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Marchâ&#x20AC;&#x192;2017

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Special Issue

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NATEv2017

4 th N AT H E A LT H A n n u a l E v e n t New Delhi, Friday 24th March

A Step towards collaboration, co-operation & progress

An Advance Media Publication

Advance Media Group A Health Journalism

EDITOR EVENT SPEAK

National Health Policy 2017 A ROAD MAP FOR HEALTH

Affordable, quality health care for all requires more human resources and cost control The National Health Policy 2017, which the Centre announced this week after a nudge from the Supreme Court last year, faces the challenging task of ensuring affordable, quality medical care to each and every citizen of India. With a fifth of the world’s disease burden, a growing incidence of the non-communicable diseases such as diabetes, and poor financial arrangements to pay for the care, India brings up the rear among the BRICS group countries in health sector performance. Against such a laggardly record, the policy now offers an opportunity to systematically rectify well-known shortage through the stronger National Health Mission. Among the glaring lacuna is the lack of capacity to use higher levels of public funding for health. Rectifying this in partnership with the States is vital if the Central government of India is to make the best use of the targeted government spending of 2.5% of GDP by 2025, up from 1.15% now. Although a major capacity expansion to produce MBBS graduates in country took place between 2009 and 2015, and more initiatives were announced later, this is unlikely to meet policy goals since only 11.3 percent of registered Allopathy doctors were working in the public sector as of 2014, & even among these, the number in rural areas were abysmally low. More health professionals need to be for primary care in the rural areas. The availability of trained doctors and nurses would be helpful to meet the new born baby death rate and maternal mortality goals, and build on the gains from higher institutional deliveries, which exceeded 85% in recent years. Contracting of health services from the private sector may be fate in the short term, given that about 70% of all outpatient care and 60% of inpatient treatments are provided by it. But this requires accountability, both on the quality and cost of care. No more time should be lost in forming regulatory and accreditation agencies for healthcare providers at the national and the State levels as suggested by the group of experts on universal health coverage of the Planning Commission more than five years ago. Without such supervision unethical commercial entities would have easy back door access to public funds in the form of the state-backed insurance. This is mandatory for all health institutions to be accredited, and to publish the approved cost of treatments, in order to remove the prevailing very common information. For the new policy to start on a firm footing, the Centre has to get robust health data. Currently this is divided because inputs from multiple sources and sample surveys are not, and the private sector is often not in the picture. To reduce high out-of-pocket spending, early deadlines should be set for the public institutions to offer essential medicines and diagnostic tests free to everyone. This was estimated in 2011 to require a spending increase of only 0.4% of GDP, which is within the 2.5% that the Centre is talking about. Have an insightful reading. Your suggestions are most welcome! E-mail: editor@medgatetoday.com Website: w w w . m e d g a t e t o d a y . c o m

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COVER STORY Massage

Rahul Khosla President, Governing Council

C.K. MISHRA Secretary Govt of India

Anjan Bose Secretary General

Preetha Reddy Vice Chairperson, Apollo Hospitals

NATHEALTH:

Creating Ecosystem for Health to Overcome Dual Disease Burden

12 MR Solutions introduces 9.4T preclinical MRI imaging solution to cardiovascular sector �� 13 Responsibility and Regulation are two sides of the same coin �� 14 IFC Supports India’s Healthcare Sector to Expand Access to Quality Healthcare �� 15 Novartis Holds Special Screening to Spread Awareness About Leprosy �� 15 MedGenome launches “ONCOTRACK”, the Liquid Biopsy blood test for cancer recurrence detection and monitoring �� 16 Beware of swine flu �� 16 In the past decade obesity has pushed kidney patients up by 40% �� 17 Asia-Pacific non-small cell lung cancer market to soar to $6.2 billion by 2023, says GBI Research �� 17 India hopes to achieve 90% immunization by 2021 stress on strengthening pharma supply chain �� 18 Fecal Calprotectin Test Evaluation of Metropolis Healthcare �� 19 Gurgaonites need to be Educated about Emotional Well-being: Author Sharat Kumar �� 19 National Health Policy 2017 Huge milestone in the history of public healthcare in India. �� 20 International Yoga Fest �� 22 Shivam Medisoft: Facilitating Patients & Hospitals: �� 23 Diabetes and its complications are influenced by Vitamin D deficiency �� 26 VOH Interview: DR. NAVEEN NISHCHAL �� 28 Strict or Stringent National Regulatory Authority for Procurement of anti-Tuberculosis Medicines? �� 30 Kmch launches india’s first mobile stroke unit with advanced ct imaging ��

Dr. Ajay H. Kantharia Heart and Blood Vessel Problems Also Seem to Be Stemming from Vitamin D Deficiency

Total Knee Replacement the latest trends Dr. Gaurav Bhardwaj

Dr. Seema Sharma

Avoiding pregnancy know the aftermath

C o n t e n t s

Be the credible and unified voice in improving access and quality of healthcare

• Enable the environment to fund long term growth • Help develop and optimize healthcare infrastructure • Help shape policy & regulations • Help bridge the skill & capacity gap • Encourage innovation • Support best practices & promote accreditation

COVER STORY

From the desk of the President Governing Council Healthcare Federation of India (NATHEALTH) Dear NATHEALTH Members, The rise of a new India has to be built on the foundation of a healthy nation. The socio-economic benefit of a robust healthcare ecosystem does not only accrue to the sector itself, but also manifests itself in the creation of a more vibrant and productive community. However, for a large number of Indians today, access to quality healthcare is both inadequate and inconsistent. Despite improvements on multiple levels in the recent past, Indian healthcare continues to grapple with considerable gaps in infrastructure and talent, regional imbalances and inconsistent delivery. The level of quality care is negligible as evident from the fact that less than 1% of hospitals in India have NABH accreditation. These issues are further compounded by a culture biased towards curative care, in which prevention and wellness receive limited focus and investments. The constantly evolving socio-economic landscape with higher income levels, greater awareness, growth in the number of the elderly, growth in medical tourism and the burgeoning incidence of non-communicable diseases, will only further increase the burden on India's healthcare industry. Myriad challenges, however, reflect a multitude of opportunities, and now is an opportune moment for all stakeholders involved to transform India's healthcare ecosystem. The Government and private healthcare providers need to work in tandem to develop a cohesive blueprint for healthcare provision and funding. At NATHEALTH, we are striving hard to create such a collaborative platform to establish healthcare as a priority sector. Working together with the Government, we need to lay out a comprehensive plan to achieve the vision of universal and consistent healthcare in India. We must be careful in clearly defining the roles of the stakeholders involved, specifically the Government. The current Government has shown a willingness to encourage public-private partnerships and we need to take this further by developing a healthcare-specific PPP framework standardising agreements across all modes of engagement and a monitoring framework that focuses on outcomes over pricing, reviews ongoing projects, and enables monitoring of healthcare service quality through regular tracking of metrics. NATHEALTH is a unique and inclusive platform that represents a collective aspiration to redefine the Indian healthcare ecosystem and serves as a credible voice of the Indian healthcare sector. On behalf of the Governing Council, I invite you to join NATHEALTH and play a critical role in the transformation of Indian healthcare. With your support, I am confident that we will be able to deliver tangible results in our endeavour of creating a sustainable healthcare ecosystem focussed on prevention and healthy living. Warm Regards,

Rahul Khosla President, Governing Council Healthcare Federation of India (NATHEALTH) Email: rahulkhosla@maxindia.com 4

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COVER STORY

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COVER STORY

From the desk of Secretary General March, 2016 Healthcare Federation of India (NATHEALTH) Dear NATHEALTH Members, It is commendable for NATHEALTH to get so many stakeholders together in a collaborative spirit in such a short period because there is much to do to make Indian Healthcare move to the next level. India is a rare country, which is engaged in simultaneously battling the dual burden of communicable and noncommunicable diseases, which developed countries have had to deal with only sequentially. Approximately, 70% of India's healthcare infrastructure is concentrated in the top 20-odd cities. About 70% of patients diagnosed with cancer still die within the first year. The addition of 650,000 beds needed to meet the minimum goal will require a capital investment of 162,500 crore INR by 4-5 years! This is precisely why we, at NATHEALTH, strive continuously to work on prioritised healthcare initiatives. Our “Make in India” initiative is undertaking a structured exercise, aimed at determining the imperatives and developing recommendations, for actualising "Make in India" for the medical devices industry. Various key stakeholders across the medical devices ecosystem – manufacturers, providers, industry associations and government have been consulted for this study. We also have “NATHEALTH MedTech Forum” comprising of 32-35 odd medical technology companies, currently working on various prioritized initiatives. Another path-breaking NATHEALTH milestone is the “IMA-NATHEALTH Code of Ethics” that was launched recently. Onvarious regulatory, tariff and other policy matters, NATHEALTH is actively engaged with the government. “Skilling in Healthcare/Medical Education” is yet another focus area for NATHEALTH. Then we have the “Health for All-Leveraging Digital India” initiative, which has made significant progress as part of the NATHEALTH NASSCOM MoU implementations. Also, as articulated in “Aarogya Bharat 2025” paper launched last year in partnership with Bain & Co. NATHEALTH strongly believes that prevention & wellness needs much more attention and hence we are working on developing a roadmap for the future. Formation of the “Diagnostics Forum” is one of the most positive developments in 2015. With a strong diagnostics group now working on the NATHEALTH platform, we are currently looking at this segment's priorities and the areas to focus on. Let me sum this up with a real thought-provoking line that a top world leader had once said, “Success has many parents, Failure is a lonely orphan”.... For the sake of protecting and progressing the health of our nation, we must take collective and individual ownership and be steady in our commitment… whether in success or in occasional failures, we must be together and we must collaborate and co-operate – this is the ultimate mantra for progress! Best Regards,

Anjan Bose

Secretary General Healthcare Federation of India (NATHEALTH) Email: anjan.bose@nathealth.co.in

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COVER STORY

Preetha Reddy

Execute Vice Chairperson

Message Over the last decade in particular, healthcare in India has been facing a crisis of an unprecedented proportion – a burgeoning burden of lifestyle diseases, an acute scarcity of health infrastructure and talent, compounded by rising costs of care. It was this environment that my father and founder of Apollo Hospitals, Dr. Prathap C Reddy catalyzed an endeavour to bring together the participants of the healthcare ecosystem in India as a credible and collective voice to influence the nation’s policy makers with a view to enable inclusive and equitable healthcare. This was genesis of NATHEALTH – The Healthcare Federation of India, an organization purpose-designed to power a new era of accessibility to healthcare through innovation and disruptive thinking. In the five years since its inception, NATHEALTH has delivered handsomely in its promise as the voice of the vibrant healthcare ecosystem in the country. At first, I congratulate the tireless efforts of the stakeholders who made this possible and do urge them to continuously enthuse India with fresh and bold ideas, essential to deliver a panacea for the mounting crisis. Today, NATHEALTH has a large number of members from diverse constituents of healthcare, all working together on a multitude of initiatives to influence policy and address critical challenges. Over the last year, a dedicated MedTech Forum was created and it has been working on priority issues of the sector and engaging with the government on policy formulation. Similarly, a team worked with the MoHFw and NITI Aayog on the aspects of public private partnerships and another submitted a concept paper to the government on the subject of “Make in India”. Each of these initiatives in our country and overseas underscores NATHEALTH’s passionate commitment to work in a collaborative manner to foster a smarter and efficacious healthcare ecosystem in India. I look forward to the 24th March 2017 when NATHEALTH will host its annual event - NATEv2017 and elicit new ideas, innovations and inspire newer collaborations. On behalf of the Apollo Hospitals family, I extend my wishes for a successful edition of this landmark annual event. Best wishes,

Preetha Reddy

Vice Chairperson, Apollo Hospitals

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COVER STORY

NATHEALTH: Creating Ecosystem for Health to Overcome Dual Disease Burden We are very hopeful that all of these aspects would be considered by the Government while setting the GST rates and exemption structures in placefor the Healthcare Sector. Mr. Anjan Bose Secretary General, Healthcare Federation of India (NATHEALTH)

India’s population is evolving and ageing, with the geriatric age group expected to constitute 11% share by 2025. Increasing urbanization has led to an explosion of non-communicable diseases (NCDs), and India now carries a dual burden of communicable diseases (CDs) and NCDs. It is widely admitted and evident that healthcare is underserved and under-consumed. NATHEALTH believes in the idea of ‘Health for All’ to provide quantity with quality healthcare services across the country. Disease growth and population growth are directly linked and this is because of the unavailability of adequate healthcare facilities. NATHEALTH, India’s apex and unique healthcare body firmly believes that, not only government but private stakeholders have to contribute to make healthcare facilities available in each and every corner of the country. Joining hands and working in collaborative spirit can make the mission ‘Health for All’ a great success.

Mr. Anjan Bose, Secretary General, NATHEALTH says

‘Health for All’ aims to achievelong-term healthcare goals. First and foremost,the aim is to reach out to a large number of private stakeholders and ask them to extend their support to the government. Health for All however is not a quick process but can be achieved in the coming years if proper planning and implementation happens on floor in time”. “We should not only look for quantitative achievement but also ensure that quality is not compromised. Government and Private sector need to work together for rapid control and reduction of both Non-Communicable (Lifestyle)Diseases as well as Communicable Diseases” he adds. Priority focus now is that the government assigns national priority to the healthcare agenda,can commit to spending more on public health and defines a holistic framework for an India-centric health system. The government also needs to set clear health priorities , clarify roles and establish enabling incentives and regulations for stakeholders. Also, inculcate a culture of personal ownership for health through education, awareness, schooling, public mandates and incentives—for example, through health savings accounts and co-payments. Prioritizing areas with critical shortages of healthcare professionals (doctors, nurses, allied health) and public health workers (ASHA, Anganwadi, trained birth attendants) will be important. It’s time to review the current health system, especially in the light of the experiences of other health systems, in particular

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COVER STORY

those in otheremerging markets such as Thailand, Indonesia, Mexico and China which recently made attempts to provide affordable accessto large populations . Through NATHEALTH, private-sector participants seek ways to collaborate with the government to provide expertise and support and thereby start moving towards the desired goal of achieving ‘Health for All’. NATHEALTH has been created with the Vision to “Be the credible and unified voice in improving access and quality of healthcare”. Leading Healthcare Service Providers, Medical Technology Providers (Devices & Equipment), Diagnostic Service Providers, Health Insurance companies, Health Education Institutions, Healthcare Publishers and other stakeholders have come together to build NATHEALTH as a common platform to power the next wave of progress in Indian Healthcare. NATHEALTH is an inclusive Institution that has representation of small & medium hospitals and nursing homes. NATHEALTH is committed to work on its Mission to encourage innovation, help bridge the skill and capacity gap, help shape policy & regulations and enable the environment to fund long term growth. NATHEALTH aims to help build a better and healthier future for both rural and urban India. Our Public-Private partnership (PPP) team chaired by Mr. Daljit Singh, has worked on developing model documentation on PPP draft concession agreement for brownfield and greenfield hospitals…The mails from the Ministry of Health have made positive remarks about NATHEALTH’s work. NATHEALTH is also working closely with NITI Aayog on developing To Rs/T&Cs for District Level PPP’s for addressing select NCDs like CV, Cancer, Pulmonary etc. Make in India initiative led by Mr. Varun Khanna: NATHEALTH has achieved milestones in the preparation of “Make in India” concept paper (supported by Deloitte), which was launched in the 3rd Annual event held in March 2016 in New Delhi. The detailed policy paper will focus on addressing issues around Demand, Regulation, Infrastructure and Financing. In Health for All-Leveraging Digital India initiative led by Mr. Swami Swaminathan, significant progress has been made as part of NATHEALTH-NASSCOM MoU implementation, with BCG as thought partner. In the Preventive and Wellness initiative led by Dr Arvind Lal and Mr. Harish Pillai, the team is working on preparing a clear road map through a pilot initiative in UP on integration of available data. Top management guru Peter Drucker said, “The best way to predict the future is to create it”.

Indian Healthcare is uniquely placed at this point of time. The positive and negatives are at constant interplay. At one end we have taken giant strides to establish ourselves as a highly skilled medical ecosystem with excellent clinical outcomes and a very powerful value proposition, at the other end our country has a massive disease burden that is compounded by significant delivery challenges of talent shortage and inadequate infrastructure. Addressing these challenges is our immediate priority and will require the joint commitment of all Healthcare stakeholders. We need to continue working together in collaborative spirit in order to achieve NATHEALTH’s vision of “Be the credible and unified voice in improving access and quality of healthcare”.

On GST

With a presumption that the Goods & Service Tax (GST) rate on the final delivery of patient care/diagnostic services by the hospitals/clinics to their patients would remain exempt from indirect taxes, NATHEALTH recommends a 5 % GST rate on earlier part of the healthcare supply chain such as supply of medical equipment/services to the hospital/clinical establishments. In a letter of recommendations, recently submitted to the GST Council, NATHEALH urges that the overall tax cost in the healthcare supply chain needs to be as low and moderate as possible to achieve the nation’s dream of affordable and accessible healthcare to all, particularly the poorest and the most underprivileged sections of society. “A rate of GST ranging between 8-10 % as applicable today for Medical Equipment supplies to hospitals will help achieve neutrality, a lower rate will support the private healthcare sector, a higher rate will increase cost in the private sector and reduce investment opportunities,” Mr. Bose writes to the Council. “While we fully welcome the revised version of the Model GST law and proposals, it is our humble request that benefits/ exemptions-as envisaged under Schedule IV vis-à-vis Government hospitals/clinical establishments - should also be granted to the hospitals/clinical establishments in the private sector,” he adds. Healthcare in India is a USD 70 billion industry accounting for 4% of the GDP. Government spending on the public health care system represents 1% of GDP per annum…and approximately 3% of the GDP is spent in the private sector on healthcare. According to National Family Health Survey-3, the private medical sector remains the primary source of healthcare for 70% of households in urban areas and 63% of households in rural areas 

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COVER STORY

Past Presidents

Current President

Dr. Prathap C Reddy Founding President, NATHEALTH Chairman, Apollo Hospitals Group

Mr. Rahul Khosla

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Dr. Shivinder M Singh Past President, NATHEALTH Vice Chairman Fortis Healthcare Limited

Mr. Sushobhan Dasgupta Immediate Past President, NATHEALTH MD, Johnson & Johnson Medical India VP, Diabetes Care Asia Pacific

COVER STORY

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NEWS Update

KMCH LAUNCHES INDIA’S FIRST MOBILE STROKE UNIT WITH ADVANCED CT IMAGING

The stroke unit will enhance KMCH’s Stroke Program and provide Kovai Medical Center and Hospital today launched the Asia’s First innovative new Mobile Stroke Unit (MSU) designed to bring time-critical stroke care to patients on the way to the hospital. This will be the world’s most comprehensive Mobile Stroke Unit that is capable of conducting and producing advanced quality imaging for stroke diagnosis and noninvasive CT-angiography. Receiving the correct treatment for stroke quickly is based on accurate diagnosis of the stroke with a rapid neurologic assessment and CT scan. Faster diagnosis and subsequent treatment can make a lot of difference. This unique Mobile Stroke Unit is a specially built, state-of-art ambulance outfitted with telemedicine technology and a CT scanner enabling brain imaging that is critical to accurate diagnosis and timely treatment. The unit features the most advanced technologies, expert staff and life-saving treatment to stroke victims. It is designed to significantly reduce the time from the onset of symptoms to the delivery of care, a crucial factor in improving stroke outcomes. Kovai Medical Center and Hospitals under the leadership of its Chairman, Dr.Nalla G Palaniswami, after several discussions with Schiller USA decided to be the first hospital in Asia to try to develop a similar strategy by ordering a mobile stroke unit, which was specifically developed for Indian roads. “Our ultimate goal is to show that patients treated on the mobile stroke unit will have better outcomes because of earlier treatment and therefore will have fewer long-term acute care needs and/or rehabilitation needs” says Dr. Palanisami Across the country, there is excitement as health care providers are keenly watching whether the same model can transform the treatment of stroke in India.

The Mobile Stroke Unit features:  A quality CT scanner with advanced imaging capabilities to not only allow brain imaging, but also imaging of blood vessels in the brain.  A dedicated gantry automatically moves the patient to obtain images, providing the same number of slices in high resolution as obtained and expected in the hospital setting. The unit is to be staffed with stroke fellowship-trained nurses and neurovascular practitioners

How does the MSU work:

Mobile Stroke Units are specialized ambulances staffed with a nurse, paramedic, emergency personnel and CT technologist. The unit also contains lab testing equipment and a CT scanner, which is required to diagnose the type of stroke. A stroke physician at the main hospital evaluated each patient via telemedicine and a neuroradiologist remotely assessed CT images. Two way video conferencing allowed communication with the patient, family and stroke experts. The CT image is an important diagnostic test distinguishing a hemorrhagic (bleeding) stroke from ischemic stroke (blood clot blocking vessels and blood flow). The treatment for these types of strokes is different, and cannot be started until the CT scan is complete. Once alerted the MSU and its specialist team will conduct critical assessments, perform a CT scan, and work with stroke specialists, neuroradiologists, and emergency room physicians at the hospital to diagnose and treat patients having an acute ischemic stroke. 12

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Images from the unit's CT scanner will be wirelessly transmitted to the hospital where our neuroradiologist will evaluate them for signs of a stroke and the type of stroke; ischemic (caused by a blood clot) or hemorrhagic (caused by a ruptured blood vessel). If it is found positive the on-board medical tea, can initiate procedures in the MSU to help the clot break. Patients are then transported to the hospital for additional care. KMCH is the first hospital in Asia to offer a fully equipped Mobile Stroke Unit.

NEWS Update

MR Solutions introduces 9.4T preclinical MRI imaging solution to cardiovascular sector MR Solutions’ new 9.4 tesla cryogen free preclinical scanners created great interest from cardiologists at the 20th Annual Scientific Sessions of the Society for Cardiovascular Magnetic Resonance (SCMR). As well as being extremely powerful this new scanner can be multi-modality, incorporating PET and/or SPECT capabilities. MR Solutions’ helium free scanners offer a compact scanner with a small stray field at a very competitive price. SCMR has worldwide attendance amongst top healthcare professionals who are committed to cardiovascular development and their clinical application. In attendance were cardiologists, radiologists, physicists and technologists. Both of MR Solutions’ range of preclinical scanners, the Flexiscan and Powerscan were on display. The scanners can incorporate integrated multi-modality options such as PET or SPECT. The Flexiscan system requires no specialist knowledge and can be operated simply by running pre-defined settings. There is no need to materially alter the parameters of the machine. Dr David Taylor, CEO of MR Solutions commented: “At the SCMR we displayed our latest scanner ranges up to 9.4T which offer multi-modality scanning (including PET or SPECT) and better performance, all at a very competitive cost. This can significantly improve cardiovascular research.” MR Solutions, which is based in Guildford, UK, is the world’s largest independent developer and manufacturer of preclinical MRI technology and remains the only company to deliver a commercial cryogen free 3T to 9.4T range of preclinical bench top MRI scanners. To provide the SPECT images, MR Solutions has devised a system where

the four gamma camera heads and focusing collimator can be easily clipped on to the front of the bore of the MRI scanner to provide state of the art 3D SPECT images. The SPECT images can be registered with the MRI images providing anatomicalfunctional combined capability. The SPECT gamma camera can also be used independently. The PET capability is provided by solid state detectors which are incorporated in the bore of the MRI scanner. The scanner combines the exquisite structural and functional characterisation of tissue provided by MRI with the extreme sensitivity of PET imaging for metabolism and tracking of uniquely labelled cell types or cell receptors. This is particularly useful in oncology, cardiology, and neurology research.

MR Solutions’ range of cryogen free, Benchtop, 3T to 9.4T MRI scanners with 17, 24 and 31 cm bores has become a complete game changer in the field of preclinical scanning. The technology not only provides superior soft tissue contrast and high spatial resolution, a vastly reduced stray magnetic field and all the benefits that brings but also allows the magnetic field strength to be easily varied. MR Solutions, a winner of the prestigious Queen’s Award for Enterprise 2016 for innovation in the UK, has over 30 years’ experience and in excess of 1000 installations across the world. This includes sales of their MRI spectrometers. Its scanners are renowned for their excellence in terms of superior soft tissue contrast and molecular imaging ability.

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NEWS Update

Responsibility and Regulation are two sides of the same coin The Latin word for doctor is ‘docere’, which means to teach. It is a moral obligation of the doctor to ensure that the patient and family members fully understand the medical situation, so decision making is transparent. Barring extreme circumstances that may force a doctor to take suo moto decisions in the larger interest of the patient, it is proven that better understanding creates cooperation, which results in better clinical outcomes. Patients not fully understanding the implications of caesarean sections could be one reason why they are skyrocketing in India. Women have the innate ability to give birth through the vagina. Due to drastic changes in the lifestyle and dietary habits, many women develop complications at a young age that affect the natural way of giving birth. At an advanced age, women start having health problems such as diabetes, obesity, cardiovascular disorders and other age related medical conditions. Moreover, delaying pregnancy to late thirties may create the need for seeking Assisted Reproductive Techniques (ART) to conceive. In modern day obstetrics, there are two ways a woman can give birth to a baby – one by vaginal route and the other by caesarean section (aka C-section). It is a common belief that C-section is less painful than going through labour. While C-section is done under anaesthesia, it is still a major surgery, involving an incision on the abdomen and uterus, and the recovery time is longer. As with any surgery, there are benefits as well as risks involved in C-section. While elective C-section reduces foetal and maternal morbidities, infection, increased blood loss or injury to abdominal organs are known complications.

Counselling is the responsibility of healthcare providers Healthcare providers need to weigh the benefits against the risks of both vaginal delivery and elective caesarean section, and counsel the patient accordingly, thereby assisting them to make an informed decision while choosing their preferred route of delivery. Couples should also know that this decision cannot be imposed on them and that they have every right to choose the method of delivery. Patient education becomes even more critical for exinfertility patients. Some obstetricians feel that once pregnant, ex-infertility patients should be treated like all other pregnant women and hence should be delivered vaginally unless a medical indication for performing a caesarean section arises. A small number of women who have conceived with IVF-ICSI feel the same. They claim to have had enough of extensive medications and now want 14

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Dr. Ritu Hinduja

Fertility Consultant, Nova IVI Fertility, Mumbai

to enjoy their pregnancy and labour and “be normal” again. However, babies conceived through ART are considered as “Precious Babies”, because they are a result of a battle against long standing years of infertility. As it has been proved by many studies that a planned elective caesarean section leads to better outcome for the baby and the mother compared to an emergency caesarean section which is mobilised after a trial at vaginal delivery fails. Also, a planned caesarean section has lesser incidence of foetal injury compared to a difficult vaginal delivery in which the need to apply forceps or vacuum may arise. Owing to these factors women may perceive caesarean delivery to be safer for their babies than vaginal birth. Clinically also at times it is the right decision to make. After having survived years of infertility and the stressful infertility treatments, by the time a woman conceives she is already in the advanced maternal age category which in itself is a high risk factor in pregnancy, as it increases the incidence of pregnancy induced hypertension and gestational diabetes. Fibroids can be a cause of infertility and a pregnancy with fibroids in itself is an indication for a caesarean section. These may reflect as an apparent rise in caesarean section rate in women who have conceived with the help of assisted reproductive techniques.

The need for regulation While there is enough room to improve patient education, the other reason for the alarming rise in C-sections in India is due to lack of regulation. Healthcare industry in India is seen growing at a rate of about 20% annually. Despite that, a large part of the population’s healthcare needs are unmet. This results in rampant growth of medical service providers and commercialisation of the profession. Today healthcare has become a lucrative business and many aspects go unregulated and unchecked. There is a need to improve transparency and put an end to unethical practices through proper regulation within the industry. In spite of many attempts by consumer groups, unfortunately we don’t have any laws on patient rights in India. Several countries across the world have recognised the rights of patients through specific laws and charters. Historically, patient rights flow from the Universal Declaration of Human Rights adopted by the United Nations General Assembly. Several countries around the world have given a legal framework to these rights. Even in India, the government should set guidelines for the crucial patient-physician relationship as it is the other important aspect of patient awareness.

NEWS Update

IFC Supports India’s Healthcare Sector to Expand Access to Quality Healthcare International Finance Corporation (IFC), a member of the World Bank Group, is the world's largest multilateral investor in private healthcare, with an active portfolio of about $1.7 billion of health investments. IFC investments in the sector are aimed at promoting greater access to affordable, highquality healthcare. In India, IFC’s healthcare investments are over $430 million, representing 25 percent of its global healthcare portfolio. IFC has also supported state governments by structuring innovative health care publicprivate partnerships, bringing reliable private players to expand access to affordable, and quality medical care in India. Like many other emerging markets, India faces a double burden of disease as it seeks to address rapidly rising incidences of non-communicable conditions like heart disease, diabetes and cancer, while also facing unresolved communicable diseases. Innovations in technology and processes are an essential element for expanding access to affordable health services. In 2016, IFC launched TechEmerge, a first of its kind matchmaking program for proven technology companies from around the world which are looking to grow their business in emerging markets. The inaugural phase of the program

is focused on the healthcare sector in India. Following a TechEmerge matchmaking event in New Delhi last June, 17 startups from 7 countries were matched with 15 leading Indian healthcare providers to pilot cutting-edge technologies, with a goal to improve healthcare delivery and patient outcomes. In addition to matching these technologies to Indian healthcare providers, IFC is also providing financial support to facilitate these pilot projects. The TechEmerge Program is being implemented in partnership with the Finnish Ministry of Employment and the Economy and the Israeli Ministry of Economy and Industry. NATHEALTH, the Healthcare Federation of India, is a very valuable partner for IFC. It is a robust platform that brings together various stakeholders in the healthcare ecosystem in India, including many of IFC’s investee partners, to work collaboratively to help address challenges facing the sector. IFC’s Principal Investment Officer, Mr. Matthew Eliot, remarks, “IFC values its collaboration with NATHEALTH. Together with NATHEALTH and its constituent institutions, we are bringing our decades of experience in global emerging markets to help transform India’s healthcare sector and increase access to affordable, quality healthcare”.

Novartis Holds Special Screening to Spread Awareness About Leprosy Did you know that there are over 10 million people in India who need daily care and support but do not receive them? Even the laws cannot help them in spite of them being good citizens of this country. Such is the sorry tale of our country with the world’s largest number of leprosy-affected people. In a bid to shed light upon the social stigma associated with the disease and to spread awareness around it, Novartis, the global healthcare company organized a special documentary screening on leprosy in the city in association with Leprosy Mission Trust India. The documentary was produced by India’s only 2-in-1 channel, NDTV Prime. The documentary titled ‘The Unwanted’ was hosted in order to draw attention to the state of leprosy-affected people by creating a conversation around the subject. Present among the guests were Ms. Swati Maliwal, Chairperson

NCW; Jawed Zia, Country President, Novartis; Dr. Anil Kumar, National Leprosy Eradication Program; Dr. Mary Verghese, The Leprosy Mission Trust India; Mr. KTS Tulsi, Rajya Sabha, Member of Parliament and Senior Advocate of the Supreme Court; Jayashree P Kunju, CA and CEO at iBAS Consulting; Stuti Kakkar, Head of Child Rights Panel by Women and Child Development Ministry; Raghu Rai, renowned photographer, etc. According to a World Health Organisation (WHO), India has reported a steady decline in the number of people with leprosy. However, a global report from 2015 states that 60% of the 2,12,000 people detected with leprosy were from India. WHO norms states that leprosy is eliminated only if the prevalence of the disease is less than one case per 10,000 population, a status which India had achieved in 2005. However, the next step

is to eradicate the disease from roots and have zero cases reported. The thought provoking documentary was aimed to shed light onto the sensitive topic and address the stories of those with Leprosy that range from abandonment, discrimination, pain to physical deformation. It also highlighted the need to render human service to those in need and in the process, help create ways to eradicate the spread of the disease. w w w.medegatetoday.com March 2017

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MedGenome launches “ONCOTRACK”, the Liquid Biopsy blood test for cancer recurrence detection and monitoring India is likely to have over 1.73 Million new cases of cancer and over 880,000 deaths due to the disease by 2020. Around 70% of all cancer patients approach the doctor when the disease has advanced, and the chances of cure are very low. To address and better manage the disease, MedGenome - India’s premier genomics based research and diagnostics company today announced the launch of “ONCOTRACK”. The liquid biopsy based Oncotrack is a non-invasive screening test that is set to transform the way physicians in India can identify genetic alterations, interpret, assess and treat various forms of cancer. “Management of cancer will undergo a massive transformation in India with NGS based liquid biopsies. We are constantly striving to get the most advanced genetic testing technology/technique at affordable prices to the patients and ONCOTRACK is one such offering.”, said Sam Santhosh, Chairman, MedGenome. The test developed entirely by MedGenome, is the only one to be validated in India and verified from samples of cancer patients from across the country. The test screens the samples by analyzing cell-free DNA that is isolated from the patients’ blood. Using high end sequencing technology, the screening process identifies specific gene mutations that are linked with Melanoma, Lung and Colon cancers. The test facilitates detection of mutation where there is difficulty of obtaining biopsy or in the event of a damaged biopsy material and non-availability of tissue biopsy. This offers Oncologists the power to look for actionable alterations in a patient's treatment, management, without having to do an invasive biopsy or where biopsy is not an option. “Liquid biopsy has the capacity to interpret infinite mutations which will pave the way for new drug discovery, research and

Beware of swine flu Bangalore: With more cases of swine flu or H1N1 coming to light, city doctors are urging people to adopt simple measures to prevent the spread of the virus. These include steps like washing hands, covering mouth & nose during coughing or sneezing, avoiding crowded spaces and boosting immunity. However, the good news is that with the soaring temperatures in the city, doctors predict a dip in the number of swine flu cases. “Heat is usually good for infections as it helps in killing the germs. The infections during summers mostly occurs due to the scarcity of water during this season which in turn can lead to the use of contaminated water in various places and poor hygiene. This can cause ailments like skin infections, diarrhoeal diseases, eye infections etc.,” said Dr. Rini Banerjee, Consultant Infectious Disease, Columbia Asia Referral Hospital, Yeshwanthpur “There is no co-relation with monsoon and H1N1. Monsoon season can lead to various infections due to humidity and people 16

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therapies. Over thirty five oncologists in India have already screened patients using our Oncotrack. Further, since it has a very patient friendly approach, we are confident it will be very well accepted by the doctors and patients.” said Dr V.L. Ramprasad, COO, MedGenome. Oncotrack is a proven molecular tool after histopathology diagnosis and detecting molecular changes at baseline and at the time of relapse in lung and colon cancer for deciding the right treatment. The test has been validated in a scientific study, in academic collaboration with Tata Memorial Hospital- Dr Kumar Prabhash, Medical Oncologist and Dr. Amit Dutt, Principal Investigator (Scientist F) at ACTREC, Tata Memorial Centre. Dr.Kumar Prabhash opines that, “As the care gets more personalised, doctors will be equipped to make correct diagnosis, prognosis and prediction of diseases. Cell free tumour DNA (ctDNA) analysis will help in avoiding repeat biopsies of difficult to get tumours and also in monitoring the overall response to treatment on real time basis.” staying indoors to avoid rains, leading to spread in infections. The main reason why we see a rise in H1N1 cases is because proper diagnostic tests are in place and the awareness about H1N1 has increased among the people. Due to this there are more cases being registered. However, the rate of mortality remains the same as earlier,” added the doctor. The symptoms of swine flu are similar to seasonal influenza which include fever with chills, cough, sore throat, headache and body ache, and occasionally associated with nausea and diarrhea. It is pertinent not to ignore any symptom and seek medical attention immediately especially if you have symptoms like shortness of breath, dizziness, vomiting, chest pain. “The H1N1 virus spreads from human to human. It typically spreads when an infected person sneezes in the open and scatters the virus in the air. It also spreads when we touch or shake hands with infected people or touch objects like doorknobs, tables, chairs in public places that may have been infected.,” said Dr. Rini

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In the past decade obesity has pushed kidney patients up by 40% In the last decade, kidney diseases and obesity have become a major health concern with rapid increase in cases along with cancer and cardiac diseases. Clinicians say a combination of these --obesity and chronic kidney disease (CKD) is a lethal condition. According to Dr Sanjeev Gulati, Director, Nephrology, Fortis Institute of Renal Sciences and Transplant (FIRST) at Fortis FLt. Lt. Rajan Dhall Hospital (FHVK) “Focal Segmental Glomerulosclerosis (FSGS) is a dangerous condition that can lead to kidney failure and the only treatment option is dialysis or kidney transplant. And it will be interesting to know that obesity is the leading cause of FSGS.” According to WHO; by 2025, obesity will affect 18% of men and over 21% of women worldwide. A growing body of evidence indicates that obesity is also a potent risk factor for the development of chronic kidney disease (CKD) and endstage renal disease (ESRD). People who are overweight or obese have 2 to 7 more chances of developing ESRD compared to those of normal weight. Obesity may lead to CKD both indirectly by increasing type 2 diabetes, hypertension and heart disease, and also by causing direct kidney damage by increasing the workload of the kidneys and other mechanisms. According to Dr Gulati,“Obesity is the leading cause of CKD directly and indirectly. It is a 50-50 situation. In one condition, obesity directly results in CKD and in the other obesity first increases the metabolic syndrome which results in CKD. In either case we have to treat both of them simultaneously because together they are taking a toll on individuals with dual

speed. In the last five years, obesity has spread to children and childhood obesity is no longer a myth. Like adults, children can also be prone and affected by CKD and as clinicians we see a steady rise in such cases. Over the years I have treated families carrying genes that cause both obesity and CKD and it is scary to know that these can be passed on to the younger generation.” How to keep the two in bay: Exercising regularly  Managing blood sugar levels  Keeping blood pressure at optimum levels  Eating healthy and keeping weight under control  Maintaining a healthy fluid intake, drinking enough water  Avoiding smoking  Avoiding self-medication and over-the-counter pills  Annual check-ups necessary for those above 40 Mr. Sandeep Guduru, Facility Director, Fortis Flt. Lt. Rajan Dhall Hospital, Vasant Kunj (FHVK) said, “The Fortis Institute of Renal Sciences and Transplant (FIRST) since its inception has done more than 900 kidney transplant and we are capable of doing advanced and comprehensive care for all our patients. Under the FIRST we have done more complex kidney transplant, pediatric kidney transplant, AOB incompatible transplant to the patients with HIV. Since day one Dr Gulati and his team has given their best to the patients and pioneered the kidney transplant program at our hospital.”

Asia-Pacific non-small cell lung cancer market to soar to $6.2 billion by 2023, says GBI Research The non-small cell lung cancer (NSCLC) market in the AsiaPacific (APAC) region will more than double from $3 billion in 2016 to $6.2 billion by 2023, representing a substantial compound annual growth rate of 10.8%, according to business intelligence provider GBI Research. The company’s latest report states that this growth will follow the introduction of a number of premium therapies such as Yervoy and necitumumab. Immune-checkpoint inhibitors, such as Opdivo and Keytruda, will also drive growth, with the former recently gaining approval in Japan, Australia and South Korea, and the latter approved only in Japan and currently undergoing Phase III trials in China, Australia, and South Korea. Gayathri Kanika, Analyst for GBI Research, explains: “Owing to strong clinical performances, immune-checkpoint inhibitors will have a greater uptake than other second-line market entrants and will compete among themselves for market share in the APAC region. “Chemotherapy will remain an integral aspect of NSCLC treatment, with platinum-based regimens being crucial in the first-line setting for all patients and docetaxel being a key

therapy for second-line patients. However, the market share of these generic treatments will slowly decline as premium targeted therapies enter the market during the forecast period.” Although new targeted and immuno-therapies will drive market growth, they will also increase the degree of NSCLC market segmentation and the complexity of the treatment algorithm, owing to their enhanced efficacy in specific patient populations. Currently, treatment is primarily determined based on histology and molecular characterizations, with non-squamous patients having greater access to therapy, and patients with epidermal growth factor receptor or anaplastic lymphoma receptor tyrosine kinase mutations having access to premium targeted therapies. Kanika continues: “Broadly speaking, histological and molecular characterization of tumors will play an even more important role in determining the best treatment options in the NSCLC market. The entry of targeted therapies into the market will offset the effect of patent expiries for drugs such as Avastin, Alimta, and Tarceva, which will have a limited impact on the market between 2016 and 2023. w w w.medegatetoday.com March 2017

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INDIA HOPES TO ACHIEVE 90% IMMUNIZATION BY 2021 STRESS ON STRENGTHENING PHARMA SUPPLY CHAIN  Pluss Advanced Technologies supports the cause, with Make in India product - ‘Celsure™’  Celsure™ is a breakthrough innovation which delivers lifesaving vaccines in perfect state Union Health Ministry, Government of India is promoting Universal Immunization Programme and vaccine management at all levels and has fixed 90% immunization targets by the year 2021. Its plans to have a robust immunization process complete from supply to delivery. Pluss Advanced Technologies Pvt. Ltd. has created Celsure™, a unique make-in-India product based of PCM technology which will revolutionize the delivery system of these lifesaving vaccines. According to data in Handbook for Vaccine and Cold Chain Handlers 2nd Edition India 2016, it has been pointed out that India hopes to achieve 90% of immunization coverage in the next 5 years by strengthening its immunization supply chain and has to spend about INR 20,000 million every year in the immunization programme. Samit Jain, Founder, Pluss Advanced Technologies Pvt. Ltd. says, “There have been tremendous efforts by many healthcare organizations and agencies to suffice the growing need of Universal Immunization but, we must not neglect the fact that about 30 to 35% Indian children miss benefits of full immunization every year. The country records about 5.5 to 6 lakh child deaths annually due to vaccine preventable diseases. This calls for an intervention to deliver lifesaving vaccines in time to the targeted beneficiaries. PLUSS brings a breakthrough yet cost effective and innovative product ‘Celsure™’ to ensure vaccine delivery at the desired temperature.. Celsure range is a set of pre-qualified shipping containers which uses the advanced savE® Phase Change Material (PCM) technology to provide the desired temperature maintenance for beyond 96 hours and ensures the vaccine remains effective prior to administration.” According to recent reports, over 25% of vaccines go waste globally, mainly due to losing its potency before the vials were opened. As per the report on vaccines spoilage by Associated Press, of all the wastage in a fiscal year, 62% wastage happens due to spoilage of vaccines, and to the industry it costs more than $ 20 billion in a year. Most of these vaccines expire due to the wrong placement of the data logger which is placed within the ice box to control the temperature of vaccine during transportation. To address this issue of vaccine packaging and solutions organizations, UNICEF suggested under the “Last Mile” project, that Phase Change Material could be potential solution for Vaccine Transportation. 18

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Prof. Somashekhar Nimbalkar, Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand said “As a pediatrician I do understand the significance that vaccines have for humanity. This issue is especially important as it is possible that break in cold chain at the last mile may go unnoticed and less effective vaccination may occur. Using technologies that can prevent this loss of vaccines and under protection of children would help us build healthier adults.” Prof Nimbalkar who is also Ex-President - National Neonatology Forum Gujarat State Chapter and National Coordinator (Scientific and Event) of the USAID funded programme - Helping 100K Babies Survive and Thrive India added, “Indian government is focused on Make in India and this product is necessary for India. It will contribute to the GDP of India in many ways -by lives saved, illnesses reduced and reducing the import bills of similar technologies and provide employment to people in our country.” Pluss Advanced Technologies Pvt. Ltd., is a materials research and manufacturing company involved in the field of specialty polymeric additives and phase change materials. Phase Change Materials (PCMs) are special thermal energy storage materials which store or release large amount of thermal energy while changing phase from solid to liquid or vice-versa at a particular temperature. PCMs can be engineered to work at a variety of temperatures as compared to ice packs which work only at 0º C. PCMs bring in the precision in temperature control critical to the Pharmaceutical Cold Chain. Celsure™ – is a unique PCM based shipping solution for Pharmaceuticals. Celsure™ is a patent pending technology, designed and developed by Pluss, which uses savE® Phase Change Materials combined with high density EPS insulation to give a precise temperature control (2-8º C or 15-25º C) for a period of more than 96 hours. Celsure™ works more effectively and efficiently than the ice packs utilized in other containers. Celsure™ maintains a fixed temperature desired for the vaccine Experts at the Pluss Advanced Technologies Pvt Ltd concluded, with the advent of newer technologies in temperature monitoring, cold chain storage and transportation equipment especially using green energy, stock and inventory management, Celsure™ has high potential to improve the existing supply chain system of vaccines.

NEWS Update

Fecal Calprotectin Test

Gurgaonites need to be Educated about Emotional Well-being: Evaluation of Metropolis Healthcare Author Sharat Kumar  Inflammatory bowel disease (IBD) involves

Alleged suicide by a cop in Sadar Police station in Gurgaon highlights the need to address growing depression among Gurgaonites, feels author Sharat Kumar. An ex- Navy man and a celebrated author, Kumar spoke  IBD can affect people with all ages and sex, but primarily about the importance of emotional well-being which leads to ultimate happiness in life. diagnosis show usually high in young adult due to the varied chronic inflammation of all or part of your digestive tract. IBD primarily includes ulcerative colitis and Crohn's disease. Both usually involve severe diarrhea, pain, fatigue and weight loss.

eating habits that they cultivate. Prevalence of IBD is 10%20%.

 The diagnosis and assessment of IBD have so far been based on clinical evaluation, serum parameters, radiology and endoscopy.  Ideally, patients with IBD need to do Colonoscopy for treatment. Colonoscopy is a test that allows your doctor to look at the inner lining of your large intestine (rectum and colon). They then use a thin, flexible tube called a colonoscope to look at the colon. Though Colonoscopy is gold standard it is invasive, needs sedation and is expensive  Faecal markers such as Calprotectin or Lactoferrin have emerged as new diagnostic tools to detect and monitor intestinal inflammation. The fecal Calprotectin test is a pretest for any patients to detect if they have inflammation. Only if the tests show, then do the patients need to go through colonoscopy.  Retrospective study of the results of Fecal Calprotectin was done for 1 year - May 2015 to May 2016 testing samples Pan India for around 1700 patients.  Basis the tests the interpretations were made of the results. <50 microgram/gram

50 to 200 microgram/gram

>200 microgram/gram

Normal- No inflammation in GIT. No need for invasive procedure.

Mild inflammation. Repeat the measurement and do further work-up

S/O Active organic disease. Further procedure suggested to determine cause.

 Basis the test conducted for children to adults between male and female it was found that predominantely in the samples received by young adults.  Variability can be seen in the concentrations of Calprotectin in stool samples collected during a single day. Since the levels of Calprotectin increases with a longer time between the bowel movements, it seems most appropriate to analyse stool from the first bowel movement in the morning.  National Institute of Health and Care Excellence (NICE) guidelines recommends using FC testing to differentiate between organic or functional disease in patients with new lower GI symptoms where cancer is not suspected.  A basic test of Fecal Calprotectin costs around Rs. 2500.  A prior screening for Calprotectin would result in a 56% reduction in the number of adults and of 58% in children requiring endoscopy.

In an attempt to create awareness about growing depression among Gurgaonites, celebrated author Sharat Kumar met a few like-minded people at Cyber Hub on Sunday and told them about secrets of happiness in life. According to a World Health Organization, nearly nine per cent people in India suffer an extended period of depression within their lifetime, nearly 36 per cent suffered from Major Depressive Episode. In Gurgaon, cases of suicides are continuously going up. “Suicide by a cop in police station on Saturday was quite upsetting. A couple of weeks ago, a medical professional attempted suicide at a metro station in Gurgaon. Despite that Gurgaon is a fast-developing city and offers a lot of opportunities, people feel lack of connect with their families and there is no awareness about emotional well-being,” says Kumar, who himself served in Indian Navy. When asked about need for understanding emotional well-being, Kumar says, “Gurgaon is a cosmopolitan city. Young, enthusiastic working professionals in Gurgaon are well aware about their physical and intellectual well-being. However, nobody even talks about emotional well-being. That is why, modern cities like Gurgaon are witnessing rise in cases of suicides, divorces and depression. There is an urgent need to understand our emotions that most of the times lead to actions in our daily life.” Kumar, who received accolades in the US for his book ‘Orange Moon’, strongly believes that emotional health is the most neglected in today's modern times. “Of the three principal areas of human life — physical, intellectual and emotional — the last has permanent influence on the quality of a person’s life. Reading books, especially fiction, can go in a long way to boost the emotional well-being of a person. It is primarily emotional well-being that leads to success in work, relationships and health," he says. “A good relationship between a man and a woman is the most essential thing in life. He strongly believes, God has made man and woman as one unit. If they work and live their lives as a single unit, tremendous amount of energy gets released and they would accomplish far more things in life. But, how we undermine the power of a good relationship in today's time where career and materialistic success have taken a priority. A healthy man-woman relationship also plays a major role in raising happy and confident children,” says Kumar. w w w.medegatetoday.com March 2017

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National Health Policy 2017 Huge milestone in the history of public healthcare in India. N ational Health Policy 2017:-Patient centric and quality driven, addresses health security and Make-In-India for drugs & devices. N ational Health Policy 2017 proposes raising public health expenditure to 2.5% of the GDP in a time bound manner. T he Main objective of National Health Policy 2017 is to achieve universal access to good quality health care services without anyone having to face financial hardship as a consequence. The Union Cabinet chaired by the Prime Minister Shri Narendra Modi in its meeting on 15th March2017, has approved the National Health Policy 2017, (NHP, 2017). This Policy seeks to reach everyone in a comprehensive integrated way to move towards wellness. Policy aims at achieving universal health coverage and delivering quality health care services to all at affordable cost. Main objective of the National Health Policy 2017 has to achieve the highest possible level of good health and wellbeing, through the preventive health care orientation in all developmental policies, and to achieve universal access to the good quality of health care services without anyone having to face financial hardship as consequences.

Important highlights of the National Health Policy 2017

 The policy aims to raise public healthcare expenditure to 2.5% of GDP from the current 1.4 %, with more than 2/3rd of those resources going towards primary healthcare.  The policy envisages providing a large package of assured comprehensive primary healthcare through the 'Health and 20

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Sh. jp nadda Health Minister of India

Sh. narendra modi Prime Minister of India

Wellness Centers'. It is a comprehensive package which includes the care for the major non-communicable diseases (NCDs), mental health, the geriatric healthcare, palliative care and rehabilitative care services.  This policy aims to ensure availability of 2 beds per 1000 population distributed in a manner to enable access within the golden hour.  In order to provide access and the financial protection, it proposes free drugs, free diagnostics and free emergency and essential healthcare services in all public hospital.  The policy proposes to increase life expectancy from 67.5 to 70 years by the year 2025. Establishing regular tracking of disability adjusted life years (DALY) Index as a measure of burden of disease and its trends by major the categories by the year 2022.  To Reduce total fertility rate (TFR) to 2.1 at national and sub-national level by 2025.  To reduce the mortality rate of children less than 5 years of

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age to 23 (per 1000) by 2025 and maternal mortality rate (MMR) from current levels to 100 by 2020. Reduce infant mortality rate to 28 by the year 2019. Reduce neo-natal mortality to 16 and still birth rate to 'single digit' by 2025.  To improve and strengthen the regulatory environment, the policy seeks putting in the place systems for setting standards and ensuring quality of healthcare.  The policy also looks to reforms in the existing regulatory systems both for easing manufacturing of drugs and devices to promote make in India, as also for reforming medical education.  The policy advocates development of mid-level service providers, nurse practitioners, public health cadre to improve availability of appropriate health human resource.

 Strengthening post market surveillance program for drugs, products and devices  Timely revision of National List of Essential Medicines along with appropriate price control  Regulating use of devices to ensure safety and quality compliance  Standard Regulatory framework for laboratories and imaging centres, specialized emerging services.

 Separate empowered medical tribunal for speedy resolution on disputes and complaints.  National Healthcare standards organisation -maintaining adequate standards in public and private sector.  Grading of establishments and active promotion of standard treatment guidelines

Background of National Health Policy:

Make-In-India for a healthy India

 Special focus on production of Active Pharmaceutical Ingredient (API)  Incentivizing local manufacturing to provide customized indigenous products  Reducing cost with indigenous medical technology and Preventive and promotive focus with pluralistic choice medical devices  Creation of Public Health Management Cadre in all States to optimise health outcomes. Digital interventions for the nation's health  Tracking behaviour change, education and counselling at all  Promoting tele-consultation linking tertiary care institutions with specialist consultation levels.  National Digital Health Authority to regulate, develop and  Interventions from early detection of issues in childhood to deploy digital health prevention of chronic illnesses.  National Knowledge Network for Tele-education, Tele-CM  Plethora of options to choose from among yoga and AYUSH E, Tele-consultations and digital library umbrella of remedies Universal, easily accessible, affordable primary healthcare  Introduction of Electronic Health Record (EHR)  Health Card for access to primary healthcare facility services Intersectoral convergence for holistic healthcare delivery anytime, anywhere.  Partnership & participation of all non-health ministries, communities and academic institutions.  Free health care to victims of gender violence in public and private sector.  Coordinated action on:  Comprehensive primary health care package with geriatric,  Swachh Bharat Abhiyan - sanitation – palliative and rehabilitative care.  Balanced, healthy diets and regular exercises.  Free drugs and diagnostics along with low cost pharmacy  Addressing tobacco, alcohol and substance abuse chains (Jan Aushadhi stores)  Yatri Suraksha - preventing deaths due to rail and road Fostering patient-focus, quality and an assurance based accidents approach  Nirbhaya Nari -against gender violence  Compliance to right of patients to access information on  Reduced stress and improved safety in the work place. condition and treatment. The National Health Policy, 2017 adopted an elaborate procedure for its formulation involving the stakeholder consultations. According to the Government of India formulated the Draft of National Health Policy and placed it in to public domain on 30thDecember 2014. Thereafter following detailed ofconsultations with the stakeholders and State Governments, based on the suggestions received, the Draft National Health System strengthening and strategic engagements  Public health system strengthening shifting from verticals to Policy was further fine-tuned. It received the endorsement an integrated approach of the Central Council for Health & Family Welfare, the apex policy making body, in its Twelfth Conference held on  Strategic purchase of secondary and tertiary care services. 27th February, 2016.  Holistic approach addressing infrastructure and human The last health policy was formulated in 2002. The socio resource gaps economic and epidemiological changes since then necessitated  Synergizing with private and not-for-profit sectors for the formulation of a New National Health Policy to address the critical gap filling current and emerging challenges.

Better regulatory mechanisms and quality control

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International Yoga Fest Morarji Desai National Institute of Yoga (MDNIY) has organised the ‘International Yoga Fest (IYF), a Curtain Raiser for International Day of Yoga (IDY), 2017' to sensitize the masses regarding celebration of IDY. MDNIY successfully organized the 1st International Yoga Fest from 20-22 April, 2016 at Talkatora Indoor Stadium. This year, the International Yoga Fest was organised by MDNIY at Talkatora Indoor Stadium, New Delhi, 110004 from 08-09 March, 2017 & Post Fest Yoga Workshops By Eminent Yoga Masters on March 10th, 2017 at MDNIY, New Delhi

Yog Rishi Swami Ramdev termed Yoga as an integral part of the ancient system of therapy and healing, he stressed that Yoga is way of life and not a religion. The revered Yoga Gurus and Masters also shared their valuable views and enriched the audience throughout the fest.

The Valedictory function of the International Yoga Fest was held on 9th March, 2017 at 5pm at Talkatora Indoor Stadium. Smt. Meenakshi Lekhi, Hon'ble Member of Parliament, Lok Sabha, New Delhi Constituency was the Chief Guest. She stressed that different streams of Yoga are the foundations of The event was organised in association with Indian Yoga practices, discharging true integration of Indian traditions. Yoga Association (IYA), A self-regulatory body of Total registration is 3800 and more than 12000 Yoga enthusiasts leading Yoga Institutions of India, New Delhi and New Delhi participated in the three days long event. Municipal Corporation (NDMC). International Yoga Fest comprised of following important The International Yoga Fest witnessed the auspicious presence events. and discourses by eminent Yoga Gurus like Yog Rishi Swami Ramdev, Dr. H.R. Nagendra, Swami Chidananda Saraswati,  Parallel Yoga Workshops by eminent Yoga Masters

Smt. Hamsa Jayadeva, Swami Bharat Bhushan, Swami  Lecture/ Special Yoga Techniques / Yoga Demo by Yoga Ritawan Bharati, Sister BK Asha, Sh. Swami Atmapriyananda, Masters Sh. S.Sridharan, Swami Darshak, Swami Ullasa, Dr. M. V.  Satsang/ Isha Music/ Discourses/ Cultural Program by Bhole, Dr. Ananda Balayogi, Sadhvi Bhagawati Saraswati, Dr. eminent Yoga Gurus Manoj Naik, Dr. Chandra Singh Jhala and many others from  Yoga Demo by the students of leading Yoga Institutions / Yoga fraternity. Yoga Professionals The International Yoga Fest-2017 was inaugurated by Shri. M. Venkaiah Naidu, Hon’ble Union Minister of Urban A Day Seminar on Life Sketch and Contributions of Swami Development, Housing and Urban Poverty Alleviation and Ved Bharati and Shri T.K.V. Desikachar for the promotion Information & Broadcasting, Govt. of India on 8th March, 2017 and development of Yoga was conducted by Swami Ritawan Bharati & disciples and Sh.S Sridharan & Dr. Kausthub at 11 AM at Talkatora Indoor Stadium, New Delhi-110004. Desikachar respectively along with their team on 9th March, All of you should practice yoga and make it a mass movement 2017. as the ancient practice promotes harmony in the society,” Naidu said. He said yoga was India’s priceless heritage and added Parallel Yoga Workshops from morning to evening by eminent Yoga Gurus and Yoga Masters was conducted from 8th to 10th, that Prime Minister Narendra Modi’s speech at the UNESCO 2017 by leading Yoga Institutions of the country. headquarters paved the path for the UN to pass a resolution for Besides the above main programmes, Yoga Demonstrations, making June 21 as International Yoga Day. Special Yoga Techniques, Cultural programmes, Exhibitions, Shri Shripad Yesso Naik, Minister of State (Independent Quiz, Elocutions, Poster Presentations, etc. will also be Charge), Ministry of AYUSH, Govt. of India presided the conducted during the event. Function. The minister highlighted that lakhs of followers of Indian Yoga Gurus & Masters are engaged in spreading the 40 exhibitions cum sale counter where books, DVDs, Yoga appliances and other Yoga related products were displayed for spirituality and healthy practices of Yoga to the whole world. promotion and sale. Sh. Ajit M Sharan, Secretary, Ministry of AYUSH stressed about different policies like Certification of Yoga professionals POST FEST YOGA WORKSHOPS was conducted by Leading through QCI, opening of Yoga departments in Universities, Yoga Masters of different Schools of Yoga on March 10th, 2017 at MDNIY, New Delhi. Training of Para-Military Personnel's, etc. 22

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NEWS Update

Shivam Medisoft: Facilitating Patients & Hospitals: The healthcare sector is seeing a rapid growth and throwing up new challanges to IT for support in order to keep pace with demands like increased patient sensitivity, better control on operations, accuracy in data etc. Traditionally, IT partners to the hospitals have been seen as essential partners to growth but not user friendly. Taking up such challenges is a 14 yr old incumbent – Shivam Medisoft Services. Based out of Secunderabad, Telangana , it is an ISO 9001:2008 certified hospital management software and EMR solutions provider. Hospital Management software on Mobile Applications: Neosoft , is the Hospital Management software by Shivam that covers the entire chain of IT solutions for a general to multi-speciality hospitals spread over one or multiple locations. The company not only delivers critical information but also manages the finances, stock or medical records of hospitals. HMS requirements in a hospital are mainly categorised into 3 areas: Income- Covering Out Patient, In Patient, Diagnostics, Pharmacy, Ward Management; Expense- Covering Accounts, Human Resource, Payroll, Central purchase Management; and EMR: Doctor Information Systems. It also provides interactive mobile applications for better control. Several hospitals including a multispecialty hospital in Jalandhar and Mother & Child in Hyderabad, are two of the many clients of Shivam Medisoft, who have been benefited from NeoSoft. The customers practice paperless OP

EMR, Task Management Bubbles at Pharmacy and nursing stations to reduce working time. Additionally, auto indent, auto consumption, auto stock through reorders level & reorder quantity help in smooth error free operations. In Go Green hospitals, patients take online appointments through Mobile/Internet and pay via mobile. Patients may even directly visit the consultant at the time of appointment through queue management system, get prescription on mobiles and carry other reports on mobile as well. Go Green hospitals are run on PCs, Tablets, Mobiles and there are direct savings in terms of cost. Innovative ‘Bubbles’ - Task Management Software: One of the most challenging part in any HMS is making it user friendly so that in-spite of its good features it should be used by the end user. Though Medical Consultants use smart phones yet they avoid EMR due to cumbursome operations and time consumption. Shivam Medisoft has simplified and developed EMR that works easier than an email. The company has introduced EMR that works on ‘one touch’ & Bubbles. It has an auto prescription facility which takes 80 percent less time as compared to writing physically. Accuracy of prescription by doctor and medication by nursing staff etc. are taken care by Shivam’s DIS and Ward Management modules. Also, the EMR features options like “My Favourite “ and “Templates” which are the customized ordering formats for every doctor. Not only does it comply with the recent laws of writing prescriptions, but

is user friendly that gives a doctor more time with patients and order error free prescriptions every time. With revisiting customers, the company has spent more than 14 years in the HMS segment, successfully serving approximately 600 hospitals with HMSNeosoft. The organization follows a protocol comprising a 4 step process – Framework, Bubbles, robust security and multi location single database. Shivam Medisoft first understands the client’s changing requirements, the “Framework”; the need to automate processes, the “Bubbles“; the need to control pilferages, the “Robust Security”, and eventually the need to reduce cost, i.e. the company’s capability for “Multi location single database” solution. The company also offers customized Hospital Mobile App named after the hospital using it. The healthcare industry is moving towards an organised structure exhibiting multiple hospitals under the umbrella of one brand. Shivam Medisoft has served an assortment of clients since 2002- including Shri Action Balaji (Action Shoes Group), Maharaja Agrasen Hospital in Delhi, Fernandez Hospital in Hyderabad and Patel Hospital in Jalandhar with some recents customers like Kamal Nayan Bajaj Hospital in Aurangabad. With customer understanding, adherence to process, honesty in approach paying the dividends, the company has endeavoured to reduce the patient wait time and effort to get medication and continues to do so today. w w w.medegatetoday.com March 2017

DOCTOR SPEAK

Heart and Blood Vessel Problems Also Seem to Be Stemming from Vitamin D Deficiency

Dr. Ajay H. Kantharia M.D. Consulting Physician & Cardiologist Critical Care Physician Saifee Hospital, Sir H. N. Hospital, and Smt. Motiben B. Dalvi Hospital.

Apart from General Medicine, he has large number of patients suffering from Ischemic Heart Disease, Cerebrovascular Disease, (Stroke) , Hypertension, Asthma, Diabetes, etc. He is a Critical Care Physician and his opinion on Critically ill patients and his participation in patient care is always in demand.

Introduction

Adults and/or children that have a Vitamin D (25-hydroxyvitamin) level of less than 50 nmol/l (20 ng/l) can be considered as deficient in Vitamin D. Strikingly, approximately 30% to 50% of all healthy, middle aged to elderly adults of the entire world population are found to be deficient is Vitamin D. It is now known that by regulating the levels and function of Calcium levels inside the heart cells, Vitamin D can affect the ability of the heart cells to contract and function optimally. Many scientific reports are now proving that Vitamin deficiency is the direct cause behind heart and blood vessel (cardiovascular) diseases such as angina, heart attacks, congestive heart failure and stroke. 24

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Heart and blood vessel problems and their associated with many inflammatory relationship with Vitamin D deficiency cells in the body, and taking Vitamin D supplementation has been found to lower High blood Pressure the overall inflammation in the body and The active form of Vitamin D, Calcitriol boost the immune system. (1,25-dihydroxyvitamin D) influences all the cells of the body. In some studies, Stroke people taking Calcitriol supplements Stroke seems be another disease which is have been found to have lower blood linked to Vitamin D deficiency due to the pressure. In other study, elderly women changes Vitamin D deficiency causes in benefitted from daily Calcium and the small blood vessels of the brain. This Calcitriol supplements since their blood has been confirmed by imaging studies pressure was found to be significantly of the brain using MRI. lower and they also experienced a lowered heart rate. These benefits were Conclusion not seen in those women taking only The risk of cardiovascular death is higher Calcium. This finding indicates that in patients with Vitamin D deficiency. Vitamin D may have been the primary This has been proven in many studies. cause of these benefits. The risk of death, heart attack, stroke and heart failure are all higher in patients Heart arteries/Coronary with Vitamin D deficiency even if they artery disease don't have any prior cardiovascular Many scientific studies have shown that diseases. the risk factors that encourage heart and blood vessel problems such as the Vitamin D deficiency is treatable and deposit of fatty material which produces daily supplementation is inexpensive. narrowing of the blood vessels, high Maintaining an optimal levels of blood pressure, high cholesterol in the Vitamin D seems to be very important blood, high level of fatty acids in the in controlling cardiovascular risk, blood, diabetes, and obesity have all been blood pressure, stroke and other heart found to be significantly associated with diseases. Supplementation Should be deficiencies of Vitamin D. Hard calcium taken daily as a simple and important deposits in the walls of the arteries which prevention from disease and death from narrow and constrict the normal flow of cardiovascular risk in elderly people. blood through the arteries seem to be the central cause for these findings. Vitamin Take home points It is now being discovered that so D supplements, when given to kidney  many risk factors leading to serious disease patients on hemodialysis, were found to lower the chances of death illnesses and deaths are associated from heart and blood vessel diseases. if with Vitamin D deficiency. their It has been proven that when low  It is now clear that cardiovascular Vitamin D levels are seen in patients diseases and its complications are with high blood pressure, they are at a associated with Vitamin D deficiency. greater risk of angina, heart attacks and There is now enough evidence that heart failure. Since these risks are even  Vitamin D supplementation has been more pronounced in males, men should a neglected area of study. also ensure that they take Vitamin D supplements.  It seems very important to take

Heart failure

Vitamin D deficiency also seems to be related to higher chances of heart failure. Vitamin D deficiency has been

Vitamin D supplements to lessen the affect and impact of cardiovascular diseases, and the illness and deaths caused from them.

DOCTOR SPEAK

Avoiding pregnancy know the aftermath. (Reality vs. myths) Dr. Seema Sharma

Obstetrician-Gynecologist Srishti- The Gynae clinic, New Delhi

In today’s fast-paced modern living, women are becoming more and more career – oriented. This along with relationship woes, financial issues and personal problems is creating the perennial dilemma of when to conceive. I am fit…. would that help me tide over fertility decline? Till a clear consensus is reached in the family, many women delay their pregnancy thereby increasing their risk of medical problems. Many women are not aware that there is a natural age related decline in fertility. As they get older, the ability of their bodies to produce good quality eggs decreases. This change is inevitable and is not reversed by exercise or reducing weight.

Is age that big an issue? While many dismiss stories of the complications of late motherhood such as lowered fertility and health risks to mother and child - as propaganda, as doctors we insist women who delay it or opt not to get pregnant face real problems. So, what is the age cut off to conceive? While there is no real cut off age by which one should complete the family, our Indian woman show a faster age related decline in egg reserves as compared to western women. As a result, we as doctors press the panic alarm faster and try to over treat the woman instead of a longer wait and watch policy which is adopted by our western counterparts. If possible one should conceive by 30 years and definitely before 35 years. What are the problems that one is likely to encounter if one conceives late? There are higher age related pregnancy complications like increased miscarriage rate and pregnancy wastages due to baby being abnormal. There may be an increase in genetic syndromes and mental retardation in a baby due to aging eggs. Thankfully, blood tests done during pregnancy and ultrasound can detect majority of problems in the baby before delivery. 3D and 4D ultrasounds done by competent doctors can almost rule out all structural defects in the baby but still there are many other problems especially the mental development aspect which one is never sure of. Also, as we age there is a natural increase in medical problems like sugar and blood pressure among others. This can further complicate a pregnancy and force early intervention by the doctors. The baby is more likely to be premature and have associated complications requiring nursery admissions etc.

Older mothers are also less likely to achieve normal deliveries as their tissues have become less pliable. We as doctors also resort to cesarean earlier in such mothers as their pregnancies are usually conceived with difficulty and considering their age they may not get many more chances at it. Having said all of it, I still strongly feel that a couple should conceive only when they are ready to welcome a baby into this world. One can visit their gynecologist and get their fertility assessment done to get a clearer picture of the time available to conceive safely. Please do not conceive just because otherwise age related complications would increase. Bringing up a baby when you are emotionally or financially not ready is very difficult and leads to poor up- bringing, higher depression rates and marital disharmony. No matter what the dadi ‘s and the nani’s are saying, listen to your own inner self and make an informed choice.

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DOCTOR SPEAK

Diabetes and its complications are influenced by Vitamin D deficiency Vitamin D and damage to the nerves

About one third of diabetic patients experience problems with their nervous system leading to numbness, jolting pain, and irritation. By taking Vitamin D supplements diabetic patients can ensure that their nerves will be less prone to damage from their diabetic condition. The pain experienced due to nerve damage is worsened when Vitamin D deficiency exists in Diabetic patients.

Vitamin D and the effect on our kidneys

Kidney disease, which frequently occurs in diabetics is a cause for low Vitamin D levels. Vitamin D supplementation in these patients has been shown to reduce the chances of heart disease and death in these patients.

Vitamin D and problems of the eyes

DR. PRADEEP V. GADGE MD (Medicine), DPH, Diploma in Diabetology, FRSH

Introduction

All over the world deficiencies of Vitamin D are rising. In the recent years, researchers have shown a link between Vitamin D deficiency and the inability for the body to make insulin, a hormone required for maintaining normal blood sugar. It is also becoming clearer that Vitamin D deficiency is associated with developing diabetes and/or worsening of diabetic complications such as painful nerves in the limbs. Vitamin D deficiency also seems to increase the risk of heart and vessel disease.

Vitamin D and Diabetes

There is plenty of evidence that shows that low levels of vitamin D lead to higher rates of deaths due to diabetes itself and/or due to the various complications of diabetes such as nerve damage, kidney failure and eye problems. Adults that suffer from diabetes and are not on insulin seem to benefit from taking Vitamin D supplementation. Another 30 year study also proved that taking Vitamin D as a supplement daily in the first year of life reduces the chances of developing insulin dependent diabetes in children. Patients taking Vitamin D supplements also seem to require less insulin levels when being supplemented with Vitamin D. Diabetic complications are also known to occur more when patients have lower levels of Vitamin D. Severe Vitamin D deficiency causes worsening of diabetic complications and earlier deaths in diabetics also. 26

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Eye disease is another known complication of diabetic patients and as such, diabetes is the leading cause of blindness in patients. Several studies have found an association between Vitamin D deficiency and the early aging of the eyes and premature thinning of the layer that produces vision in our eyes. Diabetic patients with Vitamin D deficiency are known to have worsening of their eye health and present with greater complications.

Summary and Conclusions - Key Points

 The occurrence of Vitamin D deficiency is in high proportions in the entire world , particularly in the diabetic population.  Vitamin D appears to play a very important role in the development, long-term complications, also in the treatment of diabetes.  Studies point to long term Vitamin D deficiency as being a cause of diabetic complications and producing worse painful symptoms with more nerve damage.  Adequate Vitamin D supplementation may help to reduce the number of complications in diabetic patients and better control their sugar levels.  Since Vitamin D can enhance the use of insulin by the body it can be concluded to have an effect on prevention, diabetic control and better management of complications.  Vitamin D supplement therapy represents a promising way to better manage diabetic complications. Vitamin D supplements can thus be used by the general population as a simple and cheap solution to reduce the occurrence of diabetes and also reduce the impact of diabetes complications. Vitamin D supplementation is a safe and effective method to minimize and treat the various complications of diabetes.

DOCTOR SPEAK

Total

Knee Replacement

Dr. Gaurav Bhardwaj M.S. (Ortho), MCh (Liverpool), FRCS (Ortho) UK MRCS (Edinburgh), AFRCS (Ireland) Chief Knee & Hip Replacement & Arthroscopy

the latest trends

Total knee replacement surgery is well established surgery which provides a painfree, independent life back to the patients who are crippled by pain and immobility because of arthritis.According to the American Academy of Orthopedic Surgeons, 90 percent of people who have a knee replacement have excellent pain relief. These people are able to perform daily activities and stay active. In many cases, theyâ&#x20AC;&#x2122;re able to resume activities like golf and walking that their arthritic pain made them give up years ago. About 85 percent of artificial knees still work after 20 years. Their endurance is one reason that this procedure is so popular. Most people who undergo a knee replacement are between the ages of 50 and80.The average age is about 70. About 60 percent of the recipients are women. The procedure has a high success rate and is considered very safe and effective.Â But as demands from knee replacement increase, the research is continuously going on to improve the outcome of the knees in 100 percent of cases and give them a very long lasting knee replacement with a normal life where patient can be allowed to do all activities like kneeling down and even squatting and running. The most important factors to look in as latest improvements in knee replacements are mainly 4 as follows` Exact alignment of new knee implant so they last longer (similar to fitting in new tyres in car with exact alignment and balancing). For this purpose navigation systems were used but could not prove to make any significant difference in results and therefore are not of much clinical significant benefit and their use is mainly as marketing tools. Expertise, training and experience of your surgeon is most important factor in achieving alignment consistently. Other important aspect is implants size and shapes matches to individual patients to ensure proper fits. as one size fits all approach doesnot work in all. So far only patient specific instrumentations are being offered. They are only instrumentation to aid surgeons but this is NOT patient specific implants though this is not uncommon for patients to misinterpret them otherwise. Cpmpanies are bringing gender specific knee replacements for male and female patients. To aid and to gain near normal movements at replaced knee, the new designs are being used which can full bending of knee

like kneeling down, as this is important for religious reasons and social life style in several part of world. These implants, known as Hi Flex knees are very successful in returning the normal knee movements when compared before surgery. Now a days, more emphasis is on quicker recovery and minimum pain after the surgery. For this smaller incisions and aggressive pain control measures are being used with excellent outcomes. Now a days patient stay in hospital is decreasing and patients are being sent home earlier due to quicker recovery. Partial replacements are gaining popularity as rather than changing the whole knee only part of knee which is damaged is changed. This is called unicondylar knee replacements. In suitable patients this procedure results in quicker recovery and almost full normal functions of the knee. Not all patients are suitable for this partial replacements. This is exciting times as knee replacement. Now a days this is very common to get impressed by aggressive marketing claims. Therefore, when choosing the surgery for knee replacement, the most important factor is to trust on expertise and experience of your surgeon and discuss the best option for you.

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INTERVIEW

DR. NAVEEN NISHCHAL Co-Founder, CYGNUS HOSPITALS Alumunus- INSEAD, FRANCE Chairman-Voice of Healthcare (VOH)

Healthcare is an amalgamation of various nuances which makes it a unique sector to work in. There are social, cultural, emotional, financial and political aspects to it, to name a few. I see a lot of passionate innovators in healthcare industry today and everyone comes up with a unique idea to transform healthcare. My advice to them would be to experiment with a prototype with minimum capital expenditure to test the key uncertainties in their business and get their hands dirtied in the field. That said, there are examples of various successful ventures that have emerged with the start up boom in our country. I wish all of them the very best for making a difference in this field which holds a vast potential for change.

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INTERVIEW Please tell us something about your entrepreneurship journey in healthcare? My entrepreneurship journey in healthcare has been quite exciting this far. I started out in 2008, with an ‘asset light model’ of operating hospitals with the focus to provide tertiary care in tier 2 and 3 cities. My first venture proved to be a success which provided me the confidence that the model was scalable and could be replicated in regions with similar demography. I was fortunate to have an angel investor and mentor on board to guide me through the process of expanding our operations and number of facilities. Later on, we received seed funding from Sequoia Capital, which helped in scaling up from a single facility to four hospitals within a span of 3 years. It has been five years since our Cygnus journey first started. With our experience and learnings over the years, we are better equipped to serve the tier 2 and tier 3 cities. We intend to expand ‘Cygnus’ brand to these regions which are still underserved in terms of quality of healthcare infrastructure and services.

ability to pay, alongside increased price competitiveness in a fragmented and price-sensitive market with limited insurance penetration. While several hurdles do exist, the chances of failure are far from overwhelming and the fruits of success are great.

What are your plans for VOH? VOH is a people’s organization. It was conceptualized with the aim of being a discerning & visionary think tank for healthcare sector in India. I am only one of the ‘torch bearers’ in this relay race. At VOH, we are trying to connect with each and every stakeholder of healthcare industry right from grass-roots level to the leadership at public and private institutions in shaping innovative solutions and collaborating towards policy framing and advocacy initiatives.

Please tell us about your Cygnus Model? Cygnus is essentially a chain of hospitals of tier 2 and tier 3 cities of India. It operates on an ‘asset light model’ across its facilities. Under this model, the capital investment is largely limited to medical equipment and refurbishment of the facilities. The philosophy revolves around ‘Golden Hour’ period, where we intend to provide those medical services where time is of great essence. A typical Cygnus hospital is equipped with Neuro-Trauma centres, Intensive Care units, Cardiology services along with modular OT, Radiology unit, a Physiotherapy center, Pharmacy and Dental facility apart from providing other secondary services.

What are some of the challenges you are facing in tier 2 and tier 3 cities? Some of the key challenges that have cropped up in the recent years have been availability of medical professionals in these regions. While we have been effective in managing to rope in the regional talent in all these markets, it has not been easy to attract qualified specialists and super-specialists and we are adopting various innovative strategies to engage and retain these professionals in our facilities. Another major hurdle is in receiving necessary approvals from the government which affect services in a big way. We have to accept that with the current state of demand for quality healthcare, govt. cannot suffice as the sole provider and will have to pave way for private facilities in meeting the healthcare needs of these regions. Revenue realization is another constraint given that these markets are typically priced at a significant discount to metros. Tier-II towns witness limited willingness and w w w.medegatetoday.com March 2017

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Strict or Stringent National Regulatory Authority for Procurement of anti-Tuberculosis Medicines? John F. Loeber, Port-au-Prince, Haiti

John loeber With a background in law and engineering John F. Loeber, a national of Ireland and Germany and currently Chief Procurement Officer in the UN Stabilization Mission in Haiti (MINUSTAH), has over 25 years’ experience in the UN System (UN, UNHCR, WHO, UNICEF), EU, national systems and the private sector. His expertise is in public procurement, legal affairs, risk management and technical cooperation, with a focus on Global Public Health from 2004 to 2014. Additional areas of expertise encompass programme and project management, ERP systems, product innovation, grant management, internal control and training. In more than 14 years with the UN, Mr. Loeber has overseen procurement totalling about 1 bn US$ and handled international contracts amounting to approximately 4 bn US$. His professional activities have been supplemented by voluntary ones, e.g. as Staff Member of the WHO Board of Appeal, WHO and UNHCR Staff Association Polling Officer, Editorial Adviser of the WHO Bulletin, and also as Board Chair of the Copenhagen International School.

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This article examines the requirement of strict or stringent National Regulatory Authority (NRA) environments for procurement of anti-tuberculosis (TB) medicines, with specific focus on the World Health Organisation, United Nations Office for Project Services, Stop TB Partnership/ Global Drug Facility and The Global Fund to Fight Aids, Tuberculosis and Malaria. The Global Drug Facility (GDF) operates as the procurement arm of the Stop TB Partnership (TBP) Secretariat, hosted at the World Health Organization (WHO), Geneva, Switzerland, from 2001 until 2014 and forthwith at the United Nations Office for Project Services (UNOPS). The Stop TB Partnership is a network of some 1,300 governments, donors, industry, NGOs, academia and other partners, joined in the common fight against tuberculosis (TB). The TBP i.a. provides access for countries to quality assured, affordable anti-TB medicines via GDF. As of 2014 GDF has delivered medicines for 24 mn TB patients to 133 countries in thirteen years of operation, financed by bilateral and multilateral donors such as USAID, The Global Fund to Fight Aids, Tuberculosis and Malaria (GFATM) and UNITAID. GDF’s annual purchases of TB medicines amounted to about 200 mn US$ in 2013, and the GFATM disbursed approximately 500 mn US$ for TB in 2015.

Stringent NRA requirement A condition for procurement of anti-TB medicines by the GDF or its facilitation of direct procurement by countries has been and continues to be that medicines are approved under the WHO Prequalification Programme or licensed for marketing by stringent National Regulatory Authorities (NRAs). This is established in the GDF Quality Assurance Policy. The same standard is applied by the GFATM as well as other financing institutions and procurement entities such as UNITAID and UNDP. On further examination, GDF and the GFATM define the term “stringent” as being a Member, Observer or Associate of the International Council for Harmonisation (ICH). The ICH, founded in 1990, is an association “bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration”. Current ICH Regulatory Members or Associates are Brazil, Canada, the EU, Japan, South Korea, Switzerland and the US. In regard to ICH Members having newly acceded to the EU such as Cyprus, Lithuania, Malta, Poland and Latvia, the GDF Quality Assurance Policy principles additionally

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provide that “GDF will consult with relevant WHO experts on the progress in adjusting their pharmaceutical legislation to EU laws before recognizing the approval by the national health authorities”. From 2015, a range of Regulatory Authorities joined the ICH as Observers, namely Australia, Chinese Taipei, Cuba, India, Kazakhstan, Mexico, Russia, Singapore and South Africa . Both GDF’s and the GFATM’s Quality Assurance Policies, which antedate 2015, limit recognition to “an ICH Observer, being the European Free Trade Association (EFTA) as represented by Swiss Medic, Health Canada and World Health Organization (WHO) (as may be updated from time to time)”. Despite the closing adjustment clause, given the significant development in ICH Observers and the generally restrictive nature of both organizations’ policies, including the specific formulation of this provision, referring mainly to associations and only to one individual authority, moreover now an ICH “Standing Regulatory Member”, it cannot be deduced that the nine new ICH Observers are currently recognized as representing stringent regulatory environments. The conclusion must also be drawn in view of issuance of tenders for first- and second-line anti-TB medicines in October and February 2016 with reference to the unchanged GDF Quality Assurance Policy, hence apparent lack of sourcing from those countries on the basis of ICH Observer status, as well as the absence of media releases to the contrary or other forms of clarification by the two organisations since 2015 on these significant developments at ICH. As a further qualifying option, according to the GDF Policy it will be sufficient that products are “approved or subject to a positive opinion under the Canada S.C. 2004, c. 23 (Bill C-9) procedure, or Art. 58 of European Union Regulation (EC9 No. 726/2004) or United States FDA tentative approval”, i.e. interim approvals have been given by this set of countries/intergovernmental organisation. A next to identical regulation is found in the GFATM’s Quality Assurance Policy. In the event that none of the above requirements are met, GDF’s Quality Assurance policy then allows that “Products shall be found acceptable to the GDF through a quality risk/benefit assessment process involving an Expert Review Panel (ERP)”. While this specific, exceptional process was managed by the GDF itself until 2009/2010, the ERP assessment was forthwith handled by the GFATM, in cooperation with GDF. The GFATM respectively refers to this process on its website and linked material. Under this backup process, for which approvals are limited to a 12-month period, product submissions must be pending with either the WHO Prequalification Programme or a stringent NRA. Also, the product must have been produced at a manufacturing site that was inspected and found acceptable by either the WHO Prequalification Programme,

a stringent NRA or a regulatory authority participating in the Pharmaceutical Inspection Cooperation Scheme (PIC/S). PIC/S was established in 1995 as an extension to the Pharmaceutical Inspection Convention (PIC) of 1970. There are currently 49 participating authorities (Members) in PIC/S, including beyond the 10 founding members from EFTA the following new entrants from 2000: Argentina (2008), Chinese Taipei (2013), Hong Kong (2016), Indonesia (2012), Israel (2009), Korea (Rep. of) (2014), Malaysia (2002), New Zealand (2013), Singapore (2000), South Africa (2007), Thailand (2016) and Ukraine (2011). In regard to accepting PIC/S, the GDF Quality Assurance Policy nevertheless contains a similar caveat as for the ICH, stating that “For any new PIC/s Member GDF will consult with relevant WHO experts on the level of equivalence of the GMP inspection level to those of old members PICs countries.”

Anti-TB Medicines Sourcing according to GDF and GFATM QA Policies

Strict NRA standard The above definitions, despite developments in recent years in expanding membership and observers of ICH and PIC/S, remain in stark contrast to a meanwhile long-standing respective resolution of 2009. The particular wording “strict” instead of “stringent” in regard to NRA standards was agreed on as a compromise after debate among Member States lasting several days since the start of the WHA on 18 May 2009. Draft wordings on either end of the spectrum were put forward, favoring no specific qualification in referring to regulatory authority standards (China), to maintaining the term “stringent” (US, Canada). The discussion resulting in the term “strict” was driven i.a. by Thailand, supported by other developing and middle income countries. Finally, before closing of the WHA on 22 May 2009, the proposed wording “strict” was agreed upon for Resolution WHA 62.15. w w w.medegatetoday.com March 2017

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While reaching agreement on the Resolution in the final session of the 2009 WHA, the text nevertheless omitted to define the new term “strict”. Though the change in terminology was recognized in the subsequent period in some discussions or on an individual level, there is no identifiable public record of formal attempts of stakeholders to capture or further specify the term. It could e.g. have been expected that a Working Group of Experts had been established, deliberating on the term and advising on possible consequences. A risk-based categorization scheme for procurement could have e.g. been an output from such Group, coupled with recommendations on supplementary needed quality control in procurement (pre-shipment inspection, sampling and laboratory testing, post-delivery monitoring and control). Similarly, proposals for simultaneous strengthening of national regulatory authorities which had thus been newly qualified

for sourcing pharmaceuticals could have been made by the Group. In this vein and/or as a consequence, since 2009 no principle change in approach in pharmaceutical procurement for TB medicines, in particular in respect of the applicable quality assurance policy, could be identified at WHO, the Stop TB Partnership/GDF, the GFATM or UNITAID. This appeared as a missed opportunity, as the change of terminology provided the chance to strengthen sourcing for TB, i.e. widening the supplier base. For such expansion, improved availability and lead times for pharmaceuticals as well as lower prices could regularly have been expected. This would have freed up funds to reach more patients, particularly for drug-resistant TB, and/or provide TB care or meet other related public health needs, for which there was continuous shortage of funds.

Resolution WHA 62.15 on Prevention and control of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis, adopted by the World Health Assembly (WHA) on 22 May 2009, urged Member States in its Art. 1 (1) (h): “to achieve universal access to diagnosis and treatment of multidrug-resistant and extensively drug-resistant tuberculosis … by means of: (h) ensuring uninterrupted supply of first- and second-line medicines for tuberculosis treatment, which meet WHO prequalification standards or strict national regulatory authority standards” WHA Resolution 62.15 of 22 May 2009

Considering the text of the WHA Resolution and taking into account the history of its drafting process and the achieved agreement among Member States after days of debate, WHA 62.15 appeared as a clear direction to view antiTB medicines meeting strict national regulatory authority standards as being necessary and sufficient under technical and fair competition aspects in public procurement. Fixing the broader term strict as a starting position, the WHA Resolution would then have the innate intent to expand procurement to forthwith include a next tier of advanced countries among the sources from which medicines could be purchased to treat TB. The positive development of additional members or observers recently joining ICH and PIC/S, after otherwise years of inaction by TB stakeholders, cannot replace or render WHA Resolution 62.15 obsolete in this regard. A dedicated examination of the Resolution’s meaning and its consequences remain indicated, identifying and closing gaps for implementation. Moreover, as established above, it cannot be deduced that the regulatory authorities having joined ICH as Observers since 2015 indeed meet GDF’s and the GFATM’s definition of stringent Regulatory Authorities. Additionally, the caveats contained in GDF’s quality assurance policy in ultimately in fact recognising new members as equivalent, i.e. reserving the right to disregard the status of such new entrants, is not systemic and appears unwarranted. In considering contenders for such second-tier sourcing opportunities for TB medicines, aside from necessary regulatory, administrative and legislative assessments, 32

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annual pharmaceutical export volumes may serve as in indication. According to data published by The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), the following countries - whose national regulatory authorities are currently not ICH Members, Associates or Observers (nine new ones since 2015) - are among the leading pharmaceutical exporters in the world, with more than 500 million US$ in annual sales:

Argentina, China, Hong Kong, Israel, Jordan, Panama, Turkey

National regulatory authorities from these countries would therefore need to be examined with respect to their qualification as strict national regulatory authorities, or runner-ups thereto. Substantial potential sales in global supply markets for TB-medicines, worth several hundred million US$ annually, are currently also not being realised due to this categorisation, particularly since nearly all TB-medicines are off-patent. Some advanced industrialised countries appear as clear contenders for procurement of TB medicines, particularly those already admitted to PIC/S. Progress in countries such as India and China in recent years to reach global standards has also been noteworthy. Furthermore, national regulatory authorities from countries with lesser sales, but nonetheless reputable regulatory systems may be considered under the new categorisation, such as Indonesia, Malaysia, New Zealand, Thailand, Ukraine, Vietnam and several countries in the Mediterranean Region. Under the existing quality assurance policies of the major TB medicines procurers considered herein, manufacturers from these next tier countries would be limited in qualifying

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Country Germany Switzerland Belgium United States* France United Kingdom Ireland Italy Netherlands Spain India Austria Sweden Israel Singapore Denmark Canada Hungary China Australia Slovenia Poland Japan Mexico Czech Rep. Hong Kong SAR China Greece Panama Brazil Romania South Korea Finland Argentina Bulgaria Portugal Turkey Norway Russia Jordan Croatia

See in this regard the following comparator table: NRA recog-nised as Pharmaceutical Exports ICH PIC/S stringent by GDF/ (mn US$) Affiliation Member GFATM 69483 56628 47864 36215 35414

Y Y Y Y Y

Y N Y Y Y

Y Y Y Y Y

30763

24715 22909 21077 12487 11444 8317 7054 6030 5850 5559 5007 4095 3550 3285 2992 2935 2826 1503 1499

Y Y Y Y Y Y Y N Y Y Y Y N Y Y Y Y Y Y

Y Y Y Y N Y Y Y Y Y Y Y Y N Y Y Y N Y

Y Y Y Y N Y Y N N Y Y ? N N ? ? Y N ?

1498

1357 1338 1221 1208 1102 1005 957 872 863 709 677 648 615 518

Y N Y Y Y Y N Y Y N N Y N Y

Y N N Y Y Y Y Y Y N Y N N Y

Y N Y ? Y Y N ? Y N Y N N ?

Comparator Table Pharmaceutical Sales 2013 and current ICH, PIC/S Affiliation, GDF/GFATM qualification (*excluding Puerto Rico sales, 40420 mn US$)

their products under the WHO Prequalification Programme, applying/awaiting ICH Membership/Observer status, interim procedures with the Canada, EU, US regulatory authorities, or otherwise the exceptional ERP process. This raises also the political and diplomatic question whether manufacturers from these advanced countries can indeed be expected to submit dossiers under the WHO Prequalification Programme in order to be considered for anti-TB medicines procurement. This appears unlikely and could also be a reason why manufacturers from these countries are not widely seen engaging in the business of anti-TB medicines supply or investing in it. Overriding institutional and functional concerns also raise general doubt on the approach taken in sourcing TB medicines. There is first the issue of UN organizations accepting tied aid from donors. Second, for the core question of determining the markets from which products can be sourced, it does not seem

appropriate for public procurement functions of organisations in the UN System to outsource such central issue â&#x20AC;&#x201C; moreover without an established accountability relationship - to an external entity, however well qualified it may be. Determining eligible supply sources, or defining these so as to enable direct identification, remains a core function of public procurement in the UN. These could, as mentioned, be well linked to a risk assessment scheme. In conclusion, TB stakeholders are called on to set about establishing a definition of strict national regulatory authorities and to align their quality assurance policies with such definition. Such undertaking will achieve compliance with WHA 62.15 and would be serving the public interest by realizing fair competition and thereby regularly increasing access to affordable medicines. For TB, this would mean an improvement in global TB-control and contributing to ultimate elimination of TB, both for drugresistant and drug-susceptible forms of TB. w w w.medegatetoday.com March 2017

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