Daily Hot Topic
Topic : Pharma Sector in India
GS-3 Mains : Defence
Revision Notes
Question : Evaluate the major initiatives undertaken by the Indian government to promote the growth and development of the pharmaceutical sector, and how these initiatives can contribute to enhancing the competitiveness, innovation, and self-reliance of the Indian pharma industry.
Context:
- Central Drugs Standard Control Organisation (CDSCO) now sole authority for issuing manufacturing licenses for export drugs.
Industry Status:
- India’s pharma sector:
- 3rd largest globally (volume)
- 14th largest globally (value)
- 2% of GDP contribution
- 8% of merchandise exports contribution
- 5% of global drug exports
- Vast network: 3,000 drug companies, 10,500 manufacturing units
- 500 API manufacturers contribute 8% to global API industry
- Current market size: ~$50 billion
- Nicknamed “pharmacy of the world” for supplying affordable generics
Growth Prospects:
- Expected to reach 13% of global market size
- Targeted growth to $200 billion by 2030 (4x current size)
- Focus on generic drugs improves access to essential medicines
Challenges in Indian Pharma Sector
- Import Dependence:Reliant on imported APIs and KSMs, vulnerable to disruptions and price fluctuations.
- Slow R&D:Lags in developing biologics, biosimilars, and other new products. This can hinder competitiveness.
- Regulatory Delays:Inefficient regulations lead to delays in drug approvals and higher costs. (e.g., recent CDSCO * Central Drugs Standard Control Organization (CDSCO)( decision on NOCs)
- Funding for Innovation:Limited access to capital restricts development of new drugs and therapies.
Major Initiatives
- PLI Scheme:Provides incentives for domestic manufacturing of bulk drugs and medical devices.
- FDI Relaxation:Allows 100% FDI for new pharma projects.
- Bulk Drug Parks:Aims to create world-class infrastructure for cost-effective drug production.
- PTUAS Scheme:Upgrades technology in the pharma industry for better drug quality and competitiveness.
- National R&D Policy:Promotes research and development of new drugs to make India a global leader.
- PRIP Scheme:Encourages research and innovation in medical devices and pharmaceuticals.
- Vision Pharma 2047:Aims to make India a leader in affordable, innovative & quality pharma products by 2047.
Way Forward
- Expiry of Patents:Opportunity for Indian generics market to expand with new off-patent drugs ($251 billion globally).
- Transparency & Technology:Industry is adopting stricter norms and automation for improved quality and efficiency.
Additional Information (Arora IAS)
CDSCO (Central Drugs Standard Control Organisation)
- National Regulatory Authority for drugs and cosmetics in India.
- Works under Ministry of Health & Family Welfare.
Responsibilities under Drugs and Cosmetics Act:
- Approves drugs.
- Conducts clinical trials.
- Sets drug standards.
- Controls quality of imported drugs.
- Coordinates with state drug control organizations.
Jointly with state regulators (for specific drugs):
- Grants licenses for critical drugs (vaccines, sera etc.).
Drugs Controller General of India (DCGI):
- Heads CDSCO.
- Approves licenses for specific drugs (blood products, IV fluids etc.).
- Sets drug standards for manufacturing, sales, import, and distribution.
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