UPSC Mains Current Affairs for 22 December 2025

Data Exclusivity and Its Implications for India’s Generic Drug Industry

December 22, 2025

Data Exclusivity Latest News

The Union government is exploring the introduction of data exclusivity in the pharmaceutical sector, raising concerns about delayed access to affordable generic medicines and the future of India’s generics-driven drug industry.

Understanding Data Exclusivity

When a pharmaceutical company develops a new drug, it must submit extensive clinical trial data to the drug regulator to prove the medicine’s safety and effectiveness.
Traditionally, once a drug’s patent period ends, other manufacturers are allowed to produce generic versions using abbreviated approval processes based on bioequivalence studies.
Data exclusivity changes this system. It grants the innovator company exclusive rights over its clinical trial data for a fixed period.
During this time, regulators are not allowed to rely on this data to approve generic versions, even if the patent has expired.
As a result, generic manufacturers must either wait for the exclusivity period to end or conduct their own costly clinical trials.
This protection works alongside patents, but it is distinct from them. While patents protect the invention, data exclusivity protects the underlying test data.

India’s Pharmaceutical Model and the Role of Generics

India’s pharmaceutical sector is globally known for its generic drug manufacturing capacity.
Nearly 90% of Indian pharmaceutical companies focus on generics rather than on developing new molecules. This model has ensured:
- Affordable medicines for domestic patients
- A strong export presence in developing countries
- India’s reputation as the “pharmacy of the Global South”
Crucially, India’s drug laws currently do not provide data exclusivity, which allows generic companies to enter the market immediately after patent expiry.

Government’s Current Approach

According to the report, the government has recently held inter-ministerial and industry-level consultations involving the Commerce Ministry, the Department for Promotion of Industry and Internal Trade (DPIIT), the pharmaceuticals department, and the health ministry to examine how data exclusivity could be implemented.
The move is reportedly linked to trade negotiations, particularly with the European Free Trade Association (EFTA), and the expectation that stronger intellectual property protections could attract large-scale foreign investment.
However, the Health Ministry has officially stated that there is no proposal from its side to introduce data exclusivity, indicating divergence within the government.

Impact on Access to Affordable Medicines

Introducing data exclusivity could have serious consequences for public health and the affordability:
- Delayed entry of generics even after patent expiry
- Higher drug prices due to an extended market monopoly
- Reduced availability of life-saving medicines for low-income populations
A key concern is that data exclusivity can protect even off-patent drugs, allowing innovator companies to retain exclusivity beyond the standard 20-year patent term. This can effectively extend monopolies without fresh innovation.

Implications for India’s Generic Industry

Experts argue that data exclusivity may weaken India’s generics-led growth model.
Since most Indian firms do not invest in original drug discovery, requiring them to conduct full clinical trials would significantly raise costs and reduce competitiveness.
It could also undermine patent challenges and compulsory licensing, tools that India has used to balance innovation with public health needs.
Past cases, such as court-approved generic production of expensive rare-disease drugs, may become harder if regulatory approval itself is blocked.

Role of the Drug Regulator

The Central Drugs Standard Control Organisation (CDSCO) has issued a notice suggesting that current regulations create an “uneven playing field” between original drug developers and generic manufacturers.
Critics argue that this framing indirectly supports a data exclusivity-based regulatory approach, without openly stating so.
Public health activists have warned that such regulatory incentives could lead to:
- Evergreening of patents
- Unnecessary clinical trials
- Delays in access to cheaper medicines
- Expansion of monopolies over traditional or existing drugs

Way Forward

India currently has no international legal obligation to introduce data exclusivity. Any move in this direction must balance:
- Innovation incentives
- Trade and investment goals
- Public health priorities
- Constitutional commitments to affordable healthcare

Source: IE

Data Exclusivity FAQs

Q1: What is data exclusivity in pharmaceuticals?

Ans: It is a provision that prevents regulators from using an innovator’s clinical trial data to approve generic drugs for a fixed period.

Q2: How is data exclusivity different from patents?

Ans: Patents protect the invention, while data exclusivity protects the clinical trial data submitted for regulatory approval.

Q3: Why is data exclusivity controversial in India?

Ans: It can delay access to affordable generic medicines and weaken India’s generics-based pharmaceutical industry.

Q4: Does India have an international obligation to implement data exclusivity?

Ans: No, India is not legally bound under any trade agreement to introduce data exclusivity.

Q5: How could data exclusivity affect public health?

Ans: It may increase drug prices and delay the availability of life-saving medicines, especially for poorer populations.

Elephant–Train Collisions in India: Causes, Impact, and Prevention Measures

December 22, 2025

Elephant–Train Collisions Latest News

Recently, seven elephants were killed when the Delhi-bound Rajdhani Express hit a herd in Assam’s Hojai district.
The impact derailed the locomotive and five coaches, but no passengers were injured.

Elephant Deaths on Railway Tracks: Scale and Causes

India is home to over half of the world’s Asian elephant population, and train collisions have emerged as a major human-caused threat to their survival.
Railway accidents are among the leading anthropogenic causes of elephant deaths in the country.

Alarming Mortality Data

Between 2010 and 2020, at least 1,160 elephants died due to non-natural causes.
Electrocution was the biggest killer (741 deaths), followed by train hits (186 deaths).
Notably, electrocution is often linked to high-voltage overhead railway lines, indirectly tying rail infrastructure to multiple causes of death.

Impact of Linear Transport Infrastructure (LTI)

Railways, roads, and canals cutting through forests fragment elephant habitats.
Such infrastructure can trap herds, restrict access to food and water, and increase stress, negatively affecting long-term health and survival.

Night-Time Collisions and Behavioural Factors

Studies show that most train–elephant collisions occur at night.
Male elephants are disproportionately affected, as they cross tracks more frequently, especially during crop-harvest seasons when they engage in crop-raiding, increasing exposure to railway lines.

Preventing Elephant–Train Collisions: Why Crossings Matter

According to the Handbook to Mitigate the Impacts of Roads and Railways on Asian Elephants (2023) by the International Union for Conservation of Nature (IUCN), the most effective strategy is avoiding elephant habitats and migration corridors while planning infrastructure.
Mitigation measures are not substitutes for careful route selection, but are necessary when avoidance is impractical.

Wildlife Crossing Structures: The Core Solution

Well-designed wildlife crossing structures, combined with fencing, can reduce wildlife mortality by up to 98%.
These crossings form the backbone of effective mitigation strategies for roads and railways cutting through elephant landscapes.

Types of Crossings and Design Principles

Crossings can be underpasses (beneath bridges or flyovers) or overpasses (over tunnels or green bridges).
The choice depends on terrain and animal behaviour. For elephants, openness is critical—they avoid confined spaces.
The handbook recommends minimum heights of 6–7 metres, adjusted for crossing length, to ensure usage.

Placement Based on Elephant Movement

Where and how many crossings are built matters as much as design.
Camera traps and GPS telemetry are used to map elephant movement and identify collision hotspots.
These data guide the optimal placement of crossings.

Fencing as a Support Tool

Strategic fencing along high-risk stretches prevents elephants from straying onto tracks and gently channels them toward designated crossings, enhancing the effectiveness of the entire mitigation system.

Using Technology to Prevent Elephant–Train Collisions

Role of Early-Warning Systems - Alongside habitat avoidance and physical measures like crossings and fencing, technology-based early-warning systems are emerging as effective non-structural solutions to reduce elephant–train accidents by alerting train operators in advance.
Types of Sensor-Based Technologies - Early-warning systems can be locomotive-based or ground-based. Locomotive systems use Forward Looking Infrared (FLIR) cameras, capable of detecting obstructions up to 750 metres, even in poor visibility.
- Ground-based systems deploy cameras, acoustic, or seismic sensors at known elephant crossing points.
AI and Machine Learning as Game Changers - Earlier, these systems were limited by the massive data they generated and difficulties in distinguishing real threats from false alarms.
- Artificial intelligence and machine learning now allow faster, more accurate analysis, greatly improving reliability and response time.

Indian Railways’ Pilot Initiatives

Indian Railways has begun deploying AI-based early-warning systems, though adoption remains limited.
In 2023, the Northeast Frontier Railway pioneered AI monitoring to protect elephants, followed by a similar rollout along the Kerala–Tamil Nadu border in 2024.
Early results from these pilots have been encouraging, suggesting strong potential for wider implementation.

Source: IE | BBC

Elephant–Train Collisions FAQs

Q1: Why are elephant–train collisions common in India?

Ans: Elephant–train collisions in India occur due to railways cutting through elephant habitats, night-time movement, and increased crossings during crop-raiding seasons.

Q2: How serious is the elephant mortality caused by trains?

Ans: Between 2010 and 2020, at least 186 elephants died in train hits, making rail accidents one of the leading human-caused threats to Asian elephants.

Q3: How do railway lines affect elephant habitats?

Ans: Railways fragment habitats, trap herds, restrict access to food and water, and increase stress, indirectly harming elephant health and survival.

Q4: What role do wildlife crossings play in prevention?

Ans: Well-designed underpasses or overpasses, combined with fencing, can reduce elephant–train collisions by up to 98%, according to global conservation guidelines.

Q5: How can technology reduce elephant–train collisions?

Ans: AI-based early-warning systems using FLIR cameras and sensors help detect elephants in advance, allowing train operators to slow down and avoid collisions.

Securities Markets Code Bill 2025: One Law, One Market for India’s Capital Markets

December 22, 2025

Securities Markets Code Bill 2025 Latest News

The Securities Markets Code (SMC), 2025, tabled in Parliament, proposes a sweeping overhaul of India’s securities regulation framework. It aims to strengthen investor protection, reduce compliance burdens, improve regulatory governance, and promote ease of doing business.
The Bill grants greater powers to Securities and Exchange Board of India (SEBI), decriminalises minor violations, and bolsters market infrastructure institutions.
Crucially, it consolidates three existing laws—the Securities Contracts (Regulation) Act, 1956, the SEBI Act, 1992, and the Depositories Act, 1996—into a single, comprehensive code.

What the Securities Markets Code Bill, 2025 Replaces

The Securities Markets Code Bill, 2025 proposes to merge and replace three existing securities laws—the Securities Contracts (Regulation) Act, 1956 (SCRA), the SEBI Act, 1992, and the Depositories Act, 1996.
These decades-old statutes contain overlapping and redundant provisions that no longer align with today’s technology-driven, complex markets.
The consolidation—first announced in Budget 2021—aims to move toward a single, principle-based framework that reduces interpretative conflicts and improves legal certainty.
Stronger and More Representative Regulator - Under the Code, the board of Securities and Exchange Board of India will expand from 9 to 15 members, adding representatives from the Central Government, the Reserve Bank of India, and more whole-time members to strengthen governance and expertise.
Tighter Conflict-of-Interest Norms - While earlier laws required disclosure of pecuniary interests, the new Code broadens the scope to include family members’ interests, mandating disclosure and recusal to enhance transparency and integrity in decision-making.
Investor-Centric Additions - The Code formally incorporates an Investor Charter, which earlier had no explicit statutory backing. It also introduces a statutory Ombudsman as an independent grievance redressal authority, distinct from enforcement wings—addressing a long-standing gap in investor protection.

Key Provisions of the Securities Markets Code, 2025

Strengthening SEBI’s Governance
- The Code empowers the government to remove SEBI Board members for conflicts of interest or convictions involving moral turpitude.
- It mandates disclosure of direct or indirect interests and expands the Board from 9 to 15 members, adding Central Government and RBI representation and more whole-time members.
Easier, Proportionate Compliance
- Contraventions are reclassified into two buckets.
- Lesser violations (including fraudulent and unfair practices) are decriminalised and attract only civil penalties, while market abuse—serious misconduct harming market integrity—may invite both civil penalties and criminal action.
- This aims to reduce compliance burden while preserving deterrence.
Stronger Investor Protection
- The Code requires Securities and Exchange Board of India to specify an Investor Charter, standardise grievance redressal across intermediaries and issuers, and appoint Ombudsperson(s) for time-bound resolution.
- It also opens public consultations to investors, improving transparency and participation.
Simplified Rules for Regulated Entities
- A consolidated registration framework is proposed for intermediaries and pooled investment vehicles.
- Stock exchanges, clearing corporations, and depositories are brought under a single code, with SEBI allowed to delegate registration functions to MIIs and SROs to streamline oversight.
Better Inter-Regulatory Coordination
- The Bill enables coordination among regulators to ease listing of other regulated instruments and improve interoperability among Market Infrastructure Institutions (MIIs), supporting smoother market operations, improved investment climate, and stronger market-making.

Aligning India’s Securities Law with Global Best Practices

The Securities Markets Code Bill, 2025 incorporates international best practices by strengthening regulatory governance, accountability, and transparency.
It introduces regulatory impact assessments, ensures arm’s-length separation between investigation and adjudication, establishes an Ombudsperson for investor grievances, and enables inter-regulatory coordination.
Experts note that by combining enhanced penalties, clearer adjudication, and greater regulatory flexibility for innovation, the consolidation of multiple laws into a single code marks a significant step toward a modern, globally aligned securities framework.

Source: IE | PRS

Securities Markets Code Bill 2025 FAQs

Q1: What is the Securities Markets Code Bill 2025?

Ans: The Securities Markets Code Bill 2025 is a comprehensive law that consolidates India’s securities regulations to improve investor protection, governance, and ease of doing business.

Q2: Which laws does the Securities Markets Code Bill replace?

Ans: The Bill replaces the SCRA 1956, SEBI Act 1992, and Depositories Act 1996, merging them into a single, principle-based regulatory framework.

Q3: How does the Securities Markets Code Bill strengthen SEBI?

Ans: It expands SEBI’s board, tightens conflict-of-interest rules, grants stronger enforcement powers, and allows delegation to market infrastructure institutions.

Q4: How does the Bill improve ease of compliance?

Ans: It decriminalises minor violations, introduces proportionate penalties, and distinguishes serious market abuse from procedural lapses, reducing compliance burden.

Q5: Why is the Securities Markets Code Bill 2025 important?

Ans: The Bill modernises regulation, enhances transparency, strengthens investor grievance redressal, and aligns India’s capital markets with global best practices.