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Subject: Governance

Important aspects of Society

  • What is the Emergency Use Authorization (EUA) for Drugmakers?

    The US drugmaker Moderna said it was applying for emergency use authorisation for its vaccine in India.

    Practice question for Mains:

    Q. What is Vaccine Nationalism? Discuss various ethical issues involved and its impact on vulnerable populations across the globe.

    Emergency Use Authorisation (EUA)

    • Vaccines and medicines, and even diagnostic tests and medical devices, require the approval of a regulatory authority before they can be administered.
    • In India, the regulatory authority is the Central Drugs Standard Control Organisation (CDSCO).
    • The approval is granted after an assessment of their safety and effectiveness, based on data from trials. In fact, approval from the regulator is required at every stage of these trials.
    • This is a long process, designed to ensure that medicine or vaccine is absolutely safe and effective.
    • The fastest approval for any vaccine until now — the mumps vaccine in the 1960s — took about four-and-a-half years after it was developed.

    Exceptions for emergency

    • In emergency situations, like the current one, regulatory authorities around the world have developed mechanisms to grant interim approvals.
    • However, there should sufficient evidence to suggest a medical product is safe and effective.
    • Final approval is granted only after completion of the trials and analysis of full data; until then, EUA allows the medicine or the vaccine to be used on the public.

    What is the process of getting a EUA in India?

    • India’s drug regulations do not have provisions for a EUA, and the process for receiving one is not clearly defined or consistent.
    • Despite this, CDSCO has been granting emergency or restricted emergency approvals to Covid-19 drugs during this pandemic — for remdesivir and favipiravir in June, and itolizumab in July.

    Associated risks

    • The public has to be informed that a product has only been granted a EUA and not full approval.
    • In the case of a Covid-19 vaccine, for example, people have to be informed about the known and potential benefits and risks.

    Not a compulsion

    • There has been an ongoing debate over whether people have the option of refusing to take the vaccine.
    • Incidentally, no country has made vaccination compulsory for its people.
    • Initially, all vaccines are likely to be deployed on emergency use authorizations only. Final approval from may take several months, or years.

  • Swasthya Sathi Health Insurance Scheme

    West Bengal CM has recently extended the Swasthya Sathi health insurance scheme to cover the entire population of the state.

    Do you know?

    Delhi, Telangana, Odisha and West Bengal have not implemented the Ayushman Bharat Scheme.

    Swasthya Sathi

    • The scheme was launched in West Bengal in 2016.
    • It is a basic health cover for secondary and tertiary care up to Rs five lakh per annum per family.
    • It is quite popular among rural and economically deprived sections of the state’s population.

    Highlights of the expanded scheme

    • Every family, every citizen irrespective of the age group will be included in this scheme
    • This is a basic health cover for secondary and tertiary care up to Rs 5 lakh per annum per family
    • The scheme is completely funded by the state government
    • To cover the entire population of the state, each and every family will be given one smart card to avail the benefits under this scheme, where they will get cashless treatment
    • All state-run and private hospitals are going to come under the Swasthya Sathi
    • The card will be issued to the female guardians of families

  • Is allowing Ayurvedic doctors to perform surgery legally and medically tenable?

    The Central Council of Indian Medicine, a statutory body set up under the AYUSH Ministry has allowed postgraduate (PG) Ayurvedic practitioners to receive formal training for a variety of general surgery, ENT, ophthalmology and dental procedures.

    Debate over Ayurvedic surgeries

    • The Indian Medical Association (IMA) decrying it as a mode of allowing mixing of systems of medicine by using terms from allopathy.
    • The debate revolves Ayurveda doctors allowing  ‘Shalya’ (general surgery) and ‘Shalakya’ (dealing with eye, ear, nose, throat, head and neck, oro-dentistry) to perform 58 specified surgical procedures.
    • The AYUSH Ministry has clarified that the ‘Shalya’ and ‘Shalakya’ postgraduates were already learning these procedures in their (surgical) departments in Ayurvedic medical colleges as per their training curriculum.

    Broader issue

    • The broader issue is the feasiblity of short-term training equip them to conduct surgeries and if this dilutes the medicine standards in India.
    •  As such, the postgraduate Ayurvedic surgical training is not short-term but a formal three-year course.
    • Whether the surgeries conducted in Ayurvedic medical colleges and hospitals have the same standards and outcomes as allopathic institutions requires explication and detailed formal enquiry, in the interest of patient safety.

    Why such a move?

    • The shortage and unwillingness of allopathic doctors, including surgeons, to serve in rural areas is now a chronic issue.
    • The government has tried to address this by mechanisms such as rural bonds, a quota for those who have served in rural service in postgraduate seats.
    • However, it would probably still continue to fall short of enough trained specialists in rural areas.

    Are there any restrictions on Ayurveda practitioners?

    •  As of now, no such restriction exists that limits non-allopathic doctors, including those doing Ayurvedic surgical postgraduation, to rural areas.
    • They have the same rights as allopathic graduates and postgraduates to practise in any setting of their choice.

    Is it sensible to allow Ayurvedic surgeons to only assist allopathic surgeons, rather than perform surgeries themselves?

    • The AYUSH streams are recognised systems of medicine, and as such are allowed to independently practise medicine.
    • They have medical colleges with both undergraduate and postgraduate training, which include surgical disciplines for some systems, such as Ayurveda.
    • There is, however, a difference in approach in the systems of medicine, and hence models, which allow for cross-pathy.

    Various risks associated

    • An apprenticeship model for Ayurvedic surgeons working with allopathic surgeons might fall into a regulatory grey zone.
    • It might require re-training Ayurvedic practitioners in the science of surgical approaches in modern medicine.
    • Even then, there might be a limit to what they are allowed to do. Any such experiment can put patient safety in peril, and hence, will need careful oversight and evaluation.

    Can this lead to substandard care?

    • Many patients prefer to receive treatment exclusively from AYUSH providers, while some approach this form of treatment as a complement to the existing allopathic treatment they are receiving.
    • For invasive procedures, like surgery, the risk element can be high.

    A matter of rights

    • Patients have a right to know and understand who their surgeon would be, what system of medicine they belong to, and their expertise and level of training.
    • There should not be a difference in quality of care between urban and rural patients — everyone deserves a right to quality and evidence-based care from trained professionals.

    Way forward

    • We need to explore creative ways of addressing this gap by evidence-based approaches, such as task-sharing, supported by efficient and quality referral mechanisms.
    • The advent of mid-level healthcare providers, such as Community Health Providers in many States, is also an opportunity to shift some elements of healthcare (preventive, promotive, and limited curative) to these providers, while ensuring clarity of role and career progression.

  • Linking Aadhaar to residence for targeted aid

    The article suggests the provision for a safety net with geographic targeting in case of disasters as most disasters are location specific.

    Safety net in the U.S.

    • The US Congress enacted in March a Coronavirus Aid, Relief and Economic Security (CARES) Act to sends $1,200 to each individual below the income threshold of $75,000.
    • Nonetheless, as The Washington Post reported, even in October, millions of households were yet to receive their stimulus payments.
    • The tax authorities who were charged with disbursing the funds had no way of knowing how to send the cheques.
    • But the poor had to cross several hurdles to get this money and the computer system did not make it easy for them to register their claim.

    Safety net in India and issues with it

    • In contrast to U.S., 23 per cent of Indians living in Delhi-NCR received a payment of Rs 500 in their Jan Dhan accounts within three weeks of the lockdown being declared.
    • Farmers registered for PM-KISAN also received Rs 2,000 in their accounts immediately.
    • However, there were some issues for example, recipients of PM-KISAN were not amongst the poorest households, nor were these the households that were most affected by the COVID-related lockdown.
    • The PM-Kisan Yojana applies to landowners, thereby excluding agricultural labourers as well as the urban informal sector workers who were most affected by the lockdown.
    • Similarly, for the PMJDY payment, BPL and non-BPL households record similar receipt transfers.

    Twin challenges in designing social safety nets

    • Unless a registry containing data about individuals and their bank accounts exists, money cannot be transferred expeditiously.
    • 1) Registries based on specific criteria (for example, identified BPL households) may not identify individuals most vulnerable to crises.
    • 2) Factors that contribute towards alleviating poverty may differ from the ones that push people into it — indicating the challenge of targeting welfare beneficiaries in response to shocks.
    • About 40 per cent of the poor in 2012 were pushed into poverty by special circumstances and would not have been classified as being poor based on their 2005 conditions.
    • Such exclusion errors can get magnified in the event of large-scale disasters when using pre-existing databases, since many people are likely to fall into poverty from an economy-wide negative shock, leading to coverage errors.

    Way forward

    • Recent estimates from the World Bank suggest that 88 to 115 million people could slide into poverty in 2020.
    • These observations suggest that in a disaster response situation, we cannot rely on registries based on individual characteristics to identify beneficiaries.
    • Most disasters are geographically clustered.
    • If there is a way for us to set up social registries that identify individuals, their place of residence, and their bank accounts, these linkages can be used to transfer funds to everyone living in the affected area quickly.
    • Aadhaar linkages of individuals and bank accounts already exist.
    • If residential information in the Aadhaar database can be efficiently structured, this would allow for geographic targeting.
    • Issue of violation of individual privacy can be addressed by providing that such social registries store only basic information such as location, instead of more sensitive identifiers.

    Consider the question “Disasters underscores the importance of social safety nets. However, designing a social safety net that identifies and reach the vulnerable suffers from several challenges. What are these challenes. Suggest ways to address these challenges.” 

    Conclusion

    As we try to disaster-proof future welfare programmes, these are some of the considerations that deserve attention.

  • Gender Advancement through Transforming Institutions (GATI) Initiative

    One of the focuses of the new Science, Technology and Innovation Policy, currently being drafted by the Department of Science and Technology (DST) is to increase the participation of women in science.

    Connect the dots:

    Women in STEM presents a dismal picture of gender equality in India.

    GATI

    • The DST is incorporating a system of grading institutes depending on the enrolment of women and the advancement of the careers of women faculty and scientists.
    • It will be called GATI (Gender Advancement through Transforming Institutions).
    • The concept borrows from a programme started by the UK in 2005 called the Athena SWAN (Scientific Women’s Academic Network), which is now being adopted by many countries.
    • The DST will soon launch a pilot, which the British Council has helped it develop.

    Why need such initiative?

    • India is ranked 108 out of 149 countries in the 2018 Global Gender Gap report.
    • According to DST figures, in 2015-16, the share of women involved in scientific research and development was 14.71% — after it had actually increased from 13% in 2000-2001 to 29% in 2014-15.
    • The DST has also found that women are either not promoted, or very often drop out mid-career to attend to their families.

    What is Athena SWAN?

    • The Athena SWAN Charter is an evaluation and accreditation programme in the UK enhancing gender equity in science, technology, engineering, mathematics and medicine (STEMM).
    • Participating research organisations and academic institutions are required to analyse data on gender equity and develop action plans for improvement.
    • Signatories commit to addressing various issues such as –
    1. Unequal gender representation;
    2. Tackling the gender pay gap;
    3. Removing the obstacles faced by women in career development and progression;
    4. Discriminatory treatment often experienced by trans people;
    5. Gender balance of committees and zero tolerance for bullying and sexual harassment.

    Way ahead

    • To get as many institutions as possible to sign up, the DST will need to manoeuvre around government red tape as most universities, barring the IITs and NITs, are run and funded by the government as well.
    • This means that these institutions don’t have direct control over institutional policies, recruitment and promotions.
    • The DST has tied up with the National Assessment and Accreditation Council (NAAC), under the UGC, aiming to push gender equity through them.

  • What is J&K Roshni Act?

    The J&K High Court has declared Roshni Act “illegal, unconstitutional and unsustainable” and a CBI probe has been ordered into the allotment of land under this law.

    Must read:

    [Burning Issue] One Year since the Repeal of Art. 370

    What is the Roshni Act?

    • The J&K State Lands (Vesting of Ownership to the Occupants) Act, 2001 is popularly known as the Roshni Act.
    • It envisaged the transfer of ownership rights of state land to its occupants, subject to the payment of a cost, as determined by the government.
    • It set 1990 as the cutoff for encroachment on state land.
    • The government’s target was to earn Rs 25,000 crore by transferring 20 lakh kanals (one-eighth of an acre) of state land to existing occupants against payment at market rates.
    • The government said the revenue generated would be spent on commissioning hydroelectric power projects, hence the name “Roshni”.

    What is the recent controversy?

    • In October this year, the High Court held the Roshni Act as ‘unconstitutional’.
    • The court also directed the UT government to make public names of those who grabbed the land under the scheme.
    • Last week, the UT government began publishing the names of beneficiaries on its websites.
    • The first set of names included prominent politicians and their relatives, hotels, and a trust connected each to the dominant parties of the Gupkar declaration.

    A scam being busted

    • Investigations into the land transfers subsequently found that land in Gulmarg had been given over to ineligible beneficiaries.
    • However several government officials illegally possessed and vested ownership of state land to occupants who did not satisfy criteria under the Roshni Act.
    • A report by the CAG estimated that against the targeted Rs 25,000 crore, only Rs 76 crore had been realized from the transfer of land between 2007 and 2013, thus defeating the purpose.
    • The report blamed irregularities including arbitrary reduction in prices fixed by a standing committee, and said this was done to benefit politicians and affluent people.

  • Electronic Vaccine Intelligence Network

    The government is using eVIN – Electronic Vaccine Intelligence Network in association with the United Nations Development Program (UNDP) to identify primary beneficiaries and vaccine distribution networks.

    Try this question from CSP 2016:

    Q.‘Mission Indradhanush’ launched by the Government of India pertains to:

    (a) Immunization of children and pregnant women

    (b) Construction of smart cities across the country

    (c) India’s own search for the Earth-like planets in outer space

    (d) New Educational Policy

    What is eVIN?

    • E-VIN is an indigenously developed technology that digitizes vaccine stocks and monitors the temperature of the cold chain through a smartphone application.
    • It was first launched across 12 states in 2015 to support better vaccine logistics management at cold chain points.
    • It supports the central government’s Universal Immunization Programme by providing real-time information on vaccine stocks and flows, and storage temperatures across all cold chain points across states and UTs.

    Components of eVIN

    • eVIN combines state-of-the-art technology, a strong IT infrastructure and trained human resource to enable real-time monitoring of stock and storage temperature of the vaccines kept in multiple locations across the country.
    • At present, 23,507 cold chain points across 585 districts of 22 States and 2 UTs routinely use the eVIN technology for efficient vaccine logistics management.

    Benefits of eVIN

    • It has helped create a big data architecture that generates actionable analytics encouraging data-driven decision-making and consumption-based planning.
    • It helps in maintaining optimum stocks of vaccines leading to cost savings. Vaccine availability at all times has increased to 99% in most health centres in India.
    • While instances of stock-outs have reduced by 80%, the time taken to replenish stocks has also decreased by more than half, on an average.
    • This has ensured that every child who reaches the immunization session site is immunized, and not turned back due to unavailability of vaccines.

  • National Digital Health Mission

    The National Digital Health Mission will soon be ready for a nationwide roll-out, confirmed the Chairman of National Health Authority and CEO of Ayushman Bharat.

    Must read:

    [Burning Issue] Rolling-out of National Digital Health Mission

    National Digital Health Mission

    • Our PM has launched the National Digital Health Mission on 15th August 2020.
    • The mission aims to create an integrated healthcare system linking practitioners with the patients digitally by giving them access to real-time health records.
    • It is a complete digital health ecosystem. The digital platform will be launched with four key features — health ID, personal health records, Digi Doctor and health facility registry.
    • At a later stage, it will also include e-pharmacy and telemedicine services, regulatory guidelines for which are being framed.

    Its implementation

    • The NDHM is implemented by the National Health Authority (NHA) under the Ministry of Health and Family Welfare.
    • The National Health Authority (NHA), is also the implementing agency for Ayushman Bharat.

  • Personal Vehicle on a Public Road

    The Delhi government has told the Delhi High Court that a personal vehicle on a public road cannot be said to be a private zone — rather, it is a public space.

    Do you know?

    India sees the largest number of road fatalities in the world. More than 1.5 lakh people lost their lives in road crashes in the country in 2018, according to government data.

    Why such an argument?

    • The argument was given to defend its decision of making it compulsory for people to wear masks when they are travelling.

    Supreme Court’s definition of ‘public space’

    • The Supreme Court in one of its ruling has said defined a “public place” to mean any place to which the public has access, whether as a matter of right or not — and includes all places visited by the general public, and also includes any open space.
    • The keywords are “any place to which public have access”, which phrase is further qualified by the phrase “whether as a matter of right or not”, the court noted.
    • When a private vehicle is passing through a public road it cannot be accepted that the public has no access.
    • It is true that the public may not have access to a private vehicle as a matter of right but definitely, public has the opportunity to approach the private vehicle while it is on the public road, said the court.

  • ‘Myths of Online Education’ Report

    The Azim Premji University has published the report titled “Myths of Online Education”, on the efficacy and accessibility of e-learning.

    We have studied the Impacts of COVID-19 on Education. https://www.civilsdaily.com/burning-issue-education-in-times-of-covid-19/
    This report provides decent data about the woes of online education and is easy to remember.

    About the study

    • The study was undertaken in five States across 26 districts and covered 1,522 schools. More than 80,000 students study in these government schools.
    • It examined the experience of children and teachers with online education.

    Highlights of the study

    • More than 60% of the respondents who are enrolled in government schools could not access online education.
    • Children with disabilities in fact found it more difficult to participate in online sessions.
    • 90% of the teachers who work with children with disabilities found their students unable to participate online.
    • Almost 70% of the parents surveyed were of the opinion that online classes were not effective and did not help in their child’s learnings.
    • 90% of parents of government school students surveyed were willing to send their children back to school.
    • The survey also revealed that around 75% of the teachers spent, on an average, less than an hour a day on online classes for any grade.

    Online classes are less effective

    • Teachers as well as students their expressed frustration with online classes.
    • More than 80% surveyed said they were unable to maintain emotional connect with students during online classes, while 90% of teachers felt that no meaningful assessment of children’s learning was possible.
    • Another hurdle that teachers found during the online classes was the one-way communication, which made it difficult for them to gauge whether students understood what was being taught.
    • Teachers also reported that they were ill-prepared for online learning platforms.