Healing shakti: Rs 10,000 crore to promote India as hub for complex biological drugs, Pg7

Key Highlights:

• Biopharma Shakti mission launched with an outlay of Rs 10,000 crore over the next five years to promote India as a manufacturing hub for complex biological drugs.
• The mission aims to boost domestic production of biologics and biosimilars to combat non-communicable diseases.
• Three new National Institute of Pharmaceutical Education and Research (NIPER) will be established, and seven others will be upgraded.
• A network of 1,000 accredited clinical trial sites will be created to facilitate drug development and approval.

Detailed Insights:

• The Biopharma Shakti mission addresses India's shifting disease burden towards non-communicable diseases like diabetes, cancer and auto-immune disorders.
• Biologic medicines are considered crucial for improving longevity and quality of life at affordable costs.
• Strengthening the Central Drugs Standard Control Organisation (CDSCO) to meet global standards is a key focus.
• The government plans to create a dedicated scientific review cadre and specialists to expedite drug approvals.
• The initiative aims to capture a share of the global clinical trial market by bringing manufacturing to India.

Key Concepts Involved:

• Biologics: Medicines derived from living organisms, used to treat various diseases.
• Biosimilars: Biological products that are similar to an already approved biologic medicine.
• Clinical Trials: Research studies to evaluate the safety and efficacy of new medical treatments.
• CDSCO: National regulatory body for pharmaceuticals and medical devices in India.