JUNE - 2020
What are Biosimilars?
The story of simple molecules and some difficult diseases
Ever since modern medicine started to emerge post the Industrial Revolution, simple molecules have been used to treat most diseases.
While these formulations are highly effective against some illnesses, they aren’t particularly effective against more complex diseases like cancer.
Our immune system has evolved over millions of years to specifically defend against outside intruders.
But cancer isn’t like most diseases.
It’s not caused by an invasion of a foreign pathogen.
Instead, it’s a byproduct of rogue cells that destroy our bodies from within.
To this end, using simple molecules to defend against a barrage of mutating versions of our own cells is an exercise in futility.
What is biologic?
A biologic is manufactured in a living system such as a microorganism, or plant or animal cells. Most biologics are very large, complex molecules or mixtures of molecules. Many biologics are produced using recombinant DNA technology.
What we probably need is a biologic or a complex protein isolated from natural sources that can mimic our immune cells.
Maybe this would help us in fighting cancer.
So, Biosimilars are..
A biosimilar is a biological product that is developed to be similar to an already FDA-approved biologic, known as the reference product. It can be tempting to think of a biosimilar as a “generic” version of the reference product.
But biosimilar is not an exact duplicate of another biologic. There is a degree of natural variability in all biological products; it is not possible to generate a precise copy of a product that comes from living cells. All biologics—including reference products—show some batch-to-batch variation.
Utility of patents in the pharmaceutical industry
Success in this market is deeply intertwined with the research and development process that characterizes the pharmaceutical industry.
It might take 5 years for you to develop a new drug and you might still need another 10 years to clinically test the product and get the necessary approvals from the regulatory agencies.
This is a capital intensive process and the only way to remunerate the pharma company’s contribution is to protect their investment through patent laws.
This way the companies can be incentivised to invest more in research and we can ensure a steady supply of new drugs that could cure the greatest maladies of modern time.
What happens when the patent expires?
Once the patent expires, other companies can market their own version of the drug (copycats) if they can figure out how to synthesize it.
Consider — Aspirin. It’s a simple molecule drug and it’s quite easy to replicate the manufacturing process.
Why biologics would be difficult to replicate after the patent expires
Biologics are harvested from living cells and are often produced using complicated manufacturing processes.
Most modern biologics are assembled inside vats — or bioreactors — that house genetically engineered microbes or cell cultures and can often take a whole decade of research to perfect.
So replicating the process isn’t exactly a cakewalk.
Meaning if you want to market your own version of a “biologic” once all the patents expire, you need some expertise and India’s Biocon is at the forefront of this revolution.
For the past few years, they’ve been building a “biosimilar pipeline” — copycats of famous biologics and they’ve been using it to fight cancer, diabetes, and arthritis.
And it’s not all that easy for most pharma companies to enter this market.
Why marketing a drug in the US gather headline?
Because the US provides an opportunity like no other.
Buying drugs here is expensive and pharmaceutical companies make a killing in the process.
It might not necessarily bode well for consumers.
But it does provide a lucrative market for potential Indian manufacturers who are looking to sell their products elsewhere.
Near-Earth Object (NEO)
What are NEOs?
- NASA defines NEOs as comets and asteroids nudged by the gravitational attraction of nearby planets into orbits which allows them to enter the Earth’s neighbourhood.
- These objects are composed mostly of water ice with embedded dust particles.
- NEOs occasionally approach close to the Earth as they orbit the Sun.
- NASA’s Center for Near-Earth Object Study (CNEOS) determines the times and distances of these objects as and when their approach to the Earth is close.
Significances of NEOs:
- The scientific interest in comets and asteroids is largely due to their status as relatively unchanged remnant debris from the solar system formation process over 4.6 billion years ago.
- Therefore, these NEOs offer scientists clues about the chemical mixture from the planets formed.
- Significantly, among all the causes that will eventually cause the extinction of life on Earth, an asteroid hit is widely acknowledged as one of the likeliest.
- Over the years, scientists have suggested different ways to ward off such a hit, such as blowing up the asteroid before it reaches Earth, or deflecting it off its Earth-bound course by hitting it with a spacecraft.
About 163348 (2002 NN4):
- A Near-Earth Object (NEO), the asteroid is called 163348 (2002 NN4) and is classified as a Potentially Hazardous Asteroid (PHA).
- Asteroids with a minimum orbit intersection distance (MOID) of about 0.05 (AU is the distance between the Earth and the Sun and is roughly 150 million km) or less are considered PHAs.
- This distance is about 7,480,000 km or less and an absolute magnitude (H) of 22 (smaller than about 150 m or 500 feet in diameter).
Serotonin Hormone and Locust attack
What causes Locusts to form huge swarms?
- Scientists have attempted to answer an important scientific question of how and why locusts collect together by the thousands in order to make a swarm.
- When lone locusts happen to come near each other (looking for food) and happen to touch each other, this tactile stimulation, even just in a little area of the back limbs, causes their behaviour to change.
- This mechanical stimulation affects a couple of nerves in the animal’s body, their behaviour changes, leading to their coming together.
- The central nervous system of the locust, the most important among them being serotonin which regulates mood and social behaviour is the mystery behind swarms.
- Their coming together triggers a mechanical (touch) and neurochemical (serotonin) stimulations to make crowding occur.
What is Serotonin?
- It is a monoamine neurotransmitter.
- It has a popular image as a contributor to feelings of well-being and happiness.
- Its actual biological function is complex and multifaceted, modulating cognition, reward, learning, memory, and numerous physiological processes such as vomiting and vasoconstriction.
Magnetocaloric materials for cancer treatment
What is Magnetocaloric Effect?
- Magnetocaloric effect (MCE) is a phenomenon where the application and removal of a magnetic field cause certain materials to get warmer and cooler, respectively.
- This effect normally occurs near its Curie temperature where the application of the field makes the material to warm up and cools up when the field is removed.
Issue of hyperthermia in cancer treatment:
- Advancements in magnetic materials led to the development of magnetic hyperthermia to try to address the issues of side effects of cancer treatment like chemotherapy.
- In magnetic hyperthermia, magnetic nanoparticles are subjected to alternating magnetic fields of few Gauss, which produce heat due to magnetic relaxation losses.
- Usually, the temperature required to kill the tumour cells is between 40 and 45°C.
- However, the drawback in magnetic hyperthermia is the lack of control of temperature, which may damage the healthy cells in the body and also have side effects like increased BP, hair losses etc.
Here comes in, Magnetocaloric materials:
- This hypothermia can be avoided by using magnetocaloric materials, as it can provide controlled heating.
- The advantage of magnetocaloric materials which heat up or cool down with the application and removal of the magnetic field, respectively is that as soon as the magnetic field is removed, the cooling effect is generated.
- The team at ARCI chose rare-earth-based alloy for studies as some of the rare earth materials are human body compatible.
- The heating capacity would increase with the increase in the magnetic field.
Airborne Rescue Pod for Isolated Transportation
What is ARPIT?
- The Indian Air Force has developed and inducted an Airborne Rescue Pod for Isolated Transportation (ARPIT).
- ARPIT is a lightweight isolation system made from aviation certified material.
- It has a transparent and durable cast Perspex for enhanced patient visibility which is larger, higher and wider than the existing models.
- The isolation system caters for the suitable number of air exchanges, integration of medical monitoring instruments, and ventilation to an intubated patient.
- In addition, it generates high constant negative pressure in the isolation chamber for prevention of infection risk to aircrew, ground crew and health care workers involved in air transportation.
- It utilizes High-Efficiency Particulate Air (HEPA) H-13 class filters and supports invasive ventilation using Transport Ventilator.
- This pod will be utilized for the evacuation of critical patients with infectious diseases including COVID-19 from high altitude area, isolated and remote places.
Research - Crystalline Rubrene
What is crystalline rubrene?
- Crystalline rubrene is a polycyclic aromatic hydrocarbon-based thin film.
- It is a water-free, solvent-free, environmentally friendly one-step plasma process.
- It demonstrated optoelectronic properties (which detect and control light).
- A highly uniform pin-hole-free thin film can be deposited by this process, which is useful for the fabrication of high-end devices.
- Devices made of pyro-electric materials (that generate electric charge when they are heated or cooled) and piezo-electric materials (that generate electric charge under the effect of mechanical pressure), can help detect change in temperature and pressure.
- Pyro-electric materials also show pyro-phototronic effect where pyro-electricity is associated with the change in temperature of a material when it absorbs photons.
- Pyro-electric infrared detectors are well known for application in infrared sensing for space research, defense, remote sensing, and household appliances.
Principle application: Human Skin:
- These kinds of materials are available in biological systems such as – human skin, plant cellulose leading to their significance in the understanding of basic science of biological systems and also in their huge application prospect.
- The rubrene crystal has a thin amorphous oxide layer formed over the crystalline film.
- This induces surface layer polarization effect leading to pyro-phototronic effect.
Significance of the research:
- Since last few years, scientists from around the world are working on the synthesis of organic materials for electronic applications.
- The conventional process for synthesis of organic electronic materials based on chemical processes provides very good quality materials, but the stability of the materials is not very good, and it requires use of solvents.
- Moreover, multiple steps are required for material synthesis and film deposition.
- This novel process developed by the Indian team is useful for developing advanced optoelectronic devices and preparation of Electronic Skin (E-Skin).
- It may prove to be useful tool for laboratory simulation of different biological systems for probing the organization and dynamics of those systems.
Genetically Modified Seeds - Good or Bad
Genetically Modified (GM) seeds:
- Conventional plant breeding involves crossing species of the same genus to provide the offspring with the desired traits of both parents.
- Genetic engineering aims to transcend the genus barrier by introducing an alien gene in the seeds to get the desired effects.
- The alien gene could be from a plant, an animal or even a soil bacterium.
What is the legal position of GM crops in India?
- In India, the Genetic Engineering Appraisal Committee (GEAC) is the apex body that allows for the commercial release of GM crops.
- In 2002, the GEAC had allowed the commercial release of Bt cotton.
- More than 95 per cent of the country’s cotton area has since then come under Bt cotton.
- Use of the unapproved GM variant can attract a jail term of 5 years and a fine of Rs 1 lakh under the Environmental Protection Act,1989.
GM crops in India:
- Bt cotton, the only GM crop that is allowed in India, has two alien genes from the soil bacterium Bacillus Thuringiensis (Bt) that allows the crop to develop a protein toxic to the common pest pink bollworm.
- Ht Bt, on the other, cotton is derived with the insertion of an additional gene, from another soil bacterium, which allows the plant to resist the common herbicide glyphosate.
- In Bt brinjal, a gene allows the plant to resist attacks of fruit and shoot borer.
Why are farmers rooting for GM crops?
- In the case of cotton, farmers cite the high cost of weeding, which goes down considerably if they grow Ht Bt cotton and use glyphosate against weeds.
- Brinjal growers in Haryana have rooted for Bt brinjal as it reduces the cost of production by cutting down on the use of pesticides.
- Industry estimates say that of the 4-4.5 crore packets (each weighing 400 gm) of cotton sold in the country, 50 lakh are of the unapproved Ht Bt cotton.
- Haryana has reported farmers growing Bt brinjal in pockets which had caused a major agitation there.
Why furore over GM crops?
- Environmentalists argue that the long-lasting effect of GM crops is yet to be studied and thus they should not be released commercially.
- The genetic modification brings about changes that can be harmful to humans in the long run.
Debate over: Arsenicum album 30
The Covid-19 context:
- Arsenicum album 30 could be taken as prophylactic medicine against Coronavirus infections.
- It is only “possible prevention” against flu.
- The AYUSH Ministry recommended taking the medicine for three days on an empty stomach and repeating the dose after a month if an outbreak continues locally.
- It has been recommended against COVID by the state governments in Rajasthan, Karnataka, Tamil Nadu, Andhra Pradesh and Kerala.
Arsenicum album 30:
- Arsenicum album is made by heating arsenic with distilled water, a process repeated several times over three days. The drug has less than 1% arsenic.
- A small bottle with one course costs Rs 20-30.
- Arsenicum album is considered to correct inflammation in the body. It takes care of diarrhoea, cough and cold.
- It is used commonly by homoeopaths to treat anxiety, restlessness, cold, ulcerations, burning pains.
- It is taken in powder form or as a tablet.
Issues with the use of Arsenicum album 30:
- The WHO neither has any guidelines nor any effective evidence on using Arsenicum album as a Covid-19 treatment.
- The debate stems from the fact that there is no scientific evidence that the drug works against Covid-19, a fact stressed not only by medical scientists but also by some homoeopathic practitioners themselves.
- Self-medication can prove harmful as prevention or cure for COVID-19.
- The health hazards of arsenic contamination in water are well known: long-term exposure to the metal can cause skin cancer, pulmonary and cardiovascular diseases.
Radio lights spotted from Sun’s Corona
What is Sun’s Corona?
- The corona is the outermost part of the Sun’s atmosphere.
- It is the aura of plasma that surrounds the Sun and other stars.
- The Sun’s corona extends millions of kilometres into outer space and is most easily seen during a total solar eclipse, but it is also observable with a coronagraph.
- Spectroscopy measurements indicate strong ionization in the corona and a plasma temperature in excess of 1000000 Kelvin much hotter than the surface of the Sun.
Radio lights spotted:
- A group of India scientists have recently discovered tiny flashes of radio light emanating from all over the Sun, which they say could help in explaining the long-pending coronal heating problem.
- These radio lights or signals result from beams of electrons accelerated in the aftermath of a magnetic explosion on the Sun.
- While the magnetic explosions are not yet observable, these weak radio flashes are ‘smoking guns’ or the evidence for the same.
- Hence it brought the researchers closer to explaining the coronal heating problem.
- The strength of the magnetic fields varies a lot from one place on the surface of the Sun to another, by more than a factor of 1,000.
- But the corona is hot everywhere. So, this heating process has to work all over the corona, even in regions of weak magnetic fields.
- Until now, the process of how this magnetic energy is deposited in the corona had remained a mystery.
What is their importance:
- These observations are the strongest evidence till date that the tiny magnetic explosions originally referred to as ‘nanoflares’ by eminent American solar astrophysicist Eugene Parker.
- It is the possible phenomena that could be heating up the corona (the aura of plasma that surrounds the sun and other stars).
The Murchison Widefield Array (MWA):
- The phenomenon of coronal heating has been known for the last 70 years, the availability of ground-breaking data from the Murchison Widefield Array (MWA) radio telescope proved to be a game-changer.
- The MWA is a low-frequency radio telescope, located at the Murchison Radio-astronomy Observatory (MRO) in Western Australia.
- The MWA has been developed by an international collaboration, including partners from Australia, New Zealand, Japan, China, India, Canada and the United States.
Science and Technology
Science and Technology
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Achievements of Indians
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Awareness in the fields of
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Issues relating to Intellectual Property Rights
- Need for Intellectual Property Rights,
- Types of IPR,
- IPR Regime in India,
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- Recent Issues – Evergreening, Compuslory Licensing, Prominent Cases etc.