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Current Affairs 16th February 2024 for UPSC Prelims Exam

Data Exclusivity – FTA

Context: India has rejected the demand of the four European nations EFTA bloc for inclusion of a ‘data exclusivity’ provision in proposed free trade agreements.


  • EU and EFTA Demands: Since 2008, the European Union and the European Free Trade Association (EFTA) countries (Switzerland, Norway, Iceland, Lichtenstein) have been pushing for data exclusivity clauses in trade negotiations with India.
  • Swiss Pharmaceutical Companies: Switzerland, known for its major pharmaceutical firms, has seen some of these companies engage in legal battles in India over generic drugs.
  • Leaked Draft Concerns: A leaked draft of the Trade and Economic Partnership Agreement (TEPA) suggested the presence of a data exclusivity clause, raising concerns despite advanced stage negotiations between India and EFTA.

India’s Stance

  • India has consistently rejected these demands to protect its generic drug industry.
  • Indian officials have affirmed their support for the domestic generic drug industry, emphasising its importance for the country’s health sector and export economy.
  • India vows to safeguard the interests of its generic drug industry in all free trade agreements, ensuring no compromise on this front.

Data Exclusivity: An Overview

  • Definition: Data exclusivity protects the research data generated by innovator companies, demonstrating the effectiveness of their products, from being used by competitors.
  • Importance in Pharmaceuticals: In the pharmaceutical industry, companies conduct costly international clinical trials to establish the safety and efficacy of new medications.
  • Impact on Market Competition: Exclusive rights to this data enable original drug manufacturers to block competitors from obtaining marketing approval for generic versions of their drugs during the exclusivity period.

Concerns Regarding Data Exclusivity

  • Advocacy by Developed Countries: Developed nations push for data exclusivity in developing countries to compensate for drug development investments and R&D costs, similar to patent protections.
  • Impact on Generics: Data exclusivity prevents generic drug market entry, affecting public health by limiting access to affordable medicines.
  • Pharmaceutical Strategy: Drug companies favour data exclusivity to extend their market monopolies beyond the standard 20-year patent period or to obtain exclusivity for drugs without patents, thereby stalling competition from generics.
  • Requirement for Generic Manufacturers: Generic manufacturers are compelled to conduct original clinical trials anew during the data exclusivity period instead of simply demonstrating bioequivalence, posing a considerable obstacle.
  • Consequences of Data Exclusivity: The introduction of generics is delayed in jurisdictions with data exclusivity due to the prohibitive costs and logistical hurdles of repeating clinical trials.
  • Price and Access Implications: Data exclusivity contributes to maintaining high drug prices by curtailing generic competition, rendering medications unaffordable for many.
  • Ethical Concerns: The requirement for generics to undergo fresh clinical trials raises ethical questions due to the redundancy of human testing.

India’s Positions

  • Potential Effect in India: Data exclusivity in India could challenge Section 3(d) of the Patents Act, which bars patent ever-greening, by allowing exclusive rights for non-patented drugs.
  • India’s Position: Contrary to Western practices, India does not enforce data exclusivity, permitting the approval of bioequivalent generics utilising trial data that is already available to the public.

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Global Pulses Conference

Context: The Global Pulses Conference, an annual meeting of pulse producers, processors and traders, has suggested India to augment production of pulses to meet the nutritional requirements.

About Global Pulses Conference

  • Organised By: National Agricultural Cooperative Marketing Federation of India Ltd. (NAFED) and the Global Pulse Confederation (GPC).
  • Aim: To facilitate knowledge sharing among experts, stakeholders, and policymakers.
  • Previous Editions:
    • 2023: Sydney, Australia
    • 2022: Dubai

About Global Pulse Confederation (GPC)

  • Previous Name: Initially known as CICILS IPTIC.
  • Representation: The Global Pulse Confederation (GPC) represents various sectors in the pulse industry including growers, researchers, logistics, traders, exporters, importers, governmental entities, multilateral organisations, processors, canners, and consumers.
  • Membership Composition: Comprises 24 national associations and over 600 members from the private sector.
  • Headquarters: Dubai.

Pulses Production In India

  • Global Standing in Pulses: India is the world’s largest producer (25%), consumer (27%), and importer (14%) of pulses.
  • Contribution to Agriculture:
    • Pulses occupy about 20% of the total area under food grain cultivation.
    • They contribute approximately 7-10% to India’s total foodgrain production.

Current Affairs 16th February 2024 for UPSC Prelims Exam_4.1

  • Seasonal Production:
    • Pulses are cultivated during both Kharif and Rabi seasons.
    • Over 60% of India’s pulse production comes from the Rabi season.
  • Leading Producing States: The top states for pulse production are Madhya Pradesh, Maharashtra, Rajasthan, Uttar Pradesh, and Karnataka.

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I, Sakshi Gupta, am a content writer to empower students aiming for UPSC, PSC, and other competitive exams. My objective is to provide clear, concise, and informative content that caters to your exam preparation needs. I strive to make my content not only informative but also engaging, keeping you motivated throughout your journey!

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