The newly proposed National Medical Device Policy assumes significance given that India imports about 80 per cent of its medical device requirements. There is a need for FDI in the sector as the domestic medical devices industry is fragmented into small and medium enterprises and primarily manufactures products such as disposables.

The draft National Medical Device Policy, 2015, had proposed incentives for both new and existing medical devices firms. It had asked for interest subsidy to MSMEs, concessional power tariff, seed capital, viability gap funding, tax benefits to the sector, minimum or zero duty on raw materials.

In fact, the draft policy had also suggested setting up of an autonomous body National Medical Device Authority and a single window clearance for the industry.

The global market size for medical devices is about $220 billion and India has the potential to tap the opportunity. The sector in India is relatively small compared to the rest of the manufacturing industry though India is one of the top 20 markets for medical devices in the world and 4th in Asia.

A task force under the chairmanship of the DoP secretary addressed issues concerning domestic production of high-end medical devices and pharma equipment manufacturing that have been elaborately incorporated in the new policy.

Medical devices include any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specially for human beings or animals for one or more of the specific purposes.

It also includes a device which is a reagent, calibrator, control material, kit, equipment or system whether used alone or in combination thereof intended to be used for examination and providing information for medical or diagnostic purposes.

Executive Summary

The Indian medical device market is dominated by imported products, which comprise of around 75% of total sales. The domestic companies are largely involved in manufacturing low-end products for local and as well as international consumption. Lately, many multinational companies have established local presence by acquiring established domestic companies or starting a new business.

There are few key factors about operating in India that every serious player should be aware of. Foreign Direct Investment in medical device manufacturing sector is now possible without any prior approval.

The Indian Government has introduced various fiscal measures to promote research, development, manufacturing and import of medical devices. There is no import duty on certain medical equipment. Similarly, a number of lifesaving medical equipment are exempt from payment of excise duty.

The regulatory framework in India applicable to medical devices borrows heavily from the regulatory framework applicable to drugs. At present, only 15 types of medical devices are regulated (unfortunately, as “drugs”). The rest are unregulated. After a lot of efforts of various stake holders, the government has notified the Medical Device Rules, 2017, which are to come into effect from the 1st of January, 2018. These rules will regulate a much larger set of medical devices under a framework customized for medical devices. This should boost the confidence of all stakeholders, especially those who have been hesitant to enter into Indian market because of lack of regulation.

The Indian medical device sector is Asia’s fourth largest market, and presents an exciting business landscape and opportunities for both multi-national and domestic players. Till the early 1990s, the medical device sector was significantly dominated by domestic players. But after India opened up its markets in 1991, tables have turned. The technological advancement and expertise that the global market leaders offered has proved to be an advantage.

Today, India’s medical device sector is dominated by multi-national companies, which is evident from the fact that about 75% of the sales are generated by imported medical devices.

The domestic players, on the other hand, were quick to adapt the winds of change and started to focus on low cost devices. It will come as a surprise to many that the domestic players in India export more than 60 percent of their output as Indian markets are dominated by such imported medical devices. Over the years, many multi-nationals have set up operations in India.

However, the nature of majority of the operations is to only distribute imported devices and provide support function. Few multi-nationals have started domestic production too. Some multi-nationals have also entered India by acquiring domestic manufacturers.

A significant percentage of purchasers of medical devices are private medical institutions and hospitals. Due to increased competition in Tier I cities, private enterprises have started to focus on Tier II and Tier III cities, a market which is until now untapped in India. As private enterprises expand in lesser explored markets, the demand for medical devices will expand proportionally. Other reasons for strong growth prospects of the industry are:

• Economic growth leading to higher disposable incomes
• Increased Public Spending in Healthcare
• Increased Penetration of Health Insurance
• Improving Medical infrastructure
• Increasing affordability due to growing income
• Increasing number of ailments
• Increasing demand due to “Medical tourism”

The sector is also witnessing strong Foreign Direct Investments (“FDI”) inflows, which reflects the confidence of global players in the Indian market. As per official data, the medical and surgical equipment sector received a total of INR 8344 Crore (approx. USD 1452 Million) between 2000 and 20162. In 2013 alone, the FDI inflow was almost INR 920 Crore (approx. USD 138 Million). In 2015, this number jumped to a new high of INR 1019 Crore (approx. USD 153 Million).

India Entry Strategy

Doing business in India is as big a challenge as it is an opportunity. The sensitive healthcare sector in India has long been conservative about foreign investment over concerns of foreign influence over health priorities of domestic manufacturers. However, in recent times, there is growing governmental and popular support for foreign investment in all sectors, including health. It is, therefore, significant to observe the political and economic environment of India. It is equally important to understand the business culture and consumer mindset prevalent in India. Companies that are quick to adapt to it turn out to be more profitable. To be aware of the legal framework is another must. Specifically, investors must keep an eye on the exchange control laws as they govern how profits made by the company can be realized out of India.

Investment climate in India

By and large FDI is now permitted in almost all the sectors in India without obtaining prior regulatory approvals (i.e. under the “automatic route”) barring some exceptional cases like defense, housing and real estate, print media, etc. (referred to as the “negative list”). If the FDI is not in accordance with the prescribed guidelines or if the activity falls under the negative list, prior approval has to be obtained from the Foreign Investment Promotion Board (“FIPB”) (“approval route”).

FDI in manufacturing of medical devices is permitted to the extent of 100% under the automatic route.

For the limited purpose of FDI Policy,

Medical device is defined as follows;

Medical device means;

i) any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including the software, intended by its manufacturer to be used specially for human beings or animals for one or more of the specific purposes of;

• Diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
• Diagnosis, monitoring, treatment, alleviation of, or assistance for, any injury or handicap;
• Investigation, replacement or modification or support of the anatomy or of a physiological process;
• Supporting or sustaining life;
• Disinfection of medical devices;
• Control of conception, and which does not achieve its primary intended action in or on the human body or animals by any pharmacological or immunological or metabolic means, but which may be assisted in its intended function by such means;

ii) A n accessory to such an instrument, apparatus, appliance, material or other article;

iii) A device which is reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination thereof intended to be used for examination and providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body or animals.

iv) However the definition above would be subject to the amendment in Drugs and Cosmetics Act. for manufacturing of medical devices.

Aspects of Legality

As referred to in the introduction, the medical devices industry in India is currently largely unregulated because of the absence of a medical device specific legislation specifying standards of safety and quality for most of the medical devices. However, this is set to change with the introduction of the Medical Device Rules, 2017.

Presently, there are certain medical devices which have been regulated by creating a statutory fiction and deeming these medical devices as “drugs”. By virtue of this fiction, these few medical devices get regulated by the Drugs and Cosmetics Act, 1940 (“Act”) and the rules framed there under viz. Drugs and Cosmetics Rules, 1945 (“Rules”).

The Act and Rules seek to:
• Regulate the import, manufacture, distribution and sale of Notified Medical Devices.
• Ensure the availability of standard quality Notified Medical Devices to the consumer.

Licensing Process

The regulation of Notified Medical Devices is overseen by both, the central government and the state governments. Under the applicable regulatory framework, the functions of manufacture, import, distribution and sale of medical devices require licenses or permissions, as the case may be. In specific instances such as manufacture or import of new Notified Medical Devices (discussed later), both, a permission from the central drug licensing authority and a license from the state drug licensing authority is required. The required licenses and permissions are described more specifically in the table below.

The Rules have prescribed the standard format of the application forms for relevant licenses for the benefit of the applicants. It has also prescribed the standard form (template) of the licenses that may be issued for the benefit of the regulatory authorities and the applicants.

Manufacturing process

A separate license is required for each manufacturing location and for each Notified Medical Device at such manufacturing location. Under the Act, “manufacturing” includes any process (or part) for making, altering, ornamenting, finishing, packing, labeling, breaking up or otherwise treating or adopting any drug with a view to its sale or distribution. However, “manufacturing” does not include dispensing or packing at the retail sale level.

Importing Process

The IEC Number would be required to be mentioned in the documents filed with Customs for clearance of imported goods. For obtaining the IEC Number, an application in the prescribed form has to be submitted to the office of the jurisdictional Joint Director of Foreign Trade, wherein details of Bank Account Number and Permanent Account Number have to be furnished Under the Act, the activity of import of Notified Medical Devices into India requires an import license from the office of the Drugs Controller General of India.

In order to get an import license, there is a mandatory requirement of registration of the medical devices sought to be imported, the name of the manufacturer and its manufacturing premises with the office of the DCGI. The registration is certified by grant of a registration certificate. An application for grant of a registration certificate may be made by the foreign manufacturer itself if it has a valid wholesale license for sale or distribution of Notified Medical Devices under the Rules or its authorized agent in India, either having a valid license under the Rules to manufacture for sale of a Notified Medical Device or having a valid wholesale license for sale or distribution of Notified Medical Devices in India. Many a times, foreign manufacturers do not have an Indian subsidiary which has a wholesale license for sale or distribution of Notified Medical Devices. Hence, the manufacturers choose to appoint a third party as an authorized agent to make the application for grant of registration certificate. The authorization by a manufacturer to its agent in India must be documented by a power of attorney.

Clinical Trials

The applicable regulatory framework for clinical trials is drug-trial specific. There is no medical device specific regulatory framework for clinical trials in India. The DCGI, who regulates clinical trials, is aware of this fact and has therefore, allowed for some tweaking in the drug-specific clinical trial regulatory framework to suit medical devices. For example, the DCGI has exempted Phase I clinical trials of medical devices. A number of manufacturers of Notified Medial Devices are interested in carrying out post-marketing observational study of medical devices. The core difference between an observational study and a clinical trial is the degree of interference of the manufacturer in both the scientific studies. In observational studies, the manufacturer does not interfere in the use of the device by the subject but in a clinical trial, the manufacturer sets out the way (design) in which the device would be used. There is no requirement to obtain any permission for an observational study, but permission would be required to carry out a post marketing clinical trial.

Labeling

Before a Notified Medical Device is sold or distributed in India, it must be labeled according to specifications outlined in the Rules. All medical devices sold in retail or wholesale package should are required to comply with the labeling requirements of The Legal Metrology (Packaged Commodities) Rules, 2011.

Penalties

The penalties have been significantly enhanced through the amendment for manufacture, sale, distribution, stocking or exhibiting or offering for sale or distribution of spurious or counterfeit Notified Medical Devices to INR 1,000,000 or 3 times the value of the notified medical device confiscated, whichever is higher and imprisonment of not less than 10 years which may extend up to life, for spurious or counterfeit notified medical device leading to death or grievous hurt.

The entire amount of fine that is realized from the person convicted for the offence is now paid by way of compensation, to the person who is the victim of spurious or counterfeit Notified Medical Devices.

If the victim has died due the effect of the spurious or counterfeit Notified Medical Devices, the relative of the victim is entitled to receive the same amount by way of compensation. In case the spurious or counterfeit notified medical device does not lead to death or grievous hurt, then the penalty is a fine of up to INR 300,000 or 3 times the value of the notified medical device confiscated, whichever is higher and imprisonment of not less than 7 years which may extend up to life. The Ministry also has set up a “whistle blower” policy that aims to reward citizens, who provide information on the trade and source of spurious Notified Medical Devices.

Advertising and Sales

Advertising medical devices is strictly regulated. The Rules prohibits labeling of Notified Medical Devices in a manner that may convey to the intending user that the enclosed device may be used for prevention or cure of certain ailments and diseases specified in Schedule J of the Rules. Some examples of such diseases and ailments are: Blindness, Bronchial Asthma, Cataract, Growth of New Hair, Deafness, Genetic Disorders, Improvement in vision, Myocardial Infarction etc. Please note that while the restriction on labeling applies only to Notified Medical Devices, some of the restriction on advertisement is general in nature and are applicable to all medical devices. These are dealt in detail under the sub-heading of Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954.

Concluding the Benefits

The Indian medical device industry continues its upward march of growth and is strongly supported by India’s robust legal framework. The Indian Government has identified the medical device industry as a focus industry for its flagship “Make in India” program.

There is also a proposal to launch new medical device parks in which government will provide fiscal and monetary incentives. This should give lot of confidence to potential stakeholders to consider the Indian medical device industry seriously.

With respect to the singular event of price fixation of Coronary Stents, The government had several interactions with the importers and manufacturers of Coronary Stent and took their feedback into account before fixing the price. Thus, it appears that the government sought to be restrained and transparent in its approach.

Also, it is still possible for importers and manufacturers of Coronary Stents to increase their current margins by structuring their business model or by using the available relaxations as discussed in the body of this paper. Lastly, with the introduction of the Medical Device Rules, 2017, the medical device industry in India is certain to receive a fillip.

Want to write for InnoHEALTH? send us your article at  magazine@innovatiocuris.com

Read all the issues of InnoHEALTH magazine:
InnoHEALTH Volume 1 Issue 1 (July to September 2016) – https://goo.gl/iWAwN2 
InnoHEALTH Volume 1 Issue 2 (October to December 2016) – https://goo.gl/4GGMJz
InnoHEALTH Volume 2 Issue 2 (April to June 2017) – https://goo.gl/Nv3eev
InnoHEALTH Volume 2 Issue 4 (October to December 2017) – http://amzn.to/2B2UMLw

Connect with InnovatioCuris on:
Facebook: https://www.facebook.com/innovatiocuris
Twitter: https://twitter.com/innovatiocuris
LinkedIn: https://www.linkedin.com/groups/7043791
Stay updated about IC, visit: www.innovatiocuris.com

AddressHealth, a Bangaluru based paediatric primary care continuum has received US$ 1.5 million in series A funding from Gray Matters Capital is now reaching out to schools to counsel healthcare and mental wellness programmes. It aim is to make affordable paediatric primary care available to four lakh children in India by 2018.

The company’s school health programme’s cloud-based EHR has health data of over 150,000 children, allowing it to analyze health trends amongst urban school children and help parents take preventive health action for their children.

Want to write for InnoHEALTH? send us your article at  magazine@innovatiocuris.com

[vc_empty_space]

Cervical cancer is a totally preventable cancer if women subject to screening once in five to seven years after the age of 30 years or post their sexual debut, whichever is early. It is a leading cause of cancer deaths in women in India, almost parallel to breast cancer. The most significant primary factor for cervical cancer is persistent or long term infection due to the oncogenic types of human papillomavirus (HPV). HPV is the most common sexually transmittable infection that many women would acquire sometimes in their life. Cervical pre-cancer is a clinically detectable stage by advanced mRNA testing followed by colposcopy and that can be treated by simple and inexpensive outpatient procedures that does not require hospitalization too. The national healthcare policy makers need to realize that providing a health insurance cover for screening for cervical precancer would actually save cost on national exchequerthousand folds to treat this cancer, thanks to the people centric governance in the rising India.

Major considerations behind cancer screening tests

The latest cancer mortality rates in the western world show reduction in cancer-related deaths. A high percentage of cancer patients now show a better 10-year survival rates than the past decade, thanks to their organized healthcare governance, advent and acceptance of newer diagnostic and therapeutic modalities, and consciously aware population at large. On one hand they have some cancers continuing to be chronic and lifelong conditions;cervical cancer is seen providing a greater relief towards overall reduction in cancer-related mortalities. The irrefutable role till lately was being played by a single most important test, the Pap Test (Papanicolaoutest or PapCytologyscreening test). During past 5 to 6 decades of its clinical practice Cytology wasthe most effective and most economical screening test for cervical cancer.

But why this did not do any good for the countries where there is no screening practice in place, is anybody’s guess!

With the advent of modern molecular era, for instance, an introduction of HPV testing in cervical screening, a definition of a cancer screening test is getting changed on its qualification criteria. By and large, a cancer screening test must have to be clinically very effective, measured in terms of the “test sensitivity, and the “test specificity”, that gives rise to better disease predictability for a disease prevalent in a given population, which in turn, is measured by positive and negative predictive values (PPV and NPV resp). Since the screening involves bigger population coverage in order to be effective, the screening test must also be affordable by most if not all, must have a high degree of reproducibility, must have an objectively quantifiable results and finally, that it must not have to be repeated too very often!

The Pap Cytology camecloser on only half of the criteria. No wonder, why this test did not evoke much response in the resource poor countries. While it has a high specificityof above 98%, it is known to have poor sensitivityto under 50%,or even worse in most resourcepoor population settings such as in India.A Cytology sensitivity at about 50% means that every other women with cervicallesions will stand a chance of being called as (false) negative, apart from missing disease in the otherwise healthy population. An inclusion of liquid based cytology (LBC)in place of PapCytology added some advantage, by only marginally improving the sensitivity. Higher the sensitivity for a given test, means higher the chances that a true disease will not be missed at screening, or give a false negative reaction; while higher the specificity, means higher are the chances that a true healthy (for a given disease) individuals will not be overcalled as having a disease, or give a false positive reaction. For any given clinical test, attempts to increase sensitivity would imply commensurate decrease in the specificity, and conversely, improving specificity would necessarily bring down the sensitivity. The improved sensitivity for Pap Cytology was only obtainable by repetitive testing annually, as was the practice in the west to bring some meaning to screening program, but proved a major limitation for less resourceful countries.

Given this poor sensitivity, the Pap Cytologytherefore had to be repeated annually to attain its sensitivity to correctly pick up precursor lesions in the screening population, identifiable when the dominant changes in cellular morphology have only begun to be observed. Several studies from the organized screening programs showed the LBC did not substantially alter the detection rate of high grade precancer disease (CIN 2/3) than only improving on “unsatisfactory” category of smears that often was a major gray area from the interpretation of conventional Cytology.

Changing gears!

A paradigm shift came in the screening for cervical cancer when testing for HPV DNA was added to the Pap Cytology. The poor sensitivity on Pap Cytology that only was marginally bettered by LBC, was greatly supplemented by an excellent clinical sensitivity of HPV DNA to almost 95% or above. The retrospective studies had shown that almost 99.8% of cervical cancers were attributable to the persistent infections due to one or more of 15 high risk HPV types. The mounting evidences during past decade led to the new clinical guidelines in 2012 by way of adding HPV to Cytology to increase sensitivity so as to reduce screening intervals from annual to tri-annual or even once in five years. Thus the screened negative women did not have to return for rescreening annually. Theoretically, better sensitivity by DNA with Pap Cytologyco-testing should also have given us with better positive disease predictability or positive predictive value (PPV) when it came to applying such a test for routine clinical use for symptomatic outpatients. Unfortunately it did not happen due to the fact that

many women in their 30s and 40s though remained persistently infected with HPV, identifiable by a DNA positive test, but without a clinical disease, only a small percentage of them progressed to aggressive form of precancer or early invasive disease in their 50s or 60s.HPV is largely a sexually transmitted virus and almost 80-90% of sexually active women have a chance to be infected with it sometimes in their lifespan. Given the fact that almost 80% of these women will clear this virus in 12 to 24 months of first infected, it still leaves a plethora of 20% who persistently may remain infected and thus may have a chance of reporting positive HPV DNA tests in screening set up, despite clinically being asymptomatic. In the clinical setting, this situation necessitates subjecting them to triaging by sequential tests such as HPV genotyping or frequently repeating Pap Cytology, histopathology or even other cancer biomarkers of lesser significance for staging the malignancy when presented to the clinicians with mild symptoms such as pelvic or chronic vulvarpain, abnormal bleeding, discharge, cervicitis, vaginitis or simply inflammatory conditions such as long term oral contraceptive use.In fact chronic vulvar pain is a major health concern for peri- or post-menopausal women[1] which, if compounded by persistent HPV infection, becomes challenge to correctly prognose the illness. Often, this tantamount to variety of undue patient anxieties and prognostic inaccuracies for a clinician.

The biggest advantage of HPV DNA testing is in its unmatched negative disease prediction or NPV; in that if an HPV DNA test is negative a woman does not need to return to rescreening for at least next 5years. This saves a larger burden of screening millions of women annually in the more organized countries and actually saving them millions of dollars for their national health GDP. For resource poor countries, however, this leaves a “clinical gap” between high specificity and very poor sensitivity of Pap Cytology versus high sensitivity and poor specificity of HPV DNA tests, even when following a co-testing strategy. Progressively, many western countries have begun to implement “HPV First” strategy, even without Pap Cytology in the first place. Also, efforts were directed towards applying a better molecular test having a superior specificity for detecting high grade precancer lesions withequal sensitivity of a DNA test.

HPV E6/E7 mRNA (or HPV mRNA) test was thus evolved, that filled the much needed “clinical gap”. It is a first fully quantitative and objective test that has high specificity of above 90% for detecting high grade precancer lesions with equal sensitivity as that of DNA tests. Studies have proved that HPV mRNA testing has a high concordance with histopathologic findings for high grade precancer too, identified as CIN2/3.

It is often said and widely believed that Pap test is by far a cheaper test, and hence better affordable. This has proven to be a myth through a number of cost effectiveness studies in the west. For instance, a cost of running a successful Pap Cytology based screening program in the US costs their healthcare a several billion dollars for its nearly 55 million beneficiaries. Yet, it needed to be performed annually. Triaging by HPV testing actually saved them a huge cost burden by shifting annual screening to once in five years. In fact, it amounted to co-testing with HPV for women above 30 years of age, as stipulated in the latest US-consensus guidelines (NCI/ASCCP/ACOG/ASCP) in 2012[2]. Further attempts are being made to see if theCytology with HPV co-testing could prolong screening interval to 9 years[3]. Though rather expensive way of learning, it proves Cytology as a spot-test has a very limited clinical use as a comprehensive screening program towards detecting a true disease in the given population. A woman subjecting herself for a screening by Pap Cytology test in the routine clinical practice must continue to do so at least once in five years between 30 to 60 years even if she continues to report normal findings, in order to bring some utility to Pap Cytology test.

The other important criterion of a screening test is in its ability to produce uniform results when performed repeatedly or even by different set of technical experts. Pap Cytology continues to be very subjective with very poor concordance between any two observer interpretations. Studies show that the liquid cytology only marginally improves its sensitivity though it reports far lesser number of “unsatisfactory” categories of slides.With the Pap Cytology method, cells can be obscured by blood, mucus, and inflammation as against the LBC method preserves the cells and minimizes cell overlap, blood, mucus, and inflammation for better visualization and interpretation. With the introduction of LBC in the UK a decade ago, a clear reduction in the reported rate of inadequatesmears was seen from 9% to less than 2%. Changes in reporting ofsmears lacking evidence of transformation zone sampling also had an effect onthe inadequate rate[4].

Cervical screening made easy

Inclusion of HPV testing has offered a big opportunity to cover a vast majority of population under a screening program at a relative ease, to be able to appreciate valuable gains such as quantitative reduction in mortality and morbidity rates. All that is needed for an HPV test is a tissue scraping from cervical opening in to vaginal vault with a brush like device having a long stalk. A cervical region harbors exfoliative cells those that are shed periodically with each menstrual cycle otherwise. The area between the cervical canal and cervical opening is a primary site of HPV infections and collecting exfoliative cells using a cervi-brush by a trained nursing staff is easy and simple, that does not cause any discomfiture to a woman. Alternatively, a woman may collect her own sample herself in the privacy of her home by following three simple steps to insert a cervi-brush till it finds a resistance in the vaginal vault, rotating the brush 4 to 5 turns over the cervical opening and taking the brush out with little care to collect the specimen in to the bottle that contains specimen preservative fluid. A brush and a fluid kit can be supplied by the nearest pathology lab where a properly labeled bottle with a woman’s name or ID could be simply sent. This self-collection of specimen is actually seen as a very powerful and effective means to bring a far large population under screening coverage. It is hoped that a self-sampling kit for HPV testing and a HPV test strip much like a routine pregnancy test strip may be available at the pharmacy outlets in the near future.

India marching towards cervical cancer prevention

Therefore where does India go from here in terms of seeing a successful cervical screening program? We perhaps need to normalize cervical cancer scenario in India sooner. According to WHO 2012 statistics, India sees 122,844 new cases of cervical cancer annually and is likely to increase to 148,624 by 2020, showing 21% rise in the incidence. A corresponding mortality rate is likely to increase by29% from the present number of 71,400 annual deaths. What is more concerning is nearly 35% increase in the incidence among women of 65 years or older by 2020!It is therefore very heartening to note that some of the state healthcare departments in India, such as in Tamil Nadu and Sikkim have taken up to the visual inspection (VIA) based screening programs, and parts of Maharashtra (Thane Municipal Corporation) have lately initiated a holistic VIA/Colposcopy/HPV mRNA/ HPV DNA based community screening program with an aim to provide complete treatment to women detected with high grade precursor lesions at screening.

The focus of the Thane program is to screen nearly half a million women population falling in the desired age group over a span of next 5 years. Thane is fast emerging as the best smart-city for the state of Maharashtra and theThane Municipal Corporation’s endeavor to cover the entire metropolitan population by five mobile camp vans laced with visual examination aid, colposcopy machine, and fully trained clinical and nursing staff will cover every single adult woman in the next five years. This is a very bold step to set an example for rest of the country.

The earlier studies in Tamil Nadu hadestablished nearly a 25% and 35% decline in cervical cancer incidence and mortality rates[5,6] and results of otherongoing programs are going to set up a cultural trend in the entire country in the years to follow, to see India wins over cervical cancer with thumping applaud by 2040; thanks to the newer molecular diagnostic approaches with superior specificity e.g. HPV E6/E7 mRNA, p16 IHC or ki67 markers, therapeutic interventional methodologies, vastly talented clinical excellence and conscious healthcare governance conceding to screening success to gain the huge mandate for women of India.

Concurrent mission!

Along the side lines of population based screening programs what India needs is a supportive and stronger advocacy program. The awareness about breast cancer early detection and prevention has been seen to be far better than cervical cancer, primarily owing to social taboo associated with lower genital tract diseases. This perspective needs to change. Cervical cancer is now fully preventable cancer, if detected correctly in its precancer stage and every single woman of this country need to know and be able to freely talk about it. The social and news media have lately been playing a significant role in mobilizing a mass mindset. A celebrity endorsement will certainly step up acceptance for screening. Australia became the first country to have introduced HPV vaccination in the national immunization plan in 2006 when the then prime minister John Howard’s wife was detected with cervical cancer and thus became a champion of the awareness cause. The Australian first lady, Janette Howard was treated for cervical cancer in 1996 and took up to immunizing adolescent girls no sooner the HPV vaccination became available in 2006[7].

The next step would be the role of healthcare insurance sector to consider providing reimbursement on at least 5-yearly screening using HPV and Pap Cytology co-testing through their products aimed at women’s health. A one-time reimbursement on HPV and Pap Cytology co-testing may cost under Rs 3000 once in 5 to 7 years but would fetch at least five times annual subscription and considering 100% compliance insurance sector stands to benefit out of such a product, still save few lacs of rupees of treatment cost reimbursements on patients progressing to invasive stages of cancer. On the other hand, what a boon it may be for the larger section of unorganized private sector women of modern India!

Our healthcare insurance sector is largely curative and hospitalization oriented for any reimbursement. For the first time for any cancer, we have a strong evidence of long term prognostic value resulting in to quantifiable economic benefits to insurance providers as well. Not only the cost of treatment for cervical precancer is far lower than frank cancer, but largely reduced number of cases still progressing to the invasive cancer stages would mean greater saving on insurance incomes. In addition, the insurance sector gains enormously by reaching out to our women folks who have remained a low family priority when it comes to the better family health. A market survey report suggests if only 10% of the 150 million target women (other than otherwise insured through their government or private sector employment) between the age group of 30 to 60 are reimbursed for cervical screening once in five years, it would fetch additional annual revenue of 5,500 million rupees at only a rupee-a-day subscription, while reimbursing the costs of screening only once in five years, considering 100% compliance of insurance claimants! While few states are pushing forward the cervical screening in their earnest endeavor to its women, can our union governance push for this dormant aspect of our healthcare system?

Take-home massage

Cervical cancer is fully preventable cancer if detected early and correctly. Hence screening is very important and each woman should subject herself for clinical pelvic examination at least once in five years, just as clinical breast examination to prevent breast cancer.

Testing for HPV has a better long-term predictive value and the specificity for HPV test improves with the age of a woman.

Women are encouraged to discuss their lower genital health more freely with their doctors, among friends or even with family members. Awareness is a boon and ignorance is a bane for many cancers. A socially and economically empowered woman of modern India must be ‘aware’ and share her knowledge to those who may be less privileged.

Want to write for InnoHEALTH? send us your article at  magazine@innovatiocuris.com

Diabetes, the plague of this generation, needs qualified support for patients to eliminate fear and preventable sufferings. Tele Health Help Desk offers precisely that solution- Patient relationship management that acts as a single point of contact for patients and their caretakers and provides a dedicated helpline to diabetes patients, ensuring that a hospital or Pharma Company’s brand value augments its reputation in the process. Innovation is the cornerstone of competitive advantage, and we are excited to change the old approach. Will you be a forerunner?

Diabetes is a modern day dragon that is threatening to affect a big section of the masses of the present century. The numbers are stunning beyond belief: Nearly 50 million suffer from the deadly lifestyle disease. Average cost of treatment of each diabetic patient is approximately Rs. 6000 a year, as per IDF Atlas, 2014. And this cost does not include any cost associated with more serious complications like diabetes foot, kidney and eye disease due to diabetes.

With the huge number of diabetes patients- 50 million or 5 crores- the combined colossal amount makes a big dent in any country’s economy, fragile as it is due to continuous recession around the globe.

Besides expenditure, there is a big shortage of trained workforce at all levels, especially the lowest and middle rung of the society. According to recent studies, underprivileged sections of society in urban ghettos are particularly vulnerable, if not more than as much as the rising classes.

The lack of specialized human resources is proving a major deterrent in fighting the monster and preventing major losses like diabetic nephropathy, cardiac complications and diabetic retinopathy.

Picture the scenario outside a health facility, endocrinologists are struggling to muddle through the thronging flock of patients. The benches outside the room are all crammed to capacity, the cacophony increasing with each passing minute. Waiting is never supposed to give any kind of pleasure; it is always a compromise of the poor. Challenge is defined thus. Even a willing and able doctor will be exasperated with so much to do in so little time.

So, how can the healthcare system meet this need?

First and foremost, technology should be used to offer prevention as well as treatment of diabetes. The age old adage of cure being an after-thought should be the primary motive for preferring prevention as its go-to strategy.

Experienced and well equipped tele-health companies can play a critical role by collaborating with medical institutions and the government for proactive tele health solutions that would minimize hospital visits as well as create an empathetic environment for patients to come back to, via the telephone of course!

There are a few organizations that specialize in the sphere of empathy calls and history tracking. Their tele health division is well respected for employing state of the art software that helps in tracking every single detail of all the patients and in the same time helps in issuing alerts and emergencies regarding patients.

The positive message of the services—helping patients adapt to daily life without too many restraints —is the key to success.

If we have a senior citizen diabetic whose blood sugar shot up to 300, because she couldn’t resist her grandson’s birthday cake, empathy urges us to accept what has occurred, and respond, “What’s life without celebrations and a little piece of cake!”

Bringing patients within your desired goalposts by teaching them to build their diet around a family event is more realistic than preaching the more stern and unwelcoming, “Never eat dessert.”

The challenge before hospitals is to develop a centralized function to act as the single point of contact for the end-users (patients) who require assistance for resolution of problems, concerns, question and requests. The need of the hour is a Dedicated Empathetic Helpdesk for Hospitals that would help your facility build a strong bond and a stronger brand with your customers – Patients and Prospects- before and after they are in your premises. Such improved communications, based on a predictive marketing model, result in building and sustaining trust in your facility, a crucial task in the healthcare business.

Our tele health help desk has made significant positive changes by improving customer satisfaction and exceeding performance targets. One of our clients has authorized us to disclose their figures:

1. Operational Savings of Rs. 22 lakh annually.
2. Patient retention has increased by a sizeable 8%.
3. Higher level of customer satisfaction.

It’s going to be increasingly important for you to know what’s happening when patients leave your facility.

A handful of futuristic companies, led by charismatic pioneers are engaged in providing helpdesk services to medical institutions that act as the preferred medium of interaction between them and their patients. An explainer video presentation that describes tele health services and benefits thereof can open your mind to exciting new possibilities of retaining patients and providing care for them better than ever before. You can also watch the video directly on YouTube at the URL:

https://www.youtube.com/watch?v=2c57rTr-l64

The process of proactive patient relationship management is still in a nascent stage in India. Change is beckoning you, the risk-taker and innovator. Today is a good day to do that, no?

Want to write for InnoHEALTH? send us your article at  magazine@innovatiocuris.com

Connect with InnovatioCuris on: 
Facebook: https://www.facebook.com/InnovatioCuris
Twitter: https://twitter.com/innovatiocuris
Linkedin: https://www.linkedin.com/groups/7043791
Stay update about IC by visiting: www.innovatiocuris.com

Connect with InnoHEALTH 2017 on:
Facebook: https://www.facebook.com/innohealth2017
Twitter: https://twitter.com/innhealth2017
Linkedin: https://www.linkedin.com/groups/7043791
Stay update about the conference by visiting: www.innohealth.in