04 Jan 2021: UPSC Exam Comprehensive News Analysis

4 Jan 2021 CNA:- Download PDF Here

TABLE OF CONTENTS

A. GS 1 Related
B. GS 2 Related
HEALTH
1. India approves two COVID-19 vaccines for emergency use
2. FSSAI slashes limit for transfat levels in foods
C. GS 3 Related
ECONOMY
1. Govt. ropes in I-T Dept. to crack down on GST fraud
D. GS 4 Related
E. Editorials
WOMEN ISSUES
1. Don’t ignore the women farmers
HEALTH
1. A hurried gamble
INTELLECTUAL PROPERTY RIGHTS
1. An anti-disclosure amendment that hits public health
F. Prelims Facts
1. Nendran Banana
G. Tidbits
1. China amends defence law to boost war preparedness
H. UPSC Prelims Practice Questions
I. UPSC Mains Practice Questions

2. FSSAI slashes limit for transfat levels in foods

Context:

The Food Safety and Standards Authority of India (FSSAI) has revised the transfat limits in foods.

• The amount of trans fatty acids (TFA) in oils and fats have been capped at 3% for 2021 and 2% by 2022 from the current permissible limit of 5%.
• This has been brought into effect through an amendment to the Food Safety and Standards (Prohibition and Restriction on Sales) Regulations.

Details:

• 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.
• 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.
• While the 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.
  • This allows them three years to comply with the latest norms.
• 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.

Concerns:

• 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.
• India has among the highest number of coronary heart disease cases in the world and in India, this killer ingredient remains at large in food.
• It poses 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 (HDL).

Way forward:

• Bakeries, sweet shops and other food business operators can voluntarily display ‘trans fat free’ logo on food products and in their outlets, according to the food safety regulator FSSAI.
  • FSSAI calls for declaring quantity of salt, added sugar, saturated fats and trans fats and mentioning serving size, the number of servings and per serve percentage contribution of a particular nutrient to the recommended dietary allowance (RDA).
• With India having the highest number of coronary heart disease cases in the world, efforts must be taken to completely eliminate or at least significantly reduce trans fats in food, in accordance with the World Health Organization guidelines.
  • The WHO has also called for the global elimination of trans-fats by 2023.

Category: HEALTH

1. A hurried gamble

Context:

• The rollout of COVID-19 vaccine in India has raised fears over the safety of the vaccine.

Details:

• The two vaccines Covishield by the Serum Institute of India (SII), and Covaxin by Bharat Biotech have been given formal approval by the Drugs Controller General of India for restricted use under emergency conditions.

Pharmaceutical infrastructure in India

• Advanced biotechnology laboratories and large-scale vaccine manufacturing facilities made India a front runner to produce a vaccine for COVID-19.
• India possesses state of the art infrastructure for vaccine manufacturing, they are complemented by in-house research and development laboratories.
• However, they are largely focused on research of a practical nature, for refining processes and products. There is less focus and attention on the basic and fundamental research necessary for designing new vaccine candidates.
• India has been long known as a manufacturer of vaccines but to develop a vaccine afresh, beginning from an exploratory phase, pre-clinical phase, clinical development stages have not been well-established yet.
• The COVID-19 pandemic provided 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 dodged and bypassed.

Phase-3 trials

• A double-blinded phase-3 trial is one in which neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results.
• Double-blind studies are particularly useful for preventing bias due to demand characteristics or the placebo, this method 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 the data regarding the vaccination impact on 1,600 volunteers from India have not yet been made public.
• All of the leading vaccine candidates — Pfizer, Moderna and AstraZeneca, made public at least partial results of the vaccine’s abilities in their own populations before these were given a formal clearance by the respective regulators.
• Bharat Biotech, which is conducting such a phase-3 trial in India, has not so far submitted similar data as it has not been able to complete recruiting the required number of volunteers.
• The Indian data furnished by the companies only certify the vaccine’s safety and it’s evoking some immune response. However, the experiences from the pandemic suggest that the therapies and interventions, like for example the convalescent plasma therapy, the antivirals that work well under idealised lab conditions do not always yield the same results in real-world hospital conditions.

The concern from approving an untested vaccine

• It makes it nearly impossible to conduct a proper phase-3 trial.
• It will be unethical to expect volunteers to be a part of the trial where there is only a 50% chance of being administered the actual vaccine when they have the option of the real dose elsewhere.

Emergency Use Authorization (EUA)

• There is no explicit mention of EUA in India, however, there is a provision under the New Drugs and Clinical Trials, 2019.
• New Drugs and Clinical Trials, 2019 mentions an ‘accelerated approval process’, depending on the severity, urgency and lack of alternatives.
• In the event of the above-mentioned grounds, the regulator can overrule the need to have local clinical trials if the drug has been approved elsewhere.
• Under exceptional circumstances such as
  1. It is a ‘Rare Disease’
  2. Massive disease outbreak
  3. No proven vaccine or drug available
  4. Evidence of a drug or vaccine that is tested in a country and has yielded desired results
  5. A country neither has the financial resources nor the personnel to conduct solid clinical trials to a drug/vaccine that has undergone thorough clinical trials in another country
• The above-mentioned circumstances allow health regulators to issue accelerated approvals under EUA.
• Both SII and Bharat Biotech, given the pace of recruitment and potential pool of volunteers, would have been able to generate more data within a few weeks, hence the logic behind invoking EUA is beyond understanding.

Conclusion

• Hurried approval process and opacity in the government’s decision making can create a feeling of distrust among the people of the country, which could give way to vaccine hesitancy.
• Transparency is vital for people to trust and embrace the vaccine, the regulator and the government must follow the accepted safety protocols before giving the nod to the vaccine.

Category: INTELLECTUAL PROPERTY RIGHTS

1. An anti-disclosure amendment that hits public health

Context:

• The recent amendment to the Patent Rules, 2020.

Details:

• The Central Government, in exercise of the powers conferred upon it under the Patents Act, 1970 has passed the Patents (Amendment) Rules of 2020.
• The Rules amend Form 27 of the Act through which statements regarding the working of the patented invention on a commercial scale in India have to be filed by Patentees or Licensees.

What are the amendments?

• The amendment to Rule 131(2) means that the statement with respect to the workings of the Patent has to be filed every financial year, within six months from the expiry of such financial year.
• A single Form 27 can now be filed for multiple patents, but this provision is applicable only when all the patents are inter-related and all such patents are under the same patentee or licensee.
• The amendment has eliminated the need to publicly disclose under Form 27 the nature of commercial usage of the patented inventions in the country.

Disclosure of information

• India’s patent legislation grants an exclusive privilege of a 20-year patent monopoly to an inventor.
• India’s patent law imposes an obligation on the patentee to commercially work the invention in India to ensure that its benefits reach the public.
• The central idea behind granting patents itself is to ensure innovation and public interests are well balanced.
• In an event of failing to comply by the patent rules, a compulsory licensing is issued or revocation of the patent under the Patents Act, 1970 is possible.
• Further, courts have routinely rebuffed interim injunction in cases alleging infringement of a patent which has not been worked in India.
• The information about the extent of the working of the invention in India is important for checking abuse of patent monopoly (e.g. excessive pricing or scare supply of the invention) and to serve the public interest.
• Section 146(2), a provision not common among patent legislations of 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 per the Patent Rules, 2003. This statement will 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.
• However, the patentees and licensees along with the Patent Office have overtly ignored this statutory requirement and to add to this, there has been considerable persuasion from the multinational corporations and the United States government to quash the requirement.

The PIL

• The recent amendment to the form was made in pursuance to a PIL filed in the Delhi High Court in 2015.
• The PIL revealed 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 not adequate to examine the extent of the working of the patent.

Dilution of disclosure

• The inadequacies of Form 27 as pointed out by the PIL was acknowledged by the government and the government was directed to bring about necessary changes in Form 27.
• However, the government not only took longer to come up with a new Form 27 format but instead chose to water down the disclosure format, thereby disregarding the Delhi High Court directions and the public interest.
• The government’s stance of choosing to weaken Form 27 by removing the requirement of submitting important information, thus damaging the essence of the patent working requirement defies logic.
• The form now requires the patentees and licensees to provide only 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.

Inadequate criteria

• The data on merely the revenue/value accrued from manufacturing/importing the invention is not sufficient to ascertain the extent to which the patent has been worked and to verify if the all-important public interest is being served.
• The key data that is required for assessing the working of the invention in the country is 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 pivotal role in the grant of India’s first compulsory license to Natco for the anti-cancer drug Sorafenib/Nexavar.
• The doing away with the disclosure requirement overrides 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.
• The exclusion of data regarding the 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.

Conclusion

• The amendment to patent rules has considerably weakened the intellectual property regime in India.
• The patent law obligated the patentees/licensees to disclose patent working information, to ensure that patents serve public interests and not serve the sole interests of the inventor.
• The provision of compulsory licensing will be a casualty in the absence of disclosure information.
• The amendment rules pave the way for patent abuse, monopoly of usage and make innovations inaccessible to people.
• The lack of accessibility of patented medicines, life-saving drugs could result in undesirable consequences for public health of the country.
• The government must reconsider its amendments and use the PIL recommendations as its guiding spirit.

Q1. Consider the following statements:

Q2. Which of the given pairs are correctly matched?

Q3. Consider the following statements with respect to trans fat:

Q4. Consider the following statements with respect to the Central Vigilance Commission 
(CVC):

4 Jan 2021 CNA:- Download PDF Here