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Medical Voice 7th November 2019

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Dr KK Aggarwal    07 November 2019

Centre has freedom to amend its CGHS scheme, says Delhi HC

New Delhi, Nov 5 (PTI) The Delhi High Court on Tuesday declined to interfere with the modified Central Government Health Services (CGHS) scheme, saying it is for the Centre to decide how to give health benefits and supply medicines to its serving and retired employees.

A bench of Chief Justice D N Patel and Justice C Hari Shankar said prima facie the modified policy creates no hurdles in supply of medicines to the central government employees and also curbs misuse of the scheme as was being allegedly done in the past.

The observation came while dismissing a PIL challenging an e-tender issued for empanelment of authorised local chemists under the modified CGHS scheme for the national capital area. The petition had opposed the modified scheme also.

Under the earlier scheme , if medicines prescribed by a doctor were not available at a wellness centre or dispensary, an authorisation slip was issued to the patient for procuring the medicine from a local chemist, the Health Ministry told the court.

Under the new scheme, it said, if medicine was not available at the dispensary, the local empanelled chemist supplies it to the wellness centre which in turn provides it to the patient. ....read more

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GoM meets to discuss regulating epharmacies

The Economic Times - Teena Thacker

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 anThe group of ministers (GoM) led by Rajnath Singh held its first meeting on October 30 to give teeth to new norms that will regulate the online pharmacy business. The GoM was set up after government failed to push the proposal to legalise online pharmacies within 100 days of Modi government’s second term, following opposition from the brick and mortar pharmacies. “The first meeting of GoM to regulate epharmacies was held on October 30. The health ministry made a presentation, explaining its position on the issue. Hopefully there will be a decision soon,” a source told ET. Defence minister Rajnath Singh, commerce minister Piyush Goyal, health minister Dr Harshvardhan and Gajendra Singh Shekhawat attended the meeting. Besides the health secretary and other senior officials of the health ministry, officials from ministry of electronics and information technology and department of pharmaceuticals were also present. The health ministry had released the draft rules for online pharmacies last year. According to the proposed e-pharmacy rules, which were opened for public comments in September, only government-registered e-portals could sell medicines and they must retain prescriptions and verify details of patients and doctors. d 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.

Now, antacids must carry ‘kidney injury’ warning

ET Healthworld - Rupali Mukherjee

In a bid to promote patient safety, widely-sold antacids (anti-acidity pills) will hereon need to carry a side-effect warning of ‘acute kidney injury” as part of their package insert leaflets. A directive to that end was issued by India’s Drugs Controller General on Tuesday, asking all state regulatory authorities to direct manufacturers of Proton Pump Inhibitors (PPIs) — a large chunk of the antacid market — to incorporate ‘acute kidney injury’ as an adverse drug reaction (ADR). The warning will be inserted in the packaging of these formulations, including Pantoprazole, Omeprazole, Lansoprazole, Esomeprazole, and their combinations. A package insert, or prescription drug label is directed primarily at prescribers and is intended to provide information for safe and effective use of the drug. The issue was discussed and case studies evaluated by several experts over the past few months, including the National Co-ordination Centre for Pharmacovigilance Programme, official sources said. Recent global studies on anti-acidity pills — popped for treating “gas” and heartburn — have pointed out that there can be serious adverse events due to their prolonged use like long-term kidney damage, acute renal disease and chronic kidney disease, and in certain cases, even gastric cancer. Since these reports are mostly restricted to nephrology journals, many physicians may not be aware of these adverse effects, experts pointed out. PPIs rank among the top 10 prescribed classes of drugs in a segment valued over Rs 4,500 crore and are commonly used to treat acid reflux and indigestion, but also deployed regularly across specialities like orthopaedics, cardiology, internal medicine and surgery. The directive states the based on ADR reports on certain medicinal products including these antacids, the National Co-ordination Centre for Pharmacovigilance Programme forwarded their recommendations, which were discussed on August 21. Thereafter, an expert panel recommended steps to incorporate the warning as an adverse drug reaction into the prescribing information leaflet. The recommendation were then deliberated on October 10 in a subject expert committee and formalised.

Nagpur: IMA comes up with mental health booklet for medical students

ET Healthworld/TNN-Chaitanya Deshpande

Nagpur: After back-to-back incidences of medical students’ suicides and assaults on resident doctors, the Indian Medical Association (IMA), under its Doctors4Doctors project, has come out with e-book ‘MBBS — A guide to well-being for medical students’. Experts from IMA and While Swan Foundation have drafted this booklet and its available for free online. The book covers almost every aspect — from common struggles of MBBS students who come from other states and cities, their mental well-being, the way to deal with stress, handling ragging, discrimination and bullying, and dealing with difficult people at medical college. While IMA is going to promote this booklet in medical colleges, authorities of Maharashtra University of Health Sciences (MUHS) are also mulling to include it as a reference book for first year MBBS students.

Ktaka govt to use hi-tech mechanism to curb attacks on docs

ET Healthworld – PTI

Bengaluru: In order to check attacks on doctors in government hospitals, the Karnataka government will deploy hi-tech mechanism, including artificial intelligence, Deputy Chief Minister C N Ashwath Narayan said on Tuesday. "Whatever may be the challenges, technology will be used. Walkie-talkie, facial recognition cameras, artificial intelligence or analytics", he told reporters here. He was replying to queries on the ongoing strike by a section of government doctors here protesting recent assault on one of their colleagues at an eye hospital by a few alleged activists of a pro-Kannada outfit over drug reaction in some patients who underwent cataract surgeries in July this year. The activists allegedly barged into the government Minto Eye Hospital and assaulted a doctor. Protesting this, the junior doctors at the hospital have been on the strike since Friday. Doctors in two other government hospitals also joined the protest later, causing disruption in patient services.

Pune: Robotic-assisted surgery gives youth with testicular cancer new life

ET Healthworld – Umesh Isalkar

Pune: A minimally invasive robotic surgery was successfully carried out in the city on a 27-year-old youth, who was diagnosed with testicular cancer, to remove lymph nodes behind his intestines. Since the testes develop in the abdomen and then descend in the scrotum during the embryonic stage, the lymphatic drainage of the testes goes to the retroperitoneal (behind the intestines) lymph nodes, requiring removal of these nodes. The surgery, medically termed as retroperitoneal lymph node resection (RPLND), not only ensured that the man’s nerves remained intact but also led to quicker recovery. Traditionally, an open surgery is a go-to method to remove the enlarged nodes, which entails high chances of damaging the major blood vessels of the abdomen and surrounding nerves. It requires prolonged period of convalescence due to an extensively large cut (incision) across the abdominal length. “It is the first time that such a challenging surgery was carried out in Pune. The patient was discharged on the fifth day of the surgery,” senior urologist and robotic surgeon Rajendra Shimpi, who performed the surgery at Ruby Hall Clinic on October 10, told TOI.

Heart sent from Gurugram to Delhi for transplant through green corridor on odd-even day

ET Healthworld – PTI

NEW DELHI: Heart harvested from a 43-year-old man at a Gurugram hospital was transported to another facility in Delhi through a 28-km green corridor in half-an-hour for a transplant surgery on Tuesday when odd-even traffic rule was in place in the capital, officials said. The odd-even rule allowed ease in transport of organs, the hospital authorities said. While the heart was sent from the Fortis Memorial Research Institute (FMRI) to the Fortis Escorts Heart Institute (FEHI), liver and a kidney were sent to other hospitals in the National Capital Region. Surgeons at FEHI were conducting the heart transplant on a 59-year-old man from Delhi, suffering from dilated cardiomyopathy, a Fortis spokesperson said. "The donor, declared brain dead, was a male patient suffering from brain stem bleeding. His heart was sent for the recipient at FEHI through a 28-km green corridor from FMRI in 31 minutes," the spokesperson said.

Explainer: How drug prices are regulated in India

moneycontrol - Viswanath Pilla

The price of medicines has been a sensitive subject in our country, where more than 55 million people are pushed into poverty every year due to out-of-pocket healthcare expenses. Of the total out-of-pocket healthcare expenses, a little over 50 percent is spent on purchasing medicines alone. The affordability of medicines is a crucial element in availing medical treatment by all sections of the people, particularly by the poor of the country. Price controls have become an important tool in government hands to make drugs affordable. According to data by AIOCD-AWACS, around 14 percent of drugs by value, and 25 percent by volume fall under price controls. Indias pharmaceutical industry is worth Rs 1.36 trillion for the year that ended in September. How are the prices of drugs regulated? Every few years, the Health Ministry, in consultation with experts, draws up a National List of Essential Medicines (NLEM). These medicines, deemed essential for the treatment of common conditions, automatically come under price control under the Drug Price Control Order (DPCO). Under NLEM 2015, the price of a total 376 drugs and 857 formulations are under price controls. In addition, under Para 19 of the DPCO, 2013, the government has special powers to bring any item of medical necessity under price controls. This provision was used to regulate the prices of cardiac stents and knee implants. The National Pharmaceutical Pricing Authority (NPPA), an independent body of experts in the Ministry of Chemicals and Fertilizers, enforces these prices and the availability of the medicines under the NLEM. What formula is applied? The DPCO follows a market-based pricing mechanism. The ceiling price is worked out on the basis of the simple average price of all brands having at least 1 percent market share of the total market turnover of that drug plus a notional 16 percent retailers margin.

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