India-EU trade deal: What it means for pharma sector, Pg15

Key Highlights:

• The India-EU FTA aims to boost trade by reducing tariffs on pharmaceuticals and increasing EU access to India’s medical devices market.
• Tariffs on nearly all EU pharma products and over 90% of optical, medical, and surgical equipment will be eliminated.
• The agreement seeks to restore export competitiveness for Indian generics and med-tech.
• Concerns exist regarding the potential flooding of the Indian market with second-hand medical devices from the EU.

Detailed Insights:

• The FTA is expected to lower healthcare costs in India by reducing the costs of advanced medical equipment imported from Europe, thereby improving clinical outcomes.
• Easier access to India’s market for high-end medical devices and technologies is granted to EU firms, potentially encouraging investment in India’s research-based pharma sector.
• India has resisted EU demands for stricter IP rights and data exclusivity to protect its large generic medicine sector and maintain affordable medicine prices.
• There are concerns that the deal may slow down the growth of indigenous production of medical devices due to increased competition from EU imports.
• A call for standalone legislation for the regulation of medical devices has been made, to ensure patient safety and create a level playing field for domestic and foreign manufacturers.
• Currently, only 23 devices are regulated by the Ministry of Health through amendments to the Drugs and Cosmetics Act, leaving a significant portion of imported medical devices unregulated.

Key Concepts Involved:

• Free Trade Agreement (FTA): An agreement between two or more countries to reduce or eliminate trade barriers such as tariffs and quotas.
• Intellectual Property (IP): Rights granted to creators and inventors for their original works, including patents, trademarks, and copyrights.
• Generics: Medications sold under their chemical name rather than a brand name, typically after the patent protection of the original drug has expired.