04 January, 2021 - Daily Current Affairs Analysis & MCQs - The Daily News Simplified from The Hindu
- Announcement for PTS
- True False Statements for Prelims
- An anti-disclosure amendment that hits public health Page 06 - (Economy)
- India approves two COVID-19 vaccines for emergency use Page 01 - (Science and Technology)
- A hurried gamble Page 06 - (Social Issues)
- China amends defense law to boost war preparedness Page 14 - (International Relations)
- Case Studies
UPSC Current Affairs: An anti-disclosure amendment that hits public health | Page - 06
UPSC Syllabus: Prelims: Economy | Mains – GS Paper III – Economy
Sub Theme: Patents | UPSC
Background: Under the Patents act, 1970, in order to get a patent, technical information about the invention must be disclosed in a patent application. Once a patent expires after 20 years, the invention enters the public domain and anyone can commercially exploit the invention without infringing the patent.
Hence, Patents act, 1970 imposes a duty on the patentee to commercially work the invention in India to ensure that its benefits reach the public. Apart from that, it also ensures that the inventions are made available to the public. If the patentee does not provide the accurate information or does not commercially work the invention in India, then the Indian Government can issue compulsory licensing or revoke the patent.
New Modification: Recently, the central government has published the Patent (Amendment) Rules, 2020. The new rules have amended 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 weakened the requirement of submitting such information in the disclosure format. 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.
What are Patents?
A Patent is a statutory right for an invention granted for a limited period of time. Upon being granted the patent, the patent holder enjoys exclusive monopoly with respect to making, using, or selling the patented product/process for certain period of time. To get a patent, technical information about the invention must be disclosed in a patent application.
The patents have been given protection under the WTO's Trade Related aspects of Intellectual Rights (TRIPS). Under this agreement, member countries must provide protection to Patents for a minimum period of 20 years. Once a patent expires, the invention enters the public domain and anyone can commercially exploit the invention without infringing the patent.
Types of Patents
Product Patent: Patent is issued for a particular product such as say, a Pharmaceutical drug. In that case, the patent holder enjoys the exclusive monopoly of manufacturing this patented drug.
Process Patent: Patent is issued for a particular process such as say, process used for manufacturing a specific chemical compound. In that case, the patent holder enjoys the exclusive monopoly over the process used for manufacturing the product. However, other manufacturers can manufacture the same product by using a different process (other than the patented process).
Hence, unlike Product patent, the extent of protection offered through process patent is quite limited to only the Patented process (and not the Product)
Patent System in India
The patent system in India is governed by the Patents Act, 1970
Criteria for issuing Patents:
- It should be new (that is, not be published in India or elsewhere + no prior Public Knowledge/ Public Use in India)
- It must involve an inventive step( Technical advanced in comparison to existing knowledge + non‐obvious to a person skilled in the relevant field of technology)
- It should be capable of Industrial application
What cannot be patented?
Frivolous Invention; Invention that harms public order/Morality/ health of animals, plants and humans; a method of agriculture or horticulture; Traditional Knowledge; Computer Program; Inventions related to Atomic Energy; Plants and Animals; mere discovery of scientific principle.
Are Patents filed in India Internationally accepted?
Patent protection is a territorial right and therefore it is effective only within the territory of India. There is no concept of global patent. There is need to apply for Patents separately in other countries.
However, a single International Patent application can be filed in India under the Patent Cooperation Treaty. In that case, patent would be protected in all the countries which are members of this treaty.
The Patent Cooperation Treaty (PCT) is an international treaty with more than 150 Contracting States. It is administered by the World Intellectual Property Organisation (WIPO). The PCT makes it possible to seek patent protection for an invention simultaneously in a large number of countries by filing a single “international” patent application instead of filing several separate national or regional patent applications.
Note: The TRIPS agreement provides for a flexibility mechanism to the countries wherein that new plant variety can be protected either by issuing patents or an effective "Sui generis" system or a combination of the two. The "Sui generis" system means that the country may adopt its own law in order to meet its special needs.
India decided to exclude patents for new plant varieties but exercised the sui generis option. India has enacted Protection of Plant Varieties and Farmers' Rights Act,2001(PPVFR Act,2001) for the protection of new plant varieties.
Concerns with respect to IPR Protection in India
Section 301 of the US Trade Act 1974 provides for identification of those countries whose policies result in the denial of adequate and effective intellectual property rights (IPRs) protection to the US based companies. Countries that are identified as falling short with respect to protection, enforcement, and market access for IP-intensive industries are listed in the Special 301 Report.
India has been placed on the “priority watch list" for its alleged poor enforcement of intellectual property (IP) regulations.
Section 3(d) of Patents Act 1970
- This section does not allow patent to be granted to inventions involving new forms of a known substance unless it differs significantly in properties with regard to efficacy. Thus, the Indian Patent Act does not allow ever greening of patents. This is a cause of concern to the US Pharma companies.
- Note: Ever greening of Patents refers to the practice followed by global Pharma companies in order to extend the duration of patent beyond 20 years. As part of this strategy, the Pharma companies add minor modifications to the existing patented drug just before its expiry and then apply for the extension of patent.
- The constitutional validity of Section 3(d) of the Indian Patent Act 1970 was challenged by global MNC, Novartis when its application for extending the patent of GLIVEC cancer drug was rejected.
- However, the Madras high court upheld the constitutional validity of section 3(d) and stated that this section was important in order to distinguish between real innovations and trivial tweaks.
- Compulsory licenses are authorizations given to a third-party by the Government to make, use or sell a particular patented product without the need of the permission of the patent owner. The provisions regarding compulsory licenses are given in the Indian Patents Act, 1970 and in the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement.
- There are certain pre-requisite conditions which need to be fulfilled if the Government wants to grant a compulsory license.
- India has exercised the Compulsory licencing option in 2013 for Bayer’s Nexavar, a patented kidney cancer drug. It authorised Natco Pharma to manufacture and sell Nexavar in India. Subsequently, the price of the Nexavar drug got reduced to 4% of its original price.
- The USA believes that the compulsory licensing goes against the interest of its pharma companies.
- A trademark (popularly known as brand name) in layman’s language is a visual symbol used by a company on its goods and services to distinguish them from other similar goods or services originating from another company. The trademarks are protected under Trademark Act, 1999 and TRIPS Agreement.
- The report has raised concerns with respect to excessive delays in obtaining trademarks as well as high levels of trademark counterfeiting in India.
High Customs duties on IP intensive products
- The report has highlighted that India maintains extremely high customs duties on IP-intensive products such as medical devices, pharmaceuticals, information communications technology (ICT) products, solar energy equipment and capital goods.
Poor Enforcement of IP
- The report has highlighted that India is a key producer and exporter of counterfeit foodstuffs, pharmaceuticals, perfumes and cosmetics, textiles, footwear and electronics and electrical equipment. Around 55 percent of global seizures of counterfeit pharmaceuticals originated in India—making it by far the largest producer of counterfeit pharmaceuticals.
- Further, the report has also raised concerns with respect to judicial delays in disputes related to IPR infringement.
UPSC Current Affairs:India approves two COVID-19 vaccines for emergency use| Page - 1
UPSC Syllabus: Prelims: Economy |
Sub Theme: CDSCO | Drugs Standards | UPSC
The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.
Directorate General of Health Services
Ministry of Health & Family Welfare
Major functions of CDSCO:
- Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licenses as Central License Approving Authority is exercised by the CDSCO headquarters.
- Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organisations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
- Drug Controller General of India is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera. Central Drugs Standard Control Organization Head quarter is located at FDA Bhawan, Kotla Road, New Delhi 110002 and functions under the Directorate General of Health Services.
What is Covaxin?
- It has been developed by the company Bharat Biotech India (BBIL) in collaboration with ICMR’s National Institute of Virology (NIV).
What is the mechanism of this Vaccine?
- It is an “inactivated” vaccine — one made by using particles of the Covid-19 virus that were killed, making them unable to infect or replicate.
- Injecting particular doses of these particles serves to build immunity by helping the body create antibodies against the dead virus, according to BBIL.
How does the Oxford-AstroZeneca vaccine candidate work?
- When someone is infected with the Covid-19 virus (SARS-CoV-2), the reason it spreads in the body easily is because of the spikes on its surface. These spikes, known as the ‘spike protein’, allow the virus to penetrate cells and, thereafter, multiply.
- The vaccine developed by Oxford and AstraZeneca, which belongs to a category called non-replicating viral vector vaccines, tries to build the body’s immunity against this spike protein. The idea is to create antibodies to fight this spiked surface so that the virus does not even have the chance to penetrate the cells.
- The vaccine uses a different virus — in this case, a weakened version of a common cold virus (adenovirus) that infects chimpanzees — to carry just the code to make the spike protein, like a Trojan horse. The adenovirus, genetically modified so that it cannot replicate in humans, will enter the cell and release the code to make only the spike protein. The body’s immune system is expected to recognise the spike protein as a potentially harmful foreign substance, and starts building antibodies against it.
UPSC Current Affairs:A hurried gamble| Page - 06
UPSC Syllabus: Prelims: Science & technology |
Sub Theme: COVID Vaccines | UPSC
- 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.
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.
UPSC Current Affairs:FSSAI slashes limit for trans-fat levels in foods | Page – 10
UPSC Syllabus: Prelims: Science & technology
Sub Theme: Trans-fats | UPSC
FSSAI slashes limit for transfat levels in foods
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.
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.
While the present regulation comes into effect immediately, industry players were made to take a pledge back in 2018 that they would comply with the WHO’s call for action to reduce TFA by 3% by 2021 allowing them three years to comply with the latest norm.
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.
It has been suggested that ehe regulation must not be restricted to oils and fats, but must apply to all foods. It is hoped that the FSSAI will address this as well before January 2022 to eliminate chemical trans fatty acids from the Indian platter.
Types of Trans fats:
- Naturally-occurring trans fats are produced in the gut of some animals and foods made from these animals (e.g., milk and meat products) may contain small quantities of these fats.
- Artificial trans fats are created in an industrial process that adds hydrogen to liquid vegetable oils to make them more solid. Since they are easy to use, inexpensive to produce and last a long time, and give foods a desirable taste and texture, they are still widely used despite their harmful effects being well-known.
Associated risk of trans fatty acids (TFA)
- TFAs pose a higher risk of heart disease than saturated fats. While saturated fats raise total cholesterol levels, TFAs not only raise total cholesterol levels but also reduce the good cholesterol which protect us against heart disease. Trans fats consumption increases the risk of developing heart disease and stroke.
- It can lead to compromised foetal development causing harm to the yet to be born baby.
- Some studies have found that trans fats consumption is related to risk of cancers in individuals.
- Trans fats are metabolised differently by the liver than other fats and interfere with normal liver functions.
- The risk of type 2 diabetes increases with trans fat consumption. A study has found diabetes risk associated with trans fats and other factors such as total fat intake and BMI.
- Trans fat may increase weight gain and abdominal fat, despite a similar caloric intake. TFAs enhance deposition of fat even in the absence of caloric excess.
- Trans fats are found to be associated with insulin resistance that pose a great risk to already diabetic patients.
- Trans fats as opposed to that from carbohydrates, lead to greater risk of infertility in women.
- Those who ate the most trans fats are at higher risk of depression than those who do not eat trans fats.
- Consumption of trans fats has been linked to behavioural irritability and increased general aggression.
Replacing industrially produced TFA with healthier oils and fats is feasible without changing the taste of food or its cost to the consumer.
Steps taken by FSSAI
- Heart Attack Rewind - the 30 second public service announcement that will help support FSSAI’s global target of eliminating trans-fat in India by the year 2022, a year ahead of the global target by the World Health Organization (WHO) for complete elimination of trans fat. It is a follow-up to an earlier campaign called “Eat Right”.
- Eat Right Campaign - launched in July, 2018. Edible oil industries took a pledge to reduce the levels of salt, sugar, saturated fat and trans-fat content by 2% by 2022.
- Swasth Bharat Yatra, an initiative started under the “Eat Right” campaign is a Pan-India cyclothon to engage citizens on issues of food safety, combating food adulteration and healthy diets.
- FSSAI has stated that the food establishments which use trans-fat free fats/oils and do not have industrial trans-fat more than 0.2 gms per 100 gm of the food can display ‘Trans Fat Free’ logo in their outlets and on their food products.
In May 2018, the World Health Organization (WHO) launched the REPLACE action package to support governments to eliminate industrially produced TFA from the global food supply by 2023. According to the World Health Organization, approximately 5.4 lakh deaths take place each year globally because of the intake of industrially produced trans fatty acids. The WHO has called for the global elimination of transfats by 2023.
As part of the U.N.’s Sustainable Development Goals, the global community has committed to reducing premature death from non-communicable diseases by one-third by 2030. Global elimination of industrially-produced trans fats can help achieve this goal.
Relevant Questions of UPSC
A company marketing food products advertises that its items do not contain trans-fats. What does this campaign signify to the customers?
The food products are not made out of hydrogenated oils.
The food products are not made out of animal fats/oils.
The oils used are not likely to damage the cardiovascular health of the consumers.
Which of the statements given above is/ are correct?
2 and 3 only
1 and 3 only
1, 2 and 3
Consider the following statements:
The Food Safety and Standards Act, 2006 replaced the Prevention of Food Adulteration Act, 1954.
The Food Safety and Standards Authority of India (FSSAI) is under the charge of Director General of Health Services in the Union Ministry of Health and Family Welfare.
Which of the statements given above is/ are correct ?
Both 1 and 2
Neither 1 nor 2
With reference to pre-packaged items in India, it is mandatory to the manufacturer to put which of the following information on the main label, as per the Food Safety and Standards (Packaging and Labelling) Regulations, 2011? 
List of ingredients including additives
Recommendations, if any, made by the medical profession about the possibility of any allergic reactions
Select the correct answer using the code given below:
1, 2 and 3
2, 3 and 4
1, 2 and 4
1 and 4 only
UPSC Current Affairs:China amends defence law to boost war preparedness | Page – 14
UPSC Syllabus: Mains : International Relations
Sub Theme: China | UPSC
Chinese Defense law amendment
- China has amended its National Defence Law to mobilise military and civilian resources in defence of the ‘national interest’ at home and abroad.
- It has given the Central Military Commission (CMC), which is headed by the President, greater power in mobilising resources to protect a new and broader definition of what constitutes the national interest.
- The revised regulations on military equipment, focus on “war preparedness and combat capabilities”, define the basic tasks, contents and management mechanisms for military equipment work under the new situation and system.
- The document follows - the general principle of the CMC exercising overall leadership, theatre commands responsible for military operations and the services focusing on developing capabilities.
- It states that - when China’s sovereignty, unity, territorial integrity, and security and development interests are under threat, the country can conduct nationwide or local defence mobilisation”.
- The phrase “development interests” was also added to the law, it includes the protection of China’s economic activities and assets overseas, such as those under the Belt and Road Initiative, as a reason for defence mobilisation.
- The Amendment says - China will participate in global security governance, join multilateral security talks and push for and set up a set of international rules that is widely accepted, fair and reasonable
Goals or aims of China
- It aims at increasing the control exercised by the CMC and transferring some decision-making previously exercised by the State Council, or Cabinet, that runs the government, to the CMC.
- The broader goal is to speed up the modernisation plans for the People’s Liberation Army (PLA).
- The change comes amid a push for closer civil-military fusion, with a target to make the PLA a “world class” military, or on par with the United States military, by 2049, when the People’s Republic of China turns 100.