🗞️ Why in News The Union Budget 2026-27 announced the Biopharma SHAKTI (Strategy for Healthcare Advancement through Knowledge, Technology, and Innovation) initiative with a Rs 10,000 crore allocation to position India as a global biomanufacturing hub for biologics and biosimilars.
What Are Biologics and Biosimilars?
Biologics are complex medicines derived from living cells — they include monoclonal antibodies, vaccines, gene therapies, and cell therapies. Unlike chemical drugs (generics), biologics cannot be exactly replicated because they are produced by living organisms.
Biosimilars are “similar” versions of approved biologic medicines, comparable in quality, safety, and efficacy. They are to biologics what generics are to chemical drugs — but with far greater complexity in manufacturing and regulatory approval.
Key Components of Biopharma SHAKTI
Educational Infrastructure
- 3 new NIPERs (National Institutes of Pharmaceutical Education and Research)
- 7 existing NIPERs upgraded with biopharmaceutical research facilities
- Focus on training workforce in biologics R&D, manufacturing, and regulatory science
Clinical Trial Ecosystem
- Network of 1,000+ accredited India Clinical Trial sites
- Standardised protocols aligned with ICH-GCP (International Council for Harmonisation — Good Clinical Practice) guidelines
- Faster recruitment for multi-site trials
Regulatory Strengthening
- CDSCO to be strengthened with a dedicated scientific review cadre
- Target: match global approval timeframes (currently India takes 12-18 months vs US FDA’s 10 months)
- Shift toward non-animal testing models (3Rs principle: Replace, Reduce, Refine)
India’s Pharma Industry — Current Standing
| Parameter | Data |
|---|---|
| Global pharma production rank | 3rd by volume |
| Generic medicines share | ~20% of global supply |
| Vaccine supply share | ~60% of global supply |
| Domestic biosimilars approved | 95+ |
| Global biosimilar market share | ~3.2% (2025) |
| Industry size | ~$50 billion (2025) |
| Pharma exports FY2025 | ~$28 billion |
Despite being the “Pharmacy of the World” in generics and vaccines, India’s share in the $500+ billion global biologics market remains under 4%.
Why Biologics Matter
Biologics are critical for treating:
- Cancer — monoclonal antibodies (trastuzumab, rituximab, pembrolizumab)
- Diabetes — insulin analogs
- Autoimmune diseases — adalimumab, infliximab
- Rare diseases — gene therapies, enzyme replacement therapies
The global biologics market is expected to reach $800+ billion by 2030, growing at 8-10% annually. India’s cost advantage in manufacturing could make biosimilars 30-40% cheaper than originator biologics.
NIPERs — National Institutes of Pharmaceutical Education and Research
NIPERs are institutes of national importance established under the NIPER Act, 1998. Currently, there are 7 NIPERs across India:
| NIPER | Location |
|---|---|
| NIPER-1 | S.A.S. Nagar (Mohali), Punjab |
| NIPER-2 | Hyderabad, Telangana |
| NIPER-3 | Ahmedabad, Gujarat |
| NIPER-4 | Hajipur, Bihar |
| NIPER-5 | Kolkata, West Bengal |
| NIPER-6 | Guwahati, Assam |
| NIPER-7 | Raebareli, Uttar Pradesh |
With Biopharma SHAKTI, 3 new NIPERs will be established (locations to be announced), and all existing 7 will be upgraded.
CDSCO — Regulatory Body
The Central Drugs Standard Control Organisation functions under the Drugs and Cosmetics Act, 1940. It is headed by the Drugs Controller General of India (DCGI). CDSCO regulates:
- New drug approvals
- Clinical trial permissions
- Import licences for drugs
- Blood bank regulation
UPSC Relevance
Prelims: NIPER Act 1998, CDSCO, DCGI, Drugs and Cosmetics Act 1940, biologics vs biosimilars, 3Rs principle
Mains GS-3: India’s pharmaceutical industry; Make in India for healthcare; science and technology policy
Interview: “India is the pharmacy of the world for generics but not for biologics. What structural changes does Biopharma SHAKTI address?”
📌 Facts Corner — Knowledgepedia
Biopharma SHAKTI:
- Full form: Strategy for Healthcare Advancement through Knowledge, Technology, and Innovation
- Budget allocation: Rs 10,000 crore
- New NIPERs: 3; existing upgrades: 7
- Clinical trial sites: 1,000+ accredited
- Non-animal testing: 3Rs principle (Replace, Reduce, Refine)
India’s Pharma Sector:
- Global rank: 3rd by volume
- Generic medicines: ~20% of global supply
- Vaccines: ~60% of global supply
- Biosimilar market share: ~3.2% globally
- Approved domestic biosimilars: 95+
- Industry size: ~$50 billion
- Exports: ~$28 billion/year
Regulatory Framework:
- CDSCO: under Drugs and Cosmetics Act, 1940
- DCGI: Drugs Controller General of India
- NIPERs: 7 existing (NIPER Act, 1998) + 3 new
- Indian Pharmacopoeia Commission (IPC): sets quality standards
Other Relevant Facts:
- Global biologics market: $500+ billion (2025), expected $800+ billion by 2030
- Top biologics companies: Roche, AbbVie, Johnson & Johnson, Amgen
- Indian biosimilar leaders: Biocon, Dr Reddy’s, Cipla, Zydus
- PM-ABHIM (Ayushman Bharat Health Infrastructure Mission): Rs 64,180 crore for health infra
Sources: Business Standard, Insights on India, Inc42