Current Affairs 9th May

Anti-COVID-19 drug developed by DRDO gets emergency use nod #GS3 #SnT

The Drugs Controller General of India (DCGI) has granted permission for emergency use of an anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG), developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of the Defence Research and Development Organisation (DRDO), in collaboration with Dr. Reddy’s Laboratories, Hyderabad.

In a release issued, the Ministry of Defence said that as per the order, emergency use of this drug as adjunct therapy in moderate to severe COVID-19 patients is permitted. It added that being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country.

The drug comes in powder form in sachets and is taken orally by dissolving it in water. It accumulates in the virus infected cells and prevents their growth by stopping viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique.

Supreme Court sets up task force for oxygen allocation #GS2 #Governance

The Supreme Court has constituted a 12-member National Task Force to streamline and ensure the “effective and transparent” allocation of liquid medical oxygen on a “scientific, rational and equitable basis” to the States and the Union Territories fighting COVID-19.

The top court had expressed its dissatisfaction at the Centre’s earlier “oxygen-for-bed” formula. A Bench, led by Justice D.Y. Chandrachud, in a 24-page order released on Saturday, said the formula should be scrapped and the problem of allocation of oxygen required to be looked into afresh.

The court said the decision-makers should go beyond cobbling together ad hoc solutions based on present problems.

A Bench, led by Justice D.Y. Chandrachud, in a 24-page order released on Saturday, said the formula should be scrapped and the problem of allocation of oxygen required to be looked into afresh. A new mechanism devised more scientifically should take care of present requirement for oxygen as well as be flexible enough to accommodate “unforeseen demands due to emergencies which may arise within the allocated territories”.

“Different States may peak during different time… their needs for oxygen may vary,” Justice Chandrachud had pointed out.

Scientific strategies

The court said setting up an expert body or task force “drawn of renowned national experts with diverse experience in health institutions” to function within the Central government apparatus would facilitate a public health response to the pandemic based on scientific and specialised domain knowledge.

The court said the decision-makers should go beyond cobbling together ad-hoc solutions based on present problems. They have to prepare for the future. The task force’s work would provide the Centre with inputs and strategies.

“We expect that the leading experts in the country shall associate with the work of the Task Force both as members and resource persons. This will facilitate a meeting of minds and the formulation of scientific strategies to deal with an unprecedented human crisis,” the court explained.

‘Positive test for COVID-19 not a must for admission’ #GS3 #SnT

Requirement of a positive test for the COVID-19 virus is not mandatory for admission to a COVID-19 health facility and no patient will be refused services on any count, the Health Ministry said on Saturday, announcing the revised national policy for admission to various categories of COVID-19 facilities.

This patient-centric measure aims to ensure prompt, effective and comprehensive treatment of patients suffering from COVID-19, said the Ministry. “The revised guidelines cover medications such as oxygen or essential drugs even if the patient belongs to a different city.

The revised guidelines noted that no patient shall be refused admission on the ground that he/she was not able to produce a valid identity card establishing they belonged to the city where the hospital is located.

Based on need

“Admissions to hospital must be based on need. It should be ensured that beds are not occupied by persons who do not need hospitalization. Further, the discharge should be strictly in accordance with the revised discharge policy.

Appropriate policy

The Ministry has advised Chief Secretaries of States/Union Territories to issue necessary orders and circulars, incorporating the new directions within three days, which shall be enforced till replaced by an appropriate uniform policy.

The latest directive applies to all States and UTs, hospitals under the Central government, State governments and UT administrations, including private hospitals in States and UTs managing COVID-19 patients.

Meanwhile, Health Minister Harsh Vardhan on Saturday chaired the 25th meeting of the high-level Group of Ministers (GoM) on COVID-19 and reiterated the importance of full protection through two COVID-19 vaccine doses.

He appealed to all citizens to get the second dose, which boosts the immunity against COVID-19 manifold, and requested the States to set aside 70% of the vaccines received through the Central government channel for administration of the second dose.

E.U., India relaunch FTA talks, sign connectivity partnership #GS2 #IR

India and the European Union agreed to relaunch free trade negotiations by resuming talks that were suspended in 2013 for the Bilateral Trade and Investment Agreement (BTIA), as Prime Minister Narendra Modi interacted virtually from Delhi with President of the European Commission Ursula Von der Leyen and E.U. Council President Charles Michel along with 27 European leaders gathered in Porto, Portugal, on Saturday.

The E.U.-India leaders meeting also discussed COVID recovery plans and vaccine cooperation, adopted a Connectivity Partnership document outlining plans to cooperate on digital and infrastructure projects, and signed the contract for the second tranche of $150 million from the E.U. for the Pune Metro rail project.

However, India failed to secure the support of the European leaders for its proposal at the World Trade Organisation at the meeting for patent waivers for COVID vaccine, and government officials said they hoped to see the E.U. continue to debate the issue. President of the European Commission

Briefing the media at the end of the meeting, Ms. Von Der Leyen and Mr. Michel said a greater imperative at present was for countries to ramp up the production and delivery of SARS-Cov-2 vaccines through greater investment.

“There are different feelings about the [Indian] request from around the world… In the short term many of us think that this may not be the magic solution, but we would like to keep a closer eye and keep discussing the issue,” said Mr. Michel. Ms. Von Der Leyen said the E.U., which was the “pharmacy of the world” and had exported 50% of its production of 400 million vaccine doses to other countries, had shown the way forward. India, which is facing vaccine shortages during the current crisis has had to halt its export programme for vaccines worldwide.

When asked about the E.U. hesitation over supporting the proposal jointly presented by India and South Africa at the WTO, MEA officials pointed that the U.S. had recently changed its stand and now supports the idea of waiving intellectual property rights on vaccines for the duration of the pandemic, and India would therefore watch the “evolving E.U. position on this”. The support of a major bloc like the E.U. is crucial to passing the resolution at the WTO by consensus.

The joint statement issued after the meeting said India and the E.U. agreed to work towards a “balanced, ambitious, comprehensive and mutually beneficial trade agreement which would respond to the current challenges,” and launch negotiations for a “stand-alone” investment protection agreement and a separate agreement on “geographical indications” pertaining to intellectual property rights.

Hailing the decision by the leaders to resume trade negotiations for the BTIA as a “remarkable moment”, Ms. Von Der Leyen said the talks that had begun in 2007, and stalled in 2013, will finally be picked up again.

The talks had run into trouble over market access issues, and tariffs by India on products like wine, dairy and automotive parts, as well as E.U. resistance over visas for Indian professionals. In addition, the Modi government’s decision to scrap all Bilateral Investment Treaties (BITs) in 2015 posed hurdles for new E.U. investments in India.

The India-E.U. connectivity partnership signed on Saturday also committed the two sides to working together on digital, energy, transport, people to people connectivity that was “transparent, viable, inclusive, sustainable, comprehensive, with a rules-based approach”.

The partnership is seen as a response to China’s Belt and Road Initiative, and comes as the E.U.’s negotiations with China on their Comprehensive Agreement on Investment (CAI) have run into trouble.

Probe into digging, construction activities in Kaziranga #GS3 #Environment

The authorities in Assam’s Golaghat and Nagaon districts have begun probing cases of clearance of forest land, digging and construction activities on at least three animal corridors within the eco-sensitive zone of the Kaziranga National Park and Tiger Reserve.

These two districts share large swathes of the 1,300-sq. km. tiger reserve that has nine identified animal corridors. Seven of these — Amguri, Bagori, Chirang, Deosur, Harmati, Hatidandi and Kanchanjuri — are in Nagaon district while Haldibari and Panbari corridors are in Golaghat district.

Crucial for animals

These corridors are crucial for the rhinos, elephants, tigers, deer and other animals that escape a flooded Kaziranga during the monsoon months for the safety of the hills of Karbi Anglong district beyond the highway skirting the southern boundary of the tiger reserve.

Tiger reserve’s director P. Sivakumar said he had prior to the Assembly elections in March-April written to the Golaghat district authorities underlining some construction activities on the Haldibari corridor.

“We had a joint inspection with officials of the Revenue Department two days ago and found three violations on the corridor, including expansion by a resort. Further action will be taken in the coming days.

A bid to construct a permanent stage for religious activities was stopped a couple of months ago in a tea estate on the Panbari animal corridor.

But the most blatant violation has been on the Kanchanjuri animal corridor in Nagaon district. A patch of forest land has been cleared and a section of a tea plantation dug up apparently for a water reservoir, wildlife activists in the area said.

This has been happening over the past few days in plain view beside the highway. The activities are barely 50 metres from where a structure linked to the local MLA came up a year ago.

SC’s order violated

Rohit Choudhury, a green activist based in Bokakhat (headquarters of Kaziranga), lodged an FIR at the Jakhalabandha police station in Nagaon district on May 7 with photographs of these activities. He said these activities violated the Supreme Court’s order on April 4, 2019. The order said: “No new construction shall be permitted on private lands which form part of the nine identified animal corridors.”

Mrinmoy Das, Nagaon’s DSP, said they have treated the FIR as a piece of information and would be seeking replies from the Forest and Revenue Departments concerned.

“There are no legal provisions for registering a case if a member of the public complains about contempt of court unless the court itself or the government files an FIR. We can act when the departments involved give us the feedback and seek action,” he said.

‘Immediate measures needed for welfare of children’ #GS2 #SocialIssues

The Supreme Court Juvenile Justice Committee, in coordination with UNICEF, highlighted the need to urgently provide care and protect children suddenly made vulnerable by the loss of one or both parents to the second wave of COVID-19.

Supreme Court judge S. Ravindra Bhat, who is the Chairperson of the Juvenile Justice Committee, in a review meeting held with High Courts, representatives of States and the Centre, said concerted efforts should be made to provide interim care for children who have been orphaned, abandoned or even left unaccompanied in their own homes.

“These children are more vulnerable now than ever before,” Justice Bhat noted.

A statement released by the Supreme Court on Saturday said some of the measures discussed were the setting up State-level nodal officers and a district task force for rapid response for the care and protection of such children. Other steps include sponsorship for children who had lost parent/s or bread-earners or were facing economic hardship.

Justice Bhat highlighted the need for clear guidance on steps to be taken in the event when such children in an extremely vulnerable state had been exposed to the virus or showed symptoms of infection.

Care measures for their isolation and treatment needed to be stepped up, he said. In this regard, Justice Bhat said that caregivers and employees of childcare institutions — both government and private — should be vaccinated as frontline professionals. He said childcare institutions should be declared “essential services”.

The judge emphasised the need to provide heightened medical watch for children in institutional care.

The Supreme Court has been nudging the Centre to prepare for the third wave of the pandemic. Recently, a Bench led by Justice D.Y. Chandrachud had highlighted reports that children would be affected in the third wave.

The court has pushed for aggressive vaccination, especially for parents of young children, who would be accompanying their children to hospitals as primary caregivers. Justice Bhat is also part of the Special Bench hearing issues regarding COVID-19 management and lapses.

Justice Bhat further spoke of the need to develop a mechanism to address the interim care needs of orphaned, separated, or unaccompanied children, including clear guidance on steps to be taken in the event that such a child has been exposed or has symptoms of the virus and requires a period of isolation and treatment.

FCRA hurdle may block foreign COVID aid to hospitals, NGOs #GS2 #IR

Indian entities, including hospitals and charitable trusts, hoping to receive COVID-19 relief material from overseas individual donors or donor agencies, could be in trouble, unless they are registered under the Foreign Contribution Regulation Act (FCRA) with a stated objective involving provision of medical care.

On May 3, the government permitted imports without GST levies for pandemic relief material donated from abroad for free distribution in the country, delegating States to certify the entities that will receive such imports. However, no exemption has been granted from the FCRA law that requires any domestic entity receiving foreign material or cash donations to have requisite approvals from the Ministry of Home Affairs.

Sources said this ambiguity and the prospect of facing prosecution under the FCRA Act’s strict provisions is jeopardising some large donors’ plans to buy equipment like oxygen plants and concentrators for Indian hospitals and smaller charities and informal groups of persons working in rural areas with weaker health infrastructure.

In the case of a large hospital, where nearly two-dozen patients died after Oxygen supplies were not replenished in a timely manner, foreign donors are keen to donate an oxygen production plant on its premises, but the lack of an FCRA nod is holding up the process. As FCRA approvals take a lot of time, the government needs to urgently grant an exemption for all such donations, tax and legal experts told The Hindu.

“The notification would not meet the intended objective, in the sense that no entity can receive foreign aid in cash, medicines or equipment to save lives, without an FCRA registration. Moreover, the intended use of such foreign contribution should also match the specified objective of the trust at the time of FCRA registration,” said Gaurav Gupta, a Delhi-based lawyer who is privy to several similar cases.

“The FCRA law does not provide any blanket exemption for imports exempted by the Central Government, so no such exemption is available for importers of such COVID aid. It is advisable that the Centre issues a clarification exempting the receiver/importer from complying with the FCRA provisions for approval and other compliances. The said notification may at best be beneficial only for State-approved entities with FCRA approvals and a stated objective of providing healthcare services.

Crowd-funding treatment likely to become difficult #GS3 #SnT

The government’s move to allow cash payments over Rs. 2 lakh for COVID-19 patients’ treatment could make it difficult for people to crowd-fund bill payments. Patients without a PAN card or Aadhaar, as well as those who arrange to pay their treatment costs through cash loans of over Rs. 2 lakh from a single lender may also face challenges, said tax lawyers.

Section 269ST of the Income Tax Act, introduced after demonetisation, entails a 100% penalty for receipt of all cash payments over Rs. 2 lakh, but was proving to be a hurdle for several patients’ families as many don’t have access to cashless payment options.

Following a petition filed in the Delhi High Court on Friday that sought a relaxation of the relevant Income Tax law provision, the government notified changes to permit such cash payments for COVID-19 patients’ treatment till May 31, provided the healthcare provider obtains the PAN or Aadhaar of the patient and the “payee”.

“How many people will be willing to help with cash for meeting medical bills if it requires them to share their PAN or Aadhaar, with the fear of tax department queries that could follow?” said a senior tax lawyer. Moreover, families looking to raise a cash loan from a single individual of over Rs. 2 lakh to meet medical expenses, may not be able to do so as a related section in the law prohibits such loans.

“Such large payments are usually required when a patient is becoming more critical and perhaps needs to move into an ICU from the regular ward and time is of the essence. Even digital payments through means such as NEFT sometimes take a couple of hours, but hospitals wait till these payments hit their accounts.

The hospitals will also be required to note the relationship between the patient and the “payee”, the notification said. The Finance Ministry did not respond to queries on whether the word “payee”, which refers to the person being paid, was inadvertently inserted and would be corrected.

“It is also seen that during times like this, people borrow money from family and friends and many are using the prepaid payment instruments such as Google Pay, which are faster. However, many hospitals are not accepting payment on these platforms.

Study reveals interesting facet of the novel coronavirus #GS3 #SnT

Studies of the coronavirus have largely focused on its ‘spike’ protein. A new study from IISER Bhopal has found that other proteins, in particular, the nucleocapsid or ‘N’ protein may also be responsible for the infectivity of the virus.

SARS-CoV-2 structure

The SARS-CoV-2, or novel coronavirus, consists of an RNA genome contained in a spherical capsule which has many proteins, one of which is the ‘spike’ protein that gives it its characteristic spiky surface or ‘crown’. These spike proteins are the ones that help the virus penetrate and enter the body of human hosts.

This is therefore used as a target by those developing vaccines as well as drugs. In order to test the effect of these formulations on the virus, scientists often use not live virus particles but ‘pseudotype’ them.

That is, they use a core which is a different, harmless virus, encapsulate it in a lipid–protein sphere which has spikes on them made by the spike protein. Usually only the spike protein is used in pseudotyping. However, in real situations, the spike protein does not act in isolation but in conjunction with other proteins.

Hence the IISER Bhopal team was curious to study the effect of combinations of proteins on the infectivity of the virus. In their study they used vectors of lentivirus that they had pseudotyped with not only the spike protein but with 24 other proteins in all, including the N protein.

We use lentivirus-derived vectors that have been proven really safe to handle inside the labs to study virus-entry processes.

Combination effect

The infectivity of each of pseudoviruses containing the 24 proteins was tested separately, and the group found that the pseudovirus containing the nucleocapsid ‘N’ protein had higher infectivity than the others.

The researchers used an assay where the extent of infectivity can be readily quantified using either enzymatic activity or fluorescence. “For this, we included a pair of reporter genes in the pseudoviruses (lentiviral vectors), which when delivered to the target cells expresses both an enzyme (called “luciferase”) and a green fluorescent protein.

“After allowing the viral infection to occur, we measured the level of enzyme activity and counted the number of cells showing fluorescence, which gave a quantitative estimation of how infectious the virus would have been. The inference was that stronger the signal, higher was the infectivity.

These results were found to hold when they studied the so-called U.K. variant also. “The results which hold true for the original spike protein remain unchanged in the case of this mutant as well – the N protein, when included, leads to the production of more infectious viral particles,” says Dr Chande.

More possibilities

According to him, this discovery opens up exciting possibilities. “Ongoing or planned studies which seek to screen neutralising antibodies or therapeutic drugs could benefit by incorporating the N protein as a part of their experimental setup while using such pseudotyping systems,” says Dr Chande.

“This would help obtain more physiologically relevant infectivity levels and help set a proper threshold for such preliminary screenings which could improve their success rate.”

As Dr Chande says, this work also highlights a new role for the N protein, which is worth further investigation by itself. “It is possible that a more comprehensive understanding of the impact of the N protein on the spike may help identify key portions of these proteins which help mediate this effect. Such segments could then be specifically targeted using drugs to disrupt this process

Use of CT scans and steroids for COVID-19 #GS3 #SnT

The story so far: As doctors try out different protocols to manage patients with COVID-19, Dr. Randeep Guleria, director of the All India Institute of Medical Sciences (AIIMS) and member of the National Taskforce on COVID-19, has cautioned against the use of CT scans indiscriminately to diagnose the disease, especially in the early stages. This exposes individuals to unnecessary radiation, which could be harmful in the long run, he said. A single CT scan is equal to 300 X-rays, Dr. Guleria warned, which may increase the risk of cancer later in life for young people. Doctors and the World Health Organization (WHO) are also cautioning against the use of corticosteroids like dexamethasone, a potent anti-inflammatory drug, for patients who have non-severe COVID-19. Corticosteroids have been proven to benefit patients with moderate and severe infection.

When is a CT scan advised for a COVID-19 patient?

An RT-PCR test is the standard for diagnosis or confirmation of COVID-19. Use of CT for the diagnosis of COVID-19 should be restricted to that subgroup of patients who may have classical symptoms of the illness but have a negative RT-PCR test result. However, a chest CT can be useful in evaluating patients with moderate or severe disease, to identify complications like thromboembolism or pneumomediastinum.

There are certain situations involving COVID-19 patients in which a clinician might depend on a CT scan to arrive at treatment decisions. These include scenarios where a patient may have classical symptoms of COVID-19 but his RT-PCR test is negative, or situations when a CT pulmonary angiogram might be in order to rule out pulmonary embolism in a patient who is on anti-coagulants and steroids and is not showing any signs of recovery. Also, in cases where a patient in the ICU with severe COVID-19 is not showing any improvement and a chest X-ray shows new lesions, a CT appearance might give a clue towards a diagnosis of dangerous COVID-19-associated fungal super-infections like aspergillosis or mucormycosis. In a fourth scenario, a clinician might order a CT chest to rule out spontaneous pneumomediastinum, a life-threatening complication.

“However, these four scenarios together constitute less than 2% of situations where a CT chest is ordered in COVID-19 cases. Rather than CT findings, it is oxygen saturation that is the key to treatment decisions. Yet, in 95% of the cases, CT scan is a misused tool, often prescribed to rule out pneumonia even in mild cases of COVID-19. There is no point in ordering CT early in the course of COVID-19 because even patients with mild severity may have some ground-glass opacities in the lungs, which do not merit treatment and will resolve on their own,” says R. Aravind, Head of Infectious Diseases, Government Medical College, Thiruvananthapuram.

The consensus statement from Fleischner Society, an international, multidisciplinary association for thoracic radiology, states that “imaging is not indicated” in suspected COVID-19 infection with mild clinical features. The statement supports the use of imaging in patients with worsening respiratory status as well as in those with moderate to severe clinical features that are indicative of COVID-19 pneumonia.

To sum up, although CT has been used in assessing the severity of COVID-19 pneumonia, its routine use is not recommended.

Are multiple CT scans harmful?

When indicated, a chest CT should be performed with a low-dose, single-phase protocol using fast scanning techniques to minimise motion artifacts (patient movement leading to subtle errors).

There is no evidence to support the use of routine multi-phase chest CT in patients with COVID-19 pneumonia. Dr. Guleria said according to data from the International Atomic Energy Agency, one CT scan was equivalent to almost 300 to 400 chest X-rays, which put youngsters at substantial risk of cancer in the long term.

A study published in the New England Journal of Medicine in 2007 said based on data from 1991 to 1996, 0.4% of all cancers in the U.S. may be attributable to radiation from CT studies and that the current estimate could be in the range of 1.5% to 2%.

Apart from all this, the risks of transmission and contamination faced by radiology technicians and staff every time a COVID-19 patient undergoes diagnostic imaging, especially in an air-conditioned, closed space, cannot be dismissed.

Why are steroids being prescribed for COVID-19 patients?

Even though many doctors in India had started treating seriously ill COVID-19 patients with corticosteroids like dexamethasone much earlier during the pandemic, recommendation on their use from international agencies like the WHO came only in September 2020, following the U.K.’s RECOVERY Trial, which found mortality benefit for patients who received steroids.

In many patients, death occurs following a hyper-immune response (cytokine storm) to the SARS-CoV-2 virus, which damages the lungs and other organs, leading to multi-organ dysfunction syndrome. Corticosteroids like dexamethasone, as anti-inflammatory agents, work by calming down the immune system and preventing the progression of organ damage.

“Steroids are the most potent weapon we have to combat COVID-19. But the therapeutic window for starting steroids has to be spot-on. Determining the timing, dosage and duration is an art which has to be mastered,” says Dr. Aravind.

One of the main concerns is that we do not want to start steroids too early in the illness when viral replication is happening as it might interfere with the immune system’s natural ability to fight back. We also do not want to miss that critical point when steroids can prevent the immune system from unleashing the cytokine storm, he says.

The WHO guidelines say that steroids may be administered to patients whose resting saturation levels are below 94% and whose respiration rate at rest is over 24 per minute. However, steroids can benefit some patients who are not on supplementary oxygen yet but are showing early indications that they might worsen.

Kerala’s guidelines thus talk about recognising exertional desaturation — the fall or depletion in oxygen saturation reading by over 3% from the baseline oxygen levels, post-exercise or after the six-minute walk test — and addressing it at the right time so that interstitial inflammation can be arrested.

The walk test requires individuals to walk for six straight minutes, without a pause, on an even surface with an oximeter on the finger. After six minutes, if the oxygen level does not go down, the individual will be considered healthy. But if the oxygen level drops below 93%, or by 3%, or if the individual suffers from breathlessness, then they are advised to seek medical attention.

“We want to pick up patients who are at risk of progressing to hypoxemia at rest. The earliest feature of COVID-19 pneumonia will be interstitial involvement, which leads to a demand-supply mismatch of oxygen. So, patients with normal oxygen saturation (> 94%) at rest in room air and who are clinically stable are put through the six-minutes/40-step walk test.

If the oxygen levels drop after the walk test, these patients may be started on low-dose steroids after consulting the pulmonary specialist or a physician to prevent the cytokine storm syndrome,” says Dr. Aravind.

When do steroids become a double-edged sword?

That said, steroids can turn out to be a double-edged sword if the dosage, timing or duration of the drug goes wrong. Steroids are not mandated for all patients and certainly not for mild patients in the early stages of the illness. The trigger for starting steroids has to be exertional desaturation and not the day of illness.

Dr. Guleria had pointed out recently that he was seeing many mild COVID-19 cases where steroids had stimulated viral replication, causing oxygen levels to drop. There is potential harm associated with the long-term use of steroids in a serious COVID-19 patient. This includes a rise in blood glucose levels, which will need to be carefully managed with insulin to prevent secondary bacterial or fungal infections.

IP rights and vaccines #GS3 #Economy

The story so far: Breaking with a long-held position, the U.S. Trade Representative, Katherine Tai, announced that the Biden administration would support waiving trade-related aspects of intellectual property rights (TRIPS) for the production of COVID-19 vaccines. The news was welcomed by liberal activists and some global leaders, given that the United States was until now a major World Trade Organization (WTO) member blocking such a proposal, framed by India and South Africa.

The proposal, if passed by the WTO with the support of the European Union (EU), could dramatically alter how pharmaceutical companies worldwide access proprietary trade know-how for the production of leading vaccines.

However, questions remain regarding whether the easing of TRIPS rules for COVID-19 vaccines will lead to a greater supply of efficacious vaccines in countries where they are the most needed, or if less circuitous options to boost supply are more relevant in the present scenario.

What is the argument in favour of relaxing TRIPS rules?

The broader context for emergency action aimed at rapidly increasing vaccine availability across the world is the sharp surge in COVID-19 cases in India and Brazil. Global concern also stems from the risk that the Indian variant, believed to be driving a second wave of devastating intensity in the country, could potentially fuel second or third waves across the world, causing a setback to the progress made in controlling transmission across the U.S. and EU.

Additionally, the Brazil and South African variants still pose a threat in some pockets. Across many affected nations, vaccine availability has emerged as a bottleneck impeding progress.

In this context, a fierce debate has been underway, pitting global-vaccine-access advocates against vaccine developers and pharmaceutical firms that rely on patented technology, usually of a highly specialised nature, to produce vaccines.

The latest step by the U.S. to declare its support for TRIPS waivers for such vaccines stems from the promise Joe Biden made during his election campaign, to “absolutely positively” commit to sharing vaccine technology if elected.

Can a waiver resolve the vaccine shortage?

This is a complex question to which there is, so far, no clear answer. On the one hand, it is undeniable that intellectual property rights are a part of the problem of worldwide vaccine shortages — the logic of a wider production base globally leading to an exponential increase in vaccine production is undeniable. However, several caveats remain.

First, there may be serious issues associated with manufacturing vaccines, for example, with those based on messenger RNA (mRNA) technology, if there is just an easing of the associated intellectual property rights rules but no further support to generic pharmaceutical firms in countries such as India and South Africa. This is because a “tech transfer” is also needed for the latter to actually commence production, especially for mRNA vaccines, including the ones produced by Moderna and Pfizer along with BioNTech.

To illustrate, Pfizer has pointed out that its vaccine requires the use of 280 components from 86 suppliers and highly specialised manufacturing equipment.

Second, there is a strong likelihood that it will take a considerable amount of time, even several years, for generic producers’ plants to become operational at optimal capacity. This raises the question of whether today’s vaccines would even be relevant at that point in time, especially if new variants prove resistant to vaccine formulations currently available.

Finally, there is the classic counter-argument to calls for patent relaxations, that such policies could discourage pharmaceutical companies from investing in producing next-generation vaccines. Though many, including Mr. Biden, have argued that humanitarian need trumps the profit motive during a pandemic, the decision to waive all TRIPS rules should be preceded by a rigorous analysis of the effects such a policy would have on the biotechnology sector and global supply chains for its products.

What actions are likely?

No significant steps forward will be possible until other major member nations of the WTO sign on, including the EU. The speed of potential action will also be dampened by the fact that in parallel to the waivers, a transfer of personnel, raw materials and equipment to developing nations will be necessary.

However, there is another possibility: Mr. Biden may either intend to release more of the existing U.S. vaccine stockpile to other countries to meet emergency needs and seek the cooperation of pharmaceutical companies in that mission, or he may be using the threat of the TRIPS waivers to nudge U.S. vaccine producers to ramp up their production and donate more doses to countries like India and Brazil.

Either way, it would be unwise for countries like India to rely on this initiative for an increase in vaccine supply.

The SC ruling on identifying backward classes #GS2 #Governance

The story so far: In the judgment that declared the Maratha reservation unconstitutional, a Constitution Bench of the Supreme Court dealt with another issue. By a 3:2 majority, it ruled that after the passage of the 102nd Constitution Amendment Act in 2018, the States do not have any power to identify ‘socially and educationally backward’ (SEBC) classes. The Union government argued that it was never its intention to deprive State governments of their power to identify SEBCs, but the Court interpreted the bare text of the Amendment to the effect that only the President can publish a list of backward classes in relation to each State and that only Parliament can make inclusions or exclusions in it.

What does the 102nd Amendment say?

The Amendment established a National Commission for Backward Classes by adding Article 338B to the Constitution. The five-member Commission was tasked with monitoring safeguards provided for socially and educationally backward classes, giving advice on their socio-economic development, inquiring into complaints and making recommendations, among other functions. Significantly, it was laid down that the Centre and the States shall consult the Commission on all policy matters concerning the SEBCs.

The Amendment also added Article 342A, under which the President shall notify a list of SEBCs in relation to each State and Union Territory, in consultation with Governors of the respective States. Once this ‘Central List’ is notified, only Parliament could make inclusions or exclusions in the list by law. This provision is drafted in exactly the same word as the one concerning the lists of Scheduled Castes and Scheduled Tribes. Further, a definition of ‘SEBCs’ was added to the Constitution — ‘SEBC’ means “such backward classes as are so deemed under Article 342A for the purposes of this Constitution”.

Why did this Amendment come up for judicial interpretation?

The reservation for the Maratha community was challenged in the Bombay High Court on various grounds. One of the grounds was that the Act creating the Maratha quota through a new category called ‘SEBC’ was unconstitutional because after the introduction of the 102nd Amendment, the State legislature had no power to identify any new backward class.

Separately, a writ petition was also filed in the Supreme Court questioning the validity of the Amendment as it violated the federal structure and deprived the States of their powers. In this context, the court had to examine the validity of the Amendment.

What were the rival contentions?

The crux of the issue was whether the State government’s role in identifying backward classes had been denuded by the Amendment. The Union government said Parliament’s intent was only to create a Central List that would be applied only in the Central government and its institutions. It had nothing to do with the State Lists of backward classes or the State governments’ powers to declare a community backward.

Those who questioned it contended that the effect of the Amendment was that only the President, or the Union government, was authorised to make a list in relation to each State, and thereafter, any change in it would be made only by Parliament.

How did the Supreme Court reach these conclusions?

Justice S. Ravindra Bhat, with two others concurring with him, adopted a literal interpretation of the 102nd Amendment, holding that there was no ambiguity in its drafting that warranted a “purposive interpretation”. Writing for them, Justice Bhat cited three main reasons.

One, the text was clear that the President alone could notify the list, and subsequent changes could be made only by Parliament by law.

Two, the text was identical to the provisions governing the National Commission for Scheduled Castes and the procedure to identify SCs was exactly the same, which led to the conclusion that Parliament intended to “replicate” the same process for backward classes, too.

Third, a definition clause was added to the effect that only a class found in the list notified by the President under Article 342A was an SEBC. Further, the definition was for “the purposes of the Constitution”, which meant that it was to apply to the Constitution as a whole, including Article 15(4) and Article 16(4), which enable special provisions for backward classes, including reservation in public services, and are also implemented by the States.

The Supreme Court’s judgment also drew on deliberations before a Rajya Sabha Select Committee that showed that the Centre had rejected suggestions from members who demanded that a specific clause be added saying that States would continue to have the power to identify SEBCs.

Justice Ashok Bhushan, with another judge agreeing with him and constituting the minority on this point, accepted the Union government’s position that it was never its intention to deprive the States of their powers. They held that the ‘Central List’ was only for use by the Centre in reservations for jobs and institutions under the Union government, and will not apply to States.

What next?

The Supreme Court has directed the Centre to notify the list of SEBCs for each State and Union territory, and until it is done, the present State Lists may continue to be in use. The Centre may either comply with this or seek to further amend the Constitution to clarify the position that the 102nd Amendment was not intended to denude the States of their power to identify SEBCs.

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