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	<title>Central Drugs Standard Control Organization Archives - InnoHEALTH magazine</title>
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		<title>Post Antibiotic World</title>
		<link>https://innohealthmagazine.com/2019/issues/post-antibiotic-world/</link>
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		<dc:creator><![CDATA[InnoHEALTH Magazine]]></dc:creator>
		<pubDate>Mon, 18 Nov 2019 09:25:20 +0000</pubDate>
				<category><![CDATA[Issues]]></category>
		<category><![CDATA[AMR]]></category>
		<category><![CDATA[antibiotic]]></category>
		<category><![CDATA[antibiotic waste]]></category>
		<category><![CDATA[Antimicrobial resistance]]></category>
		<category><![CDATA[Bacteria]]></category>
		<category><![CDATA[Biological]]></category>
		<category><![CDATA[biomass]]></category>
		<category><![CDATA[bioreactor]]></category>
		<category><![CDATA[Central Drugs Standard Control Organization]]></category>
		<category><![CDATA[DNA]]></category>
		<category><![CDATA[filter]]></category>
		<category><![CDATA[first generation]]></category>
		<category><![CDATA[Food Security and standards authority of India]]></category>
		<category><![CDATA[FSSAI]]></category>
		<category><![CDATA[genes]]></category>
		<category><![CDATA[Global action plan]]></category>
		<category><![CDATA[groundwater]]></category>
		<category><![CDATA[guardian of the world]]></category>
		<category><![CDATA[IMA]]></category>
		<category><![CDATA[Indian Medical Association]]></category>
		<category><![CDATA[Infection]]></category>
		<category><![CDATA[irver water]]></category>
		<category><![CDATA[management of waste water]]></category>
		<category><![CDATA[Medicines]]></category>
		<category><![CDATA[membrane bioreactor]]></category>
		<category><![CDATA[metabolization]]></category>
		<category><![CDATA[Microbes]]></category>
		<category><![CDATA[nanofilteration]]></category>
		<category><![CDATA[NAP]]></category>
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		<category><![CDATA[pharmaceutical industries]]></category>
		<category><![CDATA[pharmaceutical industry]]></category>
		<category><![CDATA[Plant]]></category>
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		<category><![CDATA[Pollution]]></category>
		<category><![CDATA[pond water]]></category>
		<category><![CDATA[public health threat]]></category>
		<category><![CDATA[resistance genes]]></category>
		<category><![CDATA[reverse osmosis]]></category>
		<category><![CDATA[SEARO]]></category>
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		<category><![CDATA[UNICEF]]></category>
		<category><![CDATA[waste products]]></category>
		<category><![CDATA[Wastewater]]></category>
		<category><![CDATA[wastewater plants]]></category>
		<category><![CDATA[waterbodies]]></category>
		<category><![CDATA[WHO]]></category>
		<category><![CDATA[World Health Assembly]]></category>
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					<description><![CDATA[<p>Though most of the antibiotics that are consumed are metabolized by the body, a negligible amount is passed through us as waste</p>
<p>The post <a href="https://innohealthmagazine.com/2019/issues/post-antibiotic-world/">Post Antibiotic World</a> appeared first on <a href="https://innohealthmagazine.com">InnoHEALTH magazine</a>.</p>
]]></description>
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	<p style="text-align: justify !important;">Like the ‘guardians of the galaxy’ the futuristic prospect of this world will be a place where the microbes have become resilient against antibiotics and the fight against infection has ceased to find its way through antibiotics. Though most of the antibiotics that are consumed are metabolized by the body, a negligible amount is passed through us as waste, which is further carried to wastewater treatment plants.</p>
<p><em><strong>Also Read: <a href="https://innohealthmagazine.comwell-being/health-and-oral-health-diseases/">Health and Oral Health Diseases</a></strong></em></p>
<p style="text-align: justify !important;">The basic methodology to clean the wastewater in plants is through membrane bioreactor that uses both biological as well as filtration process where bacteria are acclimatized to consume the waste products and help in metabolization. The antibiotic waste breakdown by bacteria often expresses resistance genes that reduce the effectiveness of the medicines. In the long run, the horizontal gene transfer develops whose expression pass from one generation to the next and the resistance genes gain prominence over the years. With the passing phase, the bacteria grow and thrive itself therefore often giving rise to biomass. The biomass is produced in tonnes by wastewater plants nearly every day. After treatment, they are often disposed of as landfills, fertilizers for agriculture and feed crops for livestock. A minute quantity of resistant bacteria and free-floating DNA often finds its way through effluent of the pharmaceutical industries. The studies have further shown that gene elements called plasmids carry resistance genes for several different types of antibiotics, therefore, resulting in a positive correlation between one type of antibiotic and the resistance gene of another. It creates a dangerous dormant situation that can erupt like an active pandemic under the favourable situation. Plasmids are a thousand times smaller than bacteria and their free-floating nature often surpasses the treatment barriers of the filtration system of the treatment process, therefore making exit through effluents. They further contaminate the surface water and groundwater – the two important sources of drinking water. Researchers have found that even low concentrations of just a single type of antibiotic in the water supply leads to resistance in multiple classes of antibiotics and hence leads to antimicrobial resistance (AMR).</p>
<p><em><strong>Also Read: <a href="https://innohealthmagazine.comissues/indian-states-health-card/">Health Card of Indian States</a></strong></em></p>
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	<p style="text-align: justify !important;">Water, as we all know, is the utmost need of our survival. Human body comprises around 60% water and the fact that less consumption of water leads to various diseases in the future. Apart from facts and figure, one simple question we often forget to inquire is where this water is coming from? Surface water i.e. lakes, rivers and ponds or groundwater i.e. tube wells, bore well, well as these are the two sources that give us a glass of water.</p>
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	<p><em><strong>Also Read: <a href="https://innohealthmagazine.comnewscope/baby-jetliner/">Passenger Gave Birth to a Baby on Jetliner</a></strong></em></p>
<p style="text-align: justify !important;">Our health concern and the credulous brainwash of our mind by the various available water filter present scenario and save our planet from the harmful effect of self-made destruction.Effective treatment and management of wastewater from the pharmaceutical industry will help in overcoming antimicrobial resistance. Advanced treatment methods such as reverse osmosis, nano filtration, and membrane bioreactors have shown to be promising processes for cleaning micro pollutants with nano gram per litre (ng/L) concentration levels.The nation where the trial/testing of most of the antibiotic occurs, there are rarely any constraints implemented on the disposal of pharmaceutical wastewater to the surface water. The current scenario of environmental issue foresees that in the near future there will be scarcity of drinking water and our hope was restored when global challenge was taken to in the market often diverts us from our prime concern of keeping our planet safe from water pollution. The pollution of water bodies has been initiated by us and still we are invariably helping it grow with every passing day. As discussed earlier, the various point sources from domestic to industrial pave the way for antibiotic to contaminate the water bodies. According to the latest report of UNICEF, 2.1 billion people lack the access to clean and safe drinking water.</p>
<p><em><strong>Also Read: <a href="https://innohealthmagazine.comtrends/vision-intraocular-lenses/">Extended range of vision intraocular lenses</a></strong></em></p>
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	<p><strong>How do we remove the problem? What do we do to save ourselves from the harmful effects?</strong></p>
<p style="text-align: justify !important;">The encouraging words of Normal Vincent Peale, American author ‘Every problem has in it the seeds of its own solution. If you don&#8217;t have any problems, you don&#8217;t get any seeds’ gives us the hope that we will successfully overcome the present scenario and save our planet from the harmful effect of self-made destruction.Effective treatment and management of wastewater from the pharmaceutical industry will help in overcoming antimicrobial resistance. Advanced treatment methods such as reverse osmosis, nano filtration, and membrane bioreactors have shown to be promising processes for cleaning micro pollutants with nano gram per litre (ng/L) concentration levels.The nation where the trial/testing of most of the antibiotic occurs, there are rarely any constraints implemented on the disposal of pharmaceutical wastewater to the surface water. The current scenario of environmental issue foresees that in the near future there will be scarcity of drinking water and our hope was restored when global challenge was taken to curb the antimicrobial resistance from environment. Remedial measures taken towards eradication are further discussed.</p>
<p><em><strong>Also Read: <a href="https://innohealthmagazine.comissues/rising-burden-of-non-communicable-diseases/">Rising burden of non-communicable diseases</a></strong></em></p>
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	<p style="text-align: justify !important;"><strong>Political commitments:</strong> International efforts: World Health Organization Jaipur declaration on antimicrobial resistance 2011 recognized AMR as a serious public health threat. With the 2014 WHO Report, the extraordinary rates of AMR prevalent in India came into focus. After this report, joint efforts were made by India and WHO. While WHO labelled AMR as the Flagship Priority area for South East Asia Regional Office (SEARO), the Indian Medical Association launched an awareness programme to train the physicians and sensitize the general public. In 2015, the 68th World Health Assembly decided to incorporate the concept of One Health in the fight against AMR and a Global Action Plan was initiated. All member countries, including India, agreed to frame their own National Action Plans (NAPs) for AMR by 2017.</p>
<p><em><strong>Also Read: <a href="https://innohealthmagazine.comissues/specific-health-situation-of-indian-states/">Specific health situation of Indian states </a></strong></em></p>
<p style="text-align: justify !important;"><strong>National efforts:</strong> The Government of India formulated a Core Working Group on AMR that drafted a NAP for the country. Six strategic priorities were listed in NAP, all of which incorporated considerations for AMR in the environment, directly or indirectly. Further, each strategic priority has defined interventions, activities and outputs, the fulfillment of which is delineated by a timeline projected for the next five years. The NAP, although promising, has not yet come into full action in any of the Indian states so far. To curtail the prevalent malpractice of over-the-counter (OTC) sale of drugs, the Central Drugs Standard Control Organization implemented Schedule H1 in India in 2014. It, however, encompasses only a few selected antimicrobial groups. In June 2017, the Food Safety and Standards Authority of India (FSSAI) published the list of maximum residue levels for antimicrobials in foods prepared from animal, poultry and fish.</p>
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	<p style="text-align: justify !important;"><strong>Health Organization in India:</strong> To know the near-exact extent of AMR, AMR surveillance networks were initiated by the Indian Council of Medical Research (ICMR) and the National Centre for Disease Control (NCDC) in 2013 and 2014, respectively. In 2015, these two organizations along with the support from Centers for Disease Control and Prevention (CDC) USA, started a systematic assessment of the prevailing IPC practices in India with the aim of formulating new guidelines for preventing hospital-acquired infections.</p>
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	<p><em><strong>Also Read: <a href="https://innohealthmagazine.comissues/rising-risks-for-cardiovascular-diseases-diabetes/">Rising risks for cardiovascular diseases &amp; diabetes</a></strong></em></p>
<p style="text-align: justify !important;">These activities, however, cater basically to the emerging AMR in the healthcare settings and do not include special provisions for AMR in the environment. Similarly, the National Health Mission&#8217;s National Health Systems Resource Centre and the National Accreditation Board deal with IPC practices and strengthening of laboratories/hospitals and not with the AMR in the environment per se. The importance of AMR in the environment has been realized recently by the national health authorities and The National Health Policy 2017 calls for a rapid standardization of guidelines regarding antibiotic use, limiting the use of antibiotics as OTC medications, banning or restricting the use of antibiotics as growth promoters in animal livestock, and pharma co-vigilance including prescription audits inclusive of antibiotic usage &#8211; in the hospital and community.</p>
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	<p style="text-align: justify !important;"><strong>Innovative ideas:</strong> The National Health Mission of India started the Swachh Bharat Abhiyan or the Swachh India Mission to improve the basic hygiene and sanitation in all spheres of life. As a part of this massive programme, education was imparted through mass media on the health hazards of open defecation. UNICEF data shows that out of one billion openly defecating people in the world, 60 percent reside in India. It is further argued that it is a behavioural problem with the Indians as other poverty struck nations of Africa and South East Asia did not have the problem of open defecation to this an extent. To deal with such socio-cultural issues, innovative ideas along with mass media are needed in India.</p>
<p><em><strong>Also Read: <a href="https://innohealthmagazine.compersona/how-to-write-healthcare-funding-proposals/">How to write a funding proposal?</a></strong></em></p>
<p style="text-align: justify !important;">So far in India, antimicrobial resistance in the environment has been a topic of least priority. With an ever-increasing threat of AMR in the environment, immediate action is required to halt its progress and spread. A combined effort of multidisciplinary and multi-sectoral approach will be able to eradicate the problem in the near future.</p>
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	<h2>About the author</h2>
<p style="text-align: justify !important;"><em><strong>Dr. Debleena Bhattacharya</strong></em> is an independent researcher. She is presently working as an Assistant Professor in the Department of Environmental Science and Engineering at MEFGI, India. She holds a doctoral degree in Environmental Science from IIT (Indian School of Mines) Dhanbad (India). Her specialisation is in the field of wastewater treatment and biotechnology.</p>
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<p>The post <a href="https://innohealthmagazine.com/2019/issues/post-antibiotic-world/">Post Antibiotic World</a> appeared first on <a href="https://innohealthmagazine.com">InnoHEALTH magazine</a>.</p>
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		<title>Digital Safety Plan for Children</title>
		<link>https://innohealthmagazine.com/2018/persona/exclusive-interview/digital-safety-plan/</link>
					<comments>https://innohealthmagazine.com/2018/persona/exclusive-interview/digital-safety-plan/#respond</comments>
		
		<dc:creator><![CDATA[InnoHEALTH Magazine]]></dc:creator>
		<pubDate>Thu, 23 Aug 2018 07:06:31 +0000</pubDate>
				<category><![CDATA[Exclusive Interview]]></category>
		<category><![CDATA[Persona]]></category>
		<category><![CDATA[abuse]]></category>
		<category><![CDATA[Adverse Events Following Immunisation]]></category>
		<category><![CDATA[AEFI]]></category>
		<category><![CDATA[Central Drugs Standard Control Organization]]></category>
		<category><![CDATA[CRC]]></category>
		<category><![CDATA[cyber bullying]]></category>
		<category><![CDATA[Digital literacy]]></category>
		<category><![CDATA[Digital media]]></category>
		<category><![CDATA[Digital safety plan]]></category>
		<category><![CDATA[Digital Technology]]></category>
		<category><![CDATA[Diphtheria]]></category>
		<category><![CDATA[Dr. Yasmin Ali]]></category>
		<category><![CDATA[exploitation]]></category>
		<category><![CDATA[InnoHEALTH Magazine]]></category>
		<category><![CDATA[Measles]]></category>
		<category><![CDATA[Measles-Rubella Vaccine Campaign]]></category>
		<category><![CDATA[Ministry of health and family welfare]]></category>
		<category><![CDATA[Mission indradhanush]]></category>
		<category><![CDATA[MR vaccine]]></category>
		<category><![CDATA[Pertussis]]></category>
		<category><![CDATA[Pneumonia]]></category>
		<category><![CDATA[Protection of Children]]></category>
		<category><![CDATA[Sexual Offences Act]]></category>
		<category><![CDATA[Tetanus]]></category>
		<category><![CDATA[trafficking]]></category>
		<category><![CDATA[UIP]]></category>
		<category><![CDATA[UNICEF]]></category>
		<category><![CDATA[Universal Immunisation Programme]]></category>
		<category><![CDATA[violence against children]]></category>
		<category><![CDATA[WHO]]></category>
		<category><![CDATA[Zero tolerance]]></category>
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					<description><![CDATA[<p>Digital safety plan for children being leveraged; zero tolerance towards violence against children need of the hour. UNICEF is working with Govt. </p>
<p>The post <a href="https://innohealthmagazine.com/2018/persona/exclusive-interview/digital-safety-plan/">Digital Safety Plan for Children</a> appeared first on <a href="https://innohealthmagazine.com">InnoHEALTH magazine</a>.</p>
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	<p style="text-align: justify !important;"><strong>A digital safety plan for children being leveraged; zero tolerance towards violence against children need of the hour.</strong></p>
<p style="text-align: justify !important;">Fresh from her experience in managing emergency situations, <strong>Dr. Yasmin Ali</strong> Haque smilingly handles the tsunami of problems as UNICEF’s Representative in India, lying next to her home Bangladesh.</p>
<p style="text-align: justify !important;">She says <strong><a href="https://www.unicef.org/">UNICEF</a></strong> is working closely with the government in developing a comprehensive plan on digital safety for children. Digital literacy is key to ensuring that all boys and all girls stay informed, engaged and safe online. There is a need to galvanize the ‘zero tolerance’ towards violence against children. In a detailed interview to <strong><a href="https://innohealthmagazine.com">InnoHEALTH magazine</a></strong>, she answered a wide range of questions and elaborated at length, UNICEF’s programmes in India where the safety of children is emerging as a major concern.</p>
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	<p style="text-align: justify !important;">Dr. Yasmin had joined as the UNICEF Representative in India in July last year and prior to that, she was Deputy Director of UNICEF’s Office of Emergency Operations where she played a leading role in the programming and policies for an effective UNICEF response for children in humanitarian crisis. She started her career in UNICEF in 1996 and held many appointments in challenging situations.</p>
<p><strong>Also Read: <a href="https://innohealthmagazine.comtrends/latest-healthcare-innovations/">10 Latest Healthcare Innovations</a></strong><br />
<a href="https://innohealthmagazine.comtrends/latest-healthcare-innovations/"><img decoding="async" class="alignnone size-medium wp-image-4513" src="https://innohealthmagazine.comwp-content/uploads/2018/08/Ten-latest-healthcare-innovations-300x189.png" alt="Ten-latest-healthcare-innovations" width="300" height="189" srcset="https://innohealthmagazine.com/wp-content/uploads/2018/08/Ten-latest-healthcare-innovations-300x189.png 300w, https://innohealthmagazine.com/wp-content/uploads/2018/08/Ten-latest-healthcare-innovations-768x484.png 768w, https://innohealthmagazine.com/wp-content/uploads/2018/08/Ten-latest-healthcare-innovations.png 1000w" sizes="(max-width: 300px) 100vw, 300px" /></a></p>
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	<p style="text-align: justify !important;"><span style="color: #0071b2;"><strong><span style="color: #000000;">Q.</span> UNICEF is guided by the Convention on the Rights of the Child (CRC) and strives to establish children’s rights as enduring ethical principles and international standards of behavior towards children. UNICEF responds in emergencies to protect the rights of children. What </strong><strong>are</strong><strong> your views are the steps that can be taken to protect children from violence and to ensure their safety?</strong></span></p>
<p style="text-align: justify !important;">One important facet of the rights of CRC is to ensure that children grow in a protective and safe environment, free of any kind of violence and abuse. Preventing and responding to sexual violence requires strong collaboration among stakeholders from diverse walks of life. UNICEF is committed to working with the government, civil society organizations, corporates, media and all the other stakeholders to support society and families to ensure that children are safe and free from abuse and exploitation. Guided by the CRC, it is imperative to act now to break the cycle of violence against children and protect survivors of violence.</p>
<p style="text-align: justify !important;">In recent years, India has made significant progress in addressing sexual abuse against children by having enacted legislation and acted on a large number of cases. The public has also become increasingly aware of sexual abuse cases that may have gone unnoticed years ago due to an increase in reporting on the issue. Digital media and immediate reporting have also contributed to this awareness. Still, a lot more needs to be done. Building on these positive developments, UNICEF collaborates with partners to enhance awareness of children and parents by focussing on the following stakeholders:</p>
<ul>
<li>Teachers and school authorities: Sexual violence in schools is a major area of concern. Schools should provide information on safety to children and online safety guidelines can be included in the curriculum. Schools also need to ensure that teachers are aware of the provisions of the Protection of Children from Sexual Offences Act.</li>
<li>Children: Child-led initiatives empower children to become advocates of change, voice their demands and take leadership in the change itself. Listening to children is also key as they can become vital stakeholders in their own safety. Decisionmakers, including parents and teachers, should listen to children so that their views can be incorporated into policies.</li>
<li>Civil society organizations, including faith-based and community-based organizations, can engage consistently with the communities and share with them important information around the need to protect children from any kind of violence and abuse and co-create local solutions.</li>
<li>Media, both traditional and digital, plays a vital role in disseminating information, mobilizing public opinion and building a discourse around the issue of child safety. Effective use of digital technology for creating further awareness on child safety is another platform that is being leveraged. We need to ensure that all children, every girl, and boy, no matter where they live or what their background is, benefit from the learning opportunities and connectivity that the digital world can provide. However, along with the benefits that digital technology provides, it has also put young people at risk of harm online, including abuse, exploitation, trafficking and cyberbullying.</li>
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	<p style="text-align: justify !important;"><strong>Q. <span style="color: #0071b2;">UNICEF has recently launched a report called ‘Every Child ALIVE’ focusing on the number of newborn deaths in the country. Has India made any progress in curbing the under-five mortality?</span></strong></p>
<p style="text-align: justify !important;">India has shown 66% reduction in the under-five mortality rate between 1990 and 2015, nearly meeting its Millennium Development Goal 4 target. This is much higher than the global decline of 55% during the same period. This progress has been due to a holistic approach to health programming for children. However, the progress has been slower for new-borns and has also been inequitable between boys and girls, with the under-five mortality rate for girls currently being 11% higher, at 41 per 1000 as against 37 per 1000 for boys.</p>
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	<p><strong>Q. <span style="color: #0071b2;">Why are more girls dying in India than boys? </span></strong></p>
<p style="text-align: justify !important;">Girls have the advantage of being biologically stronger, yet sadly they are extremely vulnerable socially. The discrimination begins even before they are born. Though the gender gap has started shrinking due to the fast decline of mortality for girls as compared to boys in the recent years, the gap still remains high in many states. The neglect of the girl child is a much broader issue and needs interventions beyond health to address the social norms and cultural practices that act as barriers to bridging the gender gap. It will require working at both the policy level for creating an enabling environment. And at the community level, to build awareness and bring emphasis to the value of the girl child. It will also need increased investments in the availability of gender-disaggregated data for more informed planning.</p>
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	<p><strong>Q. <span style="color: #0071b2;">Please share with us some details about the</span></strong><span style="color: #0071b2;"> <strong>immunization campaign in India.</strong> </span></p>
<p style="text-align: justify !important;">Immunisation is one of the most cost-effective public health interventions that currently averts an estimated 2 to 3 million child deaths globally every year. India has one of the largest immunization programmes in the world, in terms of a number of beneficiaries, geographical coverage, and quantities of vaccines used, with nearly 26 million new-borns targeted for immunization annually. However, despite this effort, only 65% of the children in India receive full immunization during the first year of their life.</p>
<p style="text-align: justify !important;">This translates to 9 million children not fully protected against preventable diseases such as Diphtheria, Pertussis, Tetanus, Measles and Preventable pneumonia. To address this issue, Government of India, with the support of UNICEF, WHO, and other partners, has launched Mission Indradhanush to achieve 90% immunization coverage by the end of 2018. UNICEF is also supporting the government for the strategic communication activities on immunization, in order to create further awareness on the need for complete immunization as well as create a discourse on the value of vaccines.</p>
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	<p><strong>Q. <span style="color: #0071b2;">What is the Measles-Rubella Vaccine Campaign and why do we need it? </span></strong></p>
<p style="text-align: justify !important;">The Measles-Rubella (MR) vaccine has been introduced as part of the Universal Immunisation Programme (UIP) in India to protect children from two diseases, Measles and Rubella, which have high mortality and morbidity respectively. Measles is one of the leading causes of death among young children. It is a highly contagious disease caused by a virus and spreads by coughing and sneezing. It reduces the immunity of the child, making a child vulnerable to life-threatening complications such as pneumonia, diarrhea and infection in the brain. Hence, the burden of diarrhea and pneumonia can also be indirectly reduced by eliminating Measles.</p>
<p style="text-align: justify !important;">Rubella, although a mild viral illness, can lead to serious consequences if pregnant women are infected during early pregnancy. It can result in miscarriages, stillbirths and a set of congenital anomalies in the foetus and new-borns known as Congenital Rubella Syndrome (CRS), which is a cause of public health concern. CRS is characterized by multiple defects, particularly affecting the eyes (glaucoma, cataract), ears (hearing loss), brain (microcephaly, mental retardation) and heart defects &#8211; many of which are lifelong disabilities, requiring treatment, surgeries and other expensive care throughout life. Hence, it is important to eliminate these diseases. The MR vaccine is provided free of cost under the campaign.</p>
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	<p><strong>Q. <span style="color: #0071b2;">What is the burden of Measles-Rubella in India and globally? </span></strong></p>
<p style="text-align: justify !important;">According to WHO estimates, an estimated 1.34 lakh deaths were caused globally by Measles in 2015. Measles and related complications killed an estimated 49,200 children in 2015 in India, contributing nearly 36% to the global figures. An estimated 84% of the global decline in Measles deaths from 2000 to 2016 was due to Measles vaccination. In 2010, an estimated 1.03 lakh children were born with Congenital Rubella Syndrome (CRS) globally, of which an estimated 40,000 children were born with CRS in India.</p>
<p style="text-align: justify !important;">The Government of India has resolved to eliminate Measles and control Rubella. The Measles-Rubella (MR) vaccination campaign is an important step in that direction. Measles immunization directly contributes to the reduction of under-five child mortality. UNICEF is a key partner in the Ministry of Health and Family Welfare’s rollout of the ongoing Measles-Rubella Vaccination Campaign, which is now in its third phase and has vaccinated 7.7 crore children in 16 states till date (3 April 2018). The MR Campaign targets around 41 crore children, making it one of the largest ever immunization campaign of its kind. It aims to eliminate Measles and control Rubella by 2020. The vaccine has already been rolled out in several states and will soon be launched in Assam, Haryana, and Punjab.</p>
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	<p><strong>Q. <span style="color: #0071b2;">How safe is the Measles-Rubella vaccine?</span></strong></p>
<p style="text-align: justify !important;">The Measles-Rubella (MR) vaccine is a safe and cost-effective vaccine that has been available for the past 40 years. The presently used vaccine is a WHO-prequalified vaccine and is licensed by the Central Drugs Standard Control Organization of India. As many as 165 WHO member countries provide Measles second dose in their national immunization programme. The Rubella vaccine has been introduced in 159 countries. India, along with 10 other member countries of South East Asia region of WHO, has resolved to eliminate Measles and control Rubella and Congenital Rubella Syndrome (CRS) by 2020.</p>
<p style="text-align: justify !important;">The surveillance of Adverse Events Following Immunisation (AEFI) is an integral part of the MR vaccination campaign. AEFI management kit is provided at all vaccination session sites including schools so that immediate response can be initiated following an AEFI.</p>
<p style="text-align: justify !important;">The Government of India has recently amended AEFI management protocol. Now Adrenalin injection is part of each AEFI kit, which is life-saving in case of anaphylaxis. Both public and private sector medical practitioners and health workers are trained prior to MR campaign to handle such adverse events.</p>
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<p>The post <a href="https://innohealthmagazine.com/2018/persona/exclusive-interview/digital-safety-plan/">Digital Safety Plan for Children</a> appeared first on <a href="https://innohealthmagazine.com">InnoHEALTH magazine</a>.</p>
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		<title>SAFETY STANDARDS: MAKING INDIA&#039;S HEALTHCARE SECTOR SAFER AND FUTURE READY!</title>
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		<pubDate>Mon, 15 May 2017 10:31:47 +0000</pubDate>
				<category><![CDATA[Blog]]></category>
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					<description><![CDATA[<p>Medical devices are crucially linked</p>
<p>The post <a href="https://innohealthmagazine.com/2017/blog/safety-standards-for-healthcare-sector/">SAFETY STANDARDS: MAKING INDIA&#039;S HEALTHCARE SECTOR SAFER AND FUTURE READY!</a> appeared first on <a href="https://innohealthmagazine.com">InnoHEALTH magazine</a>.</p>
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	<p><span style="color: #0071b2;"><strong>Safety Standards: Making India’s Healthcare Sector Safer and Future Ready!</strong></span></p>
<p style="text-align: justify !important;"><span style="color: #0071b2;">Jibu Mathew</span> is Business Head of UL’s Life and Health Business Unit for South Asia and emerging markets. He has varied experience in IT consulting, regulatory advisory and market access strategy in Medical Electronics, Healthcare and High-tech industry for more than a decade. He is also an Industry representative in Bureau of Indian Standards [BIS] Committee on Medical and Hospital Standards.</p>
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	<p style="text-align: justify !important;"><em><strong>Safety is omnipresent and intrinsic to the entire healthcare delivery spectrum and the entire medical fraternity must move towards industry equilibrium. Medical devices are crucially linked to the growing demands of the healthcare chain which need a strong regulatory framework. This also means sourcing the right kind of equipment and devices from the right vendors and checking them for regulatory approval stamps from established certifying bodies.</strong></em></p>
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	<p><span style="color: #0071b2;"><strong>Introduction: India’s Beleaguered Healthcare Infrastructure</strong></span></p>
<p style="text-align: justify !important;">Historically, healthcare set-ups were always admired for their commitment and expertise to provide their patient with a new lease of life! From a simple fever to complex surgeries and medical miracles, people from different parts of the world have traveled to India to benefit from the quality services and a comparative cost advantage. India may be a global tourism hub, with a growth rate expected to touch an astounding $8 billion by 2020<span style="color: #0071b2;">[1]</span>. However, access to safe and quality healthcare eludes a vast majority of the population<span style="color: #0071b2;">[2]</span>. Adding further woe is the dismal expenditure for the sector.</p>
<p>Consider this:</p>
<p style="text-align: justify !important;">• India has one bed for every 1,050 patients as compared to the US, which has one bed for every 350 patients.</p>
<p style="text-align: justify !important;">• India’s ratio of 0.7 doctors and 1.5 nurses per 1,000 people is much lower than the WHO average of 2.5 doctors and nurses per 1,000 people.</p>
<p style="text-align: justify !important;">• To combat this poor doctor-patient ratio, India needs to add 1.54 million doctors and 2.4 million nurses to match the global average<span style="color: #0071b2;">[3]</span>.</p>
<p><span style="color: #0071b2;"><strong>Changing Disease Burden In India</strong></span></p>
<p style="text-align: justify !important;">Over the past few years, there has been a palpable transition from infectious to non-communicable diseases (NCD) in the country, owing to change in dietary patterns, economic growth and greater life expectancy. While NCDs remove the threat of immediate mortality, they call for an urgent need to ramp up healthcare technology and innovation to prevent adverse outcomes. For instance, WHO&#8217;s health profile for India (2014) points out that 53 percent of deaths in the country are on account of non-communicable diseases (NCD), with diabetes and cardiovascular diseases taking the lead<span style="color: #0071b2;">[4]</span>. One in four Indians risks dying from an NCD before they reach the age of 70, the report states. Further, diabetes is engulfing the nation at an alarming rate &#8211; 65.1 million people are suffering from the disease in the country, compared to 50.8 million in 2010. By 2030, 100 million people are expected to be diabetic<span style="color: #0071b2;">[5]</span>.</p>
<p><span style="color: #0071b2;"><strong>India – The Healthcare Technology Paradox</strong></span></p>
<p style="text-align: justify !important;">To combat the paucity of traditional health infrastructure, e-health, m-health and home healthcare services brought about pioneering changes in healthcare delivery for the rural and inaccessible area<span style="color: #0071b2;">[6]</span>. With increasing corporatization and FDI inflows in private healthcare, state of the art treatment is becoming increasingly available to metros, tier 1 and tier 2 cities<span style="color: #0071b2;">[7]</span>.</p>
<p style="text-align: justify !important;">This brings to the front an important aspect of healthcare delivery – the use of medical devices, ranging from humble objects like gloves and syringes to complex tools like implants, ventilators and scanning technologies. The medical device sector reveals a deep-seated, but interesting paradox in India’s healthcare system – while the country boasts of being the manufacturing capital of the world for pharmaceuticals, 75% of the medical devices are imported from countries like China, with nearly 30% coming from the United States alone<span style="color: #0071b2;">[8]</span>. Most of these devices rampantly used are either substandard, un-calibrated and continue to compromise patient safety!</p>
<p style="text-align: justify !important;">These revelations imply that it takes just one faulty/substandard medical device to play havoc in our lives. When we approach our healthcare provider, we blatantly overlook what goes on behind the scene &#8211; have we ever noticed what kind of medical equipment or invasive devices are being used to cure our ailment? Is it safe and hygienic and absolutely necessary for use? Does it have a regulatory stamp of approval? Is it calibrated correctly? The steep costs of importing these devices are ultimately passed on to the consumer, making access to safe and quality healthcare unaffordable.</p>
<p><span style="color: #0071b2;"><strong>Medical Devices Market – Current Scenario</strong></span></p>
<p style="text-align: justify !important;">Despite its significant growth, the medical devices industry in India is still at a very nascent stage. In terms of market size, the total medical device consumption in the country at present is to the tune of $ 5.8 billion. When corresponded with the 1.2 billion plus population, the penetration of medical devices into healthcare sector is very minimal, especially in comparison to similar economies, such as China, Korea or Japan.</p>
<p style="text-align: justify !important;">However, the medical devices sector in India is specifically focused on two aspects &#8211; penetration and affordability. Keeping this in view, there is a lot of innovation, in pockets, that is contributing to the growth of this sector. This is specifically in non-communicable diseases space, where screening devices for point of care testing are being created for e.g: cardiovascular diseases, diabetes etc. The medical device industry in India is currently dominated by MNCs that manufacture and import products. There are also small and medium businesses, mainly dealing with disposables and implants and medical electronics. The third segment is that of the startup community.</p>
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	<p style="text-align: justify !important;"><span style="color: #0071b2;"><strong>Challenges In The Med Tech Industry: Inadequate And Antiquated Regulations</strong></span></p>
<p style="text-align: justify !important;">Despite the promising emergence of multiple startups in the med tech industry that are targeting the domestic segment, India’s regulations for medical devices are largely inadequate and antiquated. What’s more, the entire sector is loosely governed with lack of strong regulations controlling the production, import or distribution of medical equipments and devices, encouraging the inflow of substandard devices entering the Indian market and harming the consumers. While the government’s support through ‘Make in India’ campaign to help India reach the $ 50 billion devices market by 2025 has laid the platform for the growth of the med-tech sector in India, it also puts a thrust on ensuring that they follow global best practices in manufacturing them. From performance testing and usability to non-clinical testing, the devices need to pass standards tests for evaluation before medical professionals can actually use them, which call for the role of third-party testing labs to test devices and products for a minimum quality level.</p>
<p style="text-align: justify !important;">Currently, the medical devices industry is faced with an ambiguous regulatory framework, wherein medical devices are treated as drugs under the Drugs and Cosmetics Act. As a result, the distinctive identity for medical devices has been absent for long. Earlier this year, a newborn and a three-month-old were severely burned after a short circuit sparked a blaze in a hospital nursery in Meerut<span style="color: #0071b2;">[9]</span>. Over the last few years, the country has been marred by such incidents, raising serious concerns about overall safety in hospitals and the safety and quality standards of medical equipments in particular in India. Sample this… Of the 700 device makers in India and more than 2000 devices sold locally, ranging from a pair of humble reading glasses and gloves to critical MRI machines and implants, only a dismal 22 of them are presently under any direct regulatory supervision by the Drug Controller General of India&#8217;s office. India has become a dumping ground for many used and refurbished medical devices which are not calibrated to work in Indian conditions<span style="color: #0071b2;">[10]</span>.</p>
<p style="text-align: justify !important;"><span style="color: #0071b2;"><strong>Safety Compliance, Standardisation &amp; Third Party Certification Is The Key!</strong></span></p>
<p style="text-align: justify !important;">India is slowly witnessing gradual change over the last 12-18 months, with a regulatory framework currently developed by the Ministry of Health &amp; Family Welfare and CDSCO (Central Drugs Standard Control Organization). While this landmark move is definitely a welcome step to overhaul the regulatory system in the country, experts still feel that there are significant concerns to be addressed in the draft Medical Devices Rules 2016<span style="color: #0071b2;">[11]</span>.</p>
<p style="text-align: justify !important;">Experts believe that following the highest safety standards is the only way to achieve accurate and consistent medical care outcomes. Standards fuel innovation rather than acting as a barrier (as commonly thought), by ensuring a framework / boundaries under which devices can operate. “Can you imagine the impact if there were no standards on the performance requirement of a pacemaker”? Even though India is at the cusp of a quality revolution of sorts, we still have some catching up to do in terms of the conformity assessment framework. In a growingly complex, competitive economic landscape, the need to align people, processes and technology is stronger than ever. In order to compete globally, India needs to develop a culture of product safety and standards.</p>
<p style="text-align: justify !important;">Safety is omnipresent and intrinsic to the entire healthcare delivery spectrum and the entire medical fraternity must move towards industry equilibrium. Medical devices are crucially linked to the growing demands of the healthcare chain which need a strong regulatory framework. This also means sourcing the right kind of equipment and devices from the right vendors and checking them for regulatory approval stamps from established certifying bodies. From safety, performance testing and usability to non- clinical testing, any medical device requires to be compliant to standards tests for evaluation before medical professionals can actually use them, which call for the role of third party conformity assessment bodies, testing labs to test devices and products to ensure safety and quality is maintained. What India needs is a set of gold standards in the medical devices industry while strengthening the basic device testing infrastructure.</p>
<p style="text-align: justify !important;"><span style="color: #0071b2;"><strong>Conclusion – Standards Not A Market Barrier, But A Quality Enhancer</strong></span></p>
<p style="text-align: justify !important;">For the country to be in the highest pinnacle of world standards, quality cannot be compromised. Whether it is creating a safe environment for us to live, or dream big with Smart Cities and Make in India Campaigns, our country is marching towards ambitious plans of becoming a hub for global arbitration, reviving the manufacturing sector and strengthening services sector, to name a few. For any of these to become a success, the key is the need to adopt national and international standards while creating a framework for regulations and compliance. However, India has historically struggled to develop a holistic system of standards and regulatory framework. With plenty of legislations in place to drive quality, the challenge has always been enforcement and until such time non-compliant devices continues to creep into the Healthcare delivery system, keeping end users guessing when the next patient safety disaster will happen.</p>
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	<p><span style="color: #0071b2;"><strong><em>References:</em></strong></span><br />
<span style="color: #0071b2;">[1]</span> <a href="http://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/indian-medical-tourism-industry-to-touch-8-billion-by-2020-grant-thornton/articleshow/49615898.cms">http://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/indian-medical-tourism-industry-to-touch-8-billion-by-2020-grant-thornton/articleshow/49615898.cms</a><br />
[2] <a href="https://www.infosys.com/consulting/insights/Documents/indian-medical-device-industry.pdf">https://www.infosys.com/consulting/insights/Documents/indian-medical-device-industry.pdf</a><br />
[3] <a href="https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-lshc-2015-health-care-outlook-india.pdf">https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-lshc-2015-health-care-outlook-india.pdf</a><br />
[4] <a href="http://www.who.int/nmh/countries/ind_en.pdf?ua=1">http://www.who.int/nmh/countries/ind_en.pdf?ua=1</a><br />
[5] <a href="http://globalhealthaging.org/2015/07/24/india-is-diabetes-capital-of-the-world/">http://globalhealthaging.org/2015/07/24/india-is-diabetes-capital-of-the-world/</a><br />
[6] <a href="http://www.grameenfoundation.org/press-releases/nationwide-launch-mobile-health-program-rural-india-signals-new-era-mhealth-emerging">http://www.grameenfoundation.org/press-releases/nationwide-launch-mobile-health-program-rural-india-signals-new-era-mhealth-emerging</a><br />
[7] <a href="http://www.ibef.org/industry/healthcare-india.aspx">http://www.ibef.org/industry/healthcare-india.aspx</a><br />
[8] <a href="https://www.infosys.com/consulting/insights/Documents/indian-medical-device-industry.pdf">https://www.infosys.com/consulting/insights/Documents/indian-medical-device-industry.pdf</a></p>
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<p>The post <a href="https://innohealthmagazine.com/2017/blog/safety-standards-for-healthcare-sector/">SAFETY STANDARDS: MAKING INDIA&#039;S HEALTHCARE SECTOR SAFER AND FUTURE READY!</a> appeared first on <a href="https://innohealthmagazine.com">InnoHEALTH magazine</a>.</p>
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