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GS Paper: GS3-17.Awareness in the fields of IT, Space, Computers, Robotics, Nano-technology, Bio-technology and issues relating to Intellectual Property Rights.

  • Decoupling pharmaceutical industry from China should be strategic

    Abrupt ban on import from China would harm the India pharmaceutical industry and disrupt the supply of several essential medicines. Any attempt at reducing the dependence on China for APIs should be strategies, argues the author.

    Dependence of Indian pharma industry on China

    •  India is the third-largest producer of finished drugs in the world.
    • However, India relies significantly on China for supplies of active pharmaceutical ingredients APIs.
    • An estimated 70 per cent of API requirements of India’s pharmaceutical industry are sourced from China.
    • For some drugs, such as paracetamol and ibuprofen, this dependence is almost 100 per cent.
    • This import reliance has been fuelled by environmental controls in India and competition with China, which has higher volumes of production and lower costs.

    Implications of banning import from China

    • Restricting or banning the import of APIs would cause significant disruption to the Indian pharmaceutical industry
    • The pharmaceutical industry had $40 billion in revenues in 2018-19, according to Pharmexcil.
    • Such a prospect is especially of concern to potential patients.
    •  Indian pharmaceutical industry annually exports $20 billion worth of medicine.
    • An ad hoc or reactive decoupling could disrupt the production of a wide range of medicines in India and globally.
    • Such disruption could affect the availability of Dexamethasone and painkillers, such as paracetamol and ibuprofen, as well as antibiotics, such as penicillin.
    • The impacts would be especially high in low and middle-income countries.
    • In many African countries, in fact, India supplies almost 50 per cent of the medicines in value terms.

    Lessons from the past: Policy initiative matters

    • Market share of foreign-owned multinationals in India was 80-90 per cent in 1970 in the pharmaceutical industry.
    • It fell to 50 per cent by the early 1980s, and down to 23 per cent today.
    • The prices of medicines in India fell from being amongst the highest in the world to amongst the lowest.
    • But this did not happen through sudden decoupling from foreign multinationals or a complete boycott or ban on imports.
    •  The 1970 Indian Patent Act removed product patent protection in pharmaceuticals.
    • So, the 1970 Patent Act is widely lauded for facilitating the growth of India’s industry.
    • India also benefited from the 1973 Foreign Exchange Regulation Act (FERA) and the subsequent New Drug Policy (1978).
    • Thus, a series of policy initiatives succeeded in tilting the balance in favour of Indian-owned firms.

    But does it mean we have to depend on China forever?

    • No, but reducing dependence on China will not be easy to achieve.
    • In India, any decoupling from China must be strategic, with significant policy support.
    • It will take time for a paced indigenisation.

    Government moves to reduce dependence for API

    • In March, the government announced Rs 3,000 crore to develop three bulk drug parks.
    • The government also announced Rs 6,940 crore to manufacturers of 53 bulk drugs over the next eight years.
    • Planning ahead towards greater domestic production of APIs, as well as reduced dependence on China, is an understandable and sensible policy objective.
    • Despite a decline in recent decades, India has a stronger starting point than most countries given the continued presence of some API production capabilities.
    • Indian firms have capacities, for instance, to produce COVID-19 treatments, including Remdesivir.

    Consider the question “What are the APIs? Why India depends on other countries for it and what are implications of it? Suggest ways to reduce this dependence.”

    Conclusion

    In the short run, boycotts or bans would be counter-productive for the Indian industry, while also affecting access to much-needed medicines to India’s citizens and beyond. In the long run, however, reducing dependence on China would be strategically prudent.

    Back2Basics: What are APIs?

    • Active pharmaceutical ingredient (API), is the term used to refer to the biologically active component of a drug product (e.g. tablet, capsule).
    • Drug products are usually composed of several components.
    • The API is the primary ingredient.
    • Other ingredients are commonly known as “excipients” and these substances are always required to be biologically safe, often making up a variable fraction of the drug product.
    • The procedure for optimizing and compositing this mixture of components used in the drug is known as “formulation.”

  • Phobos: The closest and biggest moon of Mars

    The Mars Colour Camera (MCC) onboard ISRO’s Mars Orbiter Mission (MOM) has captured the image of Phobos, the closest and biggest moon of Mars.

    Try this question from CSP 2017:

    Q.Which region of Mars has a densely packed river deposit indicating this planet had water 3.5 billion years ago?

    (a) Aeolis Dorsa (b) Tharsis (c) Olympus Mons (d) Hellas

    About Phobos

    • Phobos is the innermost and larger of the two natural satellites of Mars, the other being Deimos.
    • Both moons were discovered in 1877 by American astronomer Asaph Hall.
    • Phobos is a small, irregularly shaped object with a mean radius of 11 km and is seven times as massive as the outer moon, Deimos.
    • Phobos is largely believed to be made up of carbonaceous chondrites.
    • The violent phase that Phobos has encountered is seen in the large section gouged out from a past collision (Stickney crater) and bouncing ejecta.

    Back2Basics: Mars Orbiter Mission (MOM)

    • The MOM also called Mangalyaan is a space probe orbiting Mars since 24 September 2014. It was launched on 5 November 2013 by the Indian Space Research Organisation (ISRO).
    • It aims at studying the Martian surface and mineral composition as well as scans its atmosphere for methane (an indicator of life on Mars).
    • It is India’s first interplanetary mission and it made it the fourth space agency to reach Mars, after Roscosmos, NASA, and the European Space Agency.
    • It made India the first Asian nation to reach Martian orbit and the first nation in the world to do so on its maiden attempt.
    • It was initially meant to last six months, but subsequently, ISRO had said it had enough fuel for it to last “many years.”

  • Gold Nanoparticles and their applications

    Indian researchers have successfully synthesized gold nanoparticles (GNPs) using psychrotolerant Antarctic bacteria through a non-toxic, low-cost, and eco-friendly way.

    Nanotechnology is a pathbreaking technology which can create many new materials and devices with a wide range of applications, such as in nanomedicine, nanoelectronics etc.   GNPs are another distinct development.

    What are Gold Nanoparticles?

    • Metallic NPs have been efficiently exploited for biomedical applications and among them, GNPs are found to be effective in biomedical research.
    • And NPs are those materials that are at least one dimension smaller than 100 nanometers.
    • NPs have a high surface-to-volume ratio and they can provide the tremendous driving force for diffusion, especially at elevated temperatures.
    • GNPs are melted at much lower temperatures (300 °C) than bulk gold (1064 °C).
    • NPs have been found to impart various desirable properties to different day-to-day products.
    • For example, GNPs are found to have greater solar radiation absorbing ability than the conventional bulk gold, which makes them a better candidate for use in the photovoltaic cell manufacturing industry.

    Properties of GNP

    1) Biomedical

    • Genotoxicity describes the property of a chemical agent that is capable of damaging the genetic information of DNA and thus causing the mutation of the cell, which can lead to cancer.
    • The study revealed the genotoxic effect of GNPs on a sulphate reducing bacteria (SRB).
    • These GNPs can be used as composite therapeutic agent clinical trials, especially in anti-cancer, anti-viral, anti-diabetic, and cholesterol-lowering drugs.

    2) Optical

    • GNPs have unique optical properties too. For example, particles above 100 nm show blue or violet colour in the water, while the colour becomes wine red in 100 nm gold colloidal particles.
    • They can thus be used for therapeutic imaging.

    3) Electronics

    • GNPs are also found to be useful in the electronics industry.
    • Scientists have constructed a transistor known as NOMFET (Nanoparticles Organic Memory Field-Effect Transistor) by embedding GNPs in a porous manganese oxide.
    • NOMFETs can mimic the feature of the human synapse known as plasticity or the variation of the speed and strength of the signal going from neuron to neuron.
    • These novel transistors can now facilitate better recreation of certain types of human cognitive processes, such as recognition and image processing and have their application in AI.

  • What is Gynandromorphism?

    Recently, a rare biological phenomenon called Gynandromorphism was observed in dragonflies at Kole wetlands of Kerala.

    Gynandromorphism is a core biology concept. We can expect a prelims question in a rare scenario.

    Try this question from CSP 2013:

    Q.Improper handling and storage of cereal grains and oilseeds result in the production of toxins known as aflatoxins which are not generally destroyed by normal cooking process. Aflatoxins are produced by

    (a) Bacteria (b) Protozoa (c) Moulds (d) Viruses

    Gynandromorphism

    • Gynandromorphs are individual animals that have both genetically male and female tissues and often have observable male and female characteristics.
    • They may be bilateral, appearing to divide down the middle into male and female sides, or they may be mosaic, with patches characteristic of one sex appearing in a body part characteristic of the other sex.
    • Gynandromorphs occur in insects, spiders, crustaceans, and other arthropods as well as in birds, but they are extremely rare, and discovering one in the field or in the laboratory is a major event.
    • Estimating how frequently they occur is difficult because they usually go unnoticed in species where sexual dimorphism is less pronounced.
    • Gynandromorphs have been reported in mosquitoes, fruit flies, and in other insects, but they are most dramatic in those butterfly species in which the male and female wing colours and patterns are dramatically different.

  • Statistics Day and P.C. Mahalanobis

    Statistics Day will be celebrated today on 29th June 2020 to popularize the use of Statistics in everyday life and sensitize the public as to how Statistics helps in shaping and framing policies.

    Try this question from CSP 2016:

    A recent movie titled The Man Who Knew Infinity is based on the biography of-

    (a) S. Ramanujan
    (b) S. Chandrasekhar
    (c) S. N. Bose
    (d) C. V. Raman

    Who was P.C. Mahalanobis?

    • Prasanta Chandra Mahalanobis (29 June 1893 – 28 June 1972) was an Indian scientist and statistician.
    • He is best remembered for the Mahalanobis distance, a statistical measure, and for being one of the members of the first Planning Commission of free India.
    • He made pioneering studies in anthropometry (the science of obtaining systematic measurements of the human body) in India.
    • He founded the Indian Statistical Institute and contributed to the design of large-scale sample surveys.
    • For his contributions, Mahalanobis has been considered the father of modern statistics in India.

  • Coccolithophores: The Ancient Algae

    A study of microscopic ancient marine algae (Coccolithophores) has found that there is a decrease in the concentration of oceanic calcium carbonate (CaCO3) in the Southern Indian Ocean.

    Try this question:

    Q.The Coccolithophores sometimes seen in news are-

    (a) Diatoms

    (b) Algae

    (c) Coral Polyps

    (d) Sea grass

    Coccolithophores

    • Coccolithophores are single-celled algae living in the upper layers of the world’s oceans.
    • They have been playing a key role in marine ecosystems and the global carbon cycle for millions of years.
    • They calcify marine phytoplankton that produces up to 40% of open ocean calcium carbonate and responsible for 20% of the global net marine primary productivity.
    • They build exoskeletons from individual CaCO3 plates consisting of chalk and seashells building the tiny plates on their exterior.

    Role as a carbon sink

    • Though carbon dioxide is produced during the formation of these plates, coccolithophores help in removing it from the atmosphere and ocean by consuming it during photosynthesis.
    • At equilibrium, they absorb more carbon dioxide than they produce, which is beneficial for the ocean ecosystem.
    • These investigations are important for future intervention to bring positive changes in the marine ecosystem and the global carbon cycle.

    Threats

    • The reduction of coccolithophores is due to an increase in the presence of diatom algae, which occurs after sea ice breakdown with climate change and ocean acidification, and increases the silicate concentration in the waters of the Southern Ocean.
    • Their existence is highly dependent on time and influenced by various environmental factors such as silicate concentrations, calcium carbonate concentration, diatom abundance, light intensity and availability of macro and possibly micronutrient concentrations.

  • Indian National Space Promotion and Authorization Centre (IN-SPACe)

    The Union Cabinet has approved the creation of the Indian National Space Promotion and Authorization Centre (IN-SPACe) to provide a level playing field for private companies to use Indian space infrastructure.

    Note the key differences between IN-SPACe, ANTRIX and NSIL. We can expect a prelims question with shuffled objectives of these organisations.

    IN-SPACe

    • The creation of IN-SPACe is part of reforms aimed at giving a boost to private sector participation in the entire range of space activities.
    • The IN-SPACe is expected to hand-hold, promote and guide the private industries in space activities through encouraging policies and a friendly regulatory environment.
    • It would endeavour to reorient space activities from a ‘supply-driven’ model to a ‘demand-driven’ one, thereby ensuring optimum utilization of the nation’s space assets.

    Why need IN-SPACe?

    • India is among a handful of countries with advanced capabilities in the space sector.
    • Space sector can play a major catalytic role in the technological advancement and expansion of our Industrial base.
    • The proposed reforms will enhance the socio-economic use of space assets and activities, including through improved access to space assets, data and facilities.

    Back2Basics: New Space India Limited (NSIL)

    • It functions under the administrative control of Department of Space (DOS).
    • It aims to commercially exploit the research and development work of ISRO Centres and constituent units of DOS.
    • The NSIL would enable Indian Industries to scale up high-technology manufacturing and production base for meeting the growing needs of the Indian space programme.
    • It would further spur the growth of Indian Industries in the space sector.

    ANTRIX

    • Antrix Corporation Limited (ACL), Bengaluru is a wholly-owned Government of India Company under the administrative control of the Department of Space.
    • It is as a marketing arm of ISRO for promotion and commercial exploitation of space products, technical consultancy services and transfer of technologies developed by ISRO.
    • Antrix is engaged in providing Space products and services to international customers worldwide.

  • What is Foldscope?

    Indian researchers have explored and validated the clinical utility of Foldscope in the diagnosis of diseases using various patient samples.

    Though trivial, Foldscope is a significant invention with most crucial applications. It somehow offers an alternative to costly microscopes for some basic diagnosis.

    What is Foldscope?

    • Foldscope is an affordable origami-based microscopy device composed of a series of paper clippings.
    • Upon assembly, the device can hold a specimen slide for observation, and this specimen can be viewed via a mobile phone camera attached to it.

    How does it work?

    • Foldscope can be assembled using paper clips and mounted on a cell phone using coupler and glue drops.
    • To do the assessment, a patient sample like urine is smeared on a transparent glass slide and visualized under a Foldscope mounted on a cell phone.
    • Sample images can be enlarged using the zoom function of the mobile, which can be stored on the mobile memory card for later reference/patient records.
    • Foldscope visualizes calcium oxalate crystals, which are a major cause of kidney stones.

    Utility of Foldscope

    • Foldscope is particularly convenient to diagnose urinary tract infection (UTI) and monitor kidney stone.
    • The study evaluated the use of Foldscope in the clinical diagnosis of oral and urinary tract infections.
    • Using this tool, one can easily monitor own-kidney stone status at home with a simple glass-slide, a Foldscope and a phone in hand.
    • Such monitoring could perhaps avoid kidney stone reaching a painful state or surgery in recurring cases.

  • Detection of Fluorine in hot Extreme Helium (EHe) Stars

    A study by the Indian Institute of Astrophysics (IIA) has detected the presence of singly ionized fluorine for the first time in the atmospheres of hot Extreme Helium Stars.

    UPSC may ask a simple statement-based question considering the following points:

    If there is the presence of hydrogen, their abundance in universe and how it is different from neutron stars etc.

    What are EHe stars?

    • An extreme helium star or EHe is a low-mass supergiant that is almost devoid of hydrogen, the most common chemical element of the universe.
    • There are 21 of them detected so far in our galaxy.
    • The origin and evolution of these Hydrogen deficient objects have been shrouded in mystery.
    • Their severe chemical peculiarities challenge the theory of well-accepted stellar evolution as the observed chemical composition of these stars do not match with that predicted for low mass evolved stars.

    Why is the study significant?

    • Clues to the evolution of extreme helium stars require accurate determinations of their chemical composition, and the peculiarities, if any, become very important.
    • Fluorine plays a very crucial role in this regard to determine the actual evolutionary sequence of these hydrogen deficient objects.
    • The scientists explored the relationship of hot EHes with the cooler EHes, based on their fluorine abundance and spotted it in the former, thus establishing an evolutionary connection across a wide range of effective temperature.
    • This makes a strong case that the main form of these objects involves a merger of a carbon-oxygen (CO) and a Helium (He) white dwarf.
    • The detection of enhanced fluorine abundances in the atmospheres of hot EHes solves a decade-old mystery about their formation.

  • What are Biosimilars?

    Recently an Indian pharma company has been granted a USFDA approval for Insulin Glargine, a biosimilar. This article briefly introduces us to this term, complexities involved in its manufacturing and also explains why the USFDA approval create hype.

    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.

    Consider the question “What is biosimilar technology? How is it different from generic medicine? Discuss its application.”

    Conclusion

    Growing expertise of Indian pharmaceutical companies in the complex research area bodes well for the Indian pharma sector which is known otherwise for the manufacturing of generic medicines.

     

    Reference Source: https://finshots.in/archive/biocon-and-the-world-of-biosimilars/