News 4: FCRA changes aim to stop unproductive NGO spending
News 5: The Black Sea Grain Initiative
News 6: First amendment to Constitution challenged
News 7: New hope for malaria vaccine
News 1: Supreme Court Judgement on EWS reservation
A Constitution Bench of the Supreme Court on Monday, in a 3:2 majority decision, upheld the validity of the 103rd Constitutional Amendment, which provides 10% reservation in government jobs and educational institutions to the Economically Weaker Sections (EWS) of society but excludes the “poorest of poor” among Scheduled Castes (SC), Scheduled Tribes (ST), Socially and Educationally Backward Classes (SEBC) and Other Backward Classes (OBC) from its scope.
A Constitution Bench of the Supreme Court, in a 3:2 majority decision, upheld the validity of the 103rd Constitutional Amendment, which provides 10% reservation in government jobs and educational institutions to the Economically Weaker Sections (EWS) of society but excludes the “poorest of poor” among Scheduled Castes (SC), Scheduled Tribes (ST), Socially and Educationally Backward Classes (SEBC) and Other Backward Classes (OBC) from its scope.
On whether such a reservation on the sole basis of economic criterion violated the Basic Structure of the Constitution, Dinesh Justice Maheshwari took the expansive view that reservation was an “instrument of affirmative action by the state” and should not be confined to the SCs, STs, SEBCs, and the non-creamy layer of the OBCs but also include “any class or sections so disadvantaged as to answer the description of ‘weaker section’”.
Views by Judges
The three judges in the majority held that reservation on economic criterion alone did not violate the Basic Structure of the Constitution.
In their minority view, Justice Bhat and Chief Justice Lalit held that though quota on the basis of economic deprivation, destitution and poverty was “per se permissible/valid” and even “constitutionally indefeasible”, the “othering” of socially and educationally disadvantaged classes, including the SC/ST/OBC/SEBC communities, on the ground that they already enjoy the benefits of a pre-existing 50% reservation on the basis of their caste and class origins, would amount to heaping injustice based on their past disability.
He said such an exclusion was simply “Orwellian” as the government’s statistics itself showed that the “bulk of economic deprived section of the society belonged to SC/ST/SEBC/OBC”.
He said the SCs make up 38% of the population, STs 48.4%, and OBCs 13.86% of the 31.7 crore people living below the poverty line. Forward castes or the unreserved category make up only 5.85%.
The petitioners had argued that the exclusion of SC/ST/SEBC/OBC had left only the “middle class” among the forward castes drawing less than ₹8 lakh as annual family income to reap the benefits of the EWS quota.
Justice Bhat said the exclusion from the EWS quota based on social or identity origins struck at the essence of the “non-discriminatory rule” and destroyed the equality code of the Constitution.
It amounted to a “hostile discrimination” of the poorest members of society, who were already socially and educationally backward and subjected to caste discrimination.
Justice Bhat said the poorest of poor among SC/ST/OBC/SEBC had been kept out of EWS quota on the delusion that they benefit from the existing 50% reservation and were thus “somehow more fortunate”. The government, Justice Bhat said, believed that including SC/ST/OBC/SEBC members in the EWS quota would bestow them a “double benefit”.
Existing reservation should not be seen as a “free pass to equal opportunity” for these backward classes, he noted, but as a reparative and compensatory mechanism to level the field for those crippled by social stigmatisation.
But Justice Trivedi countered that the 103rd Amendment only created “a separate class of EWS without affecting the special right of reservation provided to SEBCs, STs, SCs and OBCs”.
Even the SC/ST/SEBC/OBC members had been treated as a separate category for the purpose of the 50% reservation. Now, they cannot be treated at par with citizens belonging to the general or unreserved category, Justice Trivedi said.
“The amendment certainly cannot be termed as a shocking, unscrupulous travesty of equal justice. Just as equals cannot be treated as unequals, unequals cannot be treated equally. Treating unequals as equals will offend the doctrine of equality in Article 14,” Justice Trivedi reasoned.
Justice Maheshwari dismissed the argument that the 10% EWS quota would breach the ceiling limit of 50% on reservation. He said the 50% rule formed by the Supreme Court in the Indira Sawhney judgment in 1992 was “not inflexible”. Further, it had applied only to SC/ST/SEBC/OBC communities and not the general category.
In his spirited dissent, Justice Bhat responded that permitting the breach of 50% ceiling limit would become “a gateway for further infractions and result in compartmentalisation”. He kept the issue open.
Three judges on the Constitution Bench, in views which formed both the majority and minority opinions, said the policy of reservation in education and employment cannot continue for an indefinite period.
Justice Bela M. Trivedi, who was part of the majority judgment, said the reservation policy must have a time span. “At the end of 75 years of our Independence, we need to revisit the system of reservation in the larger interest of the society as a whole, as a step forward towards transformative constitutionalism,” Justice Trivedi said.
She pointed out that quota for the Scheduled Castes and the Scheduled Tribes in the House of the People and in State Legislative Assemblies would cease 80 years from the commencement of the Constitution.
The representation of Anglo-Indian communities in Parliament and Assemblies has already stopped by virtue of the 104th Constitutional Amendment from January 25, 2020.
“Therefore, a similar time limit, if prescribed, for the special provisions in respect of the reservations and representations provided in Article 15 and Article 16 of the Constitution, it could be a way forward leading to an egalitarian, casteless and classless society,” Justice Trivedi observed.
Though not expressly said, Justice Trivedi’s view on stopping quota under Articles 15 and 16 would also encompass EWS reservation.
Justice P.B. Pardiwala said “reservation is not an end but a means — a means to secure social and economic justice. Reservation should not be allowed to become a vested interest. Real solution, however, lies in eliminating the causes that have led to the social, educational and economic backwardness of the weaker sections of the community”.
He said “long-standing development and the spread of education” had resulted in tapering the gap between the classes to a considerable extent. Large percentages of Backward Class members attain acceptable standards of education and employment. They should be removed from the Backward categories so that attention could be paid toward those genuinely in need of help.
“It is very much necessary to take into review the method of identification and the ways of determination of Backward Classes, and also, ascertain whether the criteria adopted or applied for the classification of Backward is relevant for today’s conditions,” Justice Pardiwala said.
In his minority view on the Bench, Justice S. Ravindra Bhat reminded Baba Saheb Ambedkar’s observations that reservations should be seen as temporary and exceptional “or else they would eat up the rule of equality”.
Reservation as a concept can’t be ruled out in private institutions
Justice Dinesh Maheshwari, who led the majority opinions on the five-judge Bench which upheld the Economically Weaker Section (EWS) quota on Monday, held that “the 103rd Constitution Amendment which permits the state to make special provisions cannot be said to breach the Basic Structure of the Constitution”.
Justice Maheshwari was addressing the “impact” of the amendment, which introduced the EWS quota on admissions to private unaided institutions.
Justice S. Ravindra Bhat, who authored the minority opinion for himself and Chief Justice U.U. Lalit, also observed that “reservations in private institutions is not per se violative of the Basic Structure [of the Constitution]”.
Justice Bhat reasoned that reservations as a concept cannot be ruled out in private institutions where education is imparted. “Unaided private institutions, including those imparting professional education, cannot be seen as standing out of the national mainstream,” Justice Bhat observed.
Up to state to set norms to identify the beneficiaries of EWS quota
The majority judgment of the Constitution Bench held that the lack of guidelines to identify economic backwardness under the 10% EWS quota cannot be used to question the 103rd Amendment.
The judge left it to the state to set parameters to identify the beneficiaries of the EWS quota. “The question as to whether any particular section or person falls within the class of ‘economically weaker sections of citizens’ may be a question to be determined with reference to the parameters laid down and indicators taken into consideration by the state,” he observed.
Verdict may seal fate of challenge to T.N. quota law
Justice S. Ravindra Bhat, who authored the minority view on the five-judge Bench, said upholding the Economically Weaker Section (EWS) quota will run the danger of “sealing the fate” of a pending challenge to the 69% reservation in Tamil Nadu without the benefit of a hearing.
Sounding a “cautionary note” to fellow judges who formed the majority on the Bench, Justice Bhat and Chief Justice of India U.U. Lalit said the creation of 10% Economically Weaker Section reservation over and above the 50% existing quota has a “direct bearing” on the “likely outcome” of the litigation against the 69% reservation in Tamil Nadu.
The judge said the breach of the 50% limit is the principal ground of attack against the 76th Constitutional Amendment of 1994 which inserted, as Entry 257A, the Tamil Nadu Backward Classes, Scheduled Castes and Scheduled Tribes (Reservation of Seats in Educational Institutions and of Appointments or Posts in the Services under the State) Act, 1993 in the Ninth Schedule of the Constitution.
News 2: NPR needs to be updated again to incorporate changes due to birth, death, migration
There is a need to update the National Population Register (NPR) again to incorporate the changes due to birth, death and migration for which demographic and other particulars of each family and individual are to be collected, the Union Home Ministry said in its 2021-22 annual report, which was published on Monday.
The NPR, first prepared in 2010 and updated in 2015 by collecting information of all usual residents of the country, has been opposed by many States ruled by BJP rivals as the register, according to the Citizenship Rules, 2003, is the first step towards compilation of a National Register of Citizens (NRC). The Union government has clarified on multiple occasions that there was no proposal to compile the NRC as of now.
The report said the NPR is prepared under various provisions of the Citizenship Rules, 2003, framed under the Citizenship Act, 1955. “In 2015, a few fields such as name, gender, date and place of birth, place of residence and father’s and mother’s name were updated and Aadhaar, mobile and ration card numbers were collected. To incorporate the changes due to birth, death and migration, there is a need to update it again,” the Ministry said.
The NPR that has a database of 115 crore residents is to be updated along with the first phase of Census that has been indefinitely postponed due to COVID-19 pandemic.
The Ministry said the NPR could be updated through self-enumeration as it is proposed to allow residents to update their own data fields after following some authentication protocols on a web portal.
CAA not mentioned
The report, a compilation of all the achievements and functions of the Ministry, however, does not mention the Citizenship Amendment Act (CAA), 2019. The legislation, which fast-tracks the citizenship of six non-Muslim undocumented communities from Pakistan, Afghanistan and Bangladesh who entered India before December 31, 2014, is yet to be implemented as the rules have not been framed yet.
The 2020-21 report had said that the CAA is a “compassionate and ameliorative legislation” which does not apply to Indian citizens and “therefore, it does not in any way take away or abridge the rights of any Indian citizen”.
The report said that the Union government delegated its powers to grant Indian citizenship by registration or naturalisation with respect of foreigners belonging to Hindu, Sikh, Jain, Buddhist, Christian or Parsi community from Pakistan, Bangladesh and Afghanistan who entered India on valid passport and visa to Collectors of 29 districts and Home Secretaries of nine States.
National Population Register
Who is a resident?
Any person who has been living in an area or locality for six months or more or intends to live in an area/locality for the next six months at the time of a survey is considered a resident.
The NPR is a register of all ‘residents’ of the country, prepared at several levels — local (village/sub-town), subdistrict, district, state and national — according to the provisions of the Citizenship Act, 1955, and the Citizenship (Registration of Citizens and Issue of National Identity Cards) Rules, 2003.
The objective of the exercise is to create a comprehensive database of residents of the nation including their demographic particulars. The exercise is carried out under the supervision of Registrar General and ex-Officio Census Commissioner, India. Every citizen of India has to be issued a national identity card under the law.
The websites and applications related to the decennial Census exercise and the National Population Register (NPR) were on Monday notified as “protected system” or “Critical Information Infrastructure” under the Information Technology Act, 2008.
Critical Information Infrastructure tag for NPR and its implication
The notification means that any tampering or unauthorised access to the data associated with Census applications, NPR database or the data centres of the Registrar General of India (RGI) will be punishable by 10 years imprisonment.
The RGI notified on Monday that under Section 70 of the IT Act, the Central government declares the “computer resources relating to the Census Monitoring & Management Svstem (CMMS) Web Portal. Self Enumeration (SE) Web Portal.
National Critical Information Infrastructure Protection Centre
National Critical Information Infrastructure Protection Centre (NCIIPC) is an organisation of the Government of India created under the Section 70A of the Information Technology Act, 2000 (amended 2008)
The Information Technology Act, 2000 defines Critical Information Infrastructure (CII) as “… those computer resource, the incapacitation or destruction of which, shall have debilitating impact on national security, economy, public health or safety”.
NCIIPC has broadly identified the following as ‘Critical Sectors’:-
Power & Energy
Banking, Financial Services & Insurance
Strategic & Public Enterprises
News 4: FCRA changes aim to stop unproductive NGO spending
The Foreign Contribution (Regulation) Act was amended in 2020 to discourage expenditure by non-governmental organisations (NGOs) on “unproductive items” such as inflated staff salaries and luxury vehicles, the Union Home Ministry said in its 2021-22 annual report.
The Ministry said that the Foreign Contribution (Regulation) Amendment Bill, 2020 was passed by Parliament in September 2020 and notified on September 28 that year.
“The amendments would help effectively monitor the receipt and utilisation of foreign contribution,” it said.
It said provisions such as Aadhaar of key functionaries of NGOs, receipt of foreign contribution only through designated FCRA bank accounts with the State Bank of India, a complete ban on domestic transfer of foreign funds and reduction of administrative expense limit to 20% from 50%.
The Foreign Contribution (Regulation) Amendment Bill, 2020 was introduced in Lok Sabha on September 20, 2020. The Bill amends the Foreign Contribution (Regulation) Act, 2010.
The Act regulates the acceptance and utilisation of foreign contribution by individuals, associations and companies. Foreign contribution is the donation or transfer of any currency, security or article (of beyond a specified value) by a foreign source.
It would ensure exact identification of office-bearers and eliminate chances of benami/bogus entry and would discourage expenditure on unproductive items like inflated staff salaries, posh buildings and office and luxurious vehicles.
Foreign Contribution Regulation Act
The FCRA regulates foreign donations and ensures that such contributions do not adversely affect internal security.
First enacted in 1976, it was amended in 2010 when a slew of new measures were adopted to regulate foreign donations. The FCRA is applicable to all associations, groups and NGOs which intend to receive foreign donations.
It is mandatory for all such NGOs to register themselves under the FCRA. The registration is initially valid for five years and it can be renewed subsequently if they comply with all norms.
Registered associations can receive foreign contribution for social, educational, religious, economic and cultural purposes. Filing of annual returns, on the lines of Income Tax, is compulsory.
In 2015, the MHA notified new rules, which required NGOs to give an undertaking that the acceptance of foreign funds is not likely to prejudicially affect the sovereignty and integrity of India or impact friendly relations with any foreign state and does not disrupt communal harmony.
It also said all such NGOs would have to operate accounts in either nationalised or private banks which have core banking facilities to allow security agencies access on a real time basis.
News 5: The Black Sea Grain Initiative
In a move that allayed concerns about yet another disruption to global food supply chains, Russia last week re-joined the Black Sea Grain deal. The reversal came a day after Russian President Vladimir Putin stated that Moscow would suspend, but not end, its involvement in the deal.
What is the Black Sea Grain Initiative?
The Black Sea Grain deal endeavours to tackle escalating food prices emanating from supply chain disruptions because of Russia’s actions in the world’s ‘breadbasket’.
The deal, brokered by the UN and Turkey, was signed in Istanbul on July 22 this year. Initially stipulated for a period of 120 days, with an option to extend or terminate after November, the deal was to provide for a safe maritime humanitarian corridor for Ukrainian exports (particularly for food grains) from three of its key ports, namely, Chornomorsk, Odesa and Yuzhny/Pivdennyi. The central idea was to calm markets by ensuring an adequate supply of grains, thereby limiting food price inflation.
Ukraine is among the largest exporters of wheat, maize, rapeseed, sunflower seeds and sunflower oil, globally. Its access to the deep-sea ports in the Black Sea enables it to directly approach Russia and Europe along with grain importers from West Asia and North Africa.
Russia’s actions in the East European country had disturbed this route which earlier used to ship 75% of its agricultural exports — precisely what the initiative sought to address.
Why is it important?
As per the UN Office for Coordination of Humanitarian Affairs, approximately 10.1 million tonnes of grains have been shipped since the initiative commenced. The UN Food and Agricultural Organisation’s (FAO) Food Price Index, which assesses the monthly change in international prices of a basket of food commodities, fell for the sixth consecutive month in a row during the September assessment period. It was earlier inferred that the supply situation in markets was seen to be easing, with potential for further price drops.
People hoarding the grain in the hope of selling it for a sizeable profit owing to the supply crunch were obligated to sell. The initiative has also been credited for having made a “huge difference” to the global cost of living crisis.
As pointed out by several observers, notwithstanding its reach, the initiative alone cannot address global hunger; it can only avert the chances of the global food crisis spiralling further, especially when the region is yet to scale prior year levels.
What would have happened if the deal was suspended?
In a nutshell, the deal’s suspension was expected to re-introduce the price pressures on foodgrains, especially that of wheat, with inventories being at historical lows.
It could have particularly impacted countries in West Asia and Africa such as Egypt, Turkey, Lebanon, Sudan and Yemen which have benefitted from the resumption and are particularly dependent on Russian and Ukrainian exports. Thus, suspension could have spurred food insecurity as well as potentially exacerbated political tensions.
As for domestic challenges, the researchers observe that storage facilities in Ukraine are already at capacity even as farmers turn to harvest the crops planted in spring. This, combined with restricted export opportunities, would have implied lower prices for farmers even as shortfalls spur prices globally.
News 6: First amendment to Constitution challenged
The Supreme Court last week agreed to examine a plea challenging the expansion of restrictions to the fundamental right to freedom of speech and expression that was made by the first amendment to the Constitution.
The petitioner, who has challenged the law nearly seven decades after it came into force, argued that the amendment damages the basic structure doctrine.
What was the first amendment to the Constitution?
Just over a year into the working of the Constitution, then Prime Minister Jawaharlal Nehru introduced a Bill to amend the Constitution. On May 18, 1951, the amendment Bill was referred to a Select Committee which considered the issue for six days. The amendment officially came into effect on June 18, 1951.
The Constitution (First Amendment) Bill sought to make several consequential changes — from exempting land reforms from scrutiny to providing protections for backward classes in the Constitution. Notably, it also expanded on the scope of the restrictions on the right to free speech.
So what exactly is the constitutional position on free speech?
Article 19(1)(a) in Part III of the Constitution guarantees the fundamental right to freedom of speech and expression. But this freedom is not absolute or unfettered. It is followed by Article 19(2), which lists exceptions or “reasonable restrictions” on that right.
The text of Article 19(2) in the original Constitution read: “Nothing in sub-clause (a) of clause (1) shall affect the operation of any existing law in so far as it relates to, or prevent the State from making any law relating to, libel, slander, defamation, contempt of Court or any matter which offends against decency or morality or which undermines the security of, or tends to overthrow, the State.”
Following the amendment, Article 19(2) was changed to read as follows: “Nothing in sub clause (a) of clause (1) shall affect the operation of any existing law, or prevent the State from making any law, in so far as such law imposes reasonable restrictions on the exercise of the right conferred by the said sub clause in the interests of the sovereignty and integrity of India, the security of the State, friendly relations with foreign States, public order, decency or morality or in relation to contempt of court, defamation or incitement to an offence…”
Thus, the first amendment made two key changes:
First, it introduced the qualification “reasonable” to the restrictions that Article 19(2) imposed. In a 2015 paper, legal scholar Gautam Bhatia placed this term in context, and traced its origins to debates in the Constituent Assembly. The insertion of the term “reasonable”, he argued, keeps the door open for the courts to step in and examine the legitimacy of the restrictions imposed by Parliament.
Second, the amendment introduced into the Constitution the specific terms “public order” and “incitement to an offence”. This set of new, narrower terms in the provision were necessitated by two Supreme Court rulings in 1950, that went against the state’s power to curb free speech.
What were these two verdicts passed by the Supreme Court?
Both these verdicts involved the press: Brij Bhushan v State of Delhi(March 1950), and Romesh Thappar v State of Madras (May 1950). It was the verdicts in these cases that essentially promoted the first amendment.
ROMESH THAPPAR CASE:
In 1949, the Madras government (Tamil Nadu had not been created then) had banned ‘Cross Roads’, a left-leaning magazine, for its criticism of the government’s foreign policy. This led to the first significant free speech ruling by the Supreme Court in Romesh Thappar v State of Madras.
The petitioner had challenged Section 9(1-A) of the Madras Maintenance of Public Order Act, 1949 as unconstitutional. This provision authorised the government to impose restrictions for the wider purpose of securing “public safety” or the “maintenance of public order”.
The court had to define the terms “public safety” and “public order”, and examine if they fell within the scope of the restrictions allowed in Article 19(2). The government argued that the words “undermining the security of the State” in Article 19(2) could be equated with “public safety” and “maintenance of public order.”
In its majority opinion in the case, the court disagreed with the government and struck down the provision as unconstitutional. The court found a vast difference in degrees between the two provisions.
Justice Fazal Ali dissented from the majority view and said that disrupting public order is a means to undermine the security of the State.
BRIJ BHUSHAN CASE:
In 1950, the Chief Commissioner of Delhi issued a “pre-censorship order” on the RSS mouthpiece ‘Organiser’ which too was critical of the government. Its publisher Brij Bhushan challenged Section 7(1)(c) of the East Punjab Public Safety Act, which allowed pre-publication scrutiny of material “prejudicial to public safety or the maintenance of public order”.
The issue in this case was essentially the same as the one in Romesh Thappar. And the verdict of the Supreme Court followed the same pattern as in the earlier case.
Then Chief Justice of India Hiralal Kania, and Justices M Patanjali Sastri, Mehr Chand Mahajan, Sudhi Ranjan Das, B K Mukherjea formed the majority that struck down the law. Justice Fazal Ali again dissented.
News 7: New hope for malaria vaccine
Malaria kills nearly 600,000 people every year, the majority of whom are children under the age of five in sub-Saharan Africa. The need to develop an effective vaccine against the disease has long been a top priority — but given the highly complex life cycle of the parasite, characterisation of key elements that correlate with protective immunity has been very difficult.
After decades of slow progress, there seems to be light at the end of the long tunnel. WHO approval in October 2021 for RTS,S/AS01 (Mosquirix) developed by GlaxoSmithKline for immunising children was a major milestone.
Although RTS,S/AS01 has modest efficacy and reduces severe malaria cases by only about 30 per cent after four doses given to children under age 5, it still provides significant public health benefits, and could save thousands of lives every year.
GSK has granted Bharat Biotech licence to manufacture Mosquirix, and by 2029, the Hyderabad-based company is expected to be the sole global manufacturer of this vaccine.
However, RTS,S/AS01 fails to meet the WHO’s own benchmark for malaria vaccine efficacy of 75 per cent set in 2015. In September 2021, another malaria vaccine, R21/Matrix M, developed by the University of Oxford in the UK, demonstrated an efficacy of 77 per cent in phase 1 and 2 trials among 450 children in Burkina Faso.
Ways the vaccines work
RTS,S and R21 are similar in that they both contain the same part of a major protein that is found on the surface of the liver stage parasite, called sporozoite. Both also contain hepatitis B virus surface antigen (HBsAg), a protein that has an ability to self-assemble and that helps as the formation of virus-like particles of the CSP antigen fused with it.
The important difference between the two vaccines is in the amount of the HBsAg. RTS,S has about 20 per cent of the fusion protein, with the remaining 80 per cent made up of HBsAg antigen, produced separately. R21, on the other hand, is made up entirely of the CSP fusion protein moieties, resulting in much higher proportion of CSP antigen displayed on the virus-like particle surface, which significantly raises its exposure to the immune system of the host.
To boost immune responses, all protein based recombinant vaccines rely heavily on a strong adjuvant. RTS,S is formulated with an adjuvant called AS01 developed at GSK; R21 employs an adjuvant called Matrix-M developed by Novavax (Sweden).
Matrix M contains saponin-plant based material and stimulates both antibody and cellular immune responses to vaccines. Both adjuvants have shown high levels of efficacy and safety. Matrix-M has been used in a variety of vaccine formulations against influenza, and more recently in the Novovax Covid-19 vaccine.
Phase 3 results awaited
While the recent results of a booster dose of R21 have created well-deserved excitement, the results of a larger phase 3 trial of the vaccine will be keenly awaited. Phase 3 trials of R21 are already underway in children aged 5-36 months in four African countries, including two in which malaria is a year-round threat. In these trials, efficacy and safety of R21 will be tested in 4,800 children across five sites in Burkina Faso, Kenya, Mali, and Tanzania. The first results are expected by the end of 2023.
Large-scale, well-collected safety data will be required to build the risk-benefit assessment. The SARS-CoV-2 experience has served as a reminder that significant adverse events may not be detected until millions of immunisations have been recorded.
The road ahead is long, but R21, alone or in combination with an efficacious blood stage or transmission stage vaccine candidate, can continue to be developed to achieve the ultimate goal of malaria eradication. It is clear that Indian companies will play a central role in the development and/ or production of efficacious malaria vaccines at an affordable cost.
India: weakness and strength
A major gap is in the establishment of safe and scientifically robust control human infection models in India for diseases like malaria or influenza. All malaria vaccines under development need to be tested in the safe and scientific robust Controlled Human Malaria Infection (CHMI) model after completing phase 1 safety studies.
This has been established in many countries of Europe, the UK, Colombia, and Thailand. Both RTS, S and R21 were tested in CHMI before further safety and efficacy field trials.
Scientists at the International Centre for Genetic Engineering and Biotechnology (ICGEB) Delhi have carried out phase 1 safety trials of two experimental blood stage malaria vaccines developed and produced in the country.
But further development of these vaccines has been a challenge in the absence of the CHMI model in India. Scientific, long term continuous funding, regulatory and logistic processes need to be better coordinated to assist scientists in the development of novel vaccines against infectious diseases.
With a highly successful and deeply committed vaccine-producing biopharma industry and a strong scientific base, India should be able to lead the world in developing and producing vaccines.
Malaria is a life-threatening disease caused by parasites that are transmitted to people through the bites of infected female Anopheles mosquitoes. It is preventable and curable.
Malaria is an acute febrile illness caused by Plasmodium parasites, which are spread to people through the bites of infected female Anopheles mosquitoes.
There are 5 parasite species that cause malaria in humans, and 2 of these species – P. falciparum and P. vivax – pose the greatest threat. P. falciparum is the deadliest malaria parasite and the most prevalent on the African continent.
vivax is the dominant malaria parasite in most countries outside of sub-Saharan Africa.
Global burden of malaria
In 2019, there were an estimated 229 million cases of malaria worldwide, and the estimated number of malaria deaths that year stood at 409,000.
Children aged under 5 years are the most vulnerable group affected by malaria; in 2019, they accounted for 67% (274,000) of all malaria deaths worldwide.
In 2019, India had an estimated 5.6 million cases of malaria compared to about 20 million cases in 2000, according to WHO.
About 241 million cases of malaria and 627 000 deaths were reported globally in 2022. The WHO African Region continues to report a high share of the global malaria burden. In 2020, the region accounted for 95% of all malaria cases and 96% of deaths.
Whereas, the WHO South-East Asia Region showed a sharp decline in malaria cases and accounted for about 2% (5 million in 2020) of malaria cases globally. In India malaria cases have consistently declined from 2.09 million to 0.19 million during 2001 to 2020.
RTS,S/ASO1 (RTS.S), trade name Mosquirix, which was endorsed by the World Health Organisation (WHO) on Wednesday (October 6), is the first and, to date only, vaccine shown to have the capability of significantly reducing malaria, and life-threatening severe malaria, in tests on young African children.
The vaccine acts against P. falciparum, the most deadly malaria parasite globally, and the most prevalent in Africa.
It is also the first malaria vaccine to be introduced by three national ministries of health through their childhood immunization programmes — more than 800,000 children in Ghana, Kenya, and Malawi have been vaccinated, and are benefiting from the added protection provided by the vaccine as part of a pilot programme.