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GS Paper: GS2-13.Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.

  • ICMR drops Plasma Therapy for COVID-19

    The use of convalescent plasma has been dropped from the recommended treatment guidelines for COVID-19, according to an advisory from the Indian Council of Medical Research (ICMR).

    Q.What is convalescent plasma therapy and what are the issues involved in its adoption?

    Convalescent Plasma Therapy

    • The therapy seeks to make use of the antibodies developed in the recovered patient against the coronavirus.
    • The whole blood or plasma from such people is taken, and the plasma is then injected into critically ill patients so that the antibodies are transferred and boost their fight against the virus.
    • A COVID-19 patient usually develops primary immunity against the virus in 10-14 days.
    • Therefore, if the plasma is injected at an early stage, it can possibly help fight the virus and prevent severe illness.

    How often has it been used in the past?

    • This therapy is no new wonder. It has been used several times.
    • The US used plasma of recovered patients to treat patients of Spanish flu (1918-1920).
    • In 2014, the WHO released guidelines to treat Ebola patients with convalescent whole blood and plasma.
    • In 2015, plasma was used for treating MERS patients.

    How is it done?

    • The process to infuse plasma in a patient can be completed quickly.
    • It only requires standard blood collection practices and extraction of plasma.
    • If whole blood is donated (350-450 ml), a blood fractionation process is used to separate the plasma.
    • Otherwise, a special machine called aphaeresis machine can be used to extract the plasma directly from the donor.
    • While blood is indeed extracted from the donor, the aphaeresis machine separates and extracts the plasma using a plasma kit, and the remaining blood components are returned into the donor’s body.
  • NITI Aayog’s proposal of allowing private entities to take over district hospitals

    The article highlights the issue of shortage of doctors in India and issues with the involvement of private sector in it.

    Government approach

    • Market-oriented approach towards medical education: NITI Aayog’s proposal of allowing private entities to take over district hospitals for converting them into teaching hospitals with at least 150 MBBS seats.
  • India resists Community Transmission tag despite soaring cases

    How other countries are classifying themselves

    • Inspite of adding the highest number of cases in the world every day, India continues to label itself as a country with no community transmission (CT) according to the latest weekly report by the World Health Organisation (WHO) on May 11.
    • India opts for the lower, less serious classification called ‘cluster of cases’.
    • Countries such as the United States, Brazil, United Kingdom, France have all labelled themselves as being in ‘community transmission.
    • Among the 10 countries with the most number of confirmed cases, only Italy and Russia do not label themselves as being in community transmission.
    • Both countries have been on a declining trajectory for at least a month and together contribute less than 20,000 cases a day — about 5% of India’s daily numbers.
    • India, since the beginning of the pandemic has never marked itself as being in community transition.

    Understanding the classification

    • Broadly, CT is when new cases in the last 14 days can’t be traced to those who have an international travel history, when cases can’t be linked to specific cluster.
    • Instead, the classification, ‘cluster of cases’ says “Cases detected in the past 14 days are predominantly limited to well-defined clusters that are not directly linked to imported cases”.
    • The WHO guidelines further suggest four subcategories within the broader definition of CT.
    • CT-1 implying “Low incidence of locally acquired, widely dispersed cases…and low risk of infection for the general population.
    • The highest, a CT-4 suggests very high incidence of locally acquired, widely dispersed cases in the past 14 days.
    • Very high risk of infection for the general population.

    Why right classification matters

    • If cases were still a cluster, it would mean that the government ought to be prioritising testing, contact tracing and isolating to prevent further infection spread.
    • CT, on the other hand meant prioritising treatment and observing advisories to stay protected.
    • CT — far from being stigmatic or an indicator of failure — has a bearing on how authorities addressed a pandemic.
  • EdTech needs an ethics policy

    The article highlights the privacy concerns associated with EdTech apps in the absence of a regulatory framework.

    Privacy risks associated with EdTechs

    • Since the onset of the pandemic, online education has replaced conventional classroom instruction.
    • This has given rise to several EdTech apps which have become popular.
    • To perform the process of learning customisation, the apps collect large quantities of data from the learners through the gadgets that the students use.
    • These data are analysed in minute detail to customise learning and design future versions of the app.
    • The latest mobile phones and hand-held devices have a range of sensors like GPS, gyroscope, accelerometer, magnetometer and biometric sensors apart from the camera and microphones.
    • These provide data about the learner’s surroundings along with intimate data like the emotions and attitudes experienced and expressed via facial expressions and body temperature changes.
    • In short, the app and device have access to the private spaces of the learner that one would not normally have access to.

    Informed consent in research

    • Researchers dealing with human subjects need to comply with ethics rules along with global standards.
    • One of the cardinal rules that should never be broken is informed consent.
    • Before any research on human subjects is undertaken, researchers have to submit detailed proposals to their respective ethics committees and obtain their permissions.
    • Further, a researcher working with children, for example, would also have to convince schoolteachers, parents, and school managements about the nature of the research to be undertaken, type of data to be collected, method of storage, the potential harmful effects of such data, etc.

    Minimal safeguards in EdTech

    • The safeguards that traditional researchers are subject to are either missing or minimal in research that the EdTech industry promotes.
    • The concept of informed consent is not meaningful since there are no proper primers to explain to stakeholders the intricacies in layperson terms.
    • Since India does not have protection equivalent to the GDPR, private data collected by an EdTech company can be misused or sold to other companies with no oversight or protection.

    Way forward

    • Given these realities, it is necessary to formulate an ethics policy for EdTech companies.
    • Such a policy draft should be circulated both online and offline for discussions and criticism.
    • Issues of fairness, safety, confidentiality and anonymity of the user would have to be dealt with.
    • EdTech companies would have to be encouraged to comply in the interest of a healthier learning ecosystem.

    Consider the question “What are the challenges associated with the adoption of online education mode? Suggest the ways to deal with these challenges.”

    Conclusion

    The lack of a regulatory framework in India along the lines of the General Data Protection Regulation (GDPR) in Europe could impinge on the privacy of students. What we need is ethics policy in online education space.

  • Digital Technologies and Inequalities

    Impact of pandemic

    • The novel coronavirus pandemic has accelerated the use of digital technologies in India, even for essential services such as health and education, where access to them might be poor.
    • Economic inequality has increased: people whose jobs and salaries are protected, face no economic fallout.
    • Well-recognised channels of economic and social mobility — education and health — are getting rejigged in ways that make access more inequitable in an already unequal society.

    Growing inequality in access to education

    • According to National Sample Survey data from 2017, only 6% rural households and 25% urban households have a computer.
    • Access to Internet facilities is not universal either: 17% in rural areas and 42% in urban areas.
    • Surveys by the National Council of Educational Research and Training (NCERT), the Azim Premji Foundation, ASER and Oxfam suggest that between 27% and 60% could not access online classes for a range of reasons: lack of devices, shared devices, inability to buy “data packs”, etc.
    • Further, lack of stable connectivity jeopardises their evaluations.
    • Besides this, many lack a learning environment at home.
    • Peer learning has also suffered.

    Inequality in access to health care

    •  India’s public spending on health is barely 1% of GDP.
    • Partly as a result, the share of ‘out of pocket’ (OOP) health expenditure (of total health spending) in India was over 60% in 2018.
    • Even in a highly privatised health system such as the United States, OOP was merely 10%.
    • Moreover, the private health sector in India is poorly regulated in practice.
    • Both put the poor at a disadvantage in accessing good health care.
    • Right now, the focus is on the shortage of essentials: drugs, hospital beds, oxygen, vaccines.
    • In several instances, developing an app is being seen as a solution for allocation of various health services. 
    • Digital “solutions” create additional bureaucracy for all sick persons in search of these services without disciplining the culprits.
    • Platform- and app-based solutions can exclude the poor entirely, or squeeze their access to scarce health services further.
    • In other spheres (e.g., vaccination) too, digital technologies are creating extra hurdles.
    • The use of CoWIN to book a slot makes it that much harder for those without phones, computers and the Internet. 

    Issues with the creation of centralised database

    • The digital health ID project is being pushed during the pandemic when its merits cannot be adequately debated.
    • Electronic and interoperable health records are the purported benefits.
    • For patients, interoperability i.e., you do not have to lug your x-rays, past medication and investigations can be achieved by decentralising digital storage say, on smart cards as France and Taiwan have done.
    • Given that we lack a data privacy law in India, it is very likely that our health records will end up with private entities without our consent, even weaponised against us.
    • For example, a private insurance companies may use health record to deny poor people an insurance policy or charge a higher premium.
    • There are worries that the government is using the vaccination drive to populate the digital health ID database.

    Way forward

    • Unless health expenditure on basic health services (ward staff, nurses, doctors, laboratory technicians, medicines, beds, oxygen, ventilators) is increased, apps such as Aarogya Setu, Aadhaar and digital health IDs can improve little.
    • Unless laws against medical malpractices are enforced strictly, digital solutions will obfuscate and distract us from the real problem.
    • We need political, not technocratic, solutions.

    Conclusion

    Today, there is greater understanding that the harms from Aadhaar and its cousins fall disproportionately on the vulnerable. Hopefully, the pandemic will teach us to be more discerning about which digital technologies we embrace.

  • Scientists see flaws in SUTRA’s approach to forecast pandemic

    About SUTRA

    • SUTRA (Susceptible, Undetected, Tested (positive), and Removed Approach) first came into public attention when one of its expert members announced in October that India was “past its peak”.
    • Unlike many epidemiological models that extrapolated cases based on the existing number of cases, the behaviour of the virus and manner of spread, the SUTRA model chose a “data centric approach”.
    • However, the surge in the second wave was several times what any of the modellers had predicted.
    • The predictions of the SUTRA model were too variable to guide government policy.

    So, what went wrong in the model

    • The SUTRA model was problematic as it relied on too many parameters, and recalibrated those parameters whenever its predictions broke down.
    • The more parameters you have, the more you are in danger of overfitting.
    • One of the main reasons for the model not gauging an impending, exponential rise was that a constant indicating contact between people and populations went wrong.
    • Further the model was ‘calibrated’ incorrectly.
    • The model relied on a serosurvey conducted by the ICMR in May that said 0.73% of India’s population may have been infected at that time.
    • This calibration led our model to the conclusion that more than 50% population was immune by January.
    • The SUTRA model’s omission of the importance of the behaviour of the virus; the fact that some people were bigger transmitters; a lack of accounting for social or geographic heterogeneity and not stratifying the population by age as it didn’t account for contacts between different age groups also undermined its validity.
  • A ‘One Health’ approach that targets people, animals

    The article highlights the need for a holistic approach to animal and human health as more than two-thirds of existing and emerging infectious diseases are zoonotic.

    Need to document the link between environment animal and human health

    • Studies indicate that more than two-thirds of existing and emerging infectious diseases are zoonotic, or can be transferred between animals and humans, and vice versa.
    • Another category of diseases, anthropozoonotic infections, gets transferred from humans to animals.
    • The transboundary impact of viral outbreaks in recent years such as the Nipah virus, Ebola, Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) has reinforced the need for us to consistently document the linkages between the environment, animals, and human health.

    India’s ‘One Health’ vision

    • India’s ‘One Health’ vision derives its blueprint from the agreement between the tripartite-plus alliance.
    • The alliance comprises the Food and Agriculture Organization of the United Nations (FAO), the World Organisation for Animal Health (OIE), the World Health Organization (WHO) and the United Nations Environment Programme (UNEP) — a global initiative supported by the United Nations Children’s Fund (UNICEF) and the World Bank under the overarching goal of contributing to ‘One World, One Health’.
    • In keeping with the long-term objectives, India established a National Standing Committee on Zoonoses as far back as the 1980s.
    • This year, funds were sanctioned for setting up a ‘Centre for One Health’ at Nagpur.
    • Further, the Department of Animal Husbandry and Dairying (DAHD) has launched several schemes to mitigate the prevalence of animal diseases since 2015.
    • Hence, under the National Animal Disease Control Programme, â‚č13,343 crore have been sanctioned for Foot and Mouth disease and Brucellosis control.
    • In addition, DAHD will soon establish a ‘One Health’ unit within the Ministry.
    • Additionally, the government is working to revamp programmes that focus on capacity building for veterinarians such as  Assistance to States for Control of Animal Diseases (ASCAD).
    • There is increased focus on vaccination against livestock diseases and backyard poultry.
    •  DAHD has partnered with the Ministry of Health and Family Welfare in the National Action Plan for Eliminating Dog Mediated Rabies.

    Need for coordination

    •  There are more than 1.7 million viruses circulating in wildlife, and many of them are likely to be zoonotic.
    • Therefore, unless there is timely detection, India risks facing many more pandemics in times to come.
    • There is need to address challenges pertaining to veterinary manpower shortages, the lack of information sharing between human and animal health institutions, and inadequate coordination on food safety at slaughter.
    • These issues can be remedied by consolidating existing animal health and disease surveillance systems — e.g., the Information Network for Animal Productivity and Health, and the National Animal Disease Reporting System.

    Conclusion

    As we battle yet another wave of a deadly zoonotic disease (COVID-19), awareness generation, and increased investments toward meeting ‘One Health’ targets is the need of the hour.

  • A WTO waiver on patents won’t help us against covid

    There has been growing clamour across the world for waiver of intellectual property protection for Covid-19 vaccines under TRIPS. The article suggests alternatives to achieve the desired production of vaccines without setting the precedent for a waiver.

    Waiver from TRIPS

    • Last October, India and South Africa moved a motion at the WTO asking its council on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to provide a waiver on intellectual property protection for pharmaceutical patents.
    • Many developing countries have since supported the joint move.
    • While most advanced countries, home to the world’s major pharmaceutical companies, have opposed it.
    • Nobel economist Joseph Stiglitz, along with activist Lori Wallach, penned an opinion piece making a case for such a waiver.

    Voluntary licensing

    • Alternative to waiver could be voluntary licensing arrangements between pharmaceutical companies and countries that wish to make vaccine doses for their own use.
    • This is exactly what has occurred in India’s case, with a licensing agreement between AstraZeneca and Serum Institute of India.
    • The recent difficulties with this arrangement are a result of India diverting some doses intended for export (or for Covax) to its domestic vaccination drive.
    • But India will soon begin making other important global vaccines under similar licence arrangements, and a waiver would do nothing to speed up this process.

    Compulsory licensing

    • In the event that India needs to ramp up production more than is feasible via licences from global manufacturers, there is another alternative available, which is ‘compulsory licensing’.
    • Such an approach would not permit the export of vaccine doses made under a compulsory licence.
    • This approach should be taken by any developing country, if, for some reason, global pharmaceutical companies are unwilling to license a life-saving vaccine for domestic manufacture and distribution in that nation.

    Why TRIPS waiver won’t help

    • India’s limiting factors are a shortage of raw materials and low production capacity, neither of which would be cured with the supposed magic bullet of a WTO waiver.
    • Not only would a WTO waiver not do anything to address the real bottlenecks that constrain the global production and distribution of vaccines, it would also set a bad precedent.
    • It is true that governments, including the US and others, have significantly subsidized or incentivized in other ways the research and development activities of private pharmaceutical companies that now hold patents for major covid vaccines.
    • Yet, these governments required the ingenuity of private enterprise to invent these vaccines.

    Consider the question “What are the legal provisions to ensure the accessibility of life-saving drugs in the country?”

    Conclusion

    While it may seem appealing, a WTO waiver on intellectual property protection is an inappropriate priority. It’s a distraction from the heavy lifting needed to create the capacity to fight the scourge of covid.

  • Supreme Court must oversee vaccination to protect the right to life

    The article highlights the role the Supre Court can play in universal vaccination in India.

    Why Supreme Court needs to step in

    • Amid raging debate over the vaccination strategy, the role the Supreme Court of India can play to safeguard the right to life guaranteed under Article 21, for which it is duty-bound to exercise jurisdiction under Article 32 needs consideration.
    • In this regard, universal vaccination is a glimmer of hope.
    • The Supreme Court of India can facilitate speed and deeper penetration of universal vaccination, which is now commonly accepted as the only possible solution to the pandemic in the long run.

    Issue of patent of vaccine

    • It is time to question patents claimed by vaccines that have been developed with aid from the state in research and development.
    • These patents, if established, must be immediately acquired with just and adequate compensation and made accessible to all manufacturers.
    • This was done for medicines for AIDS and it can be done again under the Patents Act.
    • The Court can also issue mandamus to undertake this exercise on an emergency basis.
    • Thereafter, all pharmaceutical companies with Good Manufacturing Practices (GMP) as per the Drugs and Cosmetics Act must be allowed to manufacture vaccines at a pre-approved price of cost + 6 per cent return on investment.
    • States can also be directed to incentivise the setting up of new manufacturing facilities as a possible third wave, periodic booster doses and the need for ancillary vaccines make it a long-term phenomenon.
    • All this has to be ensured in addition to the free import of vaccines approved by advanced nations.

    Free for all

    • The availability of all the vaccines, whether indigenous or imported, must be free for all the recipients to be paid by GoI.
    • The vaccines can be distributed to states on a pro-rata basis as per population and price adjusted as part of general revenue sharing in GST.

    Vaccine administration

    •  The vaccine administration needs to be ramped up both in state and private facilities.
    • For vaccine hesitancy, we need to incentivise the vaccination through a direct deposit of Rs 500 in Jan Dhan accounts for each vaccinated member of BPL families.
    • This vaccination can be made compulsory for identifiable categories of persons from MGNREGA beneficiaries to Aadhaar Card holders to income-tax payers to bank account holders to driving-licence holders.
    • There must be a strict penalty to be recovered from those who do not get vaccinated without medical reasons.
    • Private efforts can be made eligible for reimbursement of cost.

    Conclusion

    The Supreme Court can steer us, with greater emphasis on the right to life. The pandemic may leave nothing and nobody behind to bicker about.

  • Govt leverage in Covid-19 vaccine pricing

    How government regulate prices of drugs

    • The Supreme Court flagged the issue of differential pricing for vaccines among States and the Centre and directed the central government to clarify it in an affidavit.
    • To ensure accessibility, the pricing of essential drugs is regulated centrally through The Essential Commodities Act, 1955.
    • Under Section 3 of the Act, the government has enacted the Drugs (Prices Control) Order (DPCO).
    • The DPCO lists over 800 drugs as “essential” in its schedule, and has capped their prices.
    • The capping of prices is done based on a formula that is worked out in each case by the National Pharmaceutical Pricing Authority (NPPA), which was set up in 1997.

    So, why the government is not regulating price of vaccines through DPCO

    • This is because the regulation through DPCO is not applicable for patented drugs or fixed-dose combination (FDC) drugs.
    • This is why the price of the antiviral drug remdesivir, which is currently in great demand, is not regulated by the government.
    • To bring vaccines or drugs used in the treatment of Covid-19 such as remdesivir under the DPCO policy, an amendment can be brought.

    What other options government can explore to deal with the vaccine price issue

    1) Patent Act 1970

    • The Patent Act 1970 has two key provisions that could be potentially invoked to regulate the pricing of the vaccine.
    • Section 100 of the Patents Act gives the central government the power to authorise anyone (a pharma company) to use the invention for the “purposes of the government”.
    • It enables the government to license the patents of the vaccine to specific companies to speed up manufacturing and ensure equitable pricing.
    •  Under Section 92 of the Act, which deals with compulsory licensing, the government can, without the permission of the patent holder, license the patent under specific circumstances prescribed in the Act.
    • Section 92 can be invoked in case of circumstances of national emergency or in circumstances of extreme urgency or in case of public non-commercial use.
    • After the government issues a notification under Section 92, pharma companies can approach the government for a licence to start manufacturing by reverse engineering the product.
    • However, in the case of biological vaccines like Covid-19, even though ingredients and processes are well known, it is difficult to duplicate the process from scratch.
    • The process will also entail new clinical trials to establish safety and efficacy, which makes compulsory licensing less attractive.

    2) The Epidemic Diseases Act, 1897

    • Section 2 of this law gives the government “power to take special measures and prescribe regulations as to dangerous epidemic disease”.
    • These broad, undefined powers can be used to take measures to regulate pricing.
    • However, the law lacks the teeth to implement such an important policy framework.
    • Violation of the Act is penalised under Section 188 of the Indian Penal Code, which deals with “disobedience to order duly promulgated by (a) public servant”.

    3) Direct procurement by the Centre

    • Apart from these legislative options, experts suggest that the central government procuring directly from the manufacturers could be the most beneficial route to ensure equitable pricing.
    • As the sole purchaser, it will have greater bargaining power.