The ongoing controversy over Pertuzumab highlights that, despite legal protections, Evergreening still complicates the introduction of affordable biosimilars.

Roche Raises Concerns Over Zydus Trials of Breast Cancer Drug Pertuzumab

• Controversy of Pertuzumab: Pertuzumab is a popular breast cancer treatment.
  • Roche, the world’s top seller of oncology drugs, has raised red flags against the clinical trials conducted by Indian drug maker Zydus Lifesciences on Perjeta (pertuzumab), its popular breast cancer treatment.
  • The Swiss drugmaker, Roche, has alleged that 500 vials of the drug were sourced from questionable channels for clinical trials in India.
  • Roche has reported concerns to India’s drug regulator, Central Drugs Standard Control Organisation (CDSCO), highlighting issues around proper sourcing and oversight in biosimilar trials.
• The Indian biopharmaceutical industry is one of the fastest growing globally and is valued at $60 billion. 
• India is now ranked 39th in the Global Innovation Index, up from 81 in 2015.

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About Biopharmaceuticals

• Biopharmaceuticals are medicines derived or synthesised from living cells such as humans, animals, yeast, bacteria etc using biological processes, contrasting with conventional chemical-based drugs.
• They play a crucial role in treating chronic diseases like cancer and diabetes.

Components of Biopharmaceuticals

• Biologics: This term specifically refers to products derived from living cells or organisms, such as proteins, nucleic acids, or cells. 
  • They encompass a wide range of products, including: vaccines, blood components, gene therapy, tissues, proteins, like monoclonal antibodies and cell signalling proteins etc.
• Biosimilars: A Biosimilar is a biologic that is “similar” to another biologic medicine (known as a reference product) that has been cleared by the authorities for prescription by doctors. 
  • That is why they are also called ‘follow-on biologics’ and are used to treat the same disorders as the first biologic drug.
  • Biosimilars closely match the reference product in safety, purity, and potency, though they may contain minor variations in inactive components. Example:
    • Trastuzumab (Herceptin) – Used for treating breast cancer.
    • Epoetin alfa (Epogen) – Used to treat anaemia, particularly in patients with chronic kidney disease.
  • They offer new hope for patients by providing cost-effective alternatives to original biologics, which are often expensive and complex.

Difference between Biosimilars and Generics

India and Global Biosimilar Market

• Pioneer in the Global Biosimilars Market: India was the first country to approve a biosimilars product for Hepatitis B. 
  • Today, there are 98 approved biosimilars in India, with at least 50 in the market, the most in any country. 
  • Many India-made biosimilars have been approved in markets like the US.
• Rapid Growth of the Indian Biosimilars Market: The Indian biosimilars market was valued at $349 million in 2022 and is estimated to expand at a growth rate of 25.2 per cent per annum from 2022 to 2030 to reach $2,108 million by 2030.
• Expanding Scope: By 2030, biologic products worth some $170 billion will lose patent protection. 
  • This will open a window of opportunity for Indian biopharma to launch more biosimilar products.
• Regulatory Framework in India: In India, biopharmaceuticals and generic medicines are classified as drugs and are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940.

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Challenges Faced By India With Respect to Biosimilars

• Patent Evergreening: Patent evergreening is one of the significant barriers faced by Indian biosimilar manufacturers.
  • Example: The multinational Roche extended the exclusivity of trastuzumab (Herceptin), a biologic used to treat breast cancer, by introducing a subcutaneous version just as the original patent was expiring. 
• Regulatory Challenges: Biosimilars, unlike generic drugs, are derived from living organisms and require rigorous clinical trials to demonstrate similarity in quality, safety, and efficacy.
  • The complexity of biologics leads to inherent variability, making approval and market entry more challenging.
    • Example: The biosimilar of trastuzumab (used in breast cancer treatment) took several years to gain approval, affecting its timely entry into the market.
• Limited Testing Facilities: India currently faces a significant challenge with limited testing facilities capable of conducting the extensive bio-similarity assessments required for biosimilars. 
• Adoption Hesitancy: There is often a lack of awareness among healthcare professionals and patients regarding the safety and efficacy of biosimilars, leading to hesitancy in adoption.
  • This lack of understanding can limit patient access to potentially cost-effective treatment options.
• Market Competition: Intense competition from established global players in the biosimilars market can make it challenging for Indian manufacturers to secure market share.
  • India holds only a 3% share of the global biosimilar market.
• Intellectual Property Challenges: Navigating the complexities of intellectual property laws and potential litigation can be daunting for Indian biosimilar companies.
  • Example: Reliance Life Sciences (RLS) faced legal action from Roche regarding its biosimilar trastuzumab, used for treating breast cancer. 
    • The Delhi High Court in 2015 expressed concerns about Roche’s motives, suggesting the lawsuit aimed to stifle competition. 

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Initiatives by the Government for India’s Biopharmaceutical Development

• National Biopharma Mission
  • Initiative Overview: Under the Make in India initiative, the National Biopharma Mission (NBM) has been launched as an industry-academia collaborative mission, managed by the Biotechnology Industry Research Assistance Council (BIRAC).
  • Funding and Scope: This $250 million mission is co-funded by the World Bank and aims to accelerate the development of biopharmaceuticals.
  • Support for Organisations: The NBM supports nearly 150 organisations and 300 micro, small, and medium enterprises (MSMEs) in the biopharmaceutical sector.
• India’s Patent Legislation: Particularly Section 3(d) of the Patents Act, 1970, aims to prevent “evergreening” by rejecting patents for small innovations that lack substantive improvement. 
  • • Example: In Novartis vs Union of India, the patent application of Novartis for the cancer drug Glivec (imatinib), used to treat leukaemia, was rejected as it did not show significant technical advancement. 
    • This set a strong precedent against evergreening practices. 
  • Section 3(e) of the Act restricts patenting mixtures of known compounds unless a synergistic effect is proven, and Section 3(i) prevents patents on treatment methods.
• Guidelines on Similar Biologics: Biosimilars are also known as Similar Biologics. 
  • The Guidelines on Similar Biologics are a comprehensive policy document outlining the regulatory pathway for approving similar biologics in India. It is developed collaboratively by the Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT).

Way Forward

• Strengthen Patent Laws: Reinforce Section 3(d) of India’s Patents Act, which prevents patents for minor modifications.
• Encourage Compulsory Licensing: In cases of high public health impact, leverage compulsory licensing provisions to make essential biosimilars more accessible and reduce monopolistic control.
• Expand Clinical Trial Capabilities: Increase investment in domestic clinical trial infrastructure.
  • Providing grants and incentives for companies to conduct biosimilar trials could make these trials more feasible and accessible.
• Re-establishment of Intellectual Property Appellate Board (IPAB): for early disposal of patent dispute cases.
  • The Intellectual Property Appellate Board (IPAB) was abolished in April 2021 with the passing of the Tribunals Reforms (Rationalization and Conditions of Service) Ordinance, 2021.
• Implement Quality Management Systems: Standardise production protocols to ensure consistent biosimilar quality. 
  • The National Institute of Biologicals is an autonomous institute under India’s Ministry of Health and Family Welfare for theQuality Control of Biologicals.
    • It can help set up quality control standards and monitoring.
• Encourage Venture Capital in Biopharma: Implement tax breaks or risk-sharing mechanisms to attract more private investment in the biosimilar sector, especially targeting smaller players with high growth potential.
• Advocate for Fair Intellectual Policies (IP): Through forums like World Trade Organization (WTO) and World Intellectual Property Organization (WIPO), India could advocate for fairer global IP practices, reducing litigation risks for biosimilars.
• Learning from Global Experiences: The European Medicines Agency’s 2005 biosimilar guidelines offer a streamlined approval process, resulting in substantial Biosimilar adoption in Germany, the UK, and Nordic countries, which has led to significant cost savings.
  • In the United States, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act establishes an abbreviated approval pathway for biosimilars.

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Conclusion

India’s pharmaceutical and biotech industry requires strong government support and robust patent laws to successfully capture the biologics and biosimilars market.

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Recently, the Tamil Nadu government has officially declared heatwaves a State-specific disaster and announced ex-gratia payments of ₹4 lakh for families of individuals who die of heat-related causes.

Heatwaves

• Definition: Period of unusually high temperatures compared to what is normally expected in a region.
• Criteria for Declaring a Heat Wave in India:
  • Plains: Maximum temperature reaches at least 40°C.
  • Coastal Stations: Maximum temperature reaches at least 37°C.
  • Hilly Regions: Maximum temperature reaches at least 30°C.
• Classification of Heat Waves:
  • Based on Departure from Normal:
    • Heat Wave: Departure from normal is 4.5°C to 6.4°C.
    • Severe Heat Wave: Departure from normal exceeds 6.4°C.
  • Based on Actual Maximum Temperature (Plains Only):
    • Heat Wave: Actual maximum temperature reaches 45°C.
    • Severe Heat Wave: Actual maximum temperature reaches 47°C.
• Declaration Criteria:
  • Conditions must be met in at least two stations within a Meteorological sub-division.
  • Conditions must persist for at least two consecutive days.
• Favourable Conditions for Heat Waves:
  • Hot and Dry Air: Acts as a reservoir of heat, transported by prevailing winds.
  • Low Humidity Levels: Allows heat accumulation and limits nighttime cooling.
  • Clear Skies: Enables uninterrupted sunlight, raising ground and air temperatures.
  • Large Amplitude Anticyclonic Flow: Sinking air compresses and warms adiabatically.
  • Geographical Considerations: More frequent in arid/semi-arid regions, like Northwest India.
  • Climate Change: Increased baseline temperatures enhance the likelihood and intensity of heatwaves.

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State-Specific Disasters

• Definition: Disasters that are local to a state and not listed by the Ministry of Home Affairs.
• Announcement: Declared by the State Government.
• Funding Mechanism: Utilises up to 10% of the funds from the State Disaster Response Fund (SDRF) for immediate relief.
• Responsible Authority: State Disaster Management Authority (SDMA), established under the Disaster Management Act of 2005.
• SDMA Composition: Chaired by the Chief Minister and includes no more than eight members appointed by the Chief Minister.
• Role of SDMA: Prepares and implements the state disaster management plan in line with the National Disaster Management Plan.

Heat Dome

• Definition: it is a weather phenomenon where a high-pressure system traps warm air, acting like a lid on a pot.
• Characteristics:
  • Warm air cannot rise, resulting in clear skies.
  • The high-pressure system allows more sunlight to reach the earth, leading to increased warming and soil drying.
  • Reduced evaporation limits rain cloud formation.

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The Union Government has reportedly decided to include four new components – Hydroponics, Aquaponics, Vertical Farming, and Precision Agriculture – under the Mission for Integrated Development of Horticulture (MIDH).

About Mission for Integrated Development of Horticulture (MIDH)

• Centrally Sponsored Scheme launched in 2014-15.
• It promotes the comprehensive growth of the horticulture sector in India.
• It supports crops such as fruits, vegetables, roots and tubers, mushrooms, spices, flowers, aromatic plants, coconut, cashew, and cocoa.

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• It provides technical and administrative support to State Governments and State Horticulture Missions (SHMs) for initiatives like the Saffron Mission, RKVY, and NMSA.
• Implemented under: Green Revolution – Krishonnati Yojana.

• Funding Pattern: Government of India (GoI) contributes 60% and 40% share is contributed by State Governments.
  • In the case of North Eastern States and Himalayan States, GoI contributes 90%
• Objectives
  • Enhance Production and Productivity: Increase yield and quality with better planting materials and modern technologies.
  • Post-Harvest Management: Minimise post-harvest losses by developing infrastructure for storage, processing, and marketing.
  • Promote Sustainable Practices: Encourage organic farming, eco-friendly practices, and integrated pest management.
  • Capacity Building: Train and support farmers in modern horticultural practices to improve income.
  • Market Access: Strengthen supply chains for better access to domestic and international markets.

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Key Components

• National Horticulture Mission (NHM):
  • Supports horticulture development across all states and union territories.
• Horticulture Mission for North East and Himalayan States (HMNEH):
  • Tailored to the unique needs of northeastern and Himalayan regions.
• National Bamboo Mission (NBM):
  • Promotes bamboo cultivation and its value chain.
• Coconut Development Board (CDB):
  • Focuses on the development of the coconut sector.
• Central Institute of Horticulture (CIH):
  • Located in Medizipehima, Nagaland, for technical support, training, and capacity building in the North East.

Advanced Farming Techniques

Hydroponics

• Definition: It is a method of growing plants without soil, using water enriched with balanced mineral nutrients essential for plant growth.
• Benefits:
  • Uses less water than traditional farming.
  • Suitable for regions with poor soil or limited land.
  • Allows precise nutrient control, reducing wastage.
• Limitations:
  • High initial setup costs.
  • Requires continuous monitoring and specialised knowledge of nutrient management.

Aquaponics

• Definition: it integrates hydroponics with aquaculture, creating a symbiotic system with plants, fish, and beneficial bacteria.
• Process:
  • Fish waste provides nutrients for plant growth.
  • Plants, in turn, filter and purify water, which is recycled back to the fish tanks.
• Benefits:
  • Sustainable system producing both plants and fish.
  • Reduces reliance on synthetic fertilizers.
  • Efficient water use.
• Limitations:
  • Requires knowledge to balance fish and plant needs.
  • Demands careful monitoring of water quality and nutrient levels.

Precision Agriculture

• Definition: it employs data-driven technology to manage crop production at a highly detailed level.
• Technologies Used:
  • GPS: Provides accurate mapping of fields.
  • Grid Sampling: Collects soil samples at intervals to assess pH, nutrients, and moisture.
  • Variable-Rate Technology (VRT): Adjusts the application rate of seeds, fertilizers, and water across fields, preventing over- and under-application.
  • Drones, Sensors, Satellite Imagery: Monitor crop health, growth, and field conditions in real-time.
• Benefits:
  • Increases crop yield and quality.
  • Reduces inputs like water and fertilizers, cutting costs and environmental impact.
• Limitations:
  • High initial cost of technology.
  • Requires skilled operators and reliable internet connectivity.

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Vertical Farming

• Definition: Vertical Farming means cultivating plants in vertically stacked layers or inclined surfaces, typically in controlled environments.
• Controlled-Environment Agriculture (CEA): Optimises conditions such as light, temperature, humidity, and nutrients to enhance plant growth.
• Nutrient-Providing Methods:
  • Hydroponics: Soil-free growing using nutrient solutions.
  • Aeroponics: Roots are misted with nutrient-rich water, requiring less water than hydroponics.
  • Aquaponics: Combines fish farming with hydroponic plant production in a closed system.
• Benefits:
  • Maximises space utilisation, especially in urban areas.
  • Reduces the need for large amounts of land.
• Limitations:
  • High setup and operational costs.
  • Energy-intensive due to the use of artificial lighting and climate control.

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India and Spain condemned attacks on UNIFIL, stressing peacekeeper safety, and jointly inaugurated the C-295 aircraft Final Assembly Line in Vadodara under a ₹21,935-crore Tata-Airbus collaboration.

India-Spain Strengthen Economic and Cultural Ties with New Agreements

• Economic and Cultural Agreements
  • India-Spain CEO Forum and Business Summit: PM Sanchez is set to participate in economic discussions and the 4th Spain-India Forum in Mumbai.
  • Agreements Signed:
    • Rail Transport Cooperation: A memorandum on rail collaboration was signed.
    • Customs Assistance: Agreement on mutual assistance in customs to ease trade.
    • Fast-Track Investment Mechanism: Established in both India and Spain to facilitate mutual investments.
    • Audio-Visual Co-Production: Joint commission set up to promote collaborative audio-visual projects.
  • 2026: Year of India-Spain in Culture, Tourism, and AI:
    • Focus on enhancing cultural exchanges through museums, art fairs, and tourism.
    • Promotion of AI and reciprocal investments.
• EU-India Comprehensive Negotiations: Both leaders emphasised commitment to advancing the EU-India Free Trade Agreement, Investment Protection Agreement, and Geographical Indications Agreement for stronger economic ties.

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About UNIFIL (United Nations Interim Force in Lebanon)

UNIFIL (United Nations Interim Force in Lebanon) was established in March 1978 under Security Council Resolutions.

• Objective: 
  • To confirm the withdrawal of Israeli forces from southern Lebanon.
  • Restore international peace and security.
  • Assist the Lebanese government in re-establishing effective authority in the area.
• Composition: Approximately 10,500 peacekeepers from 48 contributing countries.
• Largest Contributors: Indonesia, Italy, India, Nepal, and China.
• Funding: Funded through a separate account approved annually by the UN General Assembly, part of the broader UN Peacekeeping Force.
• Rules of Engagement: Peacekeepers may use force only in self-defence or to fulfil their mandated duties.

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Former Karnataka High Court judge  K.S. Puttaswamy, the lead petitioner in the right to privacy case challenging Aadhar, died recently.

Justice Puttaswamy’s Challenge: Aadhaar and the Right of Privacy

In 2012, Puttaswamy petitioned with the Supreme Court questioning the constitutional validity of Aadhaar. 

• Puttaswamy questioned the government policy to make Aadhaar card mandatory for every individual and its plans to link the identity card with various government schemes. 
• Puttaswamy argued that Aadhaar violated the fundamental rights of equality and privacy granted to every individual under the Constitution.

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2017 Supreme Court Judgment on Right of Privacy

The Supreme Court observed that privacy is integral to an individual’s dignity, enabling autonomy of both body and mind. 

• This autonomy supports the individual’s ability to make decisions on vital personal matters. 
• The court held that any restriction on privacy by the state must meet three criteria:
  1. Legislative Mandate: The restriction must have a legislative foundation.
  2. Legitimate State Purpose: The restriction must serve a legitimate purpose.
  3. Proportionality: The nature and extent of the restriction must be necessary in a democratic society and should be the least intrusive option available to achieve the intended outcome.

Supreme Court Upholds Aadhaar’s Constitutional Validity

• One major concern was whether Aadhaar would lead to a surveillance state. 
  • However, the Supreme Court ruled that Aadhaar does not retain transactional data. 
  • During enrolment, only minimal biometric data—such as iris scans and fingerprints—are collected by UIDAI. 
  • The purpose, location, or details of transactions are not recorded, and the information remains in isolated silos. 
  • Authenticating agencies, such as banks and tax authorities, only receive a “Yes” or “No” response regarding a person’s authentication status.
• The court found that Aadhaar, in its current form, satisfied the tests established by the privacy judgement, deeming the invasion of privacy reasonable.

Aadhaar Act as a Money Bill

• The Supreme Court upheld the Lok Sabha Speaker’s decision to recognize the Aadhaar Act as a Money Bill. 
• The court reasoned that the primary objective of the Act is to provide financial benefits—such as aid, grants, and subsidies—to marginalized sections of society from the Consolidated Fund of India.

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Aadhaar and the Doctrine of Proportionality

• The Supreme Court also upheld the use of Aadhaar for accessing government services, applying the Doctrine of Proportionality, which dictates that state interference with an individual’s rights must be proportionate to the goal it aims to achieve. 
  • However, the court also stipulated that the government cannot expand the scope of “benefits” without restriction. 
• These benefits refer to welfare schemes specifically funded by the Consolidated Fund of India.

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The government is set to conduct the much-delayed Census next year, and to complete the process by 2026, with suggestions being taken on whether caste enumeration would be part of the exercise, as per sources.

About the Census

• Conducted By: Office of the Registrar General and Census Commissioner under Ministry of Home Affairs.
• Largest Statistical Exercise Globally: Collects data on demography, literacy, housing, urbanization, SC/ST status, religion, etc.
• Legal Framework:
  • Constitutional Status: The population census is a Union subject under Article 246 of the  Constitution, listed at serial number 69 of the seventh schedule of the constitution.
  • The Census of India Act of 1948: The Act provides the legal framework for carrying out the Census
  • Neither the Constitution nor the Act provides the frequency and periodicity to conduct the census exercise. 
    • There is, therefore, no Constitutional or legal requirement that a Census has to be done every 10 years. 
• History: The Census exercise was carried out for the first time in a synchronised manner in 1881 after a trail exercise in 1872 under Viceroy Lord Mayo
  • Since the the Census exercise has been conducted every 10 years till the 2021 census was postponed ( first time in the 150-year history of India’s census operations)
  • The first complete census of India was conducted in 1830 by Henry Walter in Dacca (now Dhaka). 
• Phases:
  • House-listing and Housing Census: Lists structures, households, amenities.
  • Population Enumeration: Collects individual data on demographics, socio-economic status.
• Process: Data collection through household visits, confidential processing at data centers with ICR software.

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Significance of Current Census

• The upcoming Census is linked to two other important outcomes
  • the delimitation of Parliamentary constituencies, which has been on hold for the last five decades, and 
  • the implementation of women’s reservation in Parliament.
• There is also an expectation that the next Census may collect caste data as well to eliminate the need for a separate caste census, which has been demanded by some political parties in recent years.

Importance of Census

Provide the facts essential to the government for policy-making, planning and administration. 

• Provides important data for the analysis and appraisal of the changing patterns of rural/urban movement and concentration, the development of urbanised areas, geographical distribution of the population according to such variables as occupation and education, as well as the socio-economic characteristics of the population and the labour force. 
• Aids in the decision-making processes of the private sector. 
• Population size and characteristics influence the location of businesses and services that satisfy the needs of the target population. 
• Population censuses also constitute the principal source of records for use as a sampling frame for the household surveys during the years between censuses.

Challenges associated with Census

• Cost: Conducting a census is expensive, and the government incurs thousands of crores of rupees in the process. 
• Literacy: In countries with high illiteracy rates, it can be difficult to conduct a census. 
• Infrastructure: Poor infrastructure, such as inaccessible roads, can make it difficult to conduct a census. 
• Cultural and linguistic barriers: Language diversity and cultural variations can make it difficult to communicate with and collect data from diverse groups. 
• Privacy and confidentiality: Concerns about data misuse, identity theft, and violation of privacy rights can make it difficult to gain the trust of respondents. 
• Rapid urbanisation and migration: The increasing pace of urbanisation and internal migration can make it difficult to accurately count and track individuals. 
• Technological and infrastructure limitations: Limited access to digital devices and connectivity issues can make it difficult to adopt digital data collection methods. 
• Lack of community participation: Inadequate community participation can make it difficult to conduct a census. 
• Inadequate training of enumerators: Inadequate training of enumerators can make it difficult to collect precise and accurate data. 

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The crises in Ukraine and Gaza have raised concerns about increases in the prices of components used for making petroleum-based chemical fertilisers.

India’s Fertiliser Imports at Risk Amid Geopolitical Uncertainty

• Dependency on Imports: India relies heavily on imports to meet its fertiliser demands, particularly for urea, DAP, and MOP.
  • Around 20% of urea, 50-60% of DAP, and 100% of MOP are imported.
• Import Sources Affected: India’s primary fertiliser imports come from countries like Russia, China, Saudi Arabia, and the UAE. 
• • Current geopolitical instability could disrupt supplies from these regions.

What is meant by the term “balanced fertilisation”?

• It is the practice of applying nutrients such as  Nitrogen, Phosphate and Potash at the right time in the right amount according to the soil type and specific crop. 
• It is significant as it improves soil quality, increases crop yield, curtails environmental impact,and protects the environment. 

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Fertilizer Industry in India

• This industry is one of the core industries. 
• Fertilisers are essential for enhancing crop yields and improving soil fertility. 
• India is the second-largest consumer of fertilisers globally.
• Production: India ranks third in the world for overall fertiliser production, second in nitrogen fertilisers, and third in phosphate fertilisers
  • There are 57 fertiliser units in India, including 29 urea-producing units and 9 ammonia sulphate-producing units

Fertiliser Production in India

• 2021-22 Production vs. Demand: India consumed 579.67 lakh metric tonnes (LMT) of fertilisers, including 341.73 LMT of urea. However, domestic production was only 435.95 LMT, leaving a shortfall of 143.72 LMT.
• Comparative Data: In 2014-15, fertilizer production was 385.39 LMT, indicating only a 50 LMT increase over seven years.
• Subsidy Allocation: The 2023-24 budget allocated ₹1.79 lakh crore for fertilizer subsidies, with a significant share (₹1.04 lakh crore) directed toward indigenous urea.

Urea Continue to be the major Fertiliser: reasons

It is popular fertiliser for many reasons

• High Nitrogen Content: Urea has high high nitrogen content around (46%).
  • Nitrogen is very significant for plant growth.
• Less harmful: Urea is less harmful to soil than other fertilisers.
• Low cost: This nitrogenous fertiliser is affordable due to its low transport and storage costs. 
• Wider availability: Urea is easily available due to its wider access to the market. 
• Suitable for various crops and soil type: This fertiliser can be used directly to the soil on a wide crops such as cereals, vegetables, and fruits.

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Challenges India Faces in Fertilizer Imports

• High Dependence on Imports
  • India relies heavily on imported fertilisers like urea, DAP (Diammonium Phosphate), and MOP (Muriate of Potash).
  • This dependence makes India vulnerable to disruptions in global supply chains and price volatility.
• Impact of Geopolitical Conflicts
  • Conflicts in regions like Ukraine and West Asia affect the availability and cost of raw materials required for fertiliser production.
  • For example, the ongoing crisis in Ukraine has led to rising prices of petroleum-based inputs crucial for fertilisers.
• Limited Global Suppliers
• • With only a few suppliers for essential raw materials such as rock phosphate, phosphoric acid, and ammonia, India has limited bargaining power in the global market.
• Subsidy Burden
  • The high cost of imported fertilisers significantly increases the government’s subsidy expenses.
  • For instance, the subsidy required for imported urea is notably high, putting a strain on the national budget.
• Domestic Production Shortfall
  • India’s production capacity for fertilisers does not meet the national demand, creating a shortfall that must be supplemented through imports.
• Supply Chain Disruptions
  • Global supply chain issues, often triggered by geopolitical tensions, result in delays and shortages in fertilizer imports.

Recommendations

• Enhance Production Capacity: Increase domestic fertiliser production and reduce dependency on imports.
• Adopt New Practices: Implement nano urea, natural farming, and improve fertilizer factory capacities.
• Policy Initiatives: Encourage investments in public, cooperative, and private sectors for manufacturing and marketing fertilisers.
• Integrated Nutrient Management (INM):
  • It  is a comprehensive strategy that aims to optimize nutrient supply to crops while preserving soil health. 
    • By combining various nutrient sources, INM promotes sustainable agriculture and reduces reliance on chemical fertilizers.
• Key Components of INM:
  • Inorganic Fertilisers: Chemical fertilisers, including urea, DAP, MOP, and micronutrients, provide a quick source of essential plant nutrients.
  • Organic Manures: Natural fertilisers like farmyard manure, compost, and vermicompost improve soil structure, water-holding capacity, and nutrient content.
  • Biofertilizers: Microbial inoculants, such as Rhizobium, Azotobacter, and Mycorrhiza, enhance nutrient availability by fixing atmospheric nitrogen or improving nutrient uptake.
• Recent Developments
  • Investment Policy: Six new urea plants set up since the new investment policy in 2012, adding a production capacity of 76.2 LMT per annum.
  • Revived Units: New gas-based Greenfield units set up for urea manufacturing at Ramgundam, Gorakhpur, Sindri, and Barauni.

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Recently, Bihar’s first dry port was inaugurated at Bihta, a town near state capital Patna.

Bihta Dry Port Ships First Consignment to Russia

• The First consignment exported from the dry port at Bihta was of leather shoes, which were sent to Russia.
• As per Bihar government data, the state recorded exports worth Rs 20,000 crore in 2022-23. 
• Now, with the availability of Inland Container Depot (ICD) Bihta, the state looks at boosting its export potential.

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What is Dry Port?

• Definition: A Dry Port, also known as an Inland Container Depot (ICD), is an inland intermodal terminal directly connected by road or rail to a seaport. 
  • It acts as a transhipment of sea cargo to inland destinations.
  • It is recognised by the customs and port authorities as an extended part of the Sea port.
  • Examples: ICD Tughlakabad, Delhi (India’s largest dry port), Dadri (Uttar Pradesh),etc.

• Functions: It facilitates cargo handling, storage, and transportation, creating a bridge between sea/air ports and inland regions.
• Significance of Dry Ports:
  • Improved Supply Chain Performance: It enables smoother and more efficient movement of goods from inland areas to major ports.
  • Decongestion of Seaports: By managing a portion of the cargo that would typically go through seaports, dry ports help reduce congestion, improving the overall efficiency of maritime transport.
  • Promotion of Multimodal Transport: They enable the integration of various transport modes, including rail, road, and inland water transport, fostering a more flexible and efficient logistics network.
  • Enhanced Logistics Efficiency: Dry ports streamline the movement of goods by providing efficient cargo handling, storage, and customs clearance facilities away from seaports.

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About Dry Port In Bihar

• Public-Private Partnership (PPP): The Bihta dry port is operated in collaboration between Pristine Magadh Infrastructure Private Limited and Bihar’s state industry department.
• Reasons for Need of A Dry Port In Bihar: 
  • Diverse Production Base: Bihar exports a range of goods, including agro-based products, garments, and leather goods, which are produced in various locations across the state.
  • Consolidation of Cargo: By consolidating shipments from multiple shippers, the dry port simplifies transportation and logistics.
  • Customs Clearance: The dry port manages customs procedures locally, reducing congestion at traditional seaports and airports.
  • Make Bihar more Competitive: The businesses from Bihar and nearby areas can now access global markets with reduced logistical cost and faster turnaround time, making the state more competitive.
    • The ICD Bihta has robust rail connectivity to major ports such as Kolkata and Haldia (West Bengal), Visakhapatnam (Andhra Pradesh) and Mundra (Gujarat).

• Advantages of the Dry Port for Bihar
  • Lower Costs: Streamlined transportation and handling at the dry port helps reduce overall logistics costs.
  • Secure Storage and Handling: The dry port provides secure facilities for storage and handling, ensuring product safety and quality.
  • Improved Accessibility: Located on a seven-acre site in Bihta, the dry port enhances export capacity for Bihar.
  • Spillover Effect: The establishment of the Bihta dry port in Bihar enhances not only the state’s logistics capabilities but also positively impacts neighbouring states like Jharkhand, Uttar Pradesh, and Odisha.

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The total spending for the upcoming U.S. presidential and Congressional elections in November 2024 is projected to reach approximately $16 billion.

This amount translates to around ₹1,36,000 crores in Indian currency.

India 2024 Lok Sabha Election Expenditure

• For the 2024 Lok Sabha elections, the Centre for Media Studies (CMS) estimates that various political parties spent a combined total of about ₹1,00,000 crores.

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What is the Election Expenditure Limit?

• This limit refers to the amount of money that a candidate can spend on an election campaign.
• It is set by the Election Commission of India (ECI) which varies based on the type of elections and size of states. 
• Election Expenditure Limits in India
  • Limits for Lok Sabha Candidates
    • In larger states, the expenditure limit for each Lok Sabha constituency is ₹95 lakh.
    • For smaller states, the limit is set at ₹75 lakh per constituency.
  • Limits for Legislative Assembly Candidates
    • Candidates contesting in Legislative Assemblies have a spending cap of ₹40 lakh in larger states.
    • In smaller states, the limit for Assembly candidates is ₹28 lakh.
  • Regulation by the Election Commission
    • These expenditure limits are periodically revised and set by the Election Commission of India (ECI).

• • • Notably, there are no expenditure limits imposed on political parties during election campaigns.

These restrictions aim to promote fair competition, though the absence of limits for political party spending remains a key concern.

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Laws governing election expenditure in India

• Section 77 in The Representation of the People Act, 1951: This act outlines rules and regulations regarding election expenditure in India. 
  • Accounting keeping: every candidate is required to maintain an account of all election expenditures,  from the date of nomination to the declaration of results.
    • The account should keep all details such as date, purpose, and amount.
  • Exemptions from elections expenditures
    • Party leader travel; The expenses incurred by political parties leaders on or travel and campaigning is not considered as the expenses for individual candidates. 
    • Government official: According to Section 123(7) of the Act, expenses related to official duties of government officials are not counted as election expenditure. 
• Submission of Expenditure Statement: All candidates or their election agent are required to submit expenditure statements to the election commission of India. 
  • It is done within 30 days of the elections being declared. 
    • In case, a candidate fails to submit this statement or provides wrong information, it can cause disqualification of the candidate for up to three years. 

International Standards

• United States:
  • Election funding primarily comes from individual and PAC contributions.
  • There are spending limits for individual and PAC contributions to candidates.
  • Super PACs, with no spending limits, contribute significantly to overall costs.
  • In 2024, about $5.5 billion is expected for the presidential election, and $10.5 billion for Congress.
• United Kingdom:
  • Political parties can spend £54,010 per constituency, totaling approximately £35 million for all constituencies.
  • Candidate spending limits range from £46,000-49,000 during the long campaign and £17,000-20,000 during the short campaign.

Challenge of Rising Election Expenditure

• Excessive Spending: Political parties, especially major ones like the BJP and Congress, routinely exceed expenditure limits.
  • It is driven by significant donations that often create undue influence and conflicts of interest.
• Illicit Funding: A significant portion of election funds is spent on illegal activities like cash distribution to voters.
  • Limit Breaches: Major political parties in India frequently exceed the set candidate expenditure limits, while party spending remains unrestricted.
• Corruption: The high cost of elections fuels corruption, as politicians seek to recoup their investments.
  • Informal Spending: CMS reports that 35% of election funds are allocated to campaigns, and 25% is spent on voter inducements, with significant contributions remaining unreported.

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Potential Reforms

While there are various proposed solutions, including state funding and simultaneous elections, their implementation faces significant challenges. 

• Limit Party Funding to Candidates:
  • Legislation: Amend the law to ensure that political parties cannot provide financial assistance to candidates beyond their prescribed expenditure limits.
• Cap Political Party Expenditure:
  • Ceiling: Impose a ceiling on the total expenditure of a political party, based on the individual expenditure limits of its candidates.
• Expedite Election-Related Cases:
  • Judicial Efficiency: Appoint additional judges to High Courts to expedite the disposal of election-related cases, deterring violations of expenditure limits.

By implementing these reforms, we can create a more equitable and transparent electoral system, reducing the influence of money and promoting fair competition.

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