Why is it in the news?

• The Department of Pharmaceuticals (DoP) has recently released a draft National Pharmaceuticals Policy (NPP) for 2023.
• The aim is to craft a holistic policy for the pharmaceutical sector in India.

About the Policy

Vision and Pillars:

• Designed to make India a global leader in pharmaceuticals.
• Supports self-reliance in pharmaceutical manufacturing.
• Seeks to improve health equity and access to medicine.
• Aims to streamline regulatory processes in the sector.
• Encourages investment to enhance the sector’s growth.

Other features:

• The policy aligns with ‘Atmanirbhar Bharat’ and ‘Make in India’, driving towards domestic innovation and global quality standards.
• A high-level task force will oversee policy implementation.
• A decade-long strategy will guide timely policy and program interventions.

Current State of Indian Pharma Industry:

• It’s the world’s 3rd largest by volume, valued at around USD 50 Billion.
• Known for being a significant supplier of affordable generics and vaccines.
• Exports span 200 countries, including stringent regulatory regions.
• Bulk drug and intermediates exports amounted to Rs 33,320 crore in 2021-22.
• Imports of Bulk Drugs/APIs are economically driven, indicating a dependency.
• Infrastructure: India hosts the largest number of US FDA-approved plants outside the USA.

Government Initiatives:

• Production Linked Incentive schemes.
• Development of Bulk Drug Parks.
• Schemes like Pharmaceutical Technology Upgradation Assistance (PTUAS), National R&D Policy, and the Promotion of Research and Innovation in Pharma-MedTech (PRIP) to support sector growth.

Challenges:

• Measures to ensure the safety and quality of drugs need improvement.
• Some drugs fail quality standards, indicating a need for better oversight.
• Higher production costs compared to countries like China.
• Raw materials, electricity, and other overheads contribute to the cost.

Other Industry Challenges:

• Heavy reliance on imported Active Pharmaceutical Ingredients (API) and Key Starting Materials (KSMs).
• Regulatory inefficiencies are prevalent.
• Skilled manpower and innovation funding are limited.

Conclusion:

• The industry must prioritize innovation to maintain global competitiveness.
• There’s a need for a renewed approach for Vision 2047, focusing on the ‘Amrit Kaal’ era.