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  • 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.

  • [pib] XP100: The premium grade Petrol

    The Ministry of Petroleum & Natural Gas has launched world-class premium-grade Petrol (with Octane number 100) in the country.

    What is XP100?

    • It is petrol developed by Indian Oil with octane number 100.
    • The availability of XP100 puts India in an elite group of countries, having access to such high-quality oil. It will provide high quality and power to the engine.
    • It will be rolled out in 15 identified cities across the country in two phases.
    • Worldwide, 100 Octane petrol has a niche market for luxury vehicles that demand high performance and is available only in six countries like Germany, USA, etc.

    Try this PYQ:

    Q.Lead, ingested or inhaled, is a health hazard. After the addition of lead to petrol has been banned, what still are the sources of lead poisoning?

    1. Smelting units
    2. Pens pencils
    3. Paints
    4. Hair oils and cosmetics

    Select the correct answer using the codes given below:

    (a) 1, 2 and 3 only

    (b) 1 and 3 only

    (c) 2 and 4 only

    (d) 1, 2, 3 and 4

    What is Octane numbering of Petrol?

    • Octane number, also called Antiknock Rating, a measure of the ability of a fuel to resist knocking when ignited in a mixture with air in the cylinder of an internal-combustion engine.
    • Engine knock is a tapping, pinging sound that gets louder and more obnoxious as we accelerate.
    • The octane number is determined by comparing, under standard conditions, the knock intensity of the fuel with that of blends of two reference fuels: iso-octane, which resists knocking, and heptane, which knocks readily.
    • The octane number is the percentage by volume of iso-octane in the iso-octane–heptane mixture that matches the fuel being tested in a standard test engine.

  • World Heritage Irrigation Structure (WHIS) Sites

    Four sites in India have received the World Heritage Irrigation Structure (WHIS) tag this year.

    Try this PYQ:

    Q.The FAO accords the status of ‘Globally Important Agricultural Heritage Systems (GIAHS)’ to traditional agricultural systems. What is the overall goal of this initiative?

    1. To provide modern technology, training in modern farming methods and financial support to local communities of identified GIAHS so as to greatly enhance their agricultural productivity.
    2. To identify and safeguard eco-friendly traditional farm practices and their associated landscapes, agricultural biodiversity and knowledge systems of the local communities.
    3. To provide Geographical Indication status to all the varieties of agricultural produce in such identified GIAHS.

    Select the correct answer using the code given below:

    (a) 1 and 3 only

    (b) 2 only

    (c) 2 and 3 only

    (d) 1, 2 and 3

    World Heritage Irrigation Structure (WHIS)

    • The International Commission on Irrigation and Drainage (ICID) annually recognizes irrigation structures of international significance like UNESCO’s World Heritage Sites.
    • The recognition is aimed at recognizing and tracing the history of and understanding the evolution of irrigation in civilizations across the world.
    • It also aims at understanding the philosophy and wisdom on sustainable irrigation from these structures and to preserve them for posterity.

    Criteria for consideration

    • Major criteria for WHIS entail that a structure should be more than 100 years old, should be functional, achieving food security and have archival value.
    • Each site is evaluated based on its merits first by the state government.
    • The proposal is then sent to the Centre and a team from CWC carries out an on-ground survey to verify details.

    Which are the Indian sites?

    • The sites are Cumbum Tank, Kurnool-Cuddapah Canal, Porumamilla Tank (Anantharaja Sagaram) in Andhra Pradesh and 490-year-old Dhamapur Lake in Maharashtra’s Sindhudurg district.
    • In 2018, Pedda Cheru Tank in Kamareddy district and Sadarmat Anicut in Nirmal district, both in Telangana, were named as WHIS sites.

    Other sites

    • The rest include Tianbao Weir in China at number one followed by Longshou Canal and ancient Luohe river irrigation district, China.
    • It also includes Zarch and Moon Qanat both in Iran and Tenguiwa, Bizenkyo and Jyosai Gokuchi irrigation systems in Japan with Goseong Dumbeong in the Republic of Korea.

    About ICID

    • The ICID, established in 1950 is a leading scientific, technical, international not-for-profit, non-governmental organization.
    • It is a professional network of experts from across the world in the field of irrigation, drainage, and flood management.
    • The main mission is to promote ‘Sustainable agriculture water management’ to achieve ‘Water secure world free of poverty and hunger through sustainable rural development’.
    • ICID mission covers the entire spectrum of agricultural water management practices ranging from rainfed agriculture to supplemental irrigation, land drainage, deficit irrigation to full irrigation, etc.

  • India and the OIC

    India has hit out at the Organisation of Islamic Cooperation (OIC) for making factually incorrect and unwarranted references to Jammu and Kashmir.

    What is OIC?

    • The OIC — formerly Organisation of the Islamic Conference — is the world’s second-largest inter-governmental organisation after the UN, with a membership of 57 states.
    • The OIC’s stated objective is “to safeguard and protect the interests of the Muslim world in the spirit of promoting international peace and harmony among various people of the world”.
    • OIC has reserved membership for Muslim-majority countries. Russia, Thailand, and a couple of other small countries have Observer status.

    India’s relationship with OIC

    • At the 45th session of the Foreign Ministers’ Summit in 2018, Bangladesh suggested that India, where more than 10% of the world’s Muslims live, should be given Observer status.
    • In 1969, India was dis-invited from the Conference of Islamic Countries in Rabat, Morocco at Pakistan’s behest.
    • Then Agriculture Minister Fakhruddin Ali Ahmed was dis-invited upon arrival in Morocco after Pakistan President Yahya Khan lobbied against Indian participation.

    Recent developments

    • In 2019, India made its maiden appearance at the OIC Foreign Ministers’ meeting in Abu Dhabi, as a “guest of honour”.
    • Then External Affairs Minister Sushma Swaraj addressed the Inaugural Plenary.
    • This first-time invitation was seen as a diplomatic victory for New Delhi, especially at a time of heightened tensions with Pakistan following the Pulwama attack.
    • Pakistan had opposed the invitation to Swaraj and it boycotted the plenary after the UAE turned down his demand to rescind the invitation.

    What is the OIC’s stand on Kashmir?

    • It has been generally supportive of Pakistan’s stand on Kashmir and has issued statements criticizing India.
    • These statements over the last three decades became an annual ritual, of little significance to India.
    • Last year, after India revoked Article 370 in Kashmir, Pakistan lobbied with the OIC for their condemnation of the move.
    • To Pakistan’s surprise, Saudi Arabia and the UAE — both top leaders among the Muslim countries — issued nuanced statements, and were not as harshly critical of New Delhi as Islamabad had hoped.
    • Since then, Islamabad has tried to rouse sentiments among the Islamic countries, but only a handful of them — Turkey and Malaysia — publicly criticised India.

    How has India been responding?

    • India has consistently underlined that J&K is an integral part of India and is a matter strictly internal to India.
    • The strength with which India has made this assertion has varied slightly at times, but never the core message.
    • It has maintained its “consistent and well known” stand that the OIC had no locus standi,
    • This time, India went a step ahead and said the grouping continues to allow itself to be used by a certain country “which has a record on religious tolerance, radicalism and persecution of minorities”.

    OIC members and India

    • Individually, India has good relations with almost all member nations. Ties with the UAE and Saudi Arabia, especially, have looked up significantly in recent years.
    • The OIC includes two of India’s close neighbours, Bangladesh and Maldives.
    • Indian diplomats say both countries privately admit they do not want to complicate their bilateral ties with India on Kashmir but play along with OIC.

    What lies ahead with OIC?

    • India now sees the duality of the OIC untenable, since many of these countries have good bilateral ties and convey to India to ignore OIC statements.
    • But these countries sign off on the joint statements which are largely drafted by Pakistan.
    • South Block feels it is important to challenge the double-speak since Pakistan’s campaign and currency on the Kashmir issue has hardly any takers in the international community.

  • 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

  • In new: Annapurna Idol

    PM has announced that an ancient idol of the goddess Annapurna, stolen from India about a century ago, is being brought back from Canada.

    Must revise: Gandhara and Mathura school of Art

    [Static Revision] Chapter 6 | Post Mauryan Period (200BC to 300AD)

    Annapurna Idol

    • Annapurna, also spelt Annapoorna, is the goddess of food.
    • This 18th-century idol, carved in the Benares was stolen from a temple of Varanasi and smuggled out around 100 years ago somewhere around 1913.
    • Now is part of the University of Regina, Canada’s collection at the MacKenzie Art Gallery.
    • The idol holds a bowl of kheer in one hand and a spoon in the other.

  • 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.

  • RT-LAMP: a new technology for detecting COVID-19

    Indian Council of Medical Research has recently validated the LAMP technology for COVID-19 testing.

    What is RT-LAMP?

    • RT-LAMP stands for Reverse Transcriptase loop-mediated isothermal amplification) technology.
    • Agappe Diagnostics has recently developed the technology indigenously, and their kit has been validated and approved by the ICMR for marketing.
    • It is named LUME Screen nCoV.

    How does it work?

    • RT-LAMP technology is a one-step nucleic acid amplification method to multiply specific sequences of RNA of the coronavirus.
    • The RNA is first made into cDNA (copy DNA) by the usual reverse transcription. Then, the DNA is amplified by the LAMP technique.

    Current method

    • •The current method diagnosis is the real time reverse transcription polymerase chain reaction (RT-PCR) test which detects the presence of viral nucleic acids in nasopharyngeal swab samples.
    • But it has certain shortcomings.
    • The test requires complex and costly equipment. It requires extensive training for potential users.

    Benefits of LAMP over RT-PCR

    • The LAMP technology is superior to the PCR technology–based COVID-19 kits where specificity is around 95% only.
    • As the specificity and sensitivity of the test is about 95%, there is a possibility of false negative results.
    • The turnaround time is about 10 hours, so that the result will be available only by the next day.
    • In remote places, the turnaround time further increases depending on the distance the samples need to travel.
    • In short, the RT-PCR does not have the capacity to keep pace with the increasing demand.
    • The LAMP technology does not need laborious preparation as in the case of RT-PCR. LAMP is cost effective and does not need complex expensive equipment.

     

  • To be taken seriously, Quad needs military heft

    The article suggests projection of naval power to ensure the stability in the Indian Ocean. 

    Quad conducts Malabar exercise

    • In November, the Quad converged to continue the Malabar series, with a total of just eight ships.
    • The idea of Quad is to form a grouping of democratic nations in the Indian Ocean, and use naval power to convey a message to Beijing.
    • The message a grouping of eight ships would convey to a nation thinking in terms of five aircraft carriers remains would not be taken seriously.

    Importance of naval power in ensuring oceanic stability

    • There is no substitute for naval power to ensure oceanic stability, but one alternative lies in the area of Maritime Domain Awareness (MDA). 
    • Perhaps, some thought may already have been given to MDA in the twin agreement to BECA (Basic Exchange and Cooperation Agreement), and Maritime Information Sharing Technical Agreement (MISTA) signed between India and the US.
    • There is little information available in the public domain about MISTA.
    • But MISTA should cover an omnibus agreement for Maritime Patrol Aircraft (MPA) operating and information sharing for the entire Indo-Pacific.
    • The Pacific has a high density of MPA assets, while they are sparse in the Indian Ocean, particularly the western Indian Ocean.
    • The Australians can cover the Malacca Straits, but for the west Indian Ocean, the US will probably have to base a squadron of P-8 aircraft at Masirah or Diego Garcia.
    • Today, the primary weapon system of most warships is the surface-to-surface missile, with ranges of up to 200 km.
    • The ships’ sensor range is only up to 100 km.
    • So, accurate target information has to be supplied beyond 100 km by aircraft or helicopters in what is called Over the Horizon Targeting (OTHT).
    • With the Indo-Pacific fully covered by the MPAs of the Quad, a PLAN ship in the Indian Ocean is in imminent danger of being sunk at will

    Conclusion

    A public announcement of a division of the Indo-Pacific into areas of responsibility for MDA, between members of the Quad will send an unmistakable signal to Beijing. With a desultory Quad naval exercise, once a year of a few ships, Beijing will only be amused that a “threat” exists to its ambition to become a global power.

  • Stepping out of the shadow of India’s malnutrition

    The article takes stock of the food insecurity and malnutrition in India with the aid of two recently published reports.

    Reports about food security in India

    • Two recent reports — “The State of Food Security and Nutrition in the World 2020” by the Food and Agricultural Organization of the United Nations and the 2020 Hunger report, “Better Nutrition, Better Tomorrow” by the Bread for the World Institute  – document staggering facts about Indian food insecurity and malnutrition.
    • The reports use two globally recognised indicators, Prevalence of Undernourishment (PoU) and the Prevalence of Moderate or Severe Food Insecurity (PMSFI).
    • Using these indicators, the reports indicate India to be one of the most food-insecure countries, with the highest rates of stunting and wasting among other South Asian countries.

    Comparing rate of reduction in malnutrition with neighbouring countries

    • Malnutrition in India has not declined as much as the decline has occurred in terms of poverty.
    • On the contrary, the reduction is found to be much lower than in neighbouring China, Pakistan, Nepal and Bangladesh.
    • The decline in China is way higher than that of India, even though it had started with lower levels of PoU in 2000.

    Food security during pandemic and National Food Security Act 2013

    • Two crucial elements still got left out in the National Food Security Act – 2013.
    • These two elements are the non-inclusion of nutritious food items such as pulses and exclusion of potential beneficiaries.
    • Because of this, the current COVID-19 pandemic would make the situation worse in general, more so for vulnerable groups.
    • Though States have temporarily expanded their coverage in the wake of the crisis, the problem of malnutrition is likely to deepen in the coming years.
    • Hence, a major shift in policy has to encompass the immediate universalisation of the Public Distribution System which should definitely not be temporary in nature.

    Conclusion

    The need of the hour remains the right utilisation and expansion of existing programmes to ensure that we arrest at least some part of this burgeoning malnutrition in the country.