IndiaMedToday June 2019

JUNE 2019, VOLUME 3 ISSUE 6 `200 INDIA MED TODAY

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HOW BIG DATA CAN SOLVE THE BLOOD CRISIS NEW INNOVATION FOR BLOOD TESTING ADVANCEMENT IN BRAIN TUMOR TREATMENT

Mandate for

Blood Bank Making Safe Blood Accessible & Available

JUNE 2019

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JUNE 2019 EDITORIAL

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It is time to think differently about Healthcare AFTER A conclusive verdict in the Lok Sabha election, Prime Minister Narendra Modi begins his new term. This time around Dr Harsh Vardhan is given the mandate for the health and family welfare ministry. In the last five years, the healthcare industry has undergone a lot of change thanks to the policy initiatives of NDA-1 government.

Over the past decade, the changing demographics and lifestyles has led to a tectonic shift in terms of causes of morbidity and mortality.

There are a number of factors at play and the current situation demands that we give re-look at our health delivery system.

The NDA-2 government will have to make good on its wellfounded intention of making healthcare accessible and available. Be it Ayushman Bharat or price rationalisation should reach its logical conclusion. We must be able to stop avoidable death and suffering and the patient themselves are a big part of this effort. The patient has to be sensitized about the benefits of a healthy lifestyle and wellness centers have to take big steps in this direction.

In the last five years, the healthcare industry has undergone a lot of change thanks to the policy initiatives of NDA-1 government These efforts to enhance the nation’s healthcare infrastructure and manpower cannot bear fruit without private sector inclusion. It’s the government’s mandate to tame the private sector by creating linkages between public health infrastructure and private providers.

Those who pay close attention to the industry can see how the government efforts have started a reaction in the industry. The calls for price transparency are getting louder and the voice of patient as a consumer is surfacing. These are interesting times to be in healthcare to witness the innovation and policy reforms finally bridging the gap between the patient and the provider. Let’s see how this is going to change in the next five years. Our best wishes to the New Government and the Health Ministry.

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Editor M Neelam Kachhap

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June 2019

JUNE 2019

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CONTENTS

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UPFRONT 04 Editorial 06 News roundup 27 Event listing

APPROACH

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Smart Hospitals – Why Vanilla Digital isn’t Smart The Smart Hospital framework is best initiated during the project inception stage since a piecemeal approach is never as effective

COVER STORY

Mandate for Blood Bank Making Safe Blood Accessible & Available

IMPACT

How Big Data Is Solving the Blood Crisis Data points can be utilised for safety, patient satisfaction and cost optimisation for better blood transfusion

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INNOVATE

SPECIAL FEATURE 36 STD Safe Transfusione Timely Testing of Blood is Imperative to Reduce the Prevalence of Syphilis

38 Rapid Diagnostic Testsg Enabling Effective Blood Transfusion in Developing Countries

RESEARCH STUDY 41 Skilled health workforce in India does not meet WHO recommended threshold

Low-cost Tool for Diagnosis and Monitoring

(i)SIMPLE technology combines the advantages of paper-based and channel-based microfluidic devices

PULSE

30

Advancement in Brain Tumor Treatment

34 WWW.INDIAMEDTODAY.COM

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NEWS ROUNDUP NEW DEVICE IS ALTERNATIVE TREATMENT TO LIFELONG USE OF BLOOD THINNERS Boston Scientific has initiated the OPTION trial for reducing the risk of stroke in patients with non-valvular atrial fibrillation who undergo a cardiac ablation procedure.

The Watchman Flx LAAC Device is a catheter-delivered heart implant designed to close the left atrial appendage (LAA) in order to prevent the migration of blood clots from the left atrial appendage and thus reduce the incidence of stroke and systemic embolism for higher risk patients with non-valvular AF. The left atrial appendage is a thin, saclike appendix arising from the heart and is believed to be the source of >90 per cent of stroke-causing clots that come from the left atrium in people with non-valvular AF. The OPTION trial will compare safety and effectiveness of the next-generation Watchman Flxleft atrial appendage closure (LAAC) platform to first-line oral anticoagulants

The Watchman Flx LAAC Device

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(OAC) – including direct oral anticoagulants (DOAC) and warfarin.

The randomized, controlled OPTION trial will enroll 1,600 patients with non-valvular AF who are suitable for OAC therapy and have recently had or will have an ablation.

Patients at as many as 130 global sites will be randomized to receive the newest-generation Watchman Flxdevice or an OAC, inclusive of commonly prescribed DOACs or warfarin. The primary effectiveness endpoint is all cause death, stroke and systemic embolism through 36 months, and the primary safety endpoint is non-procedural bleeding through 36 months.

“Cardiac ablation is an effective way to treat an abnormal heart rhythm for many patients, though symptomatic relief can lead these patients to stop taking their blood thinners and unknowingly put themselves at an elevated risk for a stroke,” said Dr Oussama Wazni, co-director of the Ventricular Arrhythmia Center, Center for Atrial Fibrillation and the Atrial Fibrillation Stroke Prevention Center at Cleveland Clinic and the principal investigator for the OPTION trial. “This first-of-its-kind trial will explore

whether the one-time Watchman Flxdevice could replace commonly used anticoagulants for long-term stroke risk reduction in this growing patient population.”

The Watchman device has been implanted in more than 80,000 patients worldwide and the latest-generation Watchman Flxdevice received CE Mark in March 2019.

MODI GOVT’S MASSIVE VICTORY BRINGS CHEER TO INDIAN MEDICAL DEVICE INDUSTRY

The triumphant victory of Shri Modi has reinvoked more positive feeling of coming of acche din to the Indian Medical Devices Industry and acting on the partially finished agenda by Modi2.0.”Many congratulations to Prime Minister Narendra Modi for such a massive victory of the Bharatiya Janata Party” said the elated Mr. Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) Applauding Modi Govt’s achievements in the last five years, Mr. Rajiv Nath said,

Richard Homer, Deputy Head of Mission, British Deputy High Commission, Bengaluru & Dr. Satheesh CT, leading medical oncologist with Astra Zeneca India team during the inauguration

“The last five years witnessed significant developments in the medical devices sector with noticeable focus by various Ministries of Government focusing on this earlier neglected sector, having realized the huge potential of this sector for unleashing Make in India and to become the next big Brand India success story after IT &Pharma.

The experimental and tentative steps taken to address inverted duty structure for some devices, price caps on Stents & Knee Implants, Indian Certification for Medical Devices, bringing in medical devices rules, establishment of Kalam Institute of Healthcare Technology and Andhra Med Tech Park in Vishakapatnam, drafting an Essential list of Diagnostics and establishment of Medical Devices Promotion Council in Modi 1.0 needs to be now taken forward to the logical conclusion in Modi 2.0.

There is an urgent need for the Govt. to accelerate further reforms for which foundation has now been laid and supportive measures in order to boost medical device manufacturing within the country, reducing huge import dependency in this sector which is still at 70-90% and a staggering 31000 Cr

Rs imports bill, minimizing outgo of foreign reserves, and making quality healthcare affordable and accessible to the masses at large as initiated under Ayushman Bharat.

The first term of the Modi government has been very eventful and progressive for the presently valued $10 billion Indian Medical Device Market which saw a series of serious measures being taken by the government for the Indian Medical Devices Industry which looked positive and beneficial to the end consumer but voicing the concerns of Domestic Medical Devices Industry Mr Rajiv Nath urged for expediting steps for patients’ protection, stronger quality & Safety regulations, price controls to make devices and quality treatment accessible and affordable and ethical indigenous manufacturing viable .

ASTRA ZENECA OPENS DEDICATED DEVELOPMENT OPERATIONS OFFICE IN BENGALURU Global science-led biopharmaceutical company,

Astra Zeneca officially announces the expansion of its clinical research operations in India with the launch of a new dedicated unit in Bengaluru. Inaugurated by Richard Homer, Deputy Head of Mission, British Deputy High Commission - Bengaluru, this new Development Operations centre will cement Astra Zeneca’s position as a leading initiator of clinical research in the country. According to publicly available data, Astra Zeneca is among the top 3 initiators of clinical studies among foreign pharmaceutical companies in India in the past three years. The new centre is located at Manyata business Park alongside the India marketing and manufacturing headquarters.

The Development Operations centre will employ over 30 clinical research experts that handle over 20 studies in 150 sites across India. This expansion will focus on managing studies in India to not only support the global clinical drug development, but also the local business with clinical data and evidence.

The unit will support development of AstraZeneca’s medicines, hosting clinical trial experts focused on the company’s core therapeutic areas: oncology, cardiovascular, renal and metabolism, as well as respiratory.

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NEWS ROUNDUP BD AUNCHES PRIME IN CONJUNCTION WITH JCI IN INDIA BD (Becton, Dickinson and Company), a leading global medical technology company, has launched a new patient safety program for hospitals, called Preventing Risks of Infections and Medication Errors in IV Therapy (PRIME). Aimed at addressing the two critical challenges in a hospital setting – infection prevention and medication safety – PRIME is developed by Joint Commission International for Patient Safety, with sponsorship by BD. Speaking about JCI’s initiation of PRIME with BD, Dr Marwa JZohdy, Vice President, Global Consulting Services, Joint Commission Resources/Joint Commission International (JCI) said, “The preparation and administration of medication is critical to safe, high-quality patient care around the world. At JCI, we recognize a fundamental need on this topic, and the unique PRIME program addresses that need. Leading experts from JCI with the support of BD have created a practical curriculum that will bring critical skills to life.”

A unique programmatic approach towards patient safety will be implemented over sixmonth duration, composed of goal-setting, constant progress review, tele-consultations with experts and scientific updates through webinars. Hospitals will be certified upon successful completion of the program.

Emphasizing on launching PRIME in India, PavanMocherla, Managing Director, BD-India & South Asia said, “Increasingly, healthcare facilities across India are working to upgrade quality standards to achieve a future of better patient outcomes, increased patient safety and cost efficiency in healthcare systems.

In this pursuit of quality and safety, BD is pleased to work on enabling the hospitals achieve standardized and compliant care and improve patient outcomes through PRIME – a Gold Standard benchmarked safety program with JCI. Through this hallmark program for hospitals, BD will be able to help enhance patient and clinical outcomes by eliminating complications and improving safety for patients and providers leading to accessing better care.”

So far, the hospitals that have signed up for

Launch of Preventing Risks of infections and medications Errors in India

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the program in India are: 1. Kolkata – Belle Vue Clinic, Fortis Hospital Anandapur 2. Mumbai – Breach Candy, Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute 3. Trivandrum – Kerala Institute of Medical Sciences 4. Manipal – Kasturba Hospital 5. Mohali – Fortis Hospital 6. Delhi/NCR – Max Healthcare, Saket and Medanta The Medicity-Gurgaon PRIME has been launched across South Korea, Japan, Malaysia, Thailand, Indonesia, Philippines, Vietnam and India.

NATIONAL HEALTH AUTHORITY INKS PARTNERSHIP WITH NATIONAL CANCER GRID

National Health Authority (NHA) and National Cancer Grid (NCG) today signed anMoU to develop uniform standards of patient care to battle cancer under Ayushman Bharat – PradhanMantri Jan ArogyaYojana (AB – PMJAY). National Cancer Grid (NCG) is an initiative of the Government of India to create a network of cancer centres, research institutes, patient groups and charitable institutions across India.

Owing to the multi-disciplinary nature of care required for cancer management, both NHA and NCG recognize the importance of collaborative efforts required to strengthen delivery of cancer services under AB – PMJAY with common objectives to reduce cancer burden, ensure uniform standards of patient care towards effective and efficient patientcentric care, improve access to cancer services and ensure financial risk protection with minimum prevalence of catastrophic health spending and impoverishment.

The NCG and NHA officials met in New Delhi to discuss their new partnership on a wide range of ideas to improve cancer care in India. The main objectives of this collaboration include developing uniform standards of patient care for prevention, diagnosis, and treatment of cancer; providing specialized

training and education in oncology and facilitating collaborative basic, translational and clinical research in cancer.

NHA and NCG will jointly review existing cancer treatment packages, pricing of services, standard treatment workflows covered under AB-PMJAY and plug in necessary gaps to ensure enhanced quality of cancer care.

Both organisations will work on creating cancer services/package benefits based on priority setting tenets such as evidence of efficacy, value (cost-effectiveness), low harm, demand/ burden, medical necessity, and wide availability. NCG will work closely with NHA to rationalize payment rates for different benefit packages and treatment/diagnosis plans, and also explore mechanisms to signal right incentives to providers to ensure quality through pricing mechanisms.

Highlighting his views on this new partnership, Dr Indu Bhushan, CEO, Ayushman Bharat PM-JAY, and National Health Authority said, “We are glad to partner with National Cancer Grid and welcome their expertise in enhancing the cancer care services provided under AB – PMJAY. We look forward to NCG’s support and expertise in enabling us to expand our service delivery network by actively encouraging its member hospitals to empanel with AB – PMJAY.” Speaking on the occasion, Prof R A Badwe, Director, Tata Memorial Centre said, “Our meeting with National Health Authority has been extremely fruitful. We are partnering with NHA to establish and optimize processes and guidelines to implement top-notch standards across all levels of cancer treatment and care under AB – PMJAY.” The MOU signing was attended by Dr Dinesh Arora, Deputy CEO, AB – PMJAY and NHA, Prof CS. Pramesh, Director Tata Memorial Hospital and DrArun Gupta, Executive Director, Health Network and Quality Assurance, NHA.

NARAYANA HEALTH CITY PERFORMS THE WORLD’S FIRST PDA STENTING Team of doctors at Narayana Health City performed the world’s first PDA stenting

Pre-operative picture of Mauritian conjoined twins with a shared heart

as well as region’s first thoracopagus separation surgery and saved the life of baby CleannePapillon. Hailing from Mauritius, Baby CleannePapillon was one of the conjoined twins who had a shared heart with her sister.

Born to Mrs. and Mr. Ian Papillon, the babies were thoracopagus twins. Generally in thoracopagus twins the bodies are joined from the neck to the upper abdomen, however, in this case their heart were also joined. Instead of four chambers for each, together, they had seven chambers. As their survival required expert care, the Mauritian health department reached out to hospitals abroad. However, as it was a complex case with negligible chances for survival, many of the hospitals in Europe and other Asian countries were not open to consider the case. Narayana Health City stood up as a Good Samaritan and took up this challenging case owing to their vast

experience in handling complex pediatric cases.

As the children shared a heart and were not in a position to even breathe, they were supported by hand pumps for oxygen through the journey. As soon as they arrived, the multi-disciplinary team under the aegis of Dr. Ashley D’Cruz, Director & Sr. Consultant Pediatric Surgeon & Urologist, Dr Sanjay Rao, Sr consultant – Paediatric Surgery and Organ Tranplant, Dr. Shreesha Shankar Maiya, Consultant – Paediatric Cardiology and Electrophysiology, Dr. Riyan Shetty, Consultant Critical Care Services & Head of Extracorporeal Life Support, Dr Ganesh Sambandamoorthy, Consultant – Anaesthesia& Critical Care and Dr. HariniSreedharan, Consultant Neonatology, did a thorough examination of the babies.

Considering the babies had a shared heart and survival chances were bleak, multiple

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NEWS ROUNDUP specialties had to deliberate to find a way to save at least one of them. With the parents consent the team of doctors started the treatment. The doctors put them on intensive care. The intensive care team under the leadership of Dr. Riyan Shetty and Dr Ganesh Sambandamoorthy ensured the babies were stabilized faster. Once they were stabilized, PDA stenting was performed to improve the condition of the heart.

While the intervention was successful, as staying together will affect both the lives, the doctors advised separation surgery. Though the babies were twins, one of them suffered from non correctable congenital anomalies. In fact, the unhealthy child was becoming more like a burden on the healthy baby and hence the parents along with the doctors chose to support the healthy child. They separated the babies. The tissues of sacrificed baby were used to reconstruct the torso of surviving twin.

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SMILES INSTITUTE FOR COLORECTAL TREATMENT TO EXPAND WITH THREE MORE CLINICS The pioneer in the field of colorectal treatment and surgery in India, Smiles International Institute of Colo-Proctology (Smiles) estimates revenue of US$ 3.5 Million for FY 19-20. SMILES International Institute of Colo-Proctology, one of the First Integrated colo-rectal hospitals in India, has already generated revenue of INR 6.9 Cr. i.e. nearly US$ 1 Million in the first financial year of 2018-19 after the launch.

Smiles had opened an outreach clinic on 10th April 2019 followed by three more clinics in the year 2019 at Silk board/ HSR, Whitefield, and Nagarbhavi in Bengaluru.

Smiles currently has one tertiary care center in Bengaluru at Mathikere with India’s 1st Fourth generation laser machine for colorectal

treatment and surgery. The leading medical institute is re-defining the field of colorectal treatments with minimally invasive, painless, bloodless & cost effective procedures to everyone.

Commenting on the growth of the institution, Dr. Parameshwara C M, Chief, Smiles, said, “In India, colorectal cancer stands fourth in men and third in women with respect to incidence and mortality rates. The statistics are a great obstruction in ensuring quality healthcare across this nation. After I encountered strange incidents with my friend, a surgeon himself suffering from colorectal problem, I laid the foundation of Smiles IICP with an aim to serve millions of Indians suffering from colorectal diseases.

With the establishment of three new clinics with advanced facilities, we aim to cover the complete region with our best-inclass advanced treatment for all colorectal

problems. The revenues of our first financial year have already proven our success. We are certain to exceed the revenue of US$ 3.5 Million in the FY 19-20 and continue our expansion across India.”

TAIWAN-INDIA MEDICAL COOPERATION FORUM AIMS TO STRENGTHEN ECONOMIC AND TRADE EXCHANGES The second edition of Taiwan Expo 2019 being organised by Bureau of Foreign Trade (MOEA) and Taiwan External Trade Development Council (TAITRA) witnessed potential healthcare companies from Taiwan looking for association in Indian market. The Expo witnessed Taiwan-India Medical Cooperation Forum providing Indian companies an opportunity to learn about Taiwan’s current healthcare development, its diverse strength in the field of medical equipment, economic, trade etc. and the areas in which the two countries can co-operate in the future.

Taiwan External Trade Development Council (TAITRA) is looking at starters, venture partnership and strategic partnership for long term and help foster growth between both the countries. The world-famous high-tech industrial park, Hsinchu Science Park from Taiwan, lead 8 potential Taiwan companies to India for the Taiwan-India Medical Cooperation Forum.

India is the base for Taiwanese companies to venture into profitable industries and consumer markets worldwide, and it is also the foothold for TAITRA to lead Taiwanese entrepreneurs to explore the global market. As a multi-faceted exhibition aimed at marketing Taiwan, Taiwan Expo is the perfect platform to introduce Taiwan to India, and strengthen the exchange for both sides.

INDIA’S STATE FORENSIC LABS EXPANDING INFRASTRUCTURE ON BACK OF RISING DEMAND FOR DNA TESTING

Led by Delhi and Maharashtra, India’s forensic laboratories have managed to reduce pendency of DNA testing cases by a 50% national average. While Delhi has eliminated most of its case backlog, Maharashtra is upgrading facilities across regions like Aurangabad and Amravati as a response to the ever-increasing demand for DNA testing from law enforcement agencies and courts.

In the north, Delhi was facing a pendency of 9,000 DNA testing samples in 2017 but with concrete steps to upgrade infrastructure and manpower, the state FSL has managed to eliminate most of its backlog in over a year.

Similarly, in the western region, Maharashtra has been working on reducing a backlog that stood at 1,700 DNA cases in 2017 – a majority of which are related to sexual offences against women & children. The state receives 4,500 cases of DNA analysis in a year with demand increasing by nearly 20% annually and is expected to extend DNA testing facilities from presently five to all its eight forensic labs this year.

Dr Rajiv Giroti, Director CFSL, Hyderabad said, “There’s been a huge impetus witnessed in forensic infrastructure across India’s FSLs over the last one year, with rising demand for DNA testing in criminal investigation. This has led to substantial reduction in backlog of cases to nearly 50%. Delhi and Maharashtra have performed exceptionally well! They are seen to steadily and speedily work on expansion of district level facilities, stepping up workforce with more experts and technical staff with high-throughput equipment to expedite investigations and provide breakthroughs”.

As per recent reports, DNA testing infrastructure is being upgraded across all state forensic science laboratories. Larger states like Maharashtra and Tamil Nadu are expanding facilities across districts to increase coverage and reduce the load on existing labs.

In the south, Tamil Nadu is seen to expand a good number of regional level labs. Up north, Himachal Pradesh, has stepped up infrastructure with their two range forensic labs, and in the east, Guwahati too is expected to set up its FSL within next 6 months.

The central forensic science laboratories

(CFSL) capability in India is also on an expansion mode. Pune is soon to rebuild and upgrade its CFSL in next 8-10 months. This would be in addition to its existing FSL facility in the region.

Tim Schellberg, Founder & President, Gordon Thomas Honeywell—GA notes, “It is good to see that India is building its forensic infrastructure to tackle the increasing demand for DNA testing. However, we must remember that 20,000 DNA profiles is not near enough in a country of a billion people with half a million reported violent crimes every year. There is an immediate need to scaling that up by 10 times. I hope India continues the momentum in adopting the world’s best crime fighting technology to build safer communities.

MORGAN STANLEY INDIA INFRASTRUCTURE INVESTS INR 1BN IN MANIPAL HEALTH’S SUBSIDIARY HEALTHMAP DIAGNOSTICS Manipal Health Enterprise Pvt Ltd, the healthcare arm of Manipal Education and Medical Group, has announced an INR 1.45Bn equity commitment from Morgan Stanley India Infrastructure in HealthMaP Diagnostics Pvt Ltd, a wholly owned subsidiary of MHEPL. MSII will make an initial investment of INR 1Bn in HealthMaP. HealthMaPis a Public Private Partnership initiative for diagnostic imaging in Indian healthcare.

HealthMaP is addressing an enormous shortage in affordable diagnostic imaging services throughout India by partnering with state-owned hospitals that serve over 500 million Indians. Set up in 2015, HealthMaP has concessions to operate 37 imaging centres across the states of Haryana and Jharkhand, of which 30 are already operational. The core of HealthMaP’s business is a “shop-inshop” model in which the company owns and operates the diagnostic imaging units inside these hospitals through exclusive long-term contracts. The company proposes to expand its footprint to 75 centres in the next three years.

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NEWS ROUNDUP affordable cost to the masses”, said NirajArora, CEO of HealthMaP Diagnostics

ASIA’S LEADING VENTURE DEBT FIRM, INNOVEN CAPITAL, INVESTS INR 120 MILLION IN DOCSAPP

“Millions of our citizens are pushed deeper into poverty each year because of healthcare emergencies and costs. Very often, early diagnostic imaging can help them avoid such emergencies but the cost of the tests can be a deterrent. HealthMaP has been at the forefront of making quality diagnostic imaging available to the masses and we are proud to play a role in advancing affordable healthcare in India. With the introduction of universal healthcare in the country through the Ayushman Bharat programme, HealthMap is also exploring the opportunity to partner with private hospitals to set up facilities for diagnostics and treatment of cardiac ailments as well as cancer, and to increase access for patients especially in the underserved States”, said Dilip Jose, Managing Director and CEO of Manipal Health Enterprises.

Backed by shareholders including Temasek and TPG, Health MaP’s parent company, MHEPL, provides healthcare services across India through eleven multi-specialty hospitals in Karnataka, Andhra Pradesh, Tamil Nadu, Delhi, Rajasthan and Goa. It also manages five teaching hospitals in Karnataka and Sikkim as well as several fertility clinics across the country.

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“We are delighted to partner with MHEPL and the Manipal Group at an inflection point in the affordable healthcare revolution in our country as underscored by the recent launch of the world’s largest universal healthcare coverage program.

This creates vast opportunities for HealthMaP and, combined with MHEPL’s reputation for clinical excellence, positions HealthMaP as one of India’s leading affordable healthcare platforms”, said Raja Parthasarathy, a Managing Director with Morgan Stanley India Infrastructure.

Morgan Stanley India Infrastructure is the India infrastructure investing platform of Morgan Stanley Infrastructure Partners. Part of Morgan Stanley Investment Management, Morgan Stanley Infrastructure Partners is a leading global infrastructure investment platform with offices in New York, Houston, San Francisco, Toronto, London, Amsterdam, Frankfurt, Mumbai, Hong Kong and Melbourne.

“We are excited with the confidence reposed by the shareholders in HealthMaP. The Public Private Partnership is a huge opportunity in diagnostic and other healthcare models. Quality of service is our credo and we endeavour to deliver the best diagnostic at

InnoVen Capital, Asia’s leading venture debt and speciality is lending firm, recently invested INR 120 million as debt capital in DocsApp, India’s leading onlinedoctor consultation platform.The growing population coupled with rising prevalence of chronic diseases, the dearth ofhealthcare professionals worldwide, improvements in telecommunication infrastructure, and needfor affordable treatment options due to rising healthcare costs are some of the factors expected topropel the growth of telemedicine market in the coming years. Penetration of the internet and smartphones has also allowed people residing in rural and remote areas to have access to onlinehealthcare. The prominent reason why people are moving towards online consultation platforms isthe lack of availability of time and the fact that 70% of primary healthcare issues can be solvedwithout the physical presence of the doctor.

DocsApp was launched in 2015, with an aim to helps patients across India connect and talk tospecialist doctors, for high-quality consultations over video calls, voice call and an in-built chatapplication. The Company has over 5000 specialist doctors registered on their AI-powered digitalplatform. DocsApp provides consultation across 15 specialties including dermatology, gynaecology,sexology, paediatrics, psychiatry, general medicine and weight management among others.

Theplatform also allows the user to order medicines and book diagnostic tests online.

More than 6million Indians are using the DocsApp platform for their healthcare needs.

Through this platform,not only patients from tier-1 but also patients from smaller urban areas are able to access highlyspecialized doctors.Elaborating on this recent investment, Punit Shah, Director, InnoVen Capital India said,“DocsApp’s constant focus on bridging

the existing gaps in India’s healthcare sector has led thecompany to gain a massive scale in the country. Its solutions have had a positive impact on peoplefrom Tier 1, 2 3, and also to those that do not have access to quality healthcare. As a result of itstargeted solutions and exceptional metrics, it has achieved a leadership position in the market. Weare pleased to be a part of DocsApp’s growth journey, and believe that our investment will providethe company with the fillip it requires to achieve unbridled growth in the years to come.”

BARIATRIC CENTRE IN INDORE COMPLETES 53 SUCCESSFUL BARIATRIC OPERATIONS IN 13 HOURS Dr MohitBhandari of Mohak Bariatric and Robotic Centre, Indore has successfully completed 53 bariatric operations in a marathon 13 hours, thereby submitting its

claim to the Guinness Book of World Record.

Bariatric surgery which is performed to control obesity is a surgery full of risks and possible complications because most often, the obese patients in addition to obesity suffer from other ailments such as hypertension, diabetes, sleep apnea, asthma, heart diseases etc.

On 1st May 2019, Dr. MohitBhandari and his team operated on patients not only from India (Gujarat, Madhya Pradesh, Rajasthan, Chhattisgarh, Maharashtra, Uttar Pradesh, Punjab, Haryana and Jharkhand) but also from Bangladesh & Kenya.

These patients weighed between 100 to 182kgs. As per the surgical need of the respective patient, various types of surgeries namely Banded Gastric Bypass (15), Banded Mini Gastric Bypass (14) Banded Sleeve Gastrectomy (24) were successfully performed. All these operations were telecasted live internationally to other doctors and medical personnel.

Dr Mohit Bhandari says, “Obesity is a serious growing issue and not many people are

able to manage it or cure its related ailments only with diet and exercise. We at Mohak Bariatric and Robotic Centre have adequate equipment, infrastructure and a dexterous team to perform these weight loss surgeries using minimally invasive techniques.”

MERCK LIMITED RENAMED AS PROCTER & GAMBLE HEALTH LIMITED Following P&G’s global acquisition of the consumer health business of Merck KGaA, Darmstadt, the Company has received approval from the Registrar of Companies, Mumbai, Maharashtra for change of name from Merck Limited to Procter & Gamble Health Limited effective May 6, 2019.

Commenting on the name change, MilindThatte, Managing Director, Procter & Gamble Health Limited said, “Today marks the beginning of an exciting new era for Procter & Gamble Health Limited (formerly Merck Limited), one of India’s largest Consumer Health companies. Our new name reflects

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NEWS ROUNDUP our new identity as part of the P&G Group and signifies the coming together of strong consumer health capabilities and cultures.

Together, we are working towards leveraging our combined expertise to develop categories and brands that meet today’s needs and tomorrow’s opportunities.”

The decision to change the name of the listed entity in India follows the successful completion of P&G’s global acquisition of the consumer health business of Merck KGaA, Darmstadt, Germany. The consumer health business was transferred to P&G on December 1, 2018.

Tom Finn, President, Global Personal Health Care, Procter & Gamble shared “I am delighted to announce the new name of our listed entity which will now be known as Procter & Gamble Health Limited. With India’s OTC market growing at double the global growth rate, this is a very exciting phase for all of us as we now move forward to realize the great potential of our two health-related P&G businesses in India.”

Procter & Gamble Health Limited will be a part of P&G’s Personal Health Care International Business Unit led by Uta Kemmerich-Keil (Vice President, Personal Health Care International) which encompasses our health care businesses

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in Europe, Latin America, and Asia/IMEA (India, Middle East and Africa).

“We are extremely pleased with this development. With our strong portfolio of brands that are backed by science and trusted by doctors, pharmacists and consumers, we believe that we are well-positioned to enable consumers in India to live longer, healthier and more vibrant lives,” said UtaKemmerichKeil, Vice President, Personal Health Care International, Procter& Gamble.

BENGALURU BASED STARTUP BIOENGINEERS CORNEA TISSUE FOR SCARLESS REGENERATION Pandorum Technologies Pvt. Ltd., a tissue engineering and regenerative medicine startup company, announced the development of bioengineered cornea tissue that can Promote scarless healing of corneal wounds through bio-inspired regenerative approach. Scientists at Pandorum have successfully formulated a novel hydrogel that can encapsulate and deliver corneal stemcells to the wound site, to

stimulate scarless regeneration. Pandorum’s cell laden hydrogel can bedirectly applied in a minimally invasive manner as ‘Liquid Cornea’ to corneal wounds and perforations,and can also be 3D bio-printed as corneal lenticules for lamellar keratoplasty. This research study waspresented at the prestigious annual meeting of the Association for Research in Vision and Ophthalmology (ARVO-2019) held in Vancouver, Canada.

Dr Tuhin Bhowmick, co-founder and Director of Pandorum who holds a PhD from the Indian Institute ofScience, and is an alumnus of European Molecular Biology Labs (EMBL), said “being able to bioengineercritical tissues such as the human cornea is a significant milestone.” The work is currently in the stage ofanimal studies, and the team is preparing to move towards pilot human studies in 2020.“According to the World Health Organization, corneal disorders are one of the major causes of blindness worldwide. Though surgically replacing the opaque tissue with a clear corneal allograft is usuallyeffective in improving vision, there is an acute shortage of cadaveric human corneas available fortransplantation. In India alone, there are over a million people suffering

from bilateral loss of vision dueto corneal disorders, and at least a few folds more from unilateral corneal blindness. At Pandorum, weare working to close this gap using bioengineering approach- through stage-wise development of aplatform, which is ultimately aimed to liberate us from the dependencies on human donor cornea.” added Dr Bhowmick.

Pandorum is developing these bioengineered cornea tissues in collaboration with the L.V. Prasad EyeInstitute (LVPEI), one of the world’s largest eye institutes that has served more than 26 million people.

Cornea surgeons Dr VirenderSangwan and DrSayanBasu, and scientist DrVivek Singh, atLVPEI, have been playing a crucial role in translation of this technology. DrSangwan, a Shanti SwarupBhatnagar awardee, renowned for the development of a novel surgical technique- Simple LimbalEpithelial Transplantation (SLET), was one of the early visionaries of this collaborative project. In hisview, “Pandorum’s Bio-engineered Cornea is a transformational technology and could leadtoscarless healing of corneal injuries with rejection-free corneal graft. In a way, such platformtechnology addresses the need for the repair of corneal injuries and perforations, and also meeting therequirement for partial or total replacement of cornea.”

Pre-clinical studies involving clinically relevant corneal wound models in rabbits are presently underway, led by Dr Singh and Dr Basu. According to Dr Singh, a cornea and stem cell expert, “the technology canbe a game changer in the field of regenerative treatment of corneal wounds, after the safety andefficacy have been successfully established.”

HEALTH CANADA APPROVES BIOCON AND MYLAN’S OGIVRI Biocon Ltd. and Mylan N.V. said that Health Canada has approved Mylan’s Ogivri(trastuzumab), a biosimilar to Herceptin(trastuzumab) co-developed with Biocon, for the treatment of HER2overexpressing breast cancer and metastatic

stomach cancer (gastric or gastroesophageal junction adenocarcinoma).

Ogivri is the first trastuzumab biosimilar approved in Canada and the second biosimilar from Biocon and Mylan’s joint portfolio approved in the market. Mylanplans to launch the product this quarter and anticipates potentially being the first company to offer a trastuzumab biosimilar in Canada.

Dr Christiane Hamacher, CEO, Biocon Biologics said, “We are pleased to enable access to Ogivri, a high quality biosimilar trastuzumab co-developed and manufactured by Biocon as an affordable treatment option for HER2- positive breast and gastric cancer patients in Canada.

The Health Canada approval granted to Ogivri, will pave the way for its commercialization by our partner Mylan. Thousands of patients in Europe, India and key emerging markets are benefitting from our biosimilar trastuzumab.

Biocon Biologics is committed to address unmet patient needs through its high quality, affordable biologics, globally.”

Approval by Health Canada was based on robust data from structural and functional characterization using multiple orthogonal techniques, nonclinical studies and pharmacokinetic evaluation in healthy subjects and patients and a safety, efficacy and immunogenicity study in relevant patient populations, which compared Ogivri to Herceptin. The data demonstrated that Ogivri is highly similar to Herceptin with no clinically meaningful differences in terms of efficacy, safety, purity and potency.

VARIAN MEDICAL SYSTEMS ACQUIRES CANCER TREATMENT SERVICES INTERNATIONAL Taking an important step to accelerate innovation of new multidisciplinary solutions to address the growing global cancer burden, Varian Medical Systems announced it has entered into a definitive agreement to acquire Cancer Treatment Services International (CTSI) for $283 million. Privately held, CTSI operates

the American Oncology Institute in Hyderabad and 10 multidisciplinary—radiation, medical and surgical oncology— cancer centers across the Indian subcontinent as well as a U.S.-based Oncology Solutions division that provides cancer care professional services to healthcare providers worldwide.

This transaction will accelerate identification of unmet clinical and operational needs to facilitate advances in technology and services. As a result, the combined companies will be positioned to create new multidisciplinary solutions based on robust clinical information benefiting oncologists, and ultimately resulting in better care for patients.

These fast-growing offerings will allow Varian to expand its solutions, while helping to support the continued growth trajectory of the company’s oncology systems business.

“At Varian, the patient and clinician are at the center of our thinking as we evolve into a broad-based cancer care solutions company,” said Dow Wilson, president and chief executive officer of Varian. “Our acquisition of CTSI is consistent with this strategy and will allow us to better support oncology centers globally, accelerate access to technology-driven care and build a feedback loop that will drive cost-effective innovation.

We look forward to pooling the ingenuity of our combined team with the power of data, technology and clinical insights to achieve new victories against cancer, especially for the millions of patients globally without access to appropriate care.”This transaction will increase Varian’s expertise in cancer center operations, allowing for new partnerships globally to deliver world-class, value-based care in developed and emerging markets. In addition, the transaction expands the scope and geographic reach of CTSI’s technologyenabled clinical solutions.

“We are excited to continue our mission to address the growing global incidence of cancer and the disparity in access to treatment between the developed and emerging markets,” said Andrew Shogan, co-founder and executive director, CTSI. “Together with Varian, we will be better equipped to provide new solutions that empower more patients

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NEWS ROUNDUP

Dow R. Wilson, President and CEO, Varien Medical Systems

globally to fight cancer.”

“Effectively addressing the growing global cancer burden requires not just new technology and research, but also new ways of collaborating and partnering,” said Stanley M. Marks, M.D., co-founder of CTSI and chairman of UPMC Hillman Cancer Center.

“This acquisition should now expand the development and implementation of new solutions for cancer care around the world.”

Transaction and Closing Details Varian will finance the acquisition with a combination of borrowings under its credit facility and cash on hand. The transaction is anticipated to close in approximately two weeks, subject to the satisfaction of customary closing conditions.

CTSI generated annual revenues of $43.5 million in the fiscal year ended March 31,

2019. Varian estimates the transaction will have a 6 cents per share dilutive impact to earnings on a GAAP basis and a 3 cents per share dilutive impact to earnings on a NonGAAP basis for the remainder of fiscal year 2019. The Company expects this acquisition to be accretive to earnings per share during fiscal year 2021 on a Non-GAAP basis and fiscal year 2022 on a GAAP basis.

CARESTREAM RELEASES IMAGE VIEW SOFTWARE FOR ITS DRXREVOLUTION MOBILE X-RAY SYSTEM Carestream today introduced its ImageView Software Platformfor its CARESTREAM DRXVarien Acuity

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June 2019

Revolution Mobile X-ray System. The software is designed to offer advanced features and optimized workflow and uses a Microsoft® Windows 10 operating system to deliver enhanced security. ImageViewsoftware was first introduced with the CARESTREAM OnSight 3D Extremity Imaging System and will be further expanded across Carestream’s entire portfolio, including rooms, retrofits and additional mobile imaging X-ray systems in the future.

“ImageViewsoftware delivers an intuitive interface and consolidated screen views to boost productivity as well as new capabilities that can improve both workflow and security,” said Jill Hamman, Carestream’sWorldwide Marketing Manager for Global X-ray Solutions. “This software uses Eclipse, our advance dimage processing engine, to deliver exceptional image quality and enhanced diagnostic confidence, while providing a foundation for new applications in the future.”

ImageView software also provides the

NOVEMBER 2018, VOLUME 2 ISSUE 11 `200 INDIA MED TODAY

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SPECIAL FEATURE AMERICAN ACADEMY OF EMERGENCY MEDICINE CEO’S PERSPECTIVE DR. HARISH PILLAI, CEO – ASTER HOSPITALS & CLINICS INNOVATE PROTEMBO CEREBRAL PROTECTION SYSTEM

What Ails

EMERGENCY MEDICINE in India

Lack of standardisation, fragmented training landscape and distrust relation among doctors NOVEMBER 2018

M Neelam Kachhap

Carestream’s Image View Software

ability to manage an imaging department’s productivity and quality. The Administrative Analysis and Reportingoptioncan helpimprove performancewith a digital dashboard that allows users to track average exposure rates

by technologist, rejected images with reasons andother statistics including detector drops.

The Total Quality Tool package provides objective quality control image tests and collection of detector performance data.

Subscribe to IndiaMedToday and get 20% discount + Extra FREE issues Indiamedtoday magazine reports on the issues and trends that are shaping the business of healthcare in India and abroad today. Each month, the print magazine discusses long-term strategies to meet the challenges posed by an evolving healthcare marketplace. In every issue, our readers discover the practical advice, analysis, and receive and insight on management trends, innovative 12 + 3 FREE issue. concepts, market strategies and real-world solutions they need to navigate the changing landscape of the business of healthcare.

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IMPACT

How Big Data Is Solving the Blood Crisis Data points can be utilised for safety, patient satisfaction and cost optimisation for better blood transfusion

Navin Chandra Nigam, Health IT Thought Leader

AS IT is said that there is no greater joy than saving a soul and blood as saving agent is meant to saves lives. The universal truth is that the blood cannot be manufactured; one must look up to another at the time of lifethreatening situations since blood must come only from a human donor.

It was just 200 years ago, when authentic transfusion began to appear. At that time, transfusion used to be carried out through silver tubes without the understanding of blood groups making is hazardous in 35 per cent of the cases. Later, Landstenier’s epic discovery of blood classification made the risk of transfusion avoidable by grouping in A, B, O & AB. In 1915, Sodium citrate was discovered as anticoagulant agent to prevent clotting which opened new ways to indirect transfusion and slowly became a commodity when hematologists started keeping it refrigerated to use later.

Irony in Blood India with a total population of 1.3 billion, spread across 29 states and 7 territories, is struggling with shortage of blood and irony is millions of units are being wasted. One unit of blood can save at least three patients with plasma, platelets, and red blood cell yet there were around 2.8 million precious blood units wasted in last five years along with lifesaving components such as red blood cells, additives, platelets, and plasma. According to simple calculation considering one blood unit holds 450 ml of blood around 12, 60,000 liter of blood – enough volume to fill 210 water tankers had

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June 2019

gone in vain. In 2016-17 alone, over 6.57 lakh units of blood was wasted. There are few states that top the chart of blood collection but also scores high in wastages.

India needs three million units of blood a year more than current stock, to handle 1200 road crashes, 60 million trauma surgeries, 10 million risk-based pregnancies, 230 million major operations, and 331 chemotherapy and surgeries – a few high-level statistics.

The Indian states and UTs paints picture very differently. On one side states like Maharashtra, Punjab, Kerala tops the chart with 35 per cent excess supply of blood while on the other Uttar Pradesh, Arunanchal Pradesh, Meghalaya and Chhattisgarh are under constant pressure as there is 50 percent under supply of blood.

Shelf life of most components of blood is 35 days,which makes it difficult to over stock and finally excess blood units get wasted.

The modern health system can not be visualized without blood transfusion and this is the government’s responsibility to keep the adequate supply of blood and impose all safety norms to keep the community healthy and safe from any disease arising out from blood transfusion. Indian government has wisely implemented Hemovigilance in 2012, comprises a battery of procedures to keep the surveillance covering all possible steps of blood transfusion. Still not to forget “To err is human” and even after vigilance people make mistakes.

It’s a highly demanding mission to keep the blood supply up against the demand from various sources. This calls for a holistic, comprehensive approach embracing all

the stakeholders in planning, distribution, with objective to keep the blood safe and community healthy.

Mistakes Cost Life It is disheartening to come across news such as this;15 expectant moms died due to hemolysed blood transfusion in southern part of India in April 2019. A preliminary enquiry suggested that the staleness was the reason behind the bad quality of blood. There are several other stories where patients have tested HIV positive post blood transfusion. Several investigations have been done in such cases and various reasons were tracked down like poor combination of inventory management & decision making such as, screened and unscreened blood units kept together, or recommended level of temperature 20-60 degrees was not maintained and yet doctors certified the blood safe, etc.

An RTI filed by an activist in 2016, reveals a total of 2234 Indians got infected by HIV

because of blood transfusion in a duration of 17 months. These patients just needed blood to get better. As a matter of fact, the blood transfusion has been a source of various diseases across the world. Potentially, innumerable biological infectious agents can be transmitted during blood transfusion such as viruses, parasites, and bacteria. Of these HIV, Hepatitis and Syphilis are common as communicable disease.

Interestingly, what makes identification of HIV agents more difficult is the window period for HIV patients at start of their disease who go unidentified despite being tested for HIV at the initial stage.

In the modern age of digitization, digital information open paths to many solutions which was out of proximity till the recent past.

Digital health solutions can be looked into to find the solution for better patient blood management. Assimilation of digitised data from various sources at the centralised location can be mined for splendid researches and

India with a total population of 1.3 billion, spread across 29 states and 7 territories, is struggling with shortage of blood and irony is millions of units are being wasted

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IMPACT findings for betterment of population health.

Big data as a concept can be immensely helpful if analysed in retrospective way to formulate new strategies and defining transfusion policy better. It’s time to recognise the top challenges and create a nationwide plan to handle blood transfusion better.

Optimising costly resource Sometimes there are easy solutions to difficult problems. According to WHO, scarcity of blood can be met if only five percent of population donate annually and if only three percent of population is a regular blood donor of 1.5 to 2 units in a year, all needs can be met. So how Big data can help here – certainly it does. Data collection in different region or geography can be analyzed to find appropriate demand with indication of rise, fall patterns in previous years. If this can be drilled down further, demand of blood groups and its components can be assessed which can certainly be fulfilled with meticulously planned way of managing the inventory. There is another way to handle demand is to calculate the number of acute beds in the region and 6.7 blood units per bed per year and when this is alignedto the region and analysed in retrospective manner, a futuristic demand can be set for supply. Various blood banks in the region can be aligned for

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collaboration and timely supply before blood goes stale. A logistic supply chain can be worked out from high collection areas to low areas within definite period before units get stale.

Compliance, benchmark and best Practices Agree, it is difficult to collect the data from every nook and corner of the huge country with a population of 1.3 billion, yet it is not insuperable if we start early and financial constraints are removed gradually. The implementation of best practices in transfusion medicine needs close monitoring, benchmarking and setting key performance indicators for all blood centers covering all private or public facilities. Guidelines based comparative data among blood banks in a region can infuse a healthy competition to process adherence and monitoring better outcomes evaluation – and outcome-based incentives attached can do wonders to keep the blood and patients safe.

The collected data points can be utilized to advise blood banks and hospitals on various performance indicators such as patient satisfaction, optimum transfusion, patient safety, and cost savings.

Interesting fact is that the basic elements of blood are same, yet all blood are not same.

If a donor and a recipient share the same

ethnicity the chances of adverse reaction are reduced substantially; for an example 98 per cent of Sickle cell patients are from AfricanAmerican descent have their best hopes on donor of same origin.

Collection,Pattern and transfusion There are several important and integral segments of blood transfusion, and donor is very important part of the chain. Screening a donor is first step towards safe recipient keeping away from communicable disease.

An unscreened infected donor can possibly infect at least three patients through single donation. The chances increase in case of paid donation, though a ban on paid donors enacted in 1995 has reduced unsafe blood donations yet identification and marking donors with infected diseases is still a challenge. A national database of donors with critical illnesses can be maintained and linked to identification such as Aadhar or PAN. The donor should be required to identify themselves before donating blood. An implementation of identification bound donation process can make a lot of difference in safe blood transfusion and spurn preventable infections. Big data analytics can help to identify prevalent areas of probable infected blood and preventive action can be ordained.

There is a dire need to have a centralised database of blood transfusion related information such as transfusion patterns in different Indian geographies covering different scenarios such as during surgeries, trauma care, health condition which can help in optimal utilization of blood as Its vital to collect statistics across the nation to know the patters of blood transfusion in India. The pattern can be collected from different locations such as district level while moving gradually towards state level. With the help of digital medium such as BI (Business Intelligence), the pattern of transfusion can be analyzed across various locations in India to ensure adherence to guidelines and optimal use of scare resource.

Optimising transfusion According to an article from Healthcare Informatics, an unnecessary transfusion

can “diminish quality of care, increasing the likelihood of allergic reactions, fever, lung injury, immune suppression, iron overload and other adverse events.The unwanted supply of blood can be restricted using data analytics by collecting patients’ records from past several years and grouping under similar disease, risk factors, medical conditions, age, geographies etc. A decision support system for health providers can certainly help them to compare with peer groupswith facilities’ benchmarks makingbetter informed decisions. As a matter of fact, most similar surgeries do not require similar blood requirements as it mostly depends on age, history, blood condition such as Sickle cell or anemia, risk factor etc. Decision support system driven on BI analytics can restricts the user to place more than required unit per patient at a time, alerts them or make a provision to override the system generated alerts which can be analyzed later for better decision making.

According to WHO, scarcity of blood can be met if only five percent of population donate annually and if only three percent of population is a regular blood donor of 1.5 to 2 units in a year, all needs can be met

Conclusion The right use of data analytics with definite objectives to focus on safety, patient satisfaction, cost optimization, and utilization can bring tremendous change around blood transfusion.

This is a right time to recognize a need of national level data repository to capture specific and selected information to generate meaningful information at various level to create a decision support system and maintain an optimum level of supply across the nation.

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COVER STORY

Mandate for

Blood Bank

Making Safe Blood Accessible & Available Author: Divya Ramaswamy, M Neelam Kachhap

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B

lood transfusion has become quite common now. Unlike, a few decades ago when it was as risky as the treatment being attempted. Blood and its component have come to the aid of a wide variety of medical emergencies. Blood transfusions have now become fairlyroutine and crucial part ofhealthcare delivery, saving millions of lives every year. It has contributed to several treatments involving both routines as well as emergency situations, especially for treatments involving cancer patients, pregnant women, accident cases and other disasters.

And yet, blood and its components are not freely available. What’s more it may not be safe and the biggest taboo in India ‘you don’t know whose blood it is’.

Hospitals both in the private and government sector find it very difficult to run a blood bank. There is a huge gap between volunteer donors and replacement donors and new replacement therapies are very expensive.

So how do we combat this immediate and important medical emergency?

Donation for Life Timely availability of safe blood and blood products is quintessential in healthcare delivery. But in many developing and transitional countries, there is still a widespread gap between the needs and supplies of blood. Throughout the world, more than 108 million units of red blood cells are transfused every year and since every donated unit doesn’t really get used, the number of donated units can be even higher.

For many people for whom blood transfusion has

been an essential part of their clinical management; expects that the safest possible blood at sufficient levels will be available to meet their requirements.Per the World Health Organization, One unit of blood (450 ml) can potentially save at least three lives. Each unit of blood is divided into three components – packed cells or red blood corpuscles, platelets and plasma. However, they have a small shelf life. Packed cells can last for 35 42 days, plasma can last about a year and platelets last only 10 days.However, there are still many patients who still die or suffer unnecessarily due to lack of access to safe blood transfusions.

Blood Banking Currently, there are more than 2903 blood banks across India, among which, 1,043 are public and about 1,860 in private domains, including those run by charitable trusts. Out of these, about 55 per cent blood banks are in the government sector, five per cent are run by Indian Red Cross Society (IRCS), about 20-25 per centis run by NGOs and the rest are managed by corporates.

The capital cost involved in setting up a blood bank can be very high. It solely depends on the type of tests and procedures which might be implemented in the blood bank. While a basic set up costsabout Rs 75 Lakhs to a Crore rupees, an advanced set up which includes instruments for NAT tests, automatic blood grouping,and infectious disease testingmight cost about four Crore rupees.

Apart from this, there might be operational costs and other expenditures involving the staffing, annual

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COVER STORY maintenance charges, replacing devices, electricity and water charges,etc. Moreover, there are recurring costs of items used in the blood bank such as blood bags, aphaeresis kits, hemoglobin testing kits, kits for testing infections, blood grouping reagents, glassware, disposables, red cell antibody screening reagents, leucodepletion kits, and QC testing reagents,etc,.Also, the refreshments provided forblood donors will also add to this list. It is reported that a blood bank spends about 1000 INR per unit of collected blood.

And processing the collected blood is also subjected to charge. Per the Ministry of Health, the Nomenclature of “Service charges” has been changed to the nomenclature of “Processing charges” and the following is the most recent list of processing charges: For Government Blood banks:  Whole blood- Rs. 1050/ unit  Packed red cells- Rs. 1050/ unit  Fresh frozen plasma- Rs. 300/unit  Platelet Concentrate- Rs. 300/unit  Cryoprecipitate- Rs. 200/unit For non-government blood banks:  Whole blood- Rs. 1450/ unit  Packed red cells- Rs. 1450/ unit  Fresh frozen plasma- Rs. 400/unit  Platelet Concentrate- Rs. 400/unit  Cryoprecipitate- Rs. 250/unit For both Blood Banks and Cord Blood Banks and the services theyprovide are exempted from GST.

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Type of blood donation (Voluntary vs Replacement donation %)

28.1% 71.9% Voluntary donation

Replacement donation

Safe Blood The quality and safety of blood is one of the major concerns in transfusion medicine today. In India though, transfusion transmitted infections generally found are of HIV and Hepatitis B & C. According to 2016 NACO report, HIV positivity among blood donors was found to be 0.14%, Hepatitis C 0.34%, Hepatitis-B 0.87%,Syphilis 0.17% and Malaria 0.06%.

Nucleic acid amplification tests (NAT) was developed to detect infection in blood for these deadly pathogens, but it is expensive test and not all blood banks use it.

Currently, other tests like ELISA based test kits and rapid diagnostic tests are used to screen blood.

However, quality of screening tests and methods remains as one of the basic challenge in blood banks.

Combine this with the lack of quality reagents and test kits and paucity of adequate training for hospital staff, which makes availability of safe blood very difficult.

Poor laboratory procedures, inadequate basic facilities within a majority of blood centres and lack of awareness on safety amongst blood donors and receivers are the other issues that mars the blood banks.

Discarded Blood All blood collected by blood banks are not usable and even good blood banks discard blood. It is ironical that India faces a severe blood shortage and still discards over a million units of blood every year. It is estimated that only 9.9 million units of blood is collected annually compared to the annual need of 10-12 million units.

Shockingly, as many as 1.18 million units of blood, approximately 38 tankers of blood were reported to have been discarded in 2016-17.While No blood has been intentionally wasted, some wastage is totally inevitable.

The reasons for collected blood having to be discarded include:  Deterioration during storage  Contamination  Expiry or outdating.  The units being haemolysed  Collection of insufficient amounts  Leakage Such reasons for discarding blood units vary from one blood bank to another.The largest chunk of the wasted blood units contains ‘plasma’ which could be used for various life-saving treatments.

Multiple approaches used for donor selection; staff training, rescheduling of blood camps and sharing of collected blood with other blood banks can significantly minimise the discard rate. Also, the government should set up a committee to monitor and periodically assess

the amount of blood being discarded and focus on implementing and adopting better methods to improve the system.

Legality and Legislations The National AIDS Control Organization (NACO), under the Ministry of Health and Family Welfare, and the National Blood Transfusion Council (NBTC), which is the apex policy making body, are the prime bodies responsible for the functioning of blood transfusion services and blood safety in India. As blood and blood products are considered as drugs, the Central Drug Standard Control Organization(CDSCO) and State Drug Control Organisations play a vital role in key aspects such as, approval of licenses, and enforcement of standard transfusion practices to ensure safe, quality and efficacious blood and blood components in clinical practices.

In 2002, the Government of India framed and adopted the National Blood Policy (NBP). In 2007, the National AIDS Control Organization developed standards for blood banks and blood transfusion services. These standards talk about:  compliance to policies, guidelines of NBTC;  donor selection, recruitment, retention, counseling based on voluntary non-remunerated regular repeat blood donors;  appropriate blood collection procedures;  mandatory testing of all donated blood units for HIV, HBV, HCV, Syphilis and Malaria; transportation of blood and blood components ensuring cold chain maintenance; manpower requirements;  maintenance of quality assurance system;

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COVER STORY regular maintenance and calibration of equipment; biosafety;  waste disposal mechanisms;  documentation, record keeping and regular reporting under the national programme.

There has been some silver lining to the blood donation cloud. NACO has reported that the availability of safe blood increased from 44 lakh units in 2007 to 100lakh units by 2014-15; during this time HIV seroreactivity also declined from 1.2% to 0.2%, and Voluntary Blood Donation increased substantially. This has been possible due to the continuous efforts by all stakeholders and specially bodies like NACO. In fact, India is on the right track to strengthen its existing blood banking and transfusion system. And for India to succeed in safe accessible blood transfusion uniform implementation of policy guidelines, adoption of innovative technology and collaboration between public and private sector is important. In addition, India will have to look at rational use of blood and blood products to reduce unnecessary transfusions and minimize the risks associated with transfusion. The use of alternatives to transfusion where possible, and safe and good clinical transfusion practices, including patient blood management are an imperative for better blood availability in India.  

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Milestones of Blood Transfusion Services in India 1945 : First blood bank in Kolkata 1954 : Voluntary blood donation began.

Enhanced:1962/1965/197 Wars 1975 : Blood bank licensing process started with HBV, Syphilis & Malaria 1988 : HIV testing made mandatory 1989 : MD Programme 1992 : BTS under EMR division of DGHS 1992 : NACO started and BTS shifted under NACO as BS Division 1996 : Supreme court Judgement (PIL filed by common causes vs GoI) 1996 : NBTC and SBTC formed 1997 : Mandatory licensing of Blood banks 1998 : Professional donor banned 2001 : HCV testing made mandatory 2002 : National Blood Policy formulated 2008 : Blood Storage Centers 2009 : New Initiatives (Metro Blood Banks and plasma Fractionation Centre) 2014 : National Plasma Policy formulated 2016 : Baseline Assessment of all licensed Blood Banks in the Country Courtesy: National Blood Transfusion Council

EVENTS CAHOTECH 2019 Date: 27-28 Sep, 2019 Location: IIT Madras, Research Park City: Chennai Organizer: Consortium of Accredited

healthcare Organizations (CAHO) Click: http://cahotech.com Contact: Organizing Secretary, J Adel,

C

99444 37572 AHOTECH is one of the most primed events that brings together all stakeholders – hospitals, healthcare and technology startups.Cahotech 2019 -4th International Annual Healthcare Technology

Event, promises to bring some of the best incubation centers like IITM Research Park, HTIC, SINE (IIT Mumbai), Health Pod, Startup Podium, The Chennai Angels, TiE Global etc and their startups, the most respected healthcare leaders and the industry’s most sought after investors on board. It is primed to be event of the year with discussions on disruptive and adaptable technologies in healthcare. The event boasts of stalwart speakers, contemporary topics and provides an opportunity for professional upgradation, paper presentation, master classes, liaison and networking.

SCIENCEFORA -ICMEP

Contact: akkhokhar@iihmr.org Venue: Indian Habitat Centre, Lodhi Road

Date: 23 June, 2019 Venue: Hotel Raj Palace City: Chennai Organiser: Sciencefora Contact:info.sciencefora@gmail.com

The SDGs have been built upon the success of the Millennium Development Goals agreed upon in 2000. The SDGs have been adopted in 2015 to follow up on MDGs and determine the direction and the role of various other sectors in health. SDGs are a universal call to action to focus on People, Planet, Prosperity, Peace and Partnership. SDGs differ from MDGs and are designed to finish the unfinished agenda of MDGs and to get a statistical zero on hunger, poverty, preventable child death and other targets. The health goal is on ‘health and wellbeing for all at all ages’. It addresses the health needs of the population from womb to tomb. The social determinants of health are central to promoting well-being for all

Date: July 26-28, 2019 Organiser: Medexpert Business Consultants Pvt. City: chennai Contact: Mr.K Sundararajan, 91-7305789789 Click: info@medicall.in

Medicall is India’s largest B2B trade fair for medical devices and hospital supplies. Approx.

750 exhibitors and 15,000 trade visitors from over 20 countries, among them physicians, but also biomedical engineers, sales people, decision makers, consultants and hospital owners, are represented at this important industry event. In addition to the presentation of the best and the latest medical and medical-technical equipment, software, supplies and other devices the market has to offer the fair mainly serves as a platform to exchange knowledge and experiences among renowned industry experts. Various conferences and innovation awards in different categories complement the event.

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MARCH 2019, VOLUME

INDIA MED TODAY

An elegant and rich premier global platform for the International Conference on Medical Ethics and Professionalism (ICMEP) that uniquely describes the Academic research and development across globe. This event tries to fill in the void that is being created by the current global academic and research by the different global challenges .To be held on 23rd June, 2019 at Chennai, India , this event will provide unique and rational opportunities to all the attendees, researchers from different domains . This event globally strives towards achieving excellence in the cutting edge of all the researchers from all the disciplines of technology and tries to differentiate the gap and integrate the thoughts. Of academies and researchers worldwide.

at all ages and thus dealing with health and wellbeing. The SDGs have put emphasis on social determinants of health by taking care of environmental (7 goals), poverty and inequality (4 goals) and peace (5 goals), which all contribute to health.

IIHMR Delhi is organizing an International Conference on Health in SDGs - “Health for all and all for Health” from August 18- 21, 2019. The conference will provide a common platform for the participants from different Countries to discuss the challenges in achieving SDGs and to formulate action plans for their respective countries.

ders Women Lea in Healthcare ess atn Poised for Gre

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APPROACH

Smart Hospitals – Why Vanilla Digital isn’t Smart The Smart Hospital framework is best initiated during the project inception stage since a piecemeal approach is never as effective

Dr Vasundhra Atre, Group Medical Director Medical and Operations, Nayati Healthcare & Research Pvt. Ltd

AS THEY say, ‘All that glitters isnot gold’.

Similarly, every hospital that is digital is not a Smart Hospital.The concept of a Smart Hospital is embedded more deeply. To begin with, Smart Hospitals need to be conceptualised right at the project planning stage, rather than placing the cart before the horse by trying to go ‘Smart’ later in a piecemeal manner.

Today, most modern hospitals use advanced technologies. But sophisticated standalone medical devices per se do not qualify for the ‘Smart’ tag. These devices need to be interconnected, with the ability to ‘talk’ to one another.

Such sophisticated support systems permit storage and archiving of medical records, drive image management and tracking of medications, etc.; they seamlessly connect and integrate the hospital systems.

Crucial Connectedness Smart facilities have secure, complex data and communications networks offering and managing the Internet, telecommunications and IP connectivity across the hospital. Conversely, hospitals with digital technologies that are not fully integrated and located at various points need an immense level of manual intervention and, consequently, aren’t ‘Smart’.

In Smart Hospitals, individuals, processes and systems all work in unison. As a result, there are better outcomes in patient care,besides lower costs in services, staff and safety offerings even while driving higher infrastructure and operational efficiencies. All these smart results keep costs firmly under control.

Although healthcare facilities are keen on

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going ‘Smart’, a major barrier is the lack of cohesion between multiple technology systems and ICT service providers in hospitals. In the effort to go ‘Smart’, technology entities deploy the hospital’s existing voice and data networks for linking dissimilar systems and processes via anad-hoc initiative mainly meant to keep costs under control while making the system more efficient. But this is never as effective as replacing the entire system with truly Smart infrastructure.

On the other hand, a hospital built the ‘Smart’ way will have future-focussed technologies that intelligently coordinate patient care, research work, relevant teaching and training programmes, etc., thereby offering better outcomes in patient-care deliverables. Whether it is registration, the scheduling of appointments, room availability status, electronic medical records, billing and allied patient information, Smart Hospital infrastructure and intelligent devices will boost patient outcomes while drastically limiting the wait time for patients and helping caregivers offer the optimum benefits during the treatmentof every ailment.

Besides, the Smart Hospital framework can immensely improve the productivity of the clinicians and other staff while driving better and faster patient outcomesas well as boosting hospital revenues. The Smart framework would also build a secure setting, offering robust protection for all classified data and other records of the patients and hospital staff.

Even if the Smart Hospital’s staff and caregivers are in diverse locations, the connected ICT architecture will ensure there is clinical teamwork.

The ease of data accessibility can, therefore, ensure greater mobility for hospital staff, allowing clinicians to operate from various locations equally efficiently and conveniently.

Moreover, even when travelling, clinicians and patients will benefit by having consultations and feedback via virtual meetings through wireless LAN technologies and still taking equally meaningful decisions.

Better Benefits These Smart benefits can facilitate ‘safe’ enhanced patient outcomes as well as higher clinical and operational efficiencies.

Telemedicine is a global manifestation of this successful concept, allowing healthcare providers in remote locations to connect with city-based specialists, seeking their opinion in promoting sound treatment regimens for patients.

In turn, the patients benefit from the ease and convenience of undergoing treatment from the Smart Hospital facility closest to them.

These benefits could be available when the

patient is within the hospital or outside. Such seamless experiences can help increase patient footfalls and improve the hospital’s trust quotient too. For example, patients receiving reminders for doctor’s appointments or followup reminders can enjoy a feel-good factor.

Likewise, doctors can track patients’ progress after discharge from the hospital, allowing them to initiate remedial measures, whenever required. Such a post-hospitalisation scenario gives patients a sense of security, enhancing their overall well-being, particularly for persons with chronic diseases.

Clearly, the Smart Hospital framework of intelligent, connected devices and infrastructure is the best way to propel better patient outcomes via improved clinical efficiency and cost-effective healthcare offerings– simultaneously ensuring stronger security of classified records and data. In a nutshell, a Smart Hospital promotes greater operational efficiency, sharper clinical competency and higher patient centricity.

‘All that glitters is not gold’. Similarly, every hospital that is digital is not a Smart Hospital.

The concept of a Smart Hospital is embedded more deeply

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INNOVATE

Low-cost Tool for Diagnosis and Monitoring (i)SIMPLE technology combines the advantages of paper-based and channel-based microfluidic devices CONDITIONS IN developing countries often make it difficult to properly diagnose people. This calls for a simple yet accurate technology that can be used on the spot. Researchers at KU Leuven, Belgium are developing a flexible chip that is able to detect infections and viruses in the blood. The technology, also called lab on a chip, is perfect for diagnosing people in developing countries; places where limited medical resources are available.

The research group of Professor Jeroen Lammertyn (Division of Mechatronics, Biostatistics and Sensors) specialises in the development of technology that can detect specific molecules in blood, urine or other bodily fluids.

In this way researchers can check the blood for (i)SIMPLE technology

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signatures of a certain disease, for instance.

The project was awarded funding through the Grand Challenges Explorations initiative of the Bill & Melinda Gates Foundation.

In an e-mail interaction Dr Francesco Dal Dosso, PhD; Postdoctoral researcher; Department of Biosystems – Biosensors Group (www. biosensors.be); KU Leuven – University of Leuven; Belgium tells M Neelam Kachhap about the technology.

Kindly tell us about your lab-onchip design In the Biosensors Lab of the KU Leuven (Prof.Jeroen Lammertyn), we have developed and patented a

Biosensors Group, KU Leuven – University of Leuven; Belgium

new microfluidic pumping concept, termed (i) SIMPLE that brings numerous advantages over the existing microfluidic technologies while fulfilling a number of the ASSURED criteria as defined by the WHO [1], being disposable, autonomous, easy to use (activated by one simple finger actuation) and fabricate, robust and cost efficient. This system works both in pulling (SIMPLE [2]) and pushing (iSIMPLE[3]) mode. These pumps consist of nothing more than a porous material (i.e. filter paper) and a working liquid (i.e. water) seen as the “engine” and the “fuel” of the pumping system.

By activating the pump (i.e. fingertip pressure on the working liquid), the absorption of the working liquid in the porous material creates a pressure that pull (SIMPLE) or push (iSIMPLE) the sample in the microfluidic network. Multiple pumps can be combined to achieve complex liquid manipulation with a single user activation. The (i)SIMPLEhas shown great flexibility and versatility, being able to achieve a wide range of flow rates (0.07 to 30 µL/ min), pumping volume (0.5 to 100s of µL), and generating high pressure (up to 64 kPa).

Lab-on-chip technology has been around for some time. Why do you think it has not translated into commercially available devices?

Despite the initial excitement, the LOC devices that found their way to the POC market continue to be greatly out numbered by those remaining in the research environment. This phenomenon can be mostly explained with two arguments. First, researchers have been often focusing on increasing the versatility and thus also the complexity of the microfluidic chips without simultaneously working on their integration with pumps and readout systems. As a consequence, lab-on-achip became chip-in-a-lab and resulted in small microfluidic chips needing bulky instrumentation to operate, which is suitable for research purposes but not for POC applications [4], [5]. Second, the trend in the LOC community for many years was to develop new technologies rather than to integrate the existing ones with biological applications and make them more robust and user-friendly for non-

Researchers at KU Leuven, Belgium are developing a flexible chip that is able to detect infections and viruses in the blood

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INNOVATE

Despite the initial excitement, the LOC devices that found their way to the POC market continue to be greatly out numbered by those remaining in the research environment

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technical users [6], [7]. Number of autonomous and self-powered microfluidic approaches tried to address the integration and portability aspects such as capillary system or paper-based microfluidics.

However, the former requires complex fabrication (i.e. cleanroom facilities, surfaces treatment) and the latter showed irreproducible and limited fluid as well as aspecific interaction of the sample with the paper matrix, which hamper the bioassay performance.

How is your device different from other lab-on-chip diagnostic devices?

The (i)SIMPLE technology combines the advantages of paper-based and channel-based microfluidic devices and circumvent their challenges like complex fabrication, sample interference with paper matrix and limited manipulation capability. Most importantly, the (i) SIMPLE concept can work both in pushing and pulling mode, being the pushing mode outmost difficult to achieve in self-powered LOC devices.

This opens up many different applications (i.e. drug delivery) and by combining multiple pushing and pulling pumps we can achieve liquid manipulations (i.e. mixing, diluting, shuttling, metering) difficult to obtain with traditional approaches. Moreover, the sample (i.e. blood) does not get in contact with the porous material and flows in void channels. This prevents matrix interference like in paper microfluidics, and opens up to all optical detection methods (i.e. colorimetric, fluorescent, chemiluminescence, absorbance) since our channels are transparent.

Also, our chips are fabricated with a rapid, inexpensive and up scalable prototyping method, where the different chip layers are cut with a digital tabletop craft cutter and then sandwiched together applying pressure. Moreover, we can use untreated inexpensive plastic material (i.e. PVC, PMMA), contrary to capillary systems that require complex surface treatment. We have also demonstrated that we can process complex biological sample (i.e. whole blood) on chip, reducing even more the need of user intervention.

What disease segment are you currently focusing on?

In the Biosensors group,we are working on different diagnostics area, developing both specific and sensitive bioassay as well as innovative biosensing platforms. We are working in early detection of cancer and neurodegenerative diseases (i.e.

Alzheimer), diagnosis of infectious (i.e. malaria, HIV) and chronic diseases (i.e. chronic kidney disease). In particular, we have thoroughly investigated and characterized the potential of the (i)SIMPLE technology. We studied and modeled its fundamental fluid dynamics [8]. In addition we developed a SIMPLE-based biosensor for chronic kidney disease detection and monitoring [9]. We implemented a fast (5 min), robust (single step) and efficient (same performance as standard method) blood to plasma separation unit in a SIMPLE chip [10]. We also exploited the iSIMPLE potential for drug delivery applications coupled to a microneedle for injection of viscous liquid in ex-vivo skin mimicking substrate [3].

Additionally, we combined the SIMPLE and iSIMPLE concepts with an in-house developed microfluidic hydrophobic valving system enabling complex liquid manipulation on a self-powered chip compatible with complex bio-assay protocols towards POC testing [11].

How do you think your device can be used in future?

We aim to distribute our device initially to doctors (i.e. specialist, general practitioner), eventually to pharmacies and when regulations will allow, directly to the patients. We would like to decentralise the diagnosis/monitoring of medical conditions as much as possible in order to give the patients a much better quality of life and more timely analysis. This will also reduce the overall cost of the health care system.

You have proof of concept, what is the next phase you are working on?

Currently, our research group is exploring new applications in both the diagnostics and therapeutics field. At the same time, we are looking into valorization opportunities to bring this technology to the market by the creation of a spinoff company. We will target initially therapeutic

drug monitoring of biologic drugs for patient with autoimmune diseases but we aim to expand the portfolio of the company to other diagnostic area.

By when do you think this could be available for use in developing countries?

We currently have a project running where fieldtesting in Africa is foreseen in twoyears time for detection of Malaria. This first test will give us more information on the effectiveness and robustness of our device in low resource settings (i.e. no electricity or lab equipment) and harsh environmental conditions (i.e. high temperature and humidity).

Are you collaborating with partners in developing countries?

We are currently collaborating with developing countries (i.e. sub-Saharan Africa) through research partners but we are definitely looking for new collaborations with other developing countries (i.e. India) to field test our technology and develop new applications.We really believe our technology has a huge potential as a cost-effective diagnostic platform for developing countries.

References 1

G. Wu and M. H. Zaman, “Low-cost tools for diagnosing and monitoring HIV infection in lowresource settings.,” Bull. World Health Organ., vol. 90, no. 12, pp. 914–20, Dec. 2012.

2 Y. C. Kim, S.-H. Kim, D. Kim, S.-J. Park, and J.-K. Park, “Plasma extraction in a capillary-driven microfluidic device using surfactant-added poly(dimethylsiloxane),” Sensors Actuators B Chem., vol. 145, no. 2, pp. 861–868, Mar. 2010.

3 F. Dal Dosso, T. Kokalj, J. Belotserkovsky, D. Spasic, and J. Lammertyn, “Self-powered infusion microfluidic pump for ex vivo drug delivery,” Biomed. Microdevices, vol. 20, no. 44, pp. 1–11, Jun. 2018.

4 M. I. Mohammed, S. Haswell, and I. Gibson, “Lab-on-a-chip or Chip-in-a-lab: Challenges of Commercialization Lost in Translation,” Procedia Technol., vol. 20, pp. 54–59, Jan. 2015.

5 L. R. Volpatti and A. K. Yetisen, “Commercialization of microfluidic devices.,” Trends Biotechnol., vol. 32, no. 7, pp. 347–50, Jul. 2014.

6 E. K. Sackmann, A. L. Fulton, and D. J. Beebe, “The present and future role of microfluidics in biomedical research.,” Nature, vol. 507, no. 7491, pp. 181–9, Mar. 2014.

7 G. M. Whitesides, “Cool, or simple and cheap? Why not both?,” Lab Chip, vol. 13, no. 1, pp. 11–13, 2013.

8 F. Dal Dosso, Y. Bondarenko, T. Kokalj, and J. Lammertyn, “SIMPLE analytical model for smart microfluidic chip design,” Sensors Actuators A Phys., vol. 287, pp. 131–137, Mar. 2019.

9 F. Dal Dosso et al., “Creasensor: SIMPLE technology for creatinine detection in plasma,” Anal.

Chim. Acta, vol. 1000, pp. 191–198, Nov. 2017.

10 F. Dal Dosso, J. De Wispelaere, Wout Belotserkovsky, T. Kokalj, and J. Lammertyn, “Expanding the potential of self-powered microfluidics by combining fluid modules for blood sample preparation, drug delivery and complex liquid manipulation,” in µTAS 2018, 2018.

11 F. Dal Dosso, L. Tripodi, D. Spasic, T. Kokalj, and J. Lammertyn, “Innovative hydrophobic valve allows complex liquid manipulations in a self-powered channel-based microfluidic device,” ACS Sensors, vol. 4, no. 3, pp. 694–703, Feb. 2019.

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PULSE

Advancement in Brain Tumor Treatment Dr NK Venkataramana, Founder Chairman & Chief Neurosurgeon, Brains Hospital, Bengaluru

BRAIN TUMOR surgery has undergone a sea change over the years. With the introduction of MRI scan every brain tumor can be diagnosed irrespective of its size and location.

The present generation of MRI’s offers extended imaging in terms of MR-angiography to delineate the disposition and degree of vascularity.

MR Spectroscopy reasonably predicts tumorsvs non-tumor conditions and also the degree of malignancy to some extent. MR Tractography also known as Diffusion Tensor Imaging is the greatest addition that provides the information about the white matter tracts within the brain and its displacements as well as disruptions contributing to three-dimensional orientation to the surgeon. In addition, the surgeon has an opportunity to choose the

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surgical trajectory to make the surgery safe as well as less invasive.

In the operating room significant contribution have happened to enhance the surgical safety as well as efficacy. Operating microscopes provide zoom coupled illumination and also magnification so that every nook and corner of the brain can be visualized.

The fluorescence technology enables the tumors to take up the fluorescence material and brighten themselves in such a way that they can be clearly distinguished from the normal brain. The fluorescence is injected intravenously few hours before the surgery and with the fluorescence operating microscopes the tumor will be looking bright red or green depending upon the material used. This will enable the surgeon to see the tumor as well as

to distinguish from the normal brain tissue.

The intra-operative ultrasound can provide the real time imaging during surgery so that after the craniotomy the neurosurgeons can select the closest route to the tumor. It also helps to identify the nearest sulcus to the tumor so that we no longer make an incision on the cortex of the brain.

The trans-sulcus approach helps to preserve the neurons as well as the white matter tracts.

The neuro-navigation has introduced a concept called Computer-assisted neurosurgery leading to minimally invasive neurosurgery as well as keyhole surgeries that minimizes the tissue injury wherever possible. In addition, this will also provide a real-time orientation to the surgeon all through the surgery. The Intra-operative MRI is an additional imaging technique that can give a real-time feedback to the surgeon about the extent of tumor removal. However, the brain suitwith MRI is an expensive proposition.

The neuro-endoscopes can also help to visualize the invisible corners to ensure total removal of the tumors. The advanced Bipolar Systems also helps in removing the tumors without much bleeding. There is a brain mapping systems to identify the functional areas of the brain and intra-operative monitoring as well as magnetic stimulation which can help to map the eloquent areas in the brain related to speech, motor movements, vision, etc. Inspite of such systems the surgery for eloquent areas continue to have special challenges. To avoid damage to the eloquent areas and also to preserve the functional integrity of the brain Awake Brain Surgery has evolved as the most reliable method in the recent years. We are now operating the most intra-parenchymal brain tumors while the patient is awake during the surgery to ensure any insult to such an eloquent brain.

With these advancements in imaging and technology there has been a paradigm shift in brain tumor surgery from simple biopsy and volume reduction to a gross total resection of tumors. Such gross total resection have been proved beyond doubt in resulting the best longterm outcomes and longevity..

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SPECIAL FEATURE

STD Safe Transfusion Timely Testing of Blood is Imperative to Reduce the Prevalence of Syphilis Rashmi Jha, Asst Product ManagerImmunology, Transasia Bio-Medicals Ltd.

THE PROVISION of safe and efficacious blood and blood components for transfusion involves a number of processes and there is a risk of error in each process of this ‘transfusion chain’. A failure at any of the stages can have serious implications for the recipients of blood and blood components. Thus, while blood transfusion can be life-saving, there are associated risks, particularly the transmission of blood-borne infections.

Rising Cases The core Transfusion Transmitted Infections (TTI)tests recommended by WHO are Hepatitis B Surface antigen, antibody to Hepatitis C, HIV 1 & 2, and serologic test for Syphilis. In India,besides these core tests, donated blood is also mandatorily tested for Malaria antigen.

Speaking particularly about Syphilis, it was once a common STD, however the prevalence was brought down from eight percent of the population, to less than one per cent. Infact, in 2011, the National Aids Control Organization (NACO) had announced that the country is on the verge of elimination of the infection. Ironically, for 201718, NACO has reported a prevalence of syphilis in blood donors as 0.18 per cent in India. Recent studies indicate that the cases of primary syphilis have declined but there has been a parallel rise in secondary and early latent syphilis.

Cause of Concern The causative agent of syphilis, Treponema pallidum is highly sensitive to storage for more than 72 hours at 4°C. Due to the lower prevalence rate; fragility of T. palladium; and to save costs of testing, screening of syphilis is often ignored in spite of WHO recommendations. In addition to the serious damage it may cause to the different organs, which may turn out to be fatal, syphilis may also be seen as an additional indicator of other STDs such as HIV. Despite low prevalence, the risk of transfusion-transmitted syphilis is particularly high in developing countries like India, with limited blood supplies, where blood is collected from family donors and transfused within hours.

One example of high-risk situation is transfusion of platelets during dengue epidemics.

Platelet concentrates are usually stored at room temperature or transfused within a few hours of collection, so they carry a higher risk of transmitting syphilis.

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Testing for Syphilis The serological tests for syphilis can be divided into two categories, Non-treponemal tests (NTP) and Treponemal tests (TP). NTP tests such as Venereal Diseases Research Laboratory (VDRL) and Rapid Plasma Reagin (RPR) do not detect specific anti-treponemal antibodies. These tests detect antibodies against cardiolipin-cholesterol lecithin antigens, which may be found in human tissues as well as in bacteria. RPR is currently the most commonly used test for screening of syphilis in India. NTP tests may give false negative results in early primary syphilis in 30-50 percent of cases. Another major problem is the possibility of biological false positives, due to cross-reactivity with other molecules in conditions such as viral infections, pregnancy, malignant neoplasm, autoimmune diseases and advanced age.

TP tests such as ELISA, use native or recombinant Treponemal antigens and therefore, allow the detection of specific anti-treponemal antibodies. Some treponemal antigens have strong immunogenicity and they appear at different stages of infection. Using the right combination of these treponemal antigens ensures that total antibodies (IgM, IgG & IgA) are captured, thereby resulting to detection of infection in any stage. Therefore, TP test is used as a confirmatory test to verify reactivity in a NTP test. These tests may also serve as diagnostic tests in late syphilis and in patients with reactive NTP tests but with signs and symptoms of late syphilis.

A recent published study compared the efficacy of ELISA and RPR, as screening tests for syphilis. ELISA was found to have better sensitivity, specificity, accuracy and less probability of biological false positives. ErbaLisa Syphilis ELISA, the first Indian syphilis ELISA kit to be approved by NIB uses an ideal combination of the most immunogenic recombinant

treponemal antigens - TpN15, TpN17 & TpN47.

ErbaLisa Syphilis detects total antibodies (IgM, IgG & IgA) against T.pallidum, as early as two weeks post-infection.

Non-Disclosure due to Taboo Syphilis can be transmitted from donors who clinically and biologically do not show any signs of the disease. There are published data indicating that the prevalence of this disease is higher in replacement donors than in voluntary blood donors. In the absence of efficient testing, donors who are reactive to syphilis may sometimes persistently continue to donate blood even after pre- and post-donation counselling. This could be attributed to difficulty in understanding the questions due to low level of education and ignorance about infections transmissible by blood transfusion. Furthermore, cultural taboos prevent donors from disclosing information in response to some kinds of questions.

It is therefore recommended that regardless of proper storage of blood components and compulsory pre-/post-counselling, all blood bags be screened for syphilis by a reliable treponemal test, along with other transfusiontransmitted infections prior to transfusion, to ensure safe blood transfusion.

References  Aegoke AO, Akanni OE. Survival of Treponemapaliidum in banked blood for prevention of Syphilis transmission. North American Journal of Medical Sciences.

2011;3(7):329-332.

 Kaur G, Kaur P. Syphilis testing in blood donors: an update. Blood Transfusion.

2015;13(2):197-204.

 Sommese L, De Pascale MR, Capuano M, Napoli C. Efforts in blood safety: Integrated approach for serological diagnosis of syphilis. Asian Journal of Transfusion Science 2016;10:22-30.

 SJ Winceslaus. Screening of syphilis. The Lancet. Volume 353, Issue 9162, P1441, April 24, 1999.

 Sachdev S, Sharma AK, Sethi S, Garg S, Lamba DS, Sharma RR, et al. Comparative evaluation of enzyme-linked immunosorbent assay with rapid plasma reagin for screening of syphilis in blood donors.

Asian Journal of Transfusion Science 2018;12:165-8.

 https://timesofindia.indiatimes.com/ life-style/health-fitness/health-news/hivon-the-decline-syphilis-cases-up/articleshow/59911088.cms

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SPECIAL FEATURE

Rapid Diagnostic Tests Enabling Effective Blood Transfusion in Developing Countries

Jatin Mahajan, Managing Director, J Mitra & Co. Pvt. Ltd.

AS WE celebrate World Blood Donor Day on June 14, it is pertinent to note that India fell short of its blood requirement by 10 % (or 1.9 mn units) in 2016-17 (as per WHO report).

Blood donation and blood transfusion forms an integral part of any healthcare ecosystem. The aim of blood transfusion is protection of life, but at the same time, it can be life threatening if blood safety is not considered.

Blood is required during all forms of surgery, and safe blood becomes the key prerequisite.

Transfusion-transmissible infections (TTIs) are huge risks and are extremely prevalent in all developing countries.

Is Blood Safe Life-threatening viral infections that are transmitted through blood transfusion include HIV, HCV and HBV infections. The risk of transmission of these viruses through transfusion

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of infected blood is much higher than the other routes of transmission, mainly because of transmission of high viral load per transfusion.

Thus, pre-screening of blood for transfusion is vital.

Recent advances in the field of transfusion medicine and technology has necessitated enforcing measures to ensure quality of Blood and its products. Transfusion medicine has made significant advancement in areas of donor management, storage of blood, grouping and cross matching, testing for transmissible diseases, rationale use of blood and distribution etc. In India, NACO / NBTC through Technical Resource Group on Blood Safety, has formulated comprehensive standards to ensure better quality control system for collection, storage, testing and distribution of blood and its components to ensure a near fail-safe environment.

Eliminating Transmitted Infections An integrated strategy for blood safety is the requirement for elimination of transfusion transmitted infections (TTI) and this is where the various techniques of blood diagnostics come in.

The most prevalent techniques deployed for pre-screening of blood are –Elisa and Rapid Diagnostic Tests (RDT). While Elisa tests are time-consuming and require extensive infrastructure and trained manpower, RDTs are faster, convenient and highly cost-effective, with almost similar results.

Using RDT In resource poor setting, the use of affordable alternative screening methods such as rapid diagnostic testing ensures blood safety, including in the more rural settings, where small numbers of daily tests are performed.At present, rapid diagnostic testing is used for the screening of various infections including HIV, HBV, HCV,syphilis and malaria infections and

breakthrough technologies are being developed further.

These are simple instrument-free assays that may be performed by workers who need very little training, and without high-end laboratory facilities. The test kits are generally low in cost, ranging from US$0.40 - 2.00 per test in the WHO bulk procurement scheme.

In addition, the kits are easy to store (room temperature, with no need for refrigeration), and require very short intervals (10–30 min) to provide results. These characteristics have rendered rapid diagnostic testing especially user-friendly in resource poor settings. Consequently, rapid diagnostic testing has been integrated into, and served as a point-of-caretool, in various healthcare programmes.

Some of the key benefits of RDTs are: • High quality and easy-to-use tests in resource poor settings • Tests based on agglutination, immuno-dot, immuno-chromatographic and/or immuno-filtration techniques • Quick and easy to perform - takes 10-30

Blood donation and blood transfusion forms an integral part of any healthcare ecosystem. The aim of blood transfusion is protection of life, but at the same time, it can be life threatening if blood safety is not considered

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SPECIAL FEATURE The primary methodology for HIV testing has shifted from enzyme linked immunosorbent as say (ELISA) to rapid diagnostic tests (RDTs) in recent years, especially in resource limited settings minutes from test to results • Requires little or no additional equipment • Designed for use with individual or a limited number of samples, which make them more economical than ELISA in low throughput laboratories • Can be stored at room temperature for an extended period of time • Same-day results enable timely treatment interventions Test of Choice RDTs have emerged as the primary methodology and the technique of choice for most hospitals, phlebotomists, and laboratories, especially since the technological advances in the last couple of years have narrowed down the accuracy gap between Rapid and other techniques. For instance,early and accurate diagnosis of human immunodeficiency virus (HIV) infection is essential for timely identification of patients needing antiretroviral therapy and for instituting HIV prevention strategies. The primary methodology for HIV testing has shifted from enzyme linked immunosorbent assay (ELISA) to rapid diagnostic tests (RDTs) in recent years, especially in resource limited settings. RDTs are designed for use where a preliminary screening test result is required.

Stringent Quality Control Time and again, World Health Organisation (WHO) has come up with stringent quality control norms for various IVD tests, including RDTs, and all such tests are manufactured and deployed under these quality standards that ensures the most optimal results that are comparable with other form of tests. The quality assurance standards laid down by WHO for rapid diagnostic tests are not only extremely stringent, but also leave no scope for error. They

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specify two different principles need to be used and then confirmed.

Given the fact that a major portion of our country’s populace resides in Tier 2 & 3 cities and villages, and the fact that the other techniques are not present in these cities on account of cost, infrastructure and trained manpower issues; RDT becomes not just the technique Rashmi Jha, of choice but also the only option available.

Asst Product ManagerRapid tests are one of the key innovations in Immunology, Transasia the healthcare space that meet these challenges Ltd. and bridges the need-gapBio-Medicals by reaching out to the point-of-care, rather than forcing people to go to metros for these tedious and time-consuming processes.The Indian government has also recognised the various possibilities and challenges, and in order to ensure availability of quality tests in resource-scarce environments, they too have declared stringent quality standards, procedures and norms for the use of rapid tests in the country. National Institute of Biologicals has further raised the bar for sensitivity and specificity of these teststo ensure RDT’s of good quality are used in resource limited settings and in case of emergency situations in Blood Banks. The 100% sensitivity assures the reliability of the test results, to the end user and also safe blood transfusion.

In case of infectious diseases like HIV ,Hepatitis B& Hepatitis C (HCV), they have raised the sensitivity to 100% (for HIV/HBV) and greater than 99% (for HCV) and the specificity should be greater than 98%.

Rapid Test are the Best Option in: • Resource-scarce environments • Tier 2,3 cities and villages • Absence of trained manpower • Field situations like Blood donation camps • Emergency cases like trauma and remote locations • Time-sensitive situations Today RDTs having been making a significant impact on the lives of the people, not just in India, but globally. The fact that J Mitra, a 50year old Indian medical device manufacturer, exports to over 45 countries world-wide.This bears testimony to the fact that rapid test have heralded a sea-change in the manner in which diagnostics are handled across the world and in the way they impact human lives.

Skilled health workforce in India does not meet WHO recommended threshold The density of the total health workforce is estimated to be 29 per 10,000 population but only 16 per 10,000 for trained workers Source: BMJ

THE SKILLED health workforce in India does not meet the minimum threshold of 22.8 skilled workers per 10,000 population recommended by the World Health Organisation, shows research published in the online journal BMJ Open.

Estimates of non-health workers engaged in the health sector and technically qualified health professionals who are not part of the current workforce is able to be provided in India for the first time by the study as it is based on data from two sources.

The authors retrieved data on the number of registered practitioners, such as doctors, nurses, physiotherapists and dentists, from published literature and websites of professional councils and organisations.They also estimated the number of qualified and unqualified healthcare workers actually working in India using the 68th round

(July 2011-June 2012) of National Sample Survey Organisation (NSSO) data on ‘Employment and Unemployment Situation in India’ - a household survey conducted every five years.

As well as registered practitioners, the health workforce in India includes many informal medical practitioners, such as traditional birth attendants, faith healers, snakebite curers, and bonesetters without formal education or training.

The total size of health workforce registered with different councils and associations was 5 million, but the NSSO estimated the size of the workforce to be 1.2 million fewer at 3.8 million.

Based on the registration data, the density of the total health workforce was estimated to be 38 per 10,000 population, but the NSSO data found it be lower at 29 per 10,000 population. In eastern

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and rural states total health workforce density was lower than the WHO minimum threshold of 22.8 per 10,000 population.

According to the registry data the density of doctors and nurses and midwives per 10,000 population across India was 26.7, whereas the NSS0 data put it at 20.6.

The estimates also reveal “an alarmingly large presence of unqualified health professionals,” as adjusting for adequate qualifications of health workers reduced the workforce density from 29 to 16 health workers per 10,000 population.

The presence of unqualified health professionals in the health system is not unique in India. Unqualified health professionals are usually the first point of contact for rural and poor population in many low-income and middle-income countries.

The data also showed that approximately 25% of currently working health professionals do not

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have the required qualifications as laid down by professional councils, and that 20% of adequately qualified doctors are not in the current workforce.

More than 80% of doctors and 70% of nurses and midwives were employed in the private sector.

The researchers point to several limitations of their study, including the registration data being inadequately updated and likely to include deceased, unemployed and professionals who have migrated overseas, and the survey data being self- and also outdated reported.

Nevertheless the authors were able to conclude: “Distribution and qualification of health professionals are serious problems in India when compared with the overall size of the health workers.

“Policy should focus on enhancing the quality of health workers and mainstreaming professionally qualified persons into the health workforce,” the study concluded.