📰 Banana grit for that good gut feeling
Developed by NIIST scientists, the product can be used to make wide range of dishes
•Here is some good news for the health-conscious public and banana farmers plagued by falling prices.
•Scientists at the CSIR-National Institute for Interdisciplinary Science and Technology (NIIST) at Pappanamcode here in Kerala have come up with a new product, banana grit or granules, developed from rawNendranbananas. Billed as an ideal ingredient for a healthy diet, banana grit can be used for making a wide range of dishes, according to the NIIST. The product resembles to ‘rava’ and broken wheat.
•“The concept was introduced to utilise the presence of resistant starch in bananas, which is reported to improve gut health. Hence, the dishes prepared with banana grit and its byproduct, banana powder, incline to the new focus on gut health, which the scientific community is widely discussing now to maintain health and well-being,” the NIIST said.
•The Institute added that years of research on the Nendran variety helped it open up a new application for the starch-rich banana.
•Generally consumed ripe, Nendran banana also finds use in typical Kerala dishes such asavialandthoran. The granules can be used for making upma , or it can be mixed with banana powder for porridge, with milk or coconut milk for use as a health drink. Banana powder can be used for making cakes and breads, along with refined wheat flour.
•Developing new uses for Nendran also comes as a boon to farmers who have often been struggling against falling prices, according to the scientists.
•The technology had been transferred to Kochi-based Moza Organic and the product is expected to be in the market soon.
This allows the vaccines to be offered to healthcare workers and frontline workers in India; Neither Covishield nor Covaxin has completed a crucial phase-3 trial in India.
•Vaccines by Bharat Biotech and Serum Institute of India (SII) were formally approved by the Central Drugs and Standards Committee (CDSCO) on Sunday.
•This allows the vaccines — Covishield from SII and based on the Oxford AstraZeneca vaccine, and Covaxin from by Bharat Biotech — to be offered to healthcare workers and frontline workers in India. The Health Ministry has said 3 crore such personnel, considered at highest risk for COVID-19, will be given the vaccine for free. It isn’t yet known which vaccine will be made available to these personnel though multiple officials say rollouts can begin in less than a fortnight.
•Neither Covishield nor Covaxin has completed a crucial phase-3 trial, under which a vaccine candidate is administered to volunteers at multiple locations across the country, in India. The CDSCO approval was based on a recommendation by a Subject Expert Committee of technical experts who deliberated for two days in sessions lasting over 12 hours on approvals to the two vaccines.
•The minutes of the SEC meeting aren’t yet available. However, a press statement by the Health Ministry said the vaccine’s efficacy in Indian volunteers was “comparable” to that tested in overseas trials.
•Both the approvals accorded are for “restricted use in emergency situation” and in the case of Bharat Biotech the approval wording notes it is 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.” What these conditions are were not specified.
•Bharat Biotech whose vaccine candidate was being tested in large phase-3 efficacy trial in India, has provided safety and immunogenicity data — proof that the inoculation doesn’t harm and is capable of stimulating an immune response in the body — but no efficacy data, that shows the vaccine achieves its primarily goal of protecting against disease. Doing such a trial would have, according to the company’s timeline, taken some more months.
•Head of the CDSCO V.G. Somani, read out a prepared statement according approval and on the sidelines of the briefing told reporters that the vaccine was “110% safe” and that every adverse event, were they to happen, would be diligently followed up.
•Samiran Panda, Head of the epidemiology and communicable diseases division, ICMR, defended the emergency approval to the Covaxin on the ground that the existence of the pandemic, the detection of the UK strain and the vaccine’s safety profile meant that it could approved in ‘clinical trial mode.’
•“This isn’t the standard approval given to a vaccine. The scheduled trial (on 26,000) will continue and every person who gets the vaccine will be followed up and monitored for risk as well as benefit. It can also be withdrawn. This vaccine, as of now is not for everybody, and is being given under restricted use condition,” he said.
•Covaxin has been developed based on a inactivated Sars-CoV-2 strain cultured at the National Institute of Virology, an ICMR body. Because it was a whole virus (and therefore, more of it would be exposed to the immune system) the chances that it would mount a response against a variety of mutant virus types or strains were higher.
•“I would say scientifically Covaxin offers much better antigen presentation (and a consequent immune response) than a vaccine developed as a specific part of the(viral) protein,” Dr Panda told The Hindu. “So this is potentially more effective against mutant strains.”
•Historically there was evidence for this from polio vaccines. An interim analysis of the vaccine’s efficacy would happen around March, said Dr. Panda.
•Randeep Guleria, Director, All India Institute of Medical Sciences to referred to the Bharat Biotech vaccine as a “backup vaccine” and to be used if it was not clear how efficacious the SSI vaccine would be.
•However, not all experts were convinced.
•“I’m completely unaware of any data that suggests that Covaxin has any efficacy against any Sars Cov-2 strain, let alone the UK strain,” Dr. Gagandeep Kang, Professor, Christian Medical College, Vellore, said in an interview to CNBC-TV18.
•A medical doctor-cum-research head of a lab, affiliated to a government research lab, also expressed reservations. “At this point, I wouldn’t advise Covaxin. All we seem to know is that it’s safe and so may not be harmful but efficacy is a different matter and needs to be proved,” the expert said requesting anonymity.
•Independent activists too expressed concern over a “hasty” approval.
•“In the interest of transparency, we ask that the regulator share detailed rationale or the decision along with disclosure of data... We are baffled to understand what scientific logic has motivated top experts in the SEC to approve this vaccine (Covaxin) post haste,” Malini Aisola, of the All India Drug Action Network, said in a statement.
📰 FSSAI slashes limit for trans fat levels in foods
As per the World Health Organisation, approximately 5.4 lakh deaths take place each year globally because of intake of trans fatty acids.
•The Food Safety and Standards Authority of India (FSSAI) has capped the amount of trans fatty acids (TFA) in oils and fats to 3% for 2021 and 2% by 2022 from the current permissible limit of 5% through an amendment to the Food Safety and Standards (Prohibition and Restriction on Sales) Regulations.
•The country’s food regulatory body notified the amendment on December 29, more than a year after it issued a draft on the subject for consultation with stakeholders. The revised regulation applies to edible refined oils, vanaspati (partially hydrogenated oils), margarine, bakery shortenings, and other mediums of cooking such as vegetable fat spreads and mixed fat spreads.
•Trans fats are associated with increased risk of heart attacks and death from coronary heart disease. As per the World Health Organisation (WHO), approximately 5.4 lakh deaths take place each year globally because of intake of industrially produced trans fatty acids. The WHO has also called for global elimination of trans fats by 2023.
•“The FSSAI rule comes at the time of a pandemic where the burden of non-communicable diseases has risen. Cardiovascular diseases along with diabetes are proving fatal for COVID-19 patients,” says Ashim Sanyal, Chief Operating Officer of Consumer VOICE, adding that the regulation must not be restricted to oils and fats, but must apply to all foods. “Hopefully, FSSAI will address this as well before January 2022 to eliminate chemical trans fatty acids from the Indian platter.”
•While the regulation comes into effect immediately, industry players were made to take a pledge back in 2018 that they would comply with WHO’s call for action to reduce TFA by 3% by 2021 allowing them three years to comply with the latest regulation.
•It was in 2011 that India first passed a regulation that set a TFA limit of 10% in oils and fats, which was further reduced to 5% in 2015.
📰 Government ropes in I-T department to crack down on GST fraud
Data being pooled to track evasion, says Finance Secretary.
•Tightening the noose around fraudsters rigging the Goods and Services Tax (GST) regime, the government has roped in the Income tax department to tap illicit incomes as part of a crackdown against 7,000 fraud companies, identified using data analytics tools, Finance Secretary Ajay Bhushan Pandey told The Hindu.
•Any income traceable to the use of fake bills and other GST frauds shall be considered concealed income and attract severe penalties so direct tax collections may also get a leg-up while better compliance pushed GST collections to a record high of ₹1.15 lakh crore in December 2020.
•“GST collections in December show the economy is undoubtedly on the fast recovery track. We have also been working on improving compliance for more than a year now, at the systemic level and at the enforcement level,” Mr. Pandey said.
•“We will be honouring the honest, but at the same time, we will not hesitate from doing things to deter those who try to cheat the system. I think there is now a sense among the fringe elements, who were trying to game the system that it is not going to be so easy to continue in that fashion as the times have changed. And that is leading to better compliance,” he added.
•Over the past one and a half months, ‘concerted action’ has been taken to ensure compliance in the GST net, pooling data with States, the Income Tax (IT) and Customs departments, banks and other agencies, the Finance Secretary said.
•“So we are today in a position to undertake data analytics to pinpoint those who are trying to game the system and take targeted action against such tax frauds. We have been able to identify 7,000 companies who have been issuing fake bills or using fake bills to evade GST and Income Tax,” he said.
•In a recent case, an e-commerce player was found to have even procured manpower services from a fake company, he pointed out. Around 187 persons have already been arrested, including five chartered accountants and a company secretary.
•“Most of them had to spend 40-50 days in jail, because the crime was so grave that the courts were not inclined to give them bail. The IT Department is also taking action as the direct tax implications for beneficiaries of fake invoices, are much, much higher than the GST implication,” the top Finance Ministry official said.
•“If you see the penalties on I-T evasion, it will be more than the invoice value itself,” Mr. Pandey said. This co-ordinated action has also helped bolster Customs revenues, which crossed the ₹16,000 crore mark in December, 93% higher than the same period a year ago.
📰 A hurried gamble: On vaccines and transparency
Opacity in communication is dangerous when there is high vaccine hesitancy
•The stage is set for the biggest vaccine rollout in India’s history with the Drugs Controller General of India formally approving two vaccines for restricted use under emergency conditions: Covishield by the Serum Institute of India (SII), and Covaxin by Bharat Biotech. Though other vaccine candidates are in the fray too, these two set a precedent for how future COVID-19 vaccines will be evaluated and administered. India has been long known as a manufacturer of vaccines but less so as one that can develop from scratch, test and then provide it to the world. The pandemic offers an unprecedented opportunity to establish those credentials, but already a key step — of establishing the vaccine’s efficacy in the Indian population before rollout — has been side-stepped. A double-blinded phase-3 trial — where some volunteers get the vaccine and some do not and the rate of disease in both arms is compared to determine the vaccine’s ability — is among the foundations of evidence-based medicine. The SII because of its agreement with AstraZeneca has furnished data from a phase-3 trial in the U.K. and Brazil, but nothing publicly on how protective the vaccine was in 1,600 Indian volunteers. All of the leading vaccine candidates — Pfizer, Moderna and AstraZeneca itself — made public at least partial results of the vaccine’s abilities in their own populations before these were given a go-ahead by the respective regulators. Bharat Biotech, which is conducting such a phase-3 trial in India, is yet to furnish similar data because it has not been able to finish recruiting the required number of volunteers. The Indian data furnished by the companies only attest to the vaccine’s safety and its evoking some immune response. However, this pandemic has revealed multiple instances of therapies and interventions — from convalescent plasma therapy to a slew of antivirals — that seemed to work well under idealised lab conditions but did not measurably protect in real-world hospital conditions.
•The concern from approving an untested vaccine is that it makes it nearly impossible to conduct a proper phase-3 trial. It will be unethical to expect volunteers to participate in a trial where there is only a 50% chance of being administered the actual vaccine, when they have the option of the real dose elsewhere. Both SII and Bharat Biotech, given the pace of recruitment and potential pool of volunteers, would have been able to generate much more data within mere weeks. So, it is hard to imagine why an emergency use authorisation of these vaccines was hurried through. Opacity marks the government’s communication strategy in a country where distrust of vaccines remains in spite of years of vaccination programmes and elimination of grave diseases. The government neglects this at the country’s peril.
📰 An anti-disclosure amendment that hits public health
The dilution of patent working disclosure rules hampers the effectiveness of India’s compulsory licensing regime
•The central government recently published the Patent (Amendment) Rules, 2020, amending the format of a statement that patentees and licensees are required to annually submit to the Patent Office disclosing the extent to which they have commercially worked or made the patented inventions available to the public in the country. The amendment has significantly watered down the disclosure format, and this could hamper the effectiveness of India’s compulsory licensing regime which depends on full disclosure of patent working information. This in turn could hinder access to vital inventions including life-saving medicines, thereby impacting public health.
Disclosure of information
•In exchange of a 20-year patent monopoly granted to an inventor, India’s patent law imposes a duty on the patentee to commercially work the invention in India to ensure that its benefits reach the public. In fact, the purpose of granting patents itself is to not only encourage innovation but also ensure that the inventions are worked in India and are made available to the public in sufficient quantity at reasonable prices.
•A failure of this duty could trigger compulsory licensing or even subsequent revocation of the patent under the Patents Act, 1970. Further, courts have refused an interim injunction in cases alleging infringement of a patent which has not been worked in India. Thus, the information on the extent of the working of the invention in India is critical for the effectiveness of these public interest measures provided by law to check abuse of patent monopoly (e.g. excessive pricing or scare supply of the invention). Accordingly, section 146(2), a unique provision not found in patent laws of most other countries, requires every patentee and licensee to submit to the Patent Office an annual statement explaining the extent to which they have worked the invention in India. The disclosure is to be made in the Form 27 format as prescribed under the Patent Rules, 2003. This statement is meant to help the Patent Office, potential competitors, etc. to determine whether the patentee has worked the invention in India and made it sufficiently available to the public at reasonable prices.
•Unfortunately, patentees and licensees as well as the Patent Office have blatantly disregarded this statutory requirement. Also, there has been significant pressure from multinational corporations and the United States government to do away with this requirement.
The PIL
•The recent amendment to the form was made pursuant to a PIL filed by Shamnad Basheer before the Delhi High Court in 2015. The PIL brought to the Court’s attention the rampant non-filing and defective filing of Form 27 by patentees/licensees and sought a direction to the government to strictly enforce the patent working disclosure rules and take action against the violators. The PIL also called for a reform of Form 27, arguing that the information it sought was grossly insufficient to ascertain the extent of the working of the patent.
Dilution of disclosure
•The government acknowledged that the Form 27 format was problematic and provided an undertaking to the court to effect appropriate amendments. The court accordingly disposed of the PIL in 2018, directing the government to complete the amendment process within the timelines mentioned in the undertaking. However, in non-compliance of the court’s order, the government published the amended form recently after a delay of almost two years. More importantly, instead of strengthening the form, the amendment has significantly weakened it further, thereby defeating the entire purpose of the amendment exercise.
•Instead of calling for more elaborate details of the information already sought in the Form as suggested in the PIL, the amended form has removed the requirement of submitting a lot of such important information altogether, thus damaging the core essence of the patent working requirement and the Form 27 format. The form now requires the patentees and licensees to provide only for the following information: whether the patent has been worked or not; if the invention has been worked, the revenue or value accrued in India from manufacturing and importing the invention into India; and if it has not been worked, reasons for the same and the steps being taken towards working. They are no longer required to provide any information in respect of the quantum of the invention manufactured/imported into India, the licenses and sub-licenses granted during the year and the meeting of public requirement at a reasonable price.
•How will the data on merely the revenue/value accrued from manufacturing/importing the invention enable one to determine the extent to which it has been worked and its public requirement has been met? The most basic data required for this assessment is the quantum or the total units of the invention manufactured/imported in India. It is the disclosure of this data by Bayer in Form 27 that played a crucial role in grant of India’s first compulsory license to Natco for the anti-cancer drug Sorafenib/Nexavar. The deletion of the requirement of its disclosure is thus shocking and defeats the very purpose of this Form.
•The removal of the requirement of submitting any licensing information, including the disclosure of even the existence of licenses (instead of seeking further details such as names of licensees/sub-licensees and the broad terms of the licenses as suggested in the PIL), means that the patentees/licensees can just self-certify that they’ve worked the patent without having to support the claim with the data on how they’ve done so, including through licensing/sub-licensing the patent.
•Further, the omission to mandate disclosure of details such as the price of the invention, its estimated demand, the extent to which the demand has been met, details of any special schemes or steps undertaken by the patentee to satisfy the demand, etc., as recommended in the PIL, makes it extremely difficult to ascertain whether the invention has been made available to the public in sufficient quantity and at an affordable price.
Impact on public interest
•To conclude, the government has significantly weakened the critical duty imposed by the law on patentees/licensees to disclose patent working information, so much so that it has defeated the very purpose of it. The lack of this information could prevent invocation of compulsory licensing and other public interest measures in cases of patent abuse and make certain inventions inaccessible to the public. Such lack of accessibility in case of patented medicines could in turn have adverse consequences for public health of the country. Therefore, the government must reconsider its amendments to the form taking into account the PIL recommendations and re-amend it to restore as well as strengthen its spirit.
📰 Don’t ignore the women farmers
The gender gap in the agriculture sector will only widen more with the current farm laws
•Eminent agriculture scientist M.S. Swaminathan once said, “Some historians believe that it was women who first domesticated crop plants and thereby initiated the art and science of farming. While men went out hunting in search of food, women started gathering seeds from the native flora and began cultivating those of interest from the point of view of food, feed, fodder, fibre and fuel.”
A common misconception
•In India, whenever we talk about agriculture, we think of men as farmers. However, this is far from the truth. According to the agricultural census, 73.2% of rural women are engaged in farming activities but only 12.8% own landholdings. Due to cultural, social and religious forces, women have been denied ownership of land. This stems from the perception that farming is a man’s profession. The India Human Development Survey reports that 83% of agricultural land in the country is inherited by male members of the family and less than 2% by their female counterparts. Thus, women are mostly left without any title of land in their names and are excluded from the definition of farmers. Besides, 81% of women agricultural labourers belong to Scheduled Castes, Scheduled Tribes, and Other Backward Classes, so they also contribute to the largest share of casual and landless labourers.
•The government too turns a blind eye to their problem of non-recognition and conveniently labels them as ‘cultivators’ or ‘agricultural labourers’ but not ‘farmers’. Without any recognition, women are systematically excluded from all the benefits of government schemes. Moreover, they are not guaranteed the rights which they would otherwise be given if they were recognised as farmers, such as loans for cultivation, loan waivers, crop insurance, subsidies or even compensation to their families in cases where they commit suicide.
•Non-recognition as farmers is only one of their problems. As the Mahila Kisan Adhikaar Manch (MAKAAM) notes, they have unequal access to rights over land, water and forests. There is gendered access to support systems such as storage facilities, transportation costs, and cash for new investments or for paying off old dues or for other services related to agricultural credit. There is also gendered access to inputs and markets. Thus, despite their large contribution to the sector, women farmers have been reduced to a marginal section, vulnerable to exploitation.
The farm laws
•Now they have a new worry: the farm laws. Since the government’s policies never aimed to reduce disparity or alleviate their distress, women farmers fear that the farm laws will further deepen gender inequality in the sector. MAKAAM, in its statement, has highlighted several issues with the laws. The first is the lack of any mention of MSP (minimum support price) that protects farmers from exploitation. It also highlights how women are barely in a position as empowered agents who can either understand or negotiate (written) agreements with traders and corporate entities who are seeking to enter into agreements with the farmers to purchase their produce or for other services. It is clear that farmers will have no bargaining power in the corporatisatisation of agriculture, where corporates will decide the price with no safety net or adequate redressal mechanism for the farmers. Consequently, the small marginal and medium farmers will be forced to do sell their land to big agro-businesses and become wage labourers.
•But while this struggle rages on, we must not forget the troubles of our women farmers. Perhaps that is why they are at the front line of this protest — to remind us that they are too are farmers and have an equal stake in this fight.
