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Draft National Pharmaceuticals Policy 2023

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.

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