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Medical Voice 10th June 2019

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Dr KK Aggarwal    10 June 2019

Delaying onset of type 2 diabetes by 6 years or more significantly lowers risk of heart disease

People with impaired glucose tolerance (IGT) may significantly lower their risk of cardiovascular disease (CVD) and microvascular disease by delaying the onset of type 2 diabetes (T2D) by six years or more, or by returning to a normal level of glucose tolerance altogether, according to the study presented today at the ongoing 79th Scientific Sessions of the American Diabetes Association in San Francisco.

  • Among the 252 adults who had developed diabetes, 65.6% developed CVD and 44.3% developed microvascular disease.
  • Among the 114 who continued to have IGT, 50.6% developed CVD and 31.2% developed microvascular disease
  • Among the 174 who reverted to normal glucose tolerance, 46.1% developed CVD and 23.1% developed microvascular disease.

 

Overall, those with IGT who developed diabetes had a 69% higher incidence of CVD and a 150% higher incidence of microvascular disease.

The study concluded that delaying the onset of diabetes in people with IGT by six years or more resulted in lower rates of complications and reduces the development of both CVD and microvascular disease.


Diuretic withdrawal is safe for stable heart failure patients: ReBIC-1 trial

Drug therapy for patients with stable heart failure can be simplified by stopping diuretics, according to late breaking results from the ReBIC-1 trial presented at Heart Failure 2019, a scientific congress of the European Society of Cardiology (ESC). The trial was conducted by the Brazilian Research Network in Heart Failure (ReBIC), which includes 11 tertiary care university hospitals in Brazil.

Eligible criteria were: no or mild symptoms (defined as New York Heart Association functional class I to II), reduced left ventricular ejection fraction (45% or below), no heart failure-related hospital admission within the last six months, and receiving low-dose furosemide (40 to 80 mg per day) for at least six months.

A total of 188 outpatients with stable chronic heart failure were randomly allocated to maintain or withdraw (placebo) the diuretic furosemide. The two coprimary outcomes were: 1) patient reported dyspnoea using a visual analogue scale at four time points across 90 days; and 2) the proportion of patients maintained without additional diuretics during the 90-day follow-up (on top of the randomly allocated diuretic or placebo).

There was no difference between groups in the self-perception of dyspnoea during the 90-day follow-up period. Also, 72 patients (75.3%) in the withdrawal group and 78 patients (83.9%) in the maintenance group were free of furosemide reuse during follow-up (p=0.16).

Dr Andréia Biolo, of the Federal University of Rio Grande do Sul and Senior author of the study said: “The results show that patients with stable heart failure who stop diuretics do not have more dyspnoea than those who continue taking the drug. Withdrawal also does not lead to increased reuse of diuretics – around 20% of patients in both groups needed a top-up, presumably for symptom relief.”


Healthcare News Monitor

Pharma News

Forensic help for India’s pharma industry

The Times of India- Parth Shastri

Ahmedabad: India’s $17 billion-plus pharmaceutical industry relies heavily on exports of generic medicines globally and USA is an important destination for many drug manufacturers. Thus, when the manufacturers get Form 483 from US Food and Drug Administration (USFDA), signifying ‘objectionable conditions,’ it becomes a matter of concern for the manufacturer – not only the batch becomes non-compliant for exports but also the firm has to launch a probe to rectify the objection. “One of the issues that attracts Form 483 is presence of particulate matters (PM) in drug vials – mostly injectables – that range from 20 to 200 microns in size. To give a comparison, a cross-section of human hair is 50 microns. But the USFDA inspection finds the PM in vials and asks the manufacturer to rectify it,” said Jayrajsinh Sarvaiya, assistant professor with Institute of Research & Development (IRD), Gujarat Forensic Sciences University (GFSU).

AI may conduct random drug tests on crew

The Times of India- Saurabh Sinha

Air India could soon start drug tests for its pilots and cabin crew on a random basis, in possibly a first for Indian carriers. While pre and post-flight breath analyser (BA) tests are conducted by all airlines, the Maharaja is planning to “pioneer” this step in India to enhance flight safety. Crew members who are found to have a drug abuse problem could be barred from operating flights till they are completely give the same up for good. “There should be medical testing for drugs to ensure that our flights are operated safely. While alcohol testing is done regularly and is mandatory, there is no specific regulation monitoring drug testing… It is recommended that (AI’s) medical department is asked to devise a process for doing random testing for drugs as a safety initiative…” says a note titled “safety recommendations for psychoactive substances” sent by the airline’s ED and chief of flight safety, , Harpreet A De Singh, to AI chairman and other top officials last Thursday(June 6).

SPIEF 2019: Business between India and Russia in search of ‘new blood’

The Hindu Business Line- St Petersburg

Start-ups, artificial intelligence and manufacturing digitisation should become the growth drivers of Indo-Russian economic cooperation, which has traditionally focused on defence, energy and pharmaceuticals. This was the thought voiced at a Russia-India session during the St Petersburg International Economic Forum (SPIEF) on Friday. The two countries are keen on exploring new business opportunities, despite the fact that participation of Indian businesses at SPIEF has been limited this year, due to the recently concluded elections and Russia’s increased focus on China. Pharmaceuticals has been one of the traditional industries where India and Russia have developed strong ties. However, according to Vikram Singh Punia, founder of Pharmasyntez, one of the largest drug manufacturers in Russia, India and Russia should change the model of cooperation.

Mushrooms with sun exposure act as anti-TB drugs: Study

Daily News & Analysis

A recent study highlighted the death rate caused due to Tuberculosis in low-income countries and also how the consumption of sun-exposed oyster mushrooms is beneficial for TB patients. The study was discussed in an annual meeting Nutrition 2019 held from June 8-11 in Baltimore. TibebeSelassie Seyoum Keflie, one of the researchers said, "TB is becoming more difficult to fight due to the emergence of drug-resistant strains, creating an urgent need for new treatments that can support first-line drugs."

Lupin, Heritage recall drugs in US

Daily News & Analysis

Pharmaceutical firm Lupin has initiated a nationwide voluntary recall of pneumonia antibiotic in the US after a complaint of metal piece in the bottle was received. In a recent enforcement report, the US Food and Drug Administration (FDA) said Lupin Pharmaceuticals Inc, the US arm of Mumbai-based Lupin, has recalled 18,408 bottles of Cefdinir, 250mg/5ml powder for oral suspension in 60 ml bottle manufactured at Lupin’s Mandideep plant in Madhya Pradesh. Cefdinir is an antibiotic used to treat pneumonia, otitis media, strep throat, and cellulitis. The reason for the recall is given as complaint received of metal piece identified in the product bottle prior to the reconstitution. The ongoing Class II recall was initiated on May 23, the FDA said on its website. The products have an expiry date of November 2020.

Govt mulls mandatory barcoding of all medicines sold within India

Mint- Neetu Chandra Sharma

The government plans to make barcoding mandatory on all medicines sold locally in a bid to offset India’s growing reputation as a source of counterfeit medicines. While the system is already in place for medical devices and export of medicines to ensure their authenticity and traceability, the Union health ministry plans to take a tough stance for the domestic market as well despite resistance from drug companies. “In current times, our major concern in the pharmaceutical market is authenticity of drugs which is more important than traceability. In order to prevent counterfeit medicines in the country, we had proposed the idea of implementing barcoding back in 2015. Currently, this remains voluntary. But in the next phase of policy planning, we are planning to make it mandatory for all drug manufacturers to use barcoding in the domestic drug market as used in exports," said R. Chandrashekar, deputy drugs controller, Central Drugs Standards Control Organization (CDSCO) under the health ministry.

Natco Pharma bullish on India, Brazil, Canada biz for FY20 growth

The Hans India

Natco Pharma expects India, Brazil and Canada markets to be its revenue drivers during the current financial year, recording growth of 30 per cent to 40 per cent, according to a top company executive. The India business alone was likely to grow by about 15 per cent to 20 per cent, Natco Vice-Chairman and Chief Executive Officer Rajeev Nannapaneni has said." The second driver will be Brazil. Brazil did not do well for many years, so we had some very good launches this year and so that should drive earnings," he said replying to a query during a recently held Earnings Call of the company. Talking about Canada, he said Natco was anticipating a couple of launches and a couple of "favourable settlements". If they all come through, the city-based drug maker expected the three markets to grow at 30 per cent to 40 per cent, he added. India is expecting about eight to 10 launches this year. Brazil we are expecting about three to four launches.

Fish medicine draws thousands from afar

The Hans India

A patient from Kerala, suffering from Bronchial asthma, arrived in the city to take the famed fish medicine administered by the Bathini brothers. "Fish medicine consumption is a festive routine on Mrigasira. We come here every year along with family to take medicine. None of my family members has respiratory issues, but we believe it also prevents us from asthma attacks," said Sudha Maira, a teacher. Bronchial asthma is a medical condition which causes the airway path of the lungs to swell and narrow. Due to this swelling, the air path produces excess mucus making it hard to breathe, which results in coughing, short breath, and wheezing. The disease is chronic and interferes with daily working, according to medanta.org. Thousands of patients descended on the city, many along with their families, to take the fish medicine. Very long queues were seen at the Exhibition Grounds where the prasad was administered.

Modi 2.0 eyes big push for allopathy, Ayush integration

The Asian Age- Rahul Chhabra

Having delivered on its previous poll promise by rolling out Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) in its first term, Narendra Modi 2.0 is all set to strengthen the mega public health initiative by integrating traditional medical therapy with allopathy at public health centres (PHCs) in a big way to arrest rising chronic diseases such as diabetes and obesity. Union Ayush minister Shripad Naik recently said, “All PHCs (renamed as wellness and health centres) will now have Ayush doctors besides allopathy practitioners. People would be introduced to alternative medicine through such measures.” The need to appoint Ayush doctors has been increasingly felt at the PHCs level following the success of a pilot project launched in 2016 in three districts — Bhilwara (Rajasthan), Surendranagar (Gujarat) and Gaya (Bihar) — wherein targeted beneficiaries are being given ayurveda drugs, dietary regimen and yoga classes to treat non-communicable diseases.

Dual control of pharmacy education to continue as PCI & AICTE issue public notices

Pharmabiz- Peethaambaran Kunnathoor

By issuing public notices by the two pharmacy education regulatory bodies, PCI and AICTE, in newspapers concerning approval of institutions and courses, it has become obvious that the dual control of pharmacy education will continue further. Last year, some steps taken by the PCI and the government created an impression among the public that dual control of pharmacy education will cease to exist, and the pharmacy council of India will become the supreme controller of all pharmacy institutions and which will be delinked from the AICTE. Reiterating that the approval of the All India Council of Technical Education (AICTE) is mandatory for running pharmacy and other technical institutions, AICTE advertised Public Notice in all national newspapers in last month advising course pursuing and aspiring students to verify the status of approval of the institutions they study or want to take admissions. The council has categorically stated in the advertisement that AICTE’s approval is necessary for running the courses of pharmacy and only approved institutions can conduct the courses introduced by the PCI. If any institute is conducting a program without the prior approval of the AICTE, it is liable for punitive or criminal action in accordance with para 9 and 10 of the AICTE Regulations 2018.

State DCs seek action against pharma cos tweaking drug composition with same brand names

Pharmabiz- Shardul Nautiyal

State drug controllers from across the country have sought legal action under trademark law against pharma manufacturers who are marketing new formulations by tweaking composition without changing the existing brand names. In the interest of patient safety, Drugs Controller General of India (DCGI) had issued a circular to all the state drug controllers to ensure that changed formulations are not marketed in the country with the old brand names as it confuses both the doctors and patients. It has been brought to the notice of Central Drugs Standard Control Organisation (CDSCO) that some manufacturers while changing the API of a drug formulation are still retaining the brand name of old formulation.

Panel on e-pharmacy to meet on June 10 to discuss stakeholders’ comments, finalize rules

Pharmabiz-Peethaambaran Kunnathoor

The subcommittee constituted by the Drugs Consultative Committee (DCC) under DCGI to examine issues relating to e-pharmacy and provide operational direction for online sale of drugs will sit on Monday, June 10, to discuss the various comments and suggestions received by the union health ministry from stakeholders on the draft rules it issued on August 28, 2018. According to sources from DCGI office, the public comments and suggestions are treated as proposals for the amendment of Drugs and Cosmetics Rules 1945 to ratify e-pharmacy in India. The draft rules were released by the health ministry in September 2017 for the purpose of regulating e-pharmacies. After the meeting, the DCC will recommend the draft rules with suggestions of the subcommittee to the government for approval. The new government at the centre wants to launch the scheme in another three months as one of its new projects. Sources further added that the e-pharmacy would bring drastic changes in the whole scenario of pharmaceutical marketing and sales in India.

KDPMA feels selling changed compositions under old brand name should be patient centric

Pharmabiz- Nandita Vijay

Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) has observed that practice of selling of Drug Formulations with changed composition under the existing brand name is a matter of concern. Since trademarks and brand names are out of the purview of the Drugs and Cosmetics Act, the Association sees the need for some level of oversight on the issue by the drugs control authority. Referring to the communication note issued by the CDSCO on May 16, 2019, the Association feels that the circular is more of an advisory in nature. “As an industry, we should take it positively and should ensure only ethical practices prevail for the benefit of the patients. We are in the business of pharmaceuticals only because of the prescribers and the patients. Therefore the industry needs to be sensitive to the interest of the patients and prescribers,” Harish K Jain, secretary Karnataka Drugs and Pharmaceutical Manufacturers Association and Director, Embiotic Laboratories told Pharmabiz.

Maha FDA set to prosecute online illegal abortion drug racket in state

Pharmabiz- Shardul Nautiyal

The Maharashtra Food and Drugs Administration (FDA) has detected an online illegal abortion drug racket and has lodged 7 FIRs to curb the practice. Prosecutions will follow after the chargesheet is framed as per the Drugs and Cosmetics (D&C) Act. As a part of the crackdown, the state FDA has revealed that Medical Termination of Pregnancy (MTP) pills which is a scheduled drug was traded online in contravention to the law of the land. MTP is a schedule H drug and can be taken only against the prescription of a qualified gynaecologist. MTP Kit is a set of two essential abortion medicines -Mifepristone and Misoprostol which performs medical pregnancy termination (non-surgical embryo expel from womb) and should be taken only under the supervision and prescription of a gynaecologist.

Healthcare News

Doctors need to fight for their title on another frontier

The Times of India- Samir Shukla

Recently I met a leading neuro-physician of Gujarat. Our conversation moved across the landscape of mind covering subjects like depression, anxiety and more, making me realise that he had so much to share that can be of enormous help to public at large. When I asked him why doctors are not talking about such themes from public platforms, this conversation brought my attention to something really startling that I had not previously noticed. When I look at those who occupy the centre-stage, at least in Gujarat, talking about medically tricky malaises like clinical depression or anxiety, these luminaries had one thing common. Most of them are not trained in medicine and yet they all used the title of “Dr.”!

Nipah: NIV team collects samples from bats

The Times of India

Kochi: A team from National Institute of Virology (NIV), Pune, collected samples from 23 bats found on the premises of the house at Thodupuzha, where the Nipah-infected 23 – year old student stayed, on Sunday. Theteam aims to find the source of the infection. Forest department officials helped the team collect samples from bats. Meanwhile, the condition of the student improved. Of the three samples of the patient sent to NIV, two tested negative and one positive. Also, one more person with fever was admitted at Ernakulam Medical College. With this, the total number of people under observation at the medical college touched eight. Seven of them have tested negative for Nipah. Also, blood sample from a patient, who is undergoing treatment at a private hospital in the district, has been collected for tests. None of the 327 people, who came in contact with the Nipah-infected student, have shown any symptoms of the disease. Meanwhile, four teams of doctors from the disease control room inspected 73 private hospitals as part of preventive measures. They looked into the details of death of 1,798 people registered with local bodies in Ernakulam in the past month. No one had any symptoms of Nipah, it was found.

Mumbai police told to expedite probe in doctor’s suicide

Hindustan- PTI

A National Commission for Scheduled Tribes (NCST) team has met Mumbai Police officials and the management of the BYL Nair Hospital regarding the Payal Tadvi suicide case and demanded that the probe into the matter be expedited. The team, led by NCST chairman Nand Kumar Sai, also met Tadvi’s family Saturday. “The NCST has demanded that the probe by the Crime Branch into the case be completed as soon as possible... Even the post-mortem report has not been released yet,” Sai told PTI on Sunday. “It’s not clear yet whether it’s suicide or murder. The matter is under investigation. Let the post-mortem report come out,” he added. Tadvi, 26, a second-year gynaecology student of TN Topiwala National Medical College, allegedly committed suicide in her hostel room on May 22. Her family alleged that three of her seniors at the BYL Nair Hospital, to which the medical college is attached, taunted and hurled casteist slurs at her as she belonged to a Scheduled Tribe.

Ministry of Health proposes to convert 75 district hospitals into medical colleges

Business Today-PTI

The Health Ministry has proposed to convert 75 district hospitals into medical colleges in the third phase of a scheme which aims at boosting availability of human resource for the health sector. The proposal is a part of the centrally sponsored scheme for "establishment of new medical colleges by upgrading district or referral hospitals" preferably in underserved districts of the country. In the first phase, the government had approved converting 58 district hospitals into medical colleges while in the second phase, 24 hospitals were selected. Out of all these 39 hospitals have become functional while the remaining are still under construction.

8-month-old dies in Jalandhar, family alleges medical negligence

Asian News International

The family members of an infant on Sunday claimed that their eight-month-old child died owing to the medical negligence of the doctors here at a private clinic. The deceased identified as 8-month-old Ananya whose family hails from Bihar was taken to a doctor here and the minor allegedly died during the treatment. "They had come to Jalandhar to meet their relatives, it is when the infant fell sick and started having loose stool. Following the bad health, she was taken to a hospital. During the treatment, the doctor gave an injection to the child," said Sukhdev Singh, Station House Officer (SHO) Bhargava Kendra. "The family alleged that after the vaccination when they brought the child home, she started to collapse. They then took her back to the doctors, they declared the infant dead," Singh added. While the family of the deceased infant is alleging medical negligence, the doctor claimed that he had referred the patient to another hospital, however, he added that the family failed to do so.

Karnal Civil Hospital gets facelift

The Tribune

The emergency wards of the trauma centre and the labour room in the Karnal Civil Hospital have been partitioned with curtains to ensure privacy and prevent the spread of infections. Dr Piyush Sharma, Principal Medical Officer, said a unique look had been given to all emergency wards. More beds have been added to crowded wards. Dr Ravinder Sandhu, Additional Senior Medical Officer, Civil Hospital, said a triage protocol had been implemented at the trauma centre to ensure timely treatment to critical patients. Flex boards with colour marking had also been installed.

SGPGIMS first UP hospital to start robotic surgeries

India Today- Nelanshu Shukla

The Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGIMS) is the first in Uttar Pradesh to start robotic surgery. The institute, after making efforts for the past five years, succeeded in purchasing a robotic system in December last year. Speaking to media during its inauguration, SGPGI Director Professor Rakesh Kapoor said, "Precision is the biggest advantage of the robotic surgery because it eliminates the risk of errors made sometimes during the normal surgery. It will also reduce the time in conducting a surgery. Sixty-two institutes across the country are successfully using this technology." Dr. Amit Agrawal, chief medical superintendent (CMS) of the SGPGI said, "The surgeon can operate the system easily after getting proper training. Gastro, Endocrine, Urology and Cardio are the four departments where this technology will be used effectively. Robotic system has been manufactured by an American company. This technology also reduces the possibility of blood loss. Initially training has been given to eight surgeons. Its extremely beneficial for cardiac surgeons as it reduces the risk of big cuts."

Encephalitis outbreak: 19 kids die, dozens admitted to hospitals in Muzzafarpur

Zee News- ANI

Around 19 children have died due to suspected Acute Encephalitis Syndrome (AES) or Japanese Encephalitis (JE) in Bihars Muzaffarpur, while dozens of others with symptoms of the infection have been admitted to the citys hospitals. 15 children admitted to Shri Krishna Memorial College Hospital (SKMCH) have died in these scorching summer months till now. The private hospitals officials have confirmed the death of four children due to AES. Dr Gopal Sahni, head of Critical Care Unit of SKMCH, said, "When heat and humidity rise, the body’s sweat cannot evaporate. The humidity level is over 50 per cent in the last few days. We have about 15 such children admitted in the hospital currently. Eight-nine such cases come regularly.

13 Arrested In Delhi, Notice Sent To Fortis Doctors Over Kidney Racket

NDTV

Over a dozen leading private surgeons, including top urologists of Delhi are under the scanner of Uttar Pradesh Police in connection with a sensational international kidney transplant racket, spreading across Turkey and the Middle East countries. So far, 13 people, including CEO of Pushpawati Singhania Research Institute (PSRI) Dr Deepak Shukla have been arrested. Two leading doctors of Fortis hospital have been served notice in the kidney racket. The investigation against another leading hospital located in central Delhi is underway and more arrests are likely to be made in the case which has sent ripples across the medical fraternity. Talking to IANS, Senior Superintendent of Police Kanpur, Anant Deo said that the Fortis hospital has been served notice in cases relating to the violation of Transplantation of Human Organs Act.

Doctors across Jharkhand on warpath

The Telegraph- Praduman Choubey

Doctors across Jharkhand are up in arms over a delay in the probe into the May 26 arrest of a radiologist, Dr Seema Modi, for allegedly conducting the gender-determination test of a foetus at her clinic in Koderma’s Jhumri Telaiya. In a resolution taken on Sunday by the state unit of Indian Medical Association (IMA), doctors said they resented the fact that no inquiry was made into the validity of the arrest of Modi. The doctors decided not to conduct any ultrasonography of the gravid uterus — pregnant uterus in layperson terms — for 72 hours beginning Tuesday, June 11, across the state. The resolution was conveyed to the office-bearers of outfits such as the Jharkhand State Health Services Association (JSHSA), Sonological Society of India (SSOI), members of the state unit of the Federation of Obstetrics and Gynaecological Societies of India (Fogsi) and Radiological Society, Jharkhand.

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