Indian Express Editorial Analysis

Patent Injustice: Challenges and Opportunities in the Biopharmaceutical Sector

 

Understanding Biopharmaceuticals

• Definition: Medicines derived from living cells, unlike conventional chemical drugs.
• Applications: Transformative in treating chronic illnesses like cancer, diabetes, cardiovascular disease, and autoimmune diseases.
• Types:
  • Biologics: Original drugs developed from living cells.
  • Biosimilars: Close replicas of biologics, having the same efficacy and safety, treating identical conditions.

 

Indian Biopharmaceutical Industry

• Growth: Valued at $60 billion, making it one of the world’s fastest-growing sectors.
• Innovation Ranking: India improved from 81st in 2015 to 39th in the Global Innovation Index.

 

India’s Role in the Global Biosimilars Market

• Pioneer Status: India leads globally in biosimilars, with 98 approved products and over 50 in the market.
• Market Value: Indian biosimilars market valued at $349 million in 2022; expected to reach $2.1 billion by 2030 with a 25.2% growth rate.
• Patent Expirations: By 2030, biologics worth $170 billion globally will lose patents, opening markets for Indian biosimilars.

 

Government Support through the National Biopharma Mission

• Objective: Supports biopharmaceutical R&D under the Make in India initiative.
• Funding: $250 million initiative, co-funded by the World Bank, supporting 150 organizations and 300 MSMEs.
• Outcomes: Over 200 grantees supported, leading to 18 product launches and improved healthcare access.

 

Patent Evergreening: Hindrance to Affordable Biosimilars

• Patent Goal: Grants a 20-year market exclusivity to incentivize R&D.
• Evergreening Strategy: Minor changes in formulations extend patents, blocking biosimilar entry.
  • Example: Roche extended trastuzumab’s market hold by creating a subcutaneous version.
• Cost Impact: In the US, evergreening costs healthcare an estimated $700 million annually.

 

India’s Legal Safeguards Against Evergreening

• Patents Act, 1970:
  • Section 3(d): Disallows patents on minor modifications lacking significant advancement.
    • Example: Novartis’ patent on Glivec was rejected.
  • Section 3(e): Prevents patenting compound mixtures without proven synergy.
  • Section 3(i): Bans patents on treatment methods.
• Challenge: Despite laws, 72% of Indian pharmaceutical patents are granted for secondary modifications, limiting biosimilar availability.

 

Global Approaches and India’s Path Forward

• United States: 74% of new patents are for existing drugs, prolonging monopolies.
• European Union: EMA’s 2005 biosimilar guidelines have boosted cost savings and access, especially in Germany and the Nordic nations.

Way Forward

To ensure affordable biosimilar access, India should fortify patent opposition mechanisms, preventing monopolies via minor drug tweaks. A balanced patent system will secure affordable treatment for critical illnesses and promote authentic innovation in the biopharma sector.

 

 

 

Indian Express Editorial Analysis

TOP Crops and Price Volatility: Challenges for RBI Amid Rising Inflation

 

RBI’s Inflation Stance

• Repo Rate Hold: RBI maintains the current repo rate due to high inflation.
• CPI Inflation: 5.5% in September.
• Food Inflation: Reaches 9.2%, with vegetables driving a 36% inflation due to high CPI weighting.

 

Impact of Food Inflation on CPI and RBI Limitations

• CPI Weighting: Food and beverages contribute 45.9% to CPI, based on outdated 2011-12 data.
  • Update Needed: Revised 2022-23 data may lower food’s weight by 5-6%, making CPI more accurate.
• RBI’s Performance: Despite challenges, India’s 2024 inflation rate of 4.4% remains below the EMDE average of 7.9%.

 

Causes of Rising Food Inflation

• Vegetable Inflation: Responsible for 63% of overall food inflation.
  • Tomatoes: 42.4% price rise due to delayed harvest and pest issues.
  • Onions: 66.2% surge from storage loss and weather effects.
  • Potatoes: 65.3% spike due to low mandi arrivals and base effect from the prior year.
• Structural Issues: Supply chain inefficiencies and climate sensitivity impact perishable goods.

 

Policy Measures and Gaps in Agriculture

• Operation Greens: Launched in 2018 for tomatoes, onions, and potatoes (TOP), expanded to all fruits and vegetables, which diluted its effectiveness.
• Post-Harvest Losses: High losses persist—18-26% for potatoes, 25% for onions, and 11.6% for tomatoes.
• Export Duties: Recent 40% export duty on onions shows a short-term approach to price stabilization.

 

Long-Term Solutions to Control Vegetable Inflation

• Processing and Value Addition:
  • Process 10-15% of tomato output into paste and puree.
  • Dehydrate onions into flakes and powder, as seen in successful partnerships like Jain Irrigation.
• Specialised Agency: Establish an expert-staffed agency focused solely on TOP crops for more efficient oversight.

Conclusion: Ensuring Price Stability for RBI

The RBI requires government action on long-term agriculture policies for stable inflation control. A dedicated approach to TOP crops will ease inflationary pressures and enable more flexibility with the repo rate.