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Response to Draft ABC of UGC: Establishment and Operationalisation of Academic Bank Credit Scheme in Higher Education Regulations

Click here to see the email submitting AIPSN response to UGC

Click here to see the pdf of the AIPSN response to UGC

5th Feb 2021

AIPSN Response to Draft UGC (Establishment and Operationalisation of Academic Bank Credit (ABC) Scheme in Higher Education) Regulations 2021

The UGC during the pandemic period has brought out the draft regulations to establish and operationalise the Academic Bank Credit Scheme on 21 Jan 2021 and has asked for feedback from stakeholders by 5th Feb 2021 via the gmail id abcregulations2021@gmail.com

The response from AIPSN is given in two parts: a) Procedural inconsistencies and b) Long term deleterious impacts

A. Procedural inconsistencies

  1. A democratic exercise has once again been hijacked and made a mockery of in a process that has become familiar. Force a bill, act, ordinance, directive without any discussion to plead that it is good for the nation, farmer, academic, student, teacher worker. The farm laws have met unprecedented resistance. But that has also given the backdrop to take attention away from matters related to other issues. It is for this reason that the government released the Science, Technology, Innovation Policy document on 31st Dec 2020 with only 3 weeks to respond- the date being extended by eleven more days under demand. The same has now happened with this UGC ABC draft regulations being put up on 21st January on the UGC website with the last date to respond is 5th February, 2021 with not even a press announcement for such an important document!”
  2. The question naturally arises what is the urgency? There has to be more time given especially as colleges and universities are not fully functioning due to the pandemic. As it is a scheme that is meant for students, the students need to be involved in the discussion. The time could be given till 30th April 2021 and then the responses can be made public before a new draft is circulated.
  3. There is no postal address and contact person. The online access and internet access in India is not uniform across the country and in different social strata. A postal address and contact person must be specified for students and others to respond offline also.
  4. It is surprising that UGC has chosen a gmail id for soliciting responses rather than use an official government email id or website for the responses. If UGC does not have this capability even, how is it going to operationalise the online Academic Bank Credit? Or is it an indication that ABC will be outsourced to a private party?                                                                                                                                 B. Long term deleterious impacts
  5. The Academic Credits are a way to standardize and make education like an assembly line process borrowed from the predominantly commercial education system. The major limitation of the credit system is that it fragments knowledge as has been acknowledged in the World Bank report on American Credit System in Higher Education brought out in 1992. What we really need is a discussion on the need and the modification needed in the functioning of the credit system.
  6. In India the Choice Based Credit System (CBCS) is poorly functioning at most in a token manner and mostly a disaster in many Universities and colleges. It has been a failure considering that it does not motivate the student nor does it go towards enriching knowledge skills or broader understanding. Even within a University or College there is no possibility of transferring credits. Building on this to bring about an external centralized institution called the Academic Bank Credit for trying to transfer credits across institutions is clearly not based on the reality of what exists.
  7. In the US which pioneered the use of the credit system, ccompleting the first two years of a degree at one institution, usually a community college, and then moving to another, is very common. There is a National Institute for study of Transfer Student that has tried to create website to facilitate transfer. Most States of the USA have a range of approaches from informal efforts of transfer students to more formal institution-based agreements or state-mandated policies. But there is no centralised Credit Bank in the USA that is involved in the transfers.
  8. In China the credit transfer and inter institutional course selection or student exchange has been limited to smaller universities and those in geographical proximity. This was initiated as part of the Chinese National Outline for Medium and Long-term Education Reform and Development (2010-2020). The goal was mainly towards life long education as in Korea. A study of four such initiatives in China concluded “procedures and systems related to credit transfer need to be formulated taking into account China’s actual situation in regard to college entrance and school registration management, thereby ensuring the reliability and credibility of credit transfer”. The Chinese systems do not involve any Centralised Credit Bank.
  9. The most successful credit transfer system in place is the European Credit Transfer System. It is a central tool in the Bologna Process, which aims to make national education systems in Europe more comparable internationally. The ECTS grading systems do not replace the local grading systems, but they provide a supplement to local grades, for example, on a transcript of records. It simply provides equivalences and makes degree programmes and student performance more transparent and comparable across all countries that are members of the European Higher Education Area (EHEA). The ECTS credit system does not involve any Centralised Credit Bank.
  10. The Academic Credit Bank System (ACBS) was started in Republic of Korea in 1998 to augment a lifelong learning. It is a degree granting body. A recent review in 2019 has indicated that the system given the social stratification does not assure equality of outcomes though it theoretically provides equality of access. If this is the case in Korea, in the highly stratified Indian society full of inequities which has also been pointed out by Babasaheb Ambedkar, this current initiative of UGC Academic Bank Credit will only further exacerbate the inequalities of outcomes.
  11. The ABC of UGC is a virtual bank (see 5.1 ‘ABC shall be a digital/virtual/online store-house entity of credit data base of HEIs with students as its stakeholders’). It is not a degree granting body (see 5.4. ABC shall not be, by itself, a Degree-awarding organisation; The Statutory degree-awarding power shall continue to be vested with the eligible HEIs which have registered with ABC). This therefore does not make it suitable as a vehicle for lifelong education. Ultimately the student will be forced to run around between institutions to get the degree for which the credits are entitled as the ABC will need the HEIs to communicate the credits to the ABC (see 6.1 However, ABC shall not accept any credit course document directly from the students and shall entertain such documents as valid only when they are transmitted by the respective, registered HEI awarding the credits).
  12. A fee will be charged to the student to keep the credits in the ABC (see 8.11 ‘There would be a credit processing fee to be paid by the registering student to ABC for maintaining the student’s Academic Bank Account and related functions. It would be fixed appropriately to encourage maximal usage of the ABC scheme by students’). No mechanism has been spelt out to keep the course fees affordable for economically and socially underprivileged students. This would be a further burden on the students and would work against the utilisation by the marginalised groups further increasing the educational divide.
  13. The Higher Education Institutions (HEIs) which are part of the ABC system are those which have the NAAC grade of ‘A’. Only 205 out of a total of 875 Universities are eligible which is just 23% of the Universities. In the case of colleges 1844 have greater than A grade out of total 38498 colleges, that is just 5% are eligible. This scheme is elitist in concept and implementation.
  14. In theory, this UGC ABC sounds as if it is very useful and revolutionary. In reality it will not help first generation students. It will benefit 3rd or nth generation learners as they will be able to navigate the system better both conceptually and financially. City based students would fare better in using this ABC than rural students. In general, this UGC ABC will increase the educational divide in society along caste, minorities, and rural fault lines.
  15. AIPSN calls upon UGC to abandon this flawed Centralised Academic Bank Credit and instead initiate a discussion on the enabling the credit system to first function properly for even in the words of Abbott Lowell who was President of Harvard University in USA: “The real unit is the student. He is the only thing in education that is an end in itself”.

For clarifications contact:

S. Krishnaswamy 9442158638

P. Rajamanickam, General Secretary, AIPSN

gsaipsn@gmail.com, 9442915101 @gsaipsn

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On the draft STIP2020: Need for a people-centered and future-oriented STIP based on reality

click here to see the Gmail submission of AIPSN Response to draft STIP2020

click here for the AIPSN-response-DraftSTIP2020-30Jan2021 in English

 

30Jan2021

All India Peoples Science Network (AIPSN) Response

 

On the draft STIP2020:

Need for a people-centered and future-oriented STIP based on reality

  1. During the ongoing pandemic, the Science Policy Forum and Department of Science and Technology initiated a series of discussions in different tracks to discuss various parts for formulating a draft STIP2020. On Dec 31st a draft was released in English online and a feedback response date of 25th Jan was given. Two days before the date, the deadline was extended to 31st Jan.
  2. In the economic transformation of Japan, South Korea and China their policies relating to Science, Technology and Innovation played a significant role in these countries’ development with advanced capabilities in technologies of the second and third industrial revolutions, poised to also develop such capabilities in 4th generation technologies expected to dominate the global economy over the next two decades. Several other Asian countries such as Singapore and Taiwan have also developed advanced manufacturing capabilities and know-how. All these nations have followed what we may broadly call a self-reliant pathway in S&T, consciously investing in developing their own knowledge, industrial and human resource capabilities over the years, as against depending on “Western” MNCs or companies for this. In the Global Innovation Index China now a rank 14th for the 2nd time in a row and remains the only middle-income economy in the GII top 30. India is at the 48th position. This follows the consistent growth of Gross Expenditure on R&D (GERD) with respect to the GDP in the case of China that grew from 0.6 in 1996 to 2.2 now, while in contrast India has remained hovering around 0.6 since 1996. GERD of the “Asian Tiger” economies follows a similar trajectory. It is also important to highlight the fact that China has used per capita GDP as a metric to measure its progress, thereby placing emphasis on the share of its working population in growth, rather than just GDP as India and many other countries do.
  1. The biggest weakness of draft STIP 2020 is that the policy is not rooted in the economic and industrial scenario of the country, and the direction in which these are visualized to transform over the next, say ten to fifteen years. Without such a vision, draft STIP2020 is cast in a vacuum. Further, the draft STIP2020 does not take cognizance of the present state of Science, Technology and Innovation in India, and put forward a policy that starts from where we are and leads to where we want to go. Similarly, the suggestions proposed do not also reckon with the institutional and systemic weaknesses or strengths. In this context, the very feasibility and utility of the draft STIP2020 are open to question, however nice this or that proposal sounds. Incidentally, STIP 2013 envisioned positioning India among the top 5 global scientific powers by 2020. Do we then presume that India has achieved that and now moves towards the top 3?
  1. A well thought out and designed policy that is sensitive to the needs of not only the people of India but of the world can make a tremendous difference. However, for inclusive and sustainable growth, it is important to first chart the practical steps for effective implementation of S&T policies. Such an approach is needed for balanced and integrated development taking into account the social and environmental aspects. In order to do this, it is important to first ensure the penetration of basic infrastructure of roads, electricity, communications and internet, water, public health, education and skills, to all parts of the country. Just as India’s R&D expenditure has historically been miserably low, so too has India’s investment in the health and education of the majority of its population and potential work force.  No less is the importance of a federated approach to take into account the geographical and developmental diversity amongst the States and Union Territories of India. A rigid one shoe fits all approach will not be useful. There has to be inbuilt flexibility in terms of structures, funding and implementation considering the developmental and infrastructural variations in different regions.
  1. The draft STIP2020 is not an authentic national STI policy. At best, it is like a policy for the Department of Science and Technology (DST). A transformational STI policy needs to bring on board all the government departments of the union Government, the state governments and the public in a collaborative mode for the formulation of STIP 2020 draft.
  1. The vision of the policy as mentioned “to build individual and institutional excellence in STI with the aspiration to achieve the highest level of global recognitions and awards in the coming decade” is completely flawed. One cannot have a national policy based only on awards and recognitions: if India does outstanding science and develops novel advanced technologies, awards and recognitions will follow. As the Nobel Laureate Venkatraman Ramakrishnan has said “Science flourishes when people are free to question authority”. But that cannot be built into a policy. It is an academic, research and society-wide culture and part of the scientific temper which is encouraged by our Constitution.
  1. The draft policy keeps referring to undefined Traditional Knowledge Systems and in one place links it with heritage. This along with references to undefined grassroots innovations is in dissonance with the vision to position India among the top three scientific superpowers in the decade to come. However, highlighting these in the draft STIP2020, in the context of what is currently being done in India under the rubric of these terms, does pave the way for significant funding for spurious and inefficacious efforts, often pulling in an opposite direction to the desired future-oriented STI.
  1. The draft STIP2020 is astonishingly filled with a plethora of new Institutions and Funding Schemes: the Capacity Building Authority, the STI Policy Institute, the overarching Strategic Technology Board, a Strategic Development Fund, a national STI Financing Authority, an STI Development Bank, the national STI governance mechanism, the National STI Observatory, Indian Science and Technology Archive of Research (INDSTA), Advanced Missions in Innovative Research Ecosystems (ADMIRE), a centralized database on all forms of Financial Incentives, and Inter-State Science, Technology and Innovation Council (IS-STIC). While it is necessary that funding mechanisms be centrally coordinated, the structural framework along with the control structure also needs to be decentralized in order to take into account the spirit of cooperative federalism envisaged in the Constitution of India.  These numerous new Institutions would only lead to additional bureaucratic structures in an already top-heavy science administration, draining even more funds from actual research. There is also no point creating new institutions and funding schemes without examining the problem of non-functioning or malfunctioning of existing ones.  It is ironic that these suggestions for new Institutions come at a time when the government is engaged in closing down many S&T Institutions and driving them to raise their own funds, therefore reducing the amount of research done, showing again how distanced the draft STIP2020 is from ground realities.
  1. The draft STIP2020 talks of attracting Foreign Direct Investment (FDI) in STI, reduction in corporate tax rates for foreign MNCs, fast track clearances, easing land acquisitions, adequate means for incorporating FDI etc. to be explored on a need basis. This is definitely detrimental to public  sector research in agriculture  aiming  to strive  for food  self sufficiency, security and especially nutritional security. Self-reliant STI can certainly not be built through FDI or by foreign MNCs who may manufacture in India but will not transfer technologies as experience hitherto has amply shown. Experience of Japan, S.Korea and China is exactly the same: they embarked on a self-reliant path precisely because MNCs and Western companies will never part with their technologies, since they know full well that it is knowledge and technology, which controls industry and the economy. This is yet another cardinal mistake in the draft STIP2020; following the present Governments idea that manufacturing in India by foreign companies/MNCs directly or through FDI in junior Indian partners, is also “Make in India” and also represents Atma Nirbhar Bharat. Nothing could be further from the truth. The draft STIP2020 is extremely permissive to imports, and by this route it plans to achieve ” Atmanirbhar Bharat” and India’s emergence as the third global power in STI! And for that, science is now given a new role: “S&T for diplomatic benefits” and “diplomacy for S&T development”! In this draft STIP2020, the Indian Diaspora are to serve as conduits in the mercantilist exploitation of science, in which India’s intellectual resources, like her scientists, will be the basic inputs in this Atmanirbhar Bharat’s Global Assembly Line.
  1. The long-term and continuing reluctance of the private sector in India to invest in R&D is notorious but is not meaningfully addressed in the draft STIP2020. Much of this is due to Indian corporates’ preference to take the easy route of foreign collaboration or technology imports repeatedly incentivized by industrial and taxation policies of successive governments, even further promoted by the current emphasis on FDI as the major engine of industrial and technological development. Minor policy incentives or inducements will not change this, and a thrust for genuine self-reliance is a must.
  1. The draft STIP2020 also provides an escape clause for the Central Government from the need for enhanced investments in R&D by proposing that all other stakeholders such as State governments, PSUs, SMEs, private sector, Universities, Research Institutions and so on would be required to set aside earmarked funds for R&D. This is a futile and sub-optimal exercise and would only lead to ineffectual “R&D” on paper, merely to satisfy some bureaucratic requirement. In the absence of mission-oriented R&D programmes at scale, the goal of transformative R&D to take India into a leading position in the 4th industrial revolution would remain a pipedream.
  1. There is no meaningful discussion of employment in a potentially changed capital and technology-intensive industrial scenario, and how the draft STIP2020 proposes to address this issue. There is therefore no mention of the working people, farmers, workers, migrants, unorganized workers, rural unemployed and under-employed. Nor is there any indication of how the STI is going to benefit and take them along in the process of inclusive and sustainable growth. This begs the question as to who this draft STIP2020 bell tolls for?
  1. Another big miss in the draft STIP2020 is the absence of addressing societal goals that can be targeted through S&T and by promoting scientific temper, issues that were emphasized in the Scientific Policy Resolution 1958 (SPR1958).Even in its mention of the SPR1958 document, the draft STIP2020 does not mention these aims of the SPR1958 and limits itself to stating that “S&T were seen as vehicles for the onward journey towards socio-economic transformation and nation building”. The role that S&T can play in alleviating hunger (India stands 102 among 117 countries in World Hunger Index), combating disease, ensuring health, hygiene, housing, employment and making the reach of science equitable are not addressed at all in the document.
  1. The draft STIP2020 is anything but what it says: “It is to be noted that the new STIP policy revolves around the principles of being decentralized, evidence-informed, bottom-up, experts-driven, and inclusive.” There are a lot of hollow claims of producing an evidence-driven, inclusive and bottom-up policy process steered and coordinated for the well being of the nation and its people with socio-economic and environmental considerations. The rambling draft policy makes all the right noises but lacks foundations of reality making it a catch all bucket list which without the grounding will remain wishful thinking. It is essential to cut the fluff and make it lean but meaningful.
  1. A major appreciative aspect of the draft STIP2020 is the very mention of LGBTQ+ and all that follows. But again it is dampened by the lack of specifics and arriving at how the changes can be made. The other aspect that is appealing is the talk of Open Science but the sheen is lost, due to not trying to figure out why it has not progressed, as needed, so far.
  1. The importance given to Science Communication is welcome, but it is disappointing to see the stress on scientists rather than on imbuing the lay citizen with scientific temper, critical thinking and the world view of science. It is puzzling that, rather than acknowledge and build upon the existing almost 40 year old people’s science movements in the country committed to and involved with activities towards this goal; this policy glibly seeks to “create” new science movements. Civil society organizations should be left to themselves and supported, but government-created “science movements” would be self-defeating and work against developing critical thinking which often requires looking at governmental S&T policies with a critical eye.
  1. The STIP will affect all sections of the public and, as mentioned in the draft STIP2020, it is meant to be inclusive. Moreover, it also intends to make science literature available in all languages and geographic regions. So a good starting point will be to make the draft STIP2020 available in all the Scheduled languages in the Constitution of India so that the public including researchers at all levels can meaningfully understand and discuss it to come forward with suggestions.
  1. There is no particular urgency to have the STIP brought out within the coming months especially in the time of the pandemic. It may therefore be a good idea to revise the Draft in a transparent manner taking into account comments received, and the revised STIP then placed before parliament allowing for scrutiny by the Parliamentary Standing Committee on S&T.

 

AIPSN demands for transforming the draft STIP2020

into a people-centered and future-oriented STIP based on reality:

 

a) The draft STIP2020 be made available officially on the website in all the Scheduled languages and propagated through social media and TV. After that is made available at least two months period should be given for wide dissemination and involvement in discussions. 

b) There should be a provision for giving feedback through hard copies also apart from only online as online access is still limited in the country. One contact person should be mentioned to ensure that the hard copies will be received correctly. 

c) All the suggestions received, as hard copies and online, must be put into an indexed publicly available online database so that there can be cross checking about incorporation in the STIP. 

d) The draft STIP2020 has to reduce the rhetoric and make it more realistic 

e) The NEP has not been debated in the Parliament. Therefore, endorsing or linking NEP in sections of the STI is not democratic. It is important to involve the Parliament in the STI through formation of a Parliamentary Standing Committee for STI. This is also one of the recommendations by UNESCO for countries to democratise the STIP. 

f) The many structures that are envisaged in the STI need to be decentralised, not in funding but in functionality and structure, taking into account the cooperative federalism which is the spirit of the Constitution. 

g) The four decades old popular science movements and some even older science popularization organizations in the country need to be acknowledged and built upon rather than artificially “creating” new science movements to act at the behest of the government. 

h) There were only limited online attempts to involve or seek the opinions of the wide thriving S&T community in the country. There needs to be more engaged consultations with such S&T communities distributed across the country to evolve this national policy. 

30Jan2021

 

For clarifications contact:

  1. Krishnaswamy 9442158638
  2. Rajamanickam, General Secretary, AIPSN

gsaipsn@gmail.com, 9442915101 @gsaipsn

 

 

Statement on Vaccines Roll-out
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Statement on Vaccines Roll-out

click here to read the English pdf of the AIPSN-Statement-Vaccine-Rollout-15Jan2021

Click here to read Hindi pdf of AIPSN-Statement-Vaccine-Rollout-15Jan2021

AIPSN Statement on Vaccines Roll-out

15 Jan 2021

 

All India Peoples Science Network (AIPSN) is shocked that, as part of the mass vaccinations in India beginning on 16 January 2021 with inoculation of health workers, the Central Government is distributing 56 lakh doses of Bharat Biotech-ICMR’s Covaxin, along with 110 lakh doses of Serum Institute of India-Oxford Astra Zeneca’s Covishield. This is in open defiance of the conditions imposed by the Central Drugs Standards Control Organization (CDSCO) while granting emergency approval for Covaxin. CDSCO and its Subject Expert Committee (SEC) had clearly differentiated between Covishield and Covaxin. Whereas both vaccines were approved for “restricted use in emergency situations,” Covaxin was given conditional approval, after apparent overnight arm-twisting of the SEC, only “ in clinical trial mode (emphasis added).”

56 lakh doses, i.e. inoculation of 28 lakh persons, cannot be considered a “trial” by any stretch of the imagination, especially when Phase-3 clinical trials for Covaxin are already underway involving around 26,000 volunteers. Clearly, the Government has placed Covaxin and Covishield on similar footing, other than total numbers as of now. Any “trial mode” vaccination should involve special monitoring, follow-up and institutional arrangements. The ethical and scientific quality of the ‘trials’ cannot be disregarded. There is no information yet available in the public domain if the Government has communicated any special protocols for Covaxin inoculation. Most importantly, clinical trials should require informed consent or refusal by Covaxin recipients, after being made fully aware of conditions imposed by the CDSCO and the absence of Phase-III efficacy data.

In contrast, Secretary, Union Health Ministry stated in a press conference that recipients would have no right to choose between the two vaccines, making it clear that the Central Government is intent on shoving Covaxin down the throats of State Governments and into the arms of innocent recipients, in this first round the health workers and “Covid heroes” regardless of the CDSCO conditions.

Government has only itself to blame if public suspicion about Covaxin and vaccine skepticism increases further due to its own complete opacity in rolling out  Covaxin, with no information on any of the questions raised here. Unfortunately, the CDSCO and the Union Health Ministry, have subverted the scientific criteria regarding the regulation of vaccines including their own guidelines for emergency use. This would compromise both people’s interests and the credibility of Indian pharma internationally. Bharat Biotech CEO’s unseemly attack on people who have criticized the government’s clearance on emergency use of its vaccine and attacking other vaccines does not add any credibility to its vaccine.

 

AIPSN  urges: 

  • The Union Government issue special protocols for Covaxin administration in “clinical trial mode,” including obtaining informed consent or refusal of recipients and ensuring compliance with all CDSCO/SEC approval conditions; 
  • CDSCO and ICMR to ensure that all clinical trials conform to necessary ethical, scientific and technical standards; 
  • All State Governments take a hard decision on whether to deploy Covaxin widely, or whether to strictly conform to CDSCO/SEC conditions of limited “trial mode” deployment; 

 

 

For clarifications contact:

T.Sundararaman 99874388253 D. Raghunandan 9810098621 S. Krishnaswamy 9442158638

 

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On Hasty Regulatory Approvals in India for Covid-19 Vaccines

click here for pdf of English version AIPSNStatement-VaccineApprovals-6Jan2021

On Hasty Regulatory Approvals in India for Covid-19 Vaccines

6 Jan 2021

India’s regulatory authority for medical products, the Central Drug Standards Control Organization (CDSCO), gave  “restricted emergency approval” on 2nd January 2020 for two Covid-19 Vaccines, namely Serum Institute of India (SII)’s “Covishield” being manufactured in India under technology transfer from Oxford University-Astra Zeneca, and the indigenous “Covaxin” developed by Bharat Biotech in collaboration with ICMR/National Institute of Virology.

AIPSN salutes the efforts of Indian scientists, research institutions and vaccine manufacturers in bringing to the forefront indigenous vaccines like Covaxin in less than a year, with some other candidates just a few months behind. As and when these vaccines meet the threshold requirements for at least 50% efficacy, AIPSN will join other citizens in hailing this triumph and India’s contribution to the global battle against the Covid-19 pandemic.

Tragically, the Government and CDSCO have together seriously damaged these hopes, and also undermined confidence in Covaxin and other vaccines against Covid-19, in particular concerning Covaxin, due to lack of evidence and unsatisfactory scientific basis, non-transparency and concerns around possible political pressure.

SII’s Covishield was approved on the basis of Phase-III clinical trials data from Brazil and the UK, and the approval granted by the UK’s Medical & Healthcare Regulatory Agency (MHRA) based on 70.4% efficacy revealed by the related published data despite some remaining grey areas relating to varying dosages. CDSCO approval for SII’s Covishield could have awaited results from on-going Phase-III trials and bridge studies in India to demonstrate efficacy and bio-equivalence.  However, given the UK approval the approval by CDSCO, although not ideal, may be understandable. Questions still remain, however, about the Health Ministry’s announcement of an extended gap of up to 12 weeks between the first and second doses, whereas the SEC is understood to have recommended the original protocol of 28-days.

The approval for Bharat Biotech’s Covaxin raises more serious questions. The SEC had called for additional data from Phase-III trials, but appears to have been pressured overnight into reconsidering its decision and giving approval the next day, albeit hedged in by many conditions. CDSCO’s Statement shows that the approval is based only on Phase-I and Phase-II data on safety and immune response, but without any efficacy data from Phase-III trials. Top-ranking officials of the Government and ICMR have been strenuously defending this decision by stressing safety and arguing, without any evidence, that the design of Covaxin might make it more effective against the new UK mutation.  The opinion of ICMR, a co-developer of Covaxin, reflects possible bias and a conflict of interest, besides adding to perceptions of pressure on the regulator.

The serious doubts of the SEC on Covaxin are reflected in the CDSCO’s statement saying SII’s Covishield is approved “for restricted use in emergency situation subject to certain regulatory conditions” whereas, in contrast, approval for Bharat Biotech-ICMR’s Covaxin is given with numerous conditions such as “restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains (emphasis added).”

True to form, the Government is steamrolling the decision, and attacking all critics, including many leading Indian scientists, as opponents of Indian science who should instead be upholding “national pride” over the indigenously developed vaccine. This achievement will indeed be hailed as a major Indian scientific achievement once efficacy data are released but, by this hasty approval without evidence, the Government has shot itself in the foot. Whatever prestige India may gain abroad for an indigenously-developed vaccine will be outweighed by the damage caused to the credibility of Covaxin in particular, and of Indian science, research and regulatory institutions.

 

In light of the above, the AIPSN calls for:

  1. Re-consideration of approval for Covaxin till efficacy data is available or, at least, strict adherence to conditions specified in the CDSCO order implying no roll-out of Covaxin for mass vaccination. 
  2. Phase-III efficacy trials for both vaccines continue without extraneous pressure and the data published at the earliest
  3. No vaccine or Covid-19 related drug be released for commercial use in the private sector until regular approval as per protocols (as distinct from emergency use authorization) are obtained.

For clarifications contact:

Sundararaman 99874388253 D. Raghunandan 9810098621 S.Krishnaswamy 9442158638

Rajamanickam, General Secretary, AIPSN gsaipsn@gmail.com, 9442915101 @gsaipsn

 

Stop Monopoly Publishers Efforts To Deny Public Access to Scientific Publications
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Stop Monopoly Publishers Efforts To Deny Public Access to Scientific Publications

click here English pdf SciHub-AIPSNStatement29Dec2020FinalP

Click here for Hindi version pdf of SciHub-AIPSN statement

click here for Kannada version pdf of SciHub-AIPSN Statement

Click here for Odia version pdf of SciHub-AIPSN statement

Stop Monopoly Publishers Efforts To Deny Public Access to Scientific Publications

Three major academic publishers—Elsevier Ltd., Wiley India Pvt. Ltd., American Chemical Society— have filed a petition in Delhi High Court asking for dynamic blocking of Sci-Hub and Libgen in India. SciHub is the first site to allow mass and public access to research publications while LibGen allows access to books. These websites help Indian scientists, teachers and students to freely access and download research publications and books even if they are behind paywalls.

Why are Elsevier, Wiley and American Chemical Society filing this suit? Journal publishing has one of the highest profit margins amongst different sectors and is now a 10 billion USD industry. The profit margin from journal publishing is nearly 40% or twice that of Google! Three publishers who have filed this case together publish 40% of scientific publication and control more than 50% of the publications in science and social sciences worldwide.

Knowledge and its access are accepted under the Universal Declaration of Human Rights as a fundamental human right. In reality, it is denied by the current system where a group of publishing monopolies make super-profits from the work. It is scientists who volunteer their time to both referee the papers and uphold quality, and also sit on editorial boards that manage the publishing process. These publishers have thus no contribution whatsoever to the research writing, refereeing and editing of the papers but enjoy the fruits of the mental and physical labour of researchers. Ironically, even those who produce the content, have to pay for accessing their own work. This is the business model of scientific publishing which is bad for science, while these publishers reap huge profits.

Alexandra Elbakyan, a young Kazakhstan science scholar, started Sci-Hub due to lack of access for the bulk of science scholars to good quality journal articles. Under the cases filed in the US, she can be arrested anywhere and transported to the US to face trial and a lengthy prison sentence. It is not an accident that the case filed in Delhi High Court asks for her address to be disclosed so that the full might of the US and its extra-territorial reach can be used to stop her.

Even well-off educational institutions such as the University of California in the US, are finding it difficult to pay the huge costs charged by these monopoly publishers and have refused to pay for the subscriptions. Significantly, researchers in Universities and Institutes who have access to these publications including the US, access SciHub, as it is much easier to download papers as a one-stop place with about 80 million papers.

An analysis in 2016 showed that Indian scholars downloaded about 7 million papers in one year using SciHub. Without SciHub, it would have cost the Indian Universities or students around 200-250 million USD, which neither the students nor the universities have.

Open Access journals allow people to read and download content free but the content producers – scientists and researchers or their institutions or funding agencies — have to pay the journals to be published. Instead of access, the problem for poorer countries and universities shift to the ability of its researchers to pay for being published. Moreover, only 20% of the research content today is in such open access journals.

The three publishers have filed similar suits in other countries as well. But in India, it is not only a case of publishers’ vs SciHub/Libgen. Here there is a huge community of students, teachers, research scholars and scientists whose access to these journals and books would virtually end if the publishers get their prayer in court for dynamic blocking to these sites. There will be serious long term consequences to science and education in India.

It might be believed that Sci-Hub has no legal case in India. This is not true. Sci-Hub does not charge any student or researcher for downloads — it is a free service. So it is not profiting from making such papers available. Secondly, Indian copyright law has exceptions for education and research. It is for the Courts to decide whether Sc-Hub’s use by research scholars in India constitutes a valid use of the copyright exceptions, similar to what was argued and decided by the courts in the Delhi University photo-copying case. Blocking these websites will also mean that access to those publications which are under open access or not published by these publishers will also get blocked.  Finally, these copyright holders are sitting on content some of which is more than 60 years old and free from copyright in India. Yet we still have to pay money to access even this content.

The case filed by the copyright holders in Delhi High Court asking for a blanket ban of the sites is not against Sci-Hub and Libgen; it is against the research scholars in this country. Most of whose research would come to a halt if this case by the robber barons of the publishing industry succeeds. It is the future of research in India that is at stake, not Alexandra Elbakyan or Sci-Hub’s future.

AIPSN demands that the monopolistic model of access to knowledge be given up and the process of free access to knowledge by the public accepted.

AIPSN joins hands in support of those legally fighting these monopoly publishing industries against SciHub and Libgen which are working like the story figure of Robin Hood in making the knowledge commons work by providing the public a way to have their right to accessing knowledge.

 

Contact

Rajamanickam, General Secretary AIPSN

gsaipsn@gmail.com, 9442915101

Twitter @gsaipsn

 

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AIPSN statement on Vaccines and IPR waiver: India-South Africa Proposal for TRIPS Waiver – Putting People before Profit

click here for pdf of AIPSN-statement-on-Vaccines-and-IPR

AIPSN statement on Vaccines and IPR waiver

India-South Africa Proposal for TRIPS Waiver – Putting People before Profit

As Covid-19 pandemic continues to keep its grip on the globe, countries are facing severe shortages in medical supplies and treatments, with intellectual property rights hindering the timely provisioning of affordable medical products. To address this, India and South Africa have put in a proposal at the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS), under the World Trade Organisation (WTO), demanding a temporary waiver of certain TRIPS obligations on copyrights and related rights, industrial designs, patents, and the protection of undisclosed information in relation to the prevention, containment or treatment of Covid-19.

Most of the least developed and developing countries have supported these proposal in the TRIPS council, arguing for equitable and affordable access to medicines and medical products at least in these times of widespread catastrophe. The proposal has also got support from the World Health Organisation (WHO). However, it has been opposed by developed countries such as the US, the UK, Japan and even Brazil, on the grounds that such a move would hinder innovation and that there is no indication of intellectual property rights (IPRs) being a barrier to accessing Covid-19 related medicines and technologies.

Nothing can be farther from the truth! Over the last few months, countries have faced IP barriers in drugs, masks, ventilator valves and reagents for testing kits. Multiple patents have been filed for Covid-19 vaccines in development(https://msfaccess.org/sites/default/files/2020-10/COVID_Brief_ProposalWTOWaiver_ENG_2020.pdf ). Even the stockpiles of potential vaccines have been reportedly cornered by the rich countries.

 Unequal Access to Medical Products across Countries even in times of Global Crisis

More than nine months into the pandemic, the situation across the globe remains grim not only in terms of the spread and impact of the pandemic but also the availability of medical products. On the one hand global supply chains have broken down leading to supply shortages, on the other the demand has been increasing due to rising incidence of coronavirus. The Low and Middle Income Countries (LMICs) are the worst hit because the Covid-19 pandemic has not just been a public health crisis, it has been economically devastating as well. The national budgets of these countries are severely strained and most of them also lack the production capacity of the much needed medical products. It is unfortunate that in such dire times when the world is waiting for a vaccine we are witnessing (https://twn.my/title2/briefing_papers/twn/Inovio%20countersued%20IP-COVID%20Jul%202020%20Hammond.pdf) manufacturers relying on proprietary production techniques thereby potentially making vaccines more expensive and less available, large commitments of manufacturing capacity in 2021/2022 being sealed up in contracts, and rich countries locking down COVID-19 vaccine supplies through big money contracts(https://launchandscalefaster.org/covid-19).

Appropriating Public Funds for Private Profits

Public funding must cater to people’s needs rather than corporate greed. Ironically, out of the total funding of 96 million USD for research into Coronaviral diseases (including MERS, SARS) during 2016-18, the bulk 93% has been public funding, 6% by philanthropic organisations and less than 1% by the industry. If we look at the larger set of Emerging Infectious diseases, the proportion of public funding is 77% and that of industry 18% during 2014-18 (https://gfinderdata.policycuresresearch.org/) Even for the Covid-19 pandemic, it is largely public funds that have been committed by various governments. The big pharma, thus, uses public funds for R&D to garner private profits, taking advantage of the IPR regime without any concrete commitment to share the technologies and know how developed through public funding to scale up the production through non-originator manufactures.

Multilateral Trade Policy – Creating Monopoly Profits

Just as the TRIPS agreement was bulldozed on to the least developed and developing countries during the 1990s in the name of ‘free and fair’ trade regime, so are the developed countries arguing to protect the IPRs, which are in fact means for creation of monopoly profits. The big corporations and the rich countries were as hand in glove then as they are today. The trade policy regime has led to concentration of manufacture products in a few countries. As per a WTO report (https://www.wto.org/english/news_e/news20_e/rese_03apr20_e.pdf), Germany, the United States (US), and Switzerland supply 35% of world’s medical products; China, Germany and the US export 40% of personal protective products. Such concentration of production in times of huge global demand is bound to lead to profiteering and to deal with this is to decentralise production through local manufacturing. To do this, access to the whole range of technologies and strategies for manufacturing these products is required.

TRIPS flexibilities are insufficient

TRIPS flexibilities were included in the Doha Development Agenda in order to safeguard LMICs from the adverse impact of patent regime. However, it has been effective only on a few occasions because of arm-twisting tactics of the big pharma, operating in cahoots with the rich country governments through bilateral pressures on countries as also lobbying by the big pharma against generic drugs. Also, the rules for compulsory licensing apply only on a case-by-case and product-by-product basis, which slows down the ability of countries to scale up production. Even Article 31bis, a mechanism to supply countries with insufficient manufacturing capacity, is limited in its application. TRIPS obligations, furthering the IPR regime, would only exacerbate the crisis.

Global Solidarity – A Farce!

The WHO has got little support by pharma industry for its Covid-19 Technology Access Pool (C-TAP) initiative (https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/covid-19-technology-access-pool), aiming at voluntary contribution of IP, technologies and data to support global sharing and scale up of manufacturing and supply of COVID-19 health technologies. Voluntary cooperative approaches such as the COVAX are only a short term solution and only work towards maintaining the current business models of big pharma. The GAVI-CEPI initiative has refused to address the issue of patents and other intellectual property rights even on the issue of Covid-19 preferring to work with global pharma MNC’s on vaccine development and pooling philanthropic resources for the poorer countries. Such philanthro-capitalist measures only deepen the structural inequalities in global health architecture.

The need of the hour is to dismantle, or at least limit the IPR regime, which promotes profits for a few at the cost of lives of the people. With the world facing such unprecedented public health crisis, it is important that the TRIPS obligations are waived off, at least until the situation comes under control, as mentioned in the India-South Africa proposal. A collective global struggle is required towards ensuring that the interests of people are given precedence over profits and the greed of capital!

 

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Fog over Covid-19 Vaccines in India: All-India Peoples Science Network (AIPSN) Position Paper

click here to see the English pdf of AIPSNPositionPaper-Vaccine-Politics16Dec2020

Click here to see the Hindi pdf of AIPSN position paper

Click here to see Tamil pdf of AIPSN position paper

Fog over Covid-19 Vaccines in India

All-India Peoples Science Network (AIPSN) Position Paper

16 Dec 2020

Many new developments have come about in recent weeks regarding Vaccines against Covid19 both internationally and in India. These have raised some optimism, but also several concerns about vaccine politics, undue commercial influence and other extraneous factors playing out around the world and, specifically, in India. This Position Paper focuses chiefly on India, within the global context, whereas international dimensions have been dealt with in a separate Statement and the Indian response to EUA for vaccines was highlighted in another Statement.

AIPSN calls for a science-based, equitable and rigorously conceived nation-wide policy in India for development, manufacture and deployment of vaccines in a free, universal vaccination strategy against Covid-19 as discussed below.

 

  1. Context and Status

Accelerated development and deployment of a safe and effective vaccine is crucial to combat the rampaging Covid-19 pandemic to protect individuals and enable full and safe re-opening of the economy and society. Access to free vaccination is essential for people’s right to life and health, since the disease has a significant burden of preventable morbidity or serious illness and mortality or deaths. Though the proportion of infected persons who get serious disease is low, in absolute numbers the number of persons who are at risk is unacceptably high. Free vaccination is also necessary since it is low-income working people who have paid the maximum social costs of the lock-down and disruption of the economy, and because vaccine development has mostly been done with public funds. At the same time, a nationwide vaccination programme is a challenge and raises crucial questions including with regard to the preparedness of the public health system in India to deliver this without compromising other essential health services.

Internationally, some leading vaccine candidates have, in recent weeks, declared high levels of efficacy or effectiveness based on preliminary results from on-going Phase-3 clinical trials. US-German Pfizer-BioNTech and US-based Moderna have both declared efficacy of above 90% for their two-dose  vaccines and applied for Emergency Use Authorization (EUA) in the US and Conditional Marketing Agreement (CMA) in EU. Both these vaccines are relatively expensive (at around USD 40 (Pfizer) and USD 70 (Moderna) for two doses) and, importantly, require very low temperature cold chains, adding to the costs and delivery challenges for India and other developing countries. At the time of writing, Pfizer has obtained a global first EUA in the UK and subsequently in Bahrain, Canada, and US.

UK-based Oxford University-Astra Zeneca, which is partnering with the world’s largest vaccine manufacture Pune-based Serum Institute of India (SII), for mass production of its vaccine, has claimed average 70% efficacy across different modes and 90% efficacy at specific dosages. This double-dose vaccine is expected to be relatively inexpensive at around USD 6 and, significantly, can be stored at ordinary refrigerator temperatures, making delivery easier in India and other developing countries. SII has publicly claimed that it would be supplying around 300 million doses for India by mid-2021.

Russia’s RDIF-Gamaleya Institute too has declared effectiveness of over 90% for its “experimental” Sputnik-V vaccine. The powdered version requires storage at refrigerator-like temperatures, while the liquid version has to be at -18 deg C. The vaccine is expected to cost about USD 20 for 2 doses. This vaccine is undergoing Phase-3 trials in different countries including India and is to be manufactured by Hetero Biopharma in Hyderabad.

China’s Sinovac is being deployed widely in China and also in Brazil, and is gearing up for global supply when regulatory approvals are obtained, with a price tag internationally of around USD 60 for two doses and also requiring only refrigerator-like temperatures. Again at the time of writing, another China-origin vaccine from Sinopharm has been declared by the UAE as having 86% efficacy in Phase-3 trials in that country where it had been given EUA in September for front-line workers, but data from the trials are still not public.

These developments represent a significant achievement for science and medical research, because these promising results, however limited and preliminary have been attained in less than a year from the outbreak of the Covid-19 disease compared to the normally expected several years for vaccine development.

However, detailed data related to all these vaccine trials have not yet been published or peer-reviewed, which would bring out additional and important information such as effectiveness in different age-groups and segments of the population, prevention or reduction of severe illness and deaths, prevention of transmission, duration of immunity or protection etc. These properties may vary for different vaccines and may influence choices for deployment. Other vaccine candidates too are at various stages of clinical trials, and may similarly also obtain EUA over the next 3-6 months.

Therefore, questions have already been raised about how scientific, rigorous or transparent these EUAs have been. Both “vaccine nationalism” and commercial interests are known to be deeply involved, apart from panic response by governments in the face of failures to control the pandemic, as evidenced by pronouncements of government spokespersons in many countries including in India. The sharp rise of concerned company values in stock markets could also be contributing to the haste in these announcements.

In India, several indigenously developed vaccine candidates have also come to the forefront in recent weeks. Leading candidates are from ICMR/NIV-Bharat Biotech in Hyderabad, Zydus Cadilla in Ahmadabad and Gennova in Pune. There are already undergoing, or soon to start, Phase-3 trials and are expected to become available in early to mid-2021. Some other promising indigenous candidates are a few months behind. The Gennova vaccine, co-developed with HDT Biotech of the US and supported through seed funding by Department of Biotechnology (DBT), which has also supported indigenous development of some other vaccines, has recently received approval to start Phase-1 and 2 clinical human trials in India. This vaccine is of particular importance for future scientific and medical research in India since it is the first indigenous development of an mRNA (messenger RNA) vaccine, using a technology that may also be very useful for new-generation pharmaceuticals for treatment of infectious diseases and cancers.

After the Prime Minister’s recent visits to and meetings with several of these companies to encourage them in their efforts, he is reported to have also instructed the regulatory agencies to facilitate the expedited approvals process. It is important that data from clinical trials for all these candidates are scientifically assessed without “vaccine nationalism,” pressure from political or commercial interests, cronyism or favoritism and also meet high standards of efficacy and safety, especially since high efficacy percentages have  been announced by  leading international candidates.

 

 

  1. Need for transparent, science-based trials and approvals

In this context, extraneous considerations do appear to be creating untoward interference in scientific processes involved in vaccine trials, assessments and expedited or emergency approvals with implications for deployment as well. There are indications, covered in the media and supported by several experts, that ongoing clinical trials for vaccine candidates are “designed to succeed” in several ways.

It may be recalled that the Director General, Indian Council for Medical Research (ICMR) had, earlier this year, written to all hospitals where clinical trials were underway demanding that they expedite results by 15th August this year, clearly to enable a grand announcement from the Red Fort. Fortunately, a massive outcry by scientists, medical professionals and civil society organizations brought about a retreat from this blatant attempt at pressurization. However, the danger remains in many ways.

Thresholds for efficacy or effectiveness (i.e. the percentage of infections the vaccine prevents), different aspects of efficacy as discussed earlier, as well as the sample size required for grant of EUA, may be lowered to enable vaccine candidates to more easily pass the test. While anxiety to roll-out an indigenous vaccine quickly through EUA is understandable for several reasons, it is crucial that clinical trials and assessments of results are, and continue to be, conducted transparently by scientific-medical Data Review Boards independent of political and bureaucratic influence, and results be made public and, when completed Phase-3 trials, be published and subject to peer review. This is essential to build global and domestic public confidence in Indian-origin vaccines.

In this context, it is a matter of considerable satisfaction that the Subject Expert Committee (SEC) of the Central Drugs Standards Control Organization (DSCCO), at its meeting on 9th December 2020, has kept pending its consideration on the applications for Emergency Use Authorization (EUA) of Covid-19 Vaccines by SII and Bharat Biotech, and has asked for additional information. The regulatory agency Drugs Controller General of India (DGCI) was to have decided on grant of EUA based on SEC’s recommendations. The SEC has, at least for now, rightly asserted its responsibility for scientific assessment of Covid vaccine candidates independent of political, bureaucratic or commercial interests.

The SEC decision has come against the background of considerable pressure from different levels of government, such as several recent public statements by the Health Secretary, Dr.V.K.Paul of Niti Aayog heading the National Task Force on Covid-19, and by DG ICMR. These officials pushed for a quick grant of EUA for these and other applicants, rather than respecting due process and scientific evaluation of data relating to safety and efficacy.

Urgency for approval and deployment of vaccines is no doubt important, but not at the cost of safety or potential impact in tackling the pandemic. More robust data would be available soon, providing opportunity to “hasten slowly”.  Self-reliance and encouraging indigenous research and manufacturing industry too are important, but sloppy or unscientific decision-making relating to public health will only damage the reputation of Indian science and regulatory processes, far outweighing any brownie points gained by rolling-out vaccination a few weeks early. Problematic EUA approval may also add to existing vaccine skepticism or hesitancy among the public.

The SEC and DCGI should therefore fearlessly conduct a thorough scientific assessment of available early data from Phase-3 trials in India or abroad, resisting pressure from different quarters. SEC/DCGI should also release the data based on which any recommendation is made so as to enhance transparency and secure the confidence of the scientific and medical community in India and internationally. This is especially crucial if India is to contribute to the global fight against the Covid-19 pandemic through its indigenously developed and manufactured vaccines. While granting EUA, it is also important to set up extensive surveillance of the vaccination programme, and to continue with rigorous Phase-III trials and peer review and publication of its data.

It must be also understood that, at this stage of development of different vaccines, it is not clear whether each vaccine is efficient at preventing infection, as distinct from preventing serious disease or mortality. It is also important to know whether infection can spread from persons administered specific vaccines, and the duration for which each vaccine protects persons. These specificities need to be taken into account for decisions on deployment. These unknowns at the present stage and the need to find answers them underline the necessity for continuation of clinical trials involving the larger numbers of enrolled volunteers, extensive post-vaccination surveillance and, importantly, continuing with all other public health measures of disease prevention and epidemic management.

 

The reputation of India’s science, vaccine manufacturing industry and regulatory institutions depends heavily on such unbiased, rigorous and science-based assessments, since India could potentially emerge, now or in the future, as a major exporter of low-cost indigenously developed vaccines especially to other developing countries.

 

  1. Free and Transparent Vaccine deployment strategy

Ruling parties in different States are making promises of free vaccines to all, especially in the run-up to State elections. The nation needs a science-based and nationwide policy on vaccine deployment to be implemented by States with additional measures if desired, keeping in mind, the phased availability of different vaccines. The National Task Force on Covid-19 headed by Dr.V.K.Paul of Niti Aayog recently announced a prioritization roadmap proposing to initially vaccinate health care workers, other frontline workers, security personnel and those above 50 years of age and persons with co-morbidities, amounting to an estimated 300 million persons, starting perhaps in March 2021.

A clear, well reasoned and long term vaccination roadmap is required, especially keeping in mind the different indigenous vaccines set to obtain regulatory approval in the near future.  The policy needs to more definitively identify those included in the category of “frontline workers,” how senior citizens and those with co-morbidities would be enumerated, address phase-wise coverage of the rest of the population especially children and young adults not mentioned so far but whose immunization against Covid is necessary for early and much-needed resumption of safe and regular in-person education. It is also important to specify which categories of the population, such as infants or the elderly, would be immunized using which vaccine, depending on the efficacy characteristics of available vaccines.

The Prime Minister in his televised address to the nation on October 20 assured that the government seeks to ensure “delivery of the vaccine to every citizen.” However, the Health Secretary in the presence of DG ICMR stated categorically that the government has never committed to universal vaccination which was in fact not necessary since  the need is only to break the chain of transmission and obtain ‘herd immunity,’ and therefore the government may not vaccinate the entire population. It would, however, be extremely difficult to decide which sections to leave out of the vaccination programme and explain such a decision, since this would raise serious apprehensions of discrimination or injustice on different grounds.

Further, although achieving a threshold level of herd immunity (loosely estimated at 60% of the population) could prevent epidemic spread, the disease would still remain endemic in the country especially in population sub-groups, with significant numbers developing the disease and more limited outbreaks continuing in different parts of the country. Similar phenomena are seen in diseases like measles and diphtheria. The more skewed the demographic characteristics of the persons immunized, the less would be the braking effect of herd immunity.

In the Indian context, equity as a value and principle demands that those least able to practice social distancing, because of working and living conditions, need it most. All things considered universal vaccination may be the best option to prevent arbitrariness, real or perceived discrimination and emergence of a black market, besides enabling more robust and sustainable disease control.

A danger is that many Vaccine manufacturers in India and other corporate interests are already lobbying for the Government to allow delivery of vaccines by the private health sector at market prices to those who can afford to pay, as was done in Covid Tests and Hospital charges. Such a vaccine deployment strategy would, however, completely undermine equity and divert precious vaccine doses to privileged paying sections away from the vast poor underprivileged masses, and would also distort government procurement and equitable vaccination.

It is therefore essential that the Government of India announces a clear and transparent vaccination programme including a categorical and binding commitment to a programme of free universal vaccination with a fair and transparent policy of phase-wise prioritization for different segments of the population so as to ensure access to most vulnerable segments and marginalized sections.

 

  1. Obstacles to domestic manufacturing and deployment

            There is much confusion regarding the Indian government’s participation in COVAX, the newly created global institution under the Global Vaccine Initiative (GAVI) and WHO. COVAX is funded by donor countries, corporate philanthropy notably the Gates Foundation and Wellcome Trust, as well as the 10% down payment from self-funded participating countries. COVAX has provided financing to different vaccine developers and manufacturers in exchange for a proportion of vaccines produced, all through confidential agreements. COVAX also has agreements with participating countries to provide upto 20% of their vaccine requirement, for the duration of the agreement period which is now only till end-2021, with special arrangements for lower income countries. On the other hand, rich countries with 13% of the world’s population have already purchased over 50% of the world’s scheduled vaccine production and many other such bilateral agreements have been signed.

In this context, several Indian vaccine manufacturers who have agreements to manufacture leading vaccines developed elsewhere, would be bound by confidential agreements made with COVAX and also with their corporate partners as regards prices and supply schedules. Voluntary licenses granted by vaccine developers to Indian manufacturers prevent the latter from transferring the technology to other Indian companies or from exporting to countries not covered by COVAX.  It would therefore be difficult for Indian vaccine manufacturers to scale-up vaccine production and supply to the levels required by India.

Government of India needs to work out how to overcome this problem. It is recommended that any agreements India signs with COVAX should be within an improved framework and its governance made more multilateral and democratic with a greater role for WHO, and removal of corporate influence. Government should also make public to the Indian people the terms and conditions of agreements with COVAX.

The government should urgently evolve and implement measures for scaling up manufacture of the most appropriate vaccines for our needs, through support to existing  manufacturing units in private sector to expand their capacity and by encouraging public sector manufacture in this area irrespective of the vaccine being indigenously developed or licensed from international pharmaceuticals.

 

  1. Strengthen the public health system

Finally it should be emphasized that the vaccination programme will require massive strengthening and mobilization of the public health system in India including for follow-up, monitoring of side-effects and efficacy. The capacity of current cold chain infrastructure is only about 50% of what is required even for the existing package of immunization. The human resources gaps are also huge. Procuring, storing and distributing and administering vaccines to close to 800 million more persons, even if phased is going to require considerable expansion of cold chains equipment, infrastructure, refrigerated transport vehicles, and  skilled human resources at the field level.

Therefore any plan for vaccine deployment, must also make a firm and quantified commitment to increased financing of the public health system. In the absence of such a commitment, the vaccination programme will suffer and other essential health services including child immunization would also be undermined by large scale diversion of existing public health resources.

 

  1. AIPSN Demands

The Government of India needs to urgently undertake the following so as to ensure a safe, effective and free universal vaccination programme against Covid-19:

  1. Scrupulously monitor Phase-3 clinical trials for all indigenously developed vaccines and, after robust and independent scientific assessment of efficacy with peer review of trial results, grant Emergency Use Authorization within a definitive deadline within which such approvals can be applied for;
  2. Rapidly scale up manufacturing capacity by recruiting and re-tooling both public sector as well as private sector manufacturing units for both internationally and indigenously developed vaccines;
  3. Ensure transparency of agreements that Indian manufacturers have signed or may sign with COVAX/GAVI and Corporates. These may require further arrangements for systematic transfer of technology from international vaccine developers to Indian manufacturers to enable effective and rapid scaling-up manufacture and deployment in India;
  4. Make public the basis of approval, including evidence reviewed, provide details of the protocol, process and timelines followed in investigating any reported severe adverse events (SAEs);
  5. Make public the Government’s stand on indemnifying vaccine manufacturers;
  6. Actively advocate and lobby for declaration of all vaccines developed worldwide as global public goods and, if patents remain an obstacle, take steps to use compulsory licensing if necessary;
  7. Bring out a white paper on the system and related costs for vaccine procurement and delivery, along with details of the expansion of public health infrastructure and human resources that would go with it;
  8. Set up a Parliamentary Committee to oversee the implementation of the Covid-19 Vaccination programme in an effective, timely and equitable manner and a broad based Advisory Committee including representation of the scientific community and civil society organizations.

 

For clarifications contact:

P.Rajamanickam 9442915101;T.Sundararaman 99874388253;D. Raghunandan 9810098621

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Statement On Scientific, Independent and Transparent Process for Emergency Use Authorization (EUA) of anti-Covid Vaccines in India

 

click here to see pdf of All India Peoples Science Network (AIPSN) Statement 

On Scientific, Independent and Transparent Process for

Emergency Use Authorization (EUA) of anti-Covid Vaccines in India

 

AIPSN expresses satisfaction that the Subject Expert Committee (SEC) of the Central Drugs Standards Control Organization (DSCCO), at its meeting on 9th December 2020, has kept pending any recommendations on applications for Emergency Use Authorization (EUA) of Covid-19 Vaccines by Serum Institute of India (SII) manufacturing the Oxford Astra Zeneca vaccine of the UK, and by Bharat Biotech making the indigenously developed ICMR/NIV vaccine. The SEC sought additional data from SII relating to its Phase-III trials in India and the pending regulatory approval process in the UK. In the case of Bharat Biotech, the SEC said it would proceed only after reviewing data from its on-going Phase-3 trials in India, whereas it had submitted only Phase-I/II data.  The regulatory agency Drugs Controller General of India (DGCI) was to have decided on grant of EUA based on the recommendations of the SEC. The SEC, at least for now, has rightly asserted its role regarding scientific assessment of vaccine candidates independent of political, bureaucratic or commercial interests.

The SEC decision has come against the context of several recent public statements by the Health Secretary, Dr.V.K.Paul of Niti Aayog heading the National Task Force, and by DG ICMR pushing for a quick grant of EUA for these and other applicants, rather than respecting due process and sientific evaluation of data relating to safety and efficacy. DG ICMR in particular sought to undermine the importance of Phase-III trials data and suggested that some vague “cost-benefit assessment” would instead suffice for granting EUA, ignoring the obvious conflict of interest since one of the candidates has indeed been developed by an IMR laboratory!

The urgency for approval and deployment of vaccines is no doubt of importance, but not at the cost of safety or potential impact in reducing infection, transmission and severe illness or mortality. Robust data enabling a more scientific and considered decision based on Phase-3 trials data, whether from India or abroad, is likely to become available in a few weeks in any case. With the national case load on a declining trend, there is opportunity to hasten slowly as WHO recommends.  Self-reliance and encouraging indigenous research and manufacturing industry are undoubtedly important, but sloppy or unscientific decision-making relating to public health will only damage the reputation of Indian science and regulatory processes, far outweighing any brownie points gained by rolling-out of a vaccination programme a few weeks early, but which may later turn out to be problematic. Rolling out a vaccine without a proper appraisal of safety and efficacy may also lead to a backlash, adding to existing vaccine skepticism or hesitancy.

AIPSN therefore calls upon the SEC and DCGI to fearlessly conduct a thorough scientific assessment of available early data from Phase-3 trials in India or abroad independent of political, bureaucratic and commercial interests in deciding upon EUA for different vaccine candidates. AIPSN further calls for releasing the data based on which any recommendation is made in the interests of transparency, gain confidence of the scientific and medical community in India and internationally, and so as to allay any fears about safety and efficacy of vaccines to be rolled out. This is especially crucial if India is to contribute to the global fight against the Covid-19 pandemic through its indigenously developed vaccines. While granting EUA, it is also important to set up extensive surveillance of the vaccination programme, and to continue with rigorous Phase-III trials and peer review and publication of its data.

For clarifications contact:

  1. Rajamanickam 9442915101 T. Sundararaman 99874388253  D. Raghunandan  9810098621
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Press Note protesting attempt to rename RCGB in unscientific manner

Click here for pdf of press release

All india People’s Science Network

Central Secretariat: O/O Tamil Nadu Science Forum, 6, Kakkathoppu Street, Madurai-1 

——————————————

Press note: To The editor for the publication in the esteemed media.

It is learnt that Govt of india has decided to name  the second campus in the name of the RSS founder and ideologue Golwalkar within the campus of existing Rajiv Gandhi Centre for Biotechnology(RGCB) , Trivandram. It is highly condemnable changing the name of a modern research institute in the name of a person who was against the modern technology calling it as western technology. 

More over the  decentants of Golwalkar had been advocating pseudo sciences calling the birth of 100 Kauravs through  stem cell technology and the birth of Karna as in vitro fertilisation technology . Let not this centre become a pseudoscience centre of research and technology.

It is  like changing the name of ancient city names which were founded by Islamic rulers as per your wishes promoting hindutva ideology  and jingoism. These are research and development institutes and centres founded on the basis of scientific development. 

We also Urge the Central Government to respect the opinion of Kerala Government and main opposition Party and sentiment of the people of the State.

Hence we urge the Govt of india not to change the existing name of the RGCB for the second campus. If there is a need from the administration point of view, it could be that of a reputed scientist in the field of biotechnology.

P.Rajamanickam

General Secretary, 

9442915101