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.