India’s pharma story is more than generics and vaccines — it’s about adaptable business models that enabled us to serve the world, efficiently and affordably. Over the last decade, India’s pharma industry has:
- Supplied 60%+ of global vaccine demand
- Become the largest generic drug exporter
- Hosted thousands of formulations and API units
- Emerged as a CRAMS and CDMO hub for global pharma giants
Behind this rapid growth is a mix of operating models like loan license, third-party, CROs, CMOs, CDMOs, CRAMS, etc. While many of these terms are used interchangeably in casual discussions, each has specific legal, operational, and business implications. Here is a concise yet comprehensive breakdown of what each typically means:
Let’s know each of them with examples and their role in India’s pharma journey.
🔁 1. Third-Party Manufacturing
- What it is: A company owns a brand but outsources manufacturing to another.
- Indian example: Mankind may outsource a batch of tablets to a Baddi-based GMP unit.
- Impact: Allowed rapid brand proliferation without CapEx; 100s of MSME units survive on this.
🔄 2. Loan License
- What it is: A company gets a regulatory license to manufacture from someone else’s plant.
- Indian twist: Common in India to avoid CapEx and still show own “manufactured by” label.
- Example: A Mumbai-based company gets a loan license at a Himachal plant for their Ayurvedic syrup.
- Impact: Boosted flexibility for marketing companies and helped small units survive by “renting out” license capacity.
🔧 3. Toll Manufacturing
- What it is: The brand owner provides raw material, the other party only processes.
- Example: A Gujarat API company gives its raw API to a local formulator to make finished tablets on a “conversion cost” basis.
- Impact: Encouraged cost-efficient supply chains and control over quality by big players.
🤝 4. P2P (Principal to Principal)
- What it is: A tax/regulatory model where both buyer and seller deal as independent companies.
- Example: A Hyderabad company sells formulations to a Mumbai company under P2P; not a service, but a supply.
- Impact: Ensures clear tax documentation, helps in audits and regulatory traceability.
🧪 5. CRO (Contract Research Organization)
- What it is: Provides clinical trials, BA/BE studies, and other research services.
- Example: Companies like Veeda Clinical or Lambda Research conduct studies for both Indian and global pharma.
- Impact: Helped India become a cost-effective R&D destination.
🧪➕🏭 6. CRAMS (Contract Research & Manufacturing Services)
- What it is: From molecule discovery to large-scale production — full-spectrum outsourcing.
- Example: Syngene (Biocon), Piramal Pharma, and Divi’s Labs serve innovator companies from molecule to market.
- Impact: Big FDI inflow + high-value outsourcing made India a global CRAMS hub.
⚗️ 7. CMO (Contract Manufacturing Organization)
- What it is: Offers only manufacturing — no R&D or development.
- Example: A plant in Baddi makes WHO-GMP-certified products for clients in Africa.
- Impact: Fueled generic exports, helped in scale and specialization.
🧪 8. CDO (Contract Development Organization)
- What it is: Focuses on formulation and process development, not commercial supply.
- Example: A startup develops a novel nasal spray and uses a CDO to design formulation and get regulatory support.
- Impact: Accelerates innovation, particularly in drug delivery platforms, OTC, and nutraceuticals.
⚗️ 9. CDMO (Contract Development & Manufacturing Organization)
- What it is: Offers product development + manufacturing, including tech transfer, stability studies, scale-up.
- Example: Companies like Aragen, Suven, and Gland Pharma help multinationals develop & manufacture.
- Impact: High-margin, high-value export model; India is now a major CDMO player, especially in injectables and biologics.
🚀 How These Models Armoured India’s Pharma Industry:
Enabler | Contribution |
🏭 Manufacturing Outsourcing (Third-party, Loan License, CMOs) | Helped thousands of MSMEs grow, created jobs, low-cost capacity |
💼 Asset-Light Brands | Allowed marketing companies to launch fast, avoid CapEx |
🌍 Global Trust | CRAMS & CDMO models built trust with Big Pharma (Pfizer, Novartis, J&J, etc.) |
🧪 R&D Efficiency | CROs and CDOs helped India become a preferred clinical research destination |
💰 Economic Impact | Boosted exports, forex inflow, FDI in pharma |
🧬 Innovation Support | CDMOs and CDOs allowed Indian startups to punch above their weight |
🤝 Flexibility | Models like Toll and P2P offered custom solutions for niche markets and tax strategies |
🔮 Future Outlook (Next Decade)
- Global push for “China + 1” = More CDMO and API opportunities for India.
- High-end R&D (biologics, mRNA, gene therapy) = Boon for CRO/CDMO models.
- Innovation + IP = Indian CDOs and formulation specialists will co-develop products with innovators.
- MSME scale-up = Government support (PLI schemes, cluster models) to empower third-party & loan-license units.
At Crescentia, we see these models not as jargon, but as levers to deliver flexible, scalable, and innovation-aligned solutions to global partners.
The next decade will be shaped by value-added generics, specialty CDMOs, and integrated R&D-to-commercial journeys — and India is ready to lead from the front.