which health and social care professionals, service providers, patients, patient groups, and carers are brought together to collaborate in a unified and integrated approach. The mission will be to improve all aspects of care for individuals and communities orientated around a person-centred philosophy.

The journal will publish high quality peer-reviewed original research dealing with all aspects of integrated, multidisciplinary and patient-centred approaches to healthcare, through topics such as prevention, management, education, cost-effectiveness and safety … (BMJ)

Healthcare News Monitor

Govt may expand essential meds list, cut price of drugs

TNN-Sushmi Dey

NEW DELHI: In good news for patients, the government for the first time is considering revising the National List of Essential Medicines (NLEM) based on therapies like oncology, anti-infectives, diabetes, cardiology, respiratory etc, in line with WHOs recommendation to expand the purview of "essential medicines" that can be accessible and affordable to all. Besides, it is also looking to address the issue of anti-microbial resistance (AMR) through this exercise by adding and removing key antibiotics from the existing list, sources said. The Standing National Committee on Medicines (SCAM), headed by the secretary department of health research and ICMR director general Balram Bhargava, held a stakeholders consultation on Monday to deliberate on the revision of the existing NLEM which is based on widely used formulations. The key issues on the agenda included elimination of irrational antibiotics, inclusion of some key antibiotics which are part of the WHO list of essential medicines but are missing from the Indian NLEM, addressing scarcity of some first line antibiotics because of combination medicines and adopting WHOs categorisation of drugs to counter AMR as well as evaluate its guidance in the Indian context. Sources said the government plans to revise NLEM based on WHOs recently revised list of essential medicines which added 12 ground-breaking medicines for five cancer therapies to treat melanoma, lung, blood and prostate cancers. It has also added new oral anticoagulants to prevent stroke. The development assumes significance as NLEM typically forms the basis of price caps extended on essential medicines. The recommendations from SCAM will also go to the standing committee on affordable medicines and health products (SCAMP), headed by NITI Aayog member V K Paul.

Maharashtra: ‘Independent doctor’s view must in negligence cases’

The Times of India

MUMBAI: The Supreme Court has reiterated that an investigating officer, before proceeding in a case of medical negligence, should obtain an independent and competent medical opinion to support the charges of rashness or negligence on the part of the accused doctor. In a case pertaining to medical negligence, the SC had said that a private complaint may not be entertained unless the complainant has produced prima facie evidence in court in the form of a credible opinion given by another competent doctor. The apex court made these as guidelines while handling such cases.

Govt seeks feedback of industry on antibiotics in updated NLEM

Business Standard - Sohini Das

The government-appointed committee tasked with preparing the new National List of Essential Medicines (NLEM) on Monday asked for industry feedback on which group of antibiotics should be excluded from the list. The suggestions were sought during a stakeholders meeting in Delhi, the focus of which was fighting the menace of antimicrobial resistance (AMR) in India. The expert committee, sources claimed, is considering the industry proposal to issue a draft NLEM list for public consultation in the interest of transparency and seek industry comments in a time-bound manner. AMR refers to the ability of a bacterium, virus or some other microbe to stop an antibiotic (or antimicrobial) from working against it. This results in treatments becoming in-effective and infections not only persist but also spread to others. Industry sources claimed that the Standing National Committee on Medicine (SNCM), which is working on drafting the new NLEM, has asked the industry to get back with their list of groups of antibiotics that need to be removed from the NLEM as Indian population has become resistant to these. Also, the SNCM wants to know which other groups of antibiotics be included on the list this time. The NLEM 2015 has roughly 376 medicines and medical devices. The sources said industry representatives proposed that all non-effective drugs be deleted from the NLEM and drugs for which resistance is building up should not be considered. The industry feels inclusion in the NLEM may result in over-prescription and overuse, and increase the cases of resistance.

Experts are mulling to group antibiotics into categories to combat misuse

The Economic Times - Teena Thacker

In a bid to combat the problem of overuse and underuse of antibiotics in India, experts are mulling if antibiotics can be grouped into categories with recommendations when each category should be used. In a revision of the antibiotics section in the National List of Essential Medicines (NLEM) public health experts that met today are deliberating if the WHO’s action plan on antimicrobial resistance which aims to ensure the best use of antibiotics-can be replicated in India. The WHO in its revision exercise of antibiotics have grouped them into three categories– access, watch and reserve. WHO recommends that antibiotics in the access group be available “at all times” as treatments for a wide range of common infections. While the “watch” group includes antibiotics that are recommended as first- or second-choice treatments for a small number of infections. The third group-reserve includes antibiotics such as colistin and some cephalosporins that should be considered last-resort options. “All recommendations are taken into consideration. We are studying the WHOs recommendations,” sources told ET. The government’s Standing National Committee on medicines which has been tasked to shortlist essential medicines list met the stakeholders today to examine their recommendations before the list is updated and finalised for NLEM 2019.The committee on the National List of Essential Medicines (NLEM) headed by Balram Bhargava, secretary, department of health research and director-general of the Indian Council of Medical Research will decide on those medicines that should be available in adequate numbers and assured quality.

Regulator waives off clinical trials, clears Sanofi TB drug

The Economic Times – Teena Thacker

India’s drug regulator has approved Sanofi NSE 0.23 % (India)’s new antituberculosis drug rifapentine, waiving local clinical trials in a move to bolster efforts to prevent latent infections from progressing into active TB. “We have recently received final approval for rifapentine from the Indian regulatory authorities. Rifapentine is now officially registered in India,” Thibaud Lefort, Sanofi’s global health business chief, told ET on the sidelines of the 50th Union World Conference of Lung Health in Hyderabad. While India carries the highest burden of TB with an estimated 2.69 million cases in 2018, more alarming is the possibility of a large pool of people harbouring the ‘silent infection.’ About 40% of the country’s population is estimated to have latent TB infection. The waiver granted to Sanofi’s rifapentine, which is sold under the brand Priftin, is in the public interest, with a restricted marketing licence to supply the drug only for the government-run national TB programme. Sanofi is now in talks with the government on the price of the drug, following its decision on Thursday to slash the price by 66%. The agreement brings rifapentine 150 mg tablets down to a price of €4.62/pack of 24 tablets (?364) from €13.60/pack of 24 tablets. Rifapentine is critical in preventing TB from developing and the lower price will benefit over a million people in India, experts said.

Health | India must close the tortuous discussions on medical device regulation

moneycontrol - Gauri Kamath

Medical device regulation is in the news once again. According to reports, the government think-tank Niti Aayog wants medical technologies to be regulated by a US FDA-type super regulator which will also oversee food and drugs. The think-tank has reportedly also circulated a draft Bill, the Medical Devices (Safety, Effectiveness and Innovation) Bill, to various ministries. The move runs contrary to the proposal of the Union Ministry of Health and Family Welfare to let devices continue to be regulated by the central regulator, the Central Drugs Standard Control Organization (CDSCO) under the purview of the Drugs & Cosmetics (D&C) Act, 1940, and to widen the net to cover all devices from December 1 onwards. Indias seemingly never-ending attempt to introduce a comprehensive and effective medical device regulation seems to be reaching a jubilee of sorts. In the early eighties, India had despatched a health ministry official to an international meeting on medical devices regulation in the United States. He came back to report that of the 50 countries present there, India was the only country that did not regulate medical devices. This ignominious discovery triggered a discussion. However, it was only 20 years later, in 2006 that the Department of Science and Technology (DST) put the finishing touches on a Bill to regulate devices based on the report of a committee set up in 2000. The Medical Devices Regulation Bill, 2006, proposed the creation of an autonomous regulator for medical devices. It specified rules for governing safety, efficacy, design and manufacturing. It also proposed the risk-based classification of devices — a practice followed globally — and linked regulation to the level of risk. For instance, an implant that went into the body would be in a higher risk class than an ECG machine.

Raj govt planning health awareness campaign

ET Healthworld- PTI

Jaipur: The Ashok Gehlot-led Congress government in Rajasthan is planning to launch a large-scale heath campaign to make people aware about prevention of diseases. "Every person has the right to get good health services from the government. Now, we are going to start a new campaign on prevention of diseases. Prevention is better than cure," Chief Minister Gehlot told reporters in Bhilwara, a textile city, where he visited a medical camp. In rural areas, Gehlot said, people suffer due to a lack of timely treatment and it is the responsibility of community health centres and primary health centres to inform the district hospitals about patients whose disease cannot be cured at their level. "We want to make Rajasthan a leading state in the country in medical and health services," he said. Last month in Jaipur, the chief minister had directed medical and health department officials to launch a campaign to make Rajasthan a "healthy" state. He had asked officers to prepare a campaign to create awareness about a healthy liver, hepatitis B and C and also formed a sub-group chaired by chief secretary for this.

Varanasi: Resident doctors strike leaves thousands of patient struggling at BHU hospital

The Times of India

VARANASI: Following an attack on a junior resident doctor by the attendants of a patient on Sunday, the resident doctors of SSL hospital of Banaras Hindu University, which has AIIMS like status, went on strike from Monday morning. Their strike paralysed outdoor patient department (OPD) while no new patients were admitted in indoor patient department. Despite lodging of an FIR against 5 unidentified persons and assurance by varsity administration to enhance security on hospital campus the resident doctors remained rigid on their demand that till the arrest of assailants they will continue their strike. Due to their strike thousands of patients and their attendants could be found running from pillar to post to get service of any senior consultant. However, the agitating resident doctors also forced the senior residents and consultants, who were attending patients in some OPDs in morning, to close their units. Hospital’s medical superintendent Dr SK Mathur said that on an average over 8000 patients are registered in OPDs per day. But, he said, due to strike of junior residents on Monday less than 1000 patients could be attendants in OPDs only while no new patients was admitted to IPDs. He claimed that services in ICU, CCUs, emergency service and monitoring of patients already admitted in IPDs were not affected by the strike. He said that talks are continuing with resident doctors to convince them for calling off their strike in the interest of patients.

Ludhiana: One held for medical negligence

ET Healthworld- TNN

Ludhiana: Sahnewal police have booked a medical practitioner after a 9-year-old boy died allegedly due to negligence. The residents later vandalised the clinic. In his complaint, Ram Parvesh Moreya, a mason, of Makkar Colony, Dhandari Kalan said that, his elder son nine year old son, Arjun Moreya, fell sick on October 31and he took him for his treatment the next day. The accused treated the boy and discharged him. However, late night Arjun’s health started deteriorating, his father tried contacting the doctor but he did not respond to his calls. Moreya said on November 2, he took his son to Civil hospital where he was declared dead. Father alleged that his son has died because of negligence by the accused, Girish Kumar of Dr Ambedkar Nagar, Giaspura. On protests and his kin, the police reached the spot. Investigating officer, ASI Kulwinder Singh said that, the police have registered a case against Girish Kumar under section of 304-A (causing death by negligence) of IPC. The police will also look into if Girish is a quack or a registered medical practitioner.

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