“I didn’t fail the test. I just found 100 ways to do it wrong.” – Benjamin Franklin
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Current Affairs News Analysis for UPSC | 9th Dec 2020
Today's Must Read Articles :Nickel, lead found in patients : Eluru
HEADLINES:
Nickel, lead found in patients’ blood samples
WHY IN NEWS:
Probe on into source of toxins; WHO, NIV, ICMR experts camping in Eluru
SYLLABUS COVERED: GS 3 : Diseases
ISSUE:
MYSTERIOUS DISEASE
- Officials of the All India Institute of Medical Sciences (AIIMS), the National Institute of Nutrition (NIN) and other teams found the presence of nickel and lead elements in blood samples .
- Presence of lead and nickel chemicals in the blood may affect the neurological system.
IASbhai WINDUP:
- The team also collected blood, smear, stool, urine and other samples from the patients and recorded their statements on their symptoms.
SOURCES: THE HINDU | Current Affairs News Analysis for UPSC | 9th Dec 2020
Urban Governance Index, 2020
HEADLINES:
Praja report: No state has devolved all 18 municipal functions to urban local bodies
WHY IN NEWS:
No state has managed to devolve 18 municipal functions to urban local bodies, according to a report by the Praja Foundation, ‘Urban Governance Index, 2020’.
SYLLABUS COVERED: GS 2 : 3 : Reports
ISSUE:
The report found that Odisha and Maharashtra have the most accessible open data portal.
URBAN GOVERNANCE INDEX 2020
OVERVIEW
- The 74th Constitutional Amendment Act was passed in 1992 aimed at strengthening democracy at the grassroots level through local bodies.
- This is their first Urban Governance Index.
PUBLISHED BY
- In the study which spanned over three years (2017-2020) in 40 cities across 28 states and National Capital Territory of Delhi,.
- Praja looked at the structural empowerment of the city governments by respective state governments.
- From Maharashtra, Mumbai and Pimpri Chinchwad were part of the 40 cities.
KEYPOINTS
- No state has devolved all the municipal functions, the municipal bodies are dependent on the state for funds and decision-making.
- Majority of the schemes and indices have focused predominantly on the aspect of mapping the performance/delivery of urban services.
- But what we require are changes in the ‘enabler’ i.e., core reforms in the structure of city governments and long-term management of our cities.
The index ranked the states on a 100-point scale across 42 indicators under four heads:
- Empowered elected representatives and legislative structure (30 marks)
- Empowered city administration (15)
- Citizens (25)
- Fiscal empowerment (30 marks).
SIGNIFICANCE
- The study was conducted mainly from the perspective of mapping the status of urban reforms in individual states.
- The report found that Odisha and Maharashtra have the most accessible open data portal.
- Maharashtra and Kerala ranked first for devolution of financial power and financial accountability.
- Praja Foundation is working in the field of accountability in governance.
IASbhai WINDUP:
- The study which formed the basis of the index included 1,568 interviews held with the city’s elected representatives, city administrators and city-based civil society organisations.
SOURCES: THE HINDU | Current Affairs News Analysis for UPSC | 9th Dec 2020
Emergency use authorisation
HEADLINES:
Three Covid-19 vaccine developers seek emergency use approval in India: what are the rules?
WHY IN NEWS:
Three vaccine developers have sought emergency use approval while their candidates are still in trials.
SYLLABUS COVERED: GS 3:Health:Diseases
ISSUE:
- Three vaccine developers have now made applications to the Central Drug Standard Control Organisation (CDSCO)
- None of these has yet generated data about the effectiveness of their vaccine from phase-III trials conducted in India
WHAT ARE THE RULES?
WHAT ARE THESE VACCINE CANDIDATES?
COVISHIELD
- Pune-based Serum Institute of India has sought approval for its version of the vaccine developed by Oxford University and AstraZeneca.
- The candidate is currently in phase-III trials in India.
- Serum has submitted the safety data from phase I and phase II trials.
COVAXIN
- The vaccine is manufactured in collaboration with National Institute of Virology, an ICMR institute in Pune, has started phase-III trials only recently.
- The vaccine is yet to enrol all the participants as per its design.
- Its application is based mainly on the safety data from phase-I and phase-II trials.
BNT162b2
- US pharmaceutical major Pfizer hasn’t carried out clinical trials in India of its vaccine.
- The Pfizer-BioNTech vaccine is the first one to receive the regulator’s approval anywhere in the world, having been granted emergency use authorisation in the UK last week.
REGULATORY PROVISIONS FOR APPROVAL OF VACCINES IN INDIA?
- Clinical trials of new drugs and vaccines, and their approvals, are governed by the New Drugs and Clinical Trials Rules, 2019.
- This term is used mainly by the regulatory agencies in the US and some other countries, and has become popular in the context of the current epidemic.
- However, that does not mean that the Indian regulatory system does not have provisions for “special situations” like the current one.
- The 2019 rules provide for “accelerated approval process” in several situations that would include the one like the current pandemic.
- There is a provision for granting approval to a drug that is still in clinical trials, “provided there is a prima facie case of the product being of meaningful therapeutic benefit”.
ACCELERATED APPROVAL AND GRANTS
- “Accelerated approval may also be granted to a new drug if it is intended for the treatment of a serious, or life-threatening condition, or disease of special relevance to the country, and addresses unmet medical needs,”.
- The definition of new drug in the 2019 Rules includes a vaccine.
- Further, it makes it clear that a new drug, or a vaccine, can be considered for approval if “remarkable” effectiveness is reported even from phase-II trials.
- In such cases, additional post licensure studies may be required to be conducted after approval to generate the data on larger population.
- Such a provision, therefore, makes even Bharat Biotech eligible to apply for approval, although it is still in early stages of phase-III clinical trials.
HOW DIFFERENT ARE INDIAN REGULATIONS FROM THOSE ELSEWHERE?
- Some provisions in the 2019 Rules, like those mentioned above, are different compared to what has been prescribed by the US Food and Drugs Administration (FDA).
- Even an application cannot be made on the basis of data only from phase-1 or phase-2 trials.
- It has also said that preliminary phase-3 data should show at least 50% effectiveness in preventing the disease.
- The total sample size of this data needed to be generated from “well over” 3,000 trial participants.
WHAT ABOUT VACCINES THAT HAVE DONE WELL IN TRIALS OUTSIDE THE COUNTRY?
- The 2019 Rules do not say anything specific about whether data from a trial conducted in another country .
- The Indian health authorities decision would all depend on what scientists and experts make of the data that are presented to them.
- They stressed that in evaluating the vaccine applications, the subject expert committees will carefully weigh the risks with the potential benefits.
- In making this assessment, the expert committee in India would be willing to look at data generated during trials conducted in other countries as well.
IASbhai WINDUP:
- The Indian authorities also pointed out that an application need not always result in an approval, which will be granted only after a rigorous scientific analysis of the data presented.
- The subject expert committees can reject an application or ask for more data if it is not satisfied.
SOURCES: THE HINDU | Current Affairs News Analysis for UPSC | 9th Dec 2020
What is Molnupiravir ?
HEADLINES:
What is Molnupiravir, the drug shown to stop Covid-19 spread in 24 hours?
WHY IN NEWS:
Indian researchers plan to apply to the drug regulator to conduct human trials with the drug.
SYLLABUS COVERED: GS 3: Diseases
ISSUE:
MOLNUPIRAVIR
- The antiviral drug Molnupiravir, or MK-4482/EIDD-2801, is taken orally.
- The research team repurposed MK-4482/EIDD-2801 against SARS-CoV-2 and tested it on ferrets.
- This is the first demonstration of an orally available drug to rapidly block SARS-CoV-2 transmission and it can be a game-changer.
- The group discovered that the drug is potent against influenza viruses.
MOLNUPIRAVIR IN ACTION
- In ferrets, the drug was shown to completely suppress transmission of SARS-CoV-2 in 24 hours.
- The drug is like any other anti-flu drug and was on our list of drugs to go into clinical trials.
IASbhai WINDUP:
- Globally, clinical testing of Molnupiravir is carried out by Merck.
- The drug is now in advanced phase 2/3 human trials at multiple centres.
SOURCES: IE | Current Affairs News Analysis for UPSC | 9th Dec 2020
How Mount Everest got 3 feet higher?
HEADLINES:
How Mount Everest got 3 feet higher, endorsed by both Nepal and China
WHY IN NEWS:
The common declaration by Nepal and China meant the two countries have shed their long-standing difference in opinion about the height of Mount Everest.
SYLLABUS COVERED: GS 2 : Survey of India
ISSUE:
- This is 86 cm higher than what was recognised since 1954.
- The common declaration meant that the two countries have shed their long-standing difference in opinion about the mountain’s height.
- Previously , 29,017 feet (8,844 m) was claimed by China and 29,028 ft (8,848 m) by Nepal.
MOUNT EVEREST AND ITS HEIGHT
In 1954, the Survey of India determined that the elevation of Everest is 8,848 m (29,028 ft). This came to be recognised worldwide.Except by China.- In feet, the new elevation is about 29,031 ft, or about 3 ft higher than Nepal’s previous claim.
EARLIER MEASUREMENTS
- The elevation of 8,848 m came to be accepted in all references worldwide — except by China.
- Mount Everest rises from the border between Nepal and China.
- In 1999, a US team put the elevation at 29,035 feet (nearly 8,850 m).
- This survey was sponsored by the National Geographic Society excepted Chinese claim of 8,848 m so far.
HOW DID CHINA COME TO BE PART OF IT?
- China’s measurements were done separately.
- Nepal, in fact, had completed its mission early last year.
- The team of 120 (field workers and data analysts) were processing the data and computing results, which took four months.
- The two sides subsequently signed a memorandum of understanding to jointly make public their results.
- The Chinese side conducted its measurements early this year.
THE METHODOLOGY USED?
- Kathmandu and Beijing, simply announced the new height, and appreciated the mutual cooperation.
- They did not go into technical details.
IASbhai WINDUP:
- The world community and those in adventure tourism will be able to gain a higher record by climbing Mt Everest that is taller than it was assumed yesterday.
SOURCES: THE HINDU | Current Affairs News Analysis for UPSC | 9th Dec 2020
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