Securing the Future: HACCP’s Role in Quality Assurance for Indian Biosimilars

Securing the Future: HACCP’s Role in Quality Assurance for Indian Biosimilars 

India is rapidly emerging as a global leader in biosimilars—biological products that are highly similar to already approved biologics. These therapies are transforming treatment landscapes for chronic conditions like cancer, rheumatoid arthritis, and diabetes. As Indian manufacturers expand biosimilar production for both domestic use and global export, maintaining consistent quality and safety has never been more critical. 

Enter Hazard Analysis and Critical Control Points (HACCP)—a structured, science-based system that enables manufacturers to proactively identify and mitigate risks throughout the production process. While traditionally associated with food and vaccine safety, HACCP has found a crucial new role in ensuring the integrity, traceability, and regulatory compliance of biosimilars. 

This blog explores the importance of HACCP in biosimilar manufacturing in India, its benefits for domestic and export readiness, and how it helps align with the goals of Make in India and Atmanirbhar Bharat. 

Why Biosimilars Are India’s Next Biopharma Breakthrough 

Biologics have revolutionized medicine, but their high costs make them inaccessible to many. Biosimilars—almost identical versions of approved biologics—offer a cost-effective alternative while maintaining similar efficacy and safety. 

India holds a competitive edge in biosimilars due to: 

Several Indian firms are already exporting biosimilars to regulated markets, including the EU, Latin America, and Southeast Asia. However, success in biosimilars is impossible without robust quality systems—a space where HACCP plays a transformative role. 

Challenges Unique to Biosimilar Manufacturing 

Unlike generics, biosimilars are not simple chemical copies. They are made from living cells and are sensitive to minor changes in: 

Even the slightest variation can alter product behavior, leading to: 

Given this complexity, traditional end-product testing is not enough. A preventive, process-focused approach like HACCP is required to build control across all production stages. 

How HACCP Supports Biosimilar Quality Assurance 

HACCP principles—hazard identification, critical control point (CCP) determination, monitoring, verification, and documentation—map perfectly onto the biosimilar manufacturing lifecycle. 

Here’s how HACCP strengthens quality: 

1. Cell Line and Upstream Process Control 

2. Bioreactor Operations 

3. Downstream Purification 

4. Formulation and Fill-Finish 

Each CCP is aligned with biosimilar-specific risks and is continuously monitored and documented, ensuring that product variability is kept within tightly controlled limits. 

Make in India: Building Biosimilars the World Can Trust 

The Make in India initiative encourages domestic innovation and global competitiveness. Biosimilars represent a high-value sector where Indian companies can deliver both affordability and excellence—if supported by reliable quality systems. 

By implementing HACCP: 

Incorporating HACCP into biosimilar operations ensures that Make in India isn’t just about making more—it’s about making better. 

Atmanirbhar Bharat: Biosimilar Independence Backed by Process Mastery 

India’s push for self-reliance in healthcare is deeply tied to reducing import dependency for critical therapies. Biosimilars offer a way to: 

But this independence must be backed by process mastery. 

HACCP enables: 

These capabilities make India not only self-sufficient in biologics but also globally competitive. 

Regulatory Alignment Through HACCP 

Global regulatory bodies expect biosimilars to match their reference products in: 

HACCP provides a structured, evidence-based approach to meet these expectations by: 

According to a study on HACCP in Indian biopharma, facilities with strong HACCP integration had higher success rates in global regulatory audits, especially for biologics and vaccines. 

HACCP and Biosimilar Tech Transfers 

Tech transfers—when a biosimilar is moved from development labs to full-scale production—are high-risk transitions. HACCP systems streamline this process by: 

For Indian companies taking on international contract manufacturing or licensing deals, HACCP-driven tech transfers build credibility and long-term business partnerships. 

Digital Tools for Biosimilar HACCP 

Digitization makes HACCP easier to manage and scale, especially for biosimilar operations that involve multiple variables and equipment interfaces. 

Common tools include: 

These tools support: 

Workforce Training for Biosimilar HACCP Systems 

Biosimilar manufacturing requires highly trained personnel. HACCP helps structure training programs based on real risks and responsibilities. 

Companies are now: 

Trained employees not only ensure compliance but also contribute to continuous improvement by identifying new risks and refining CCP strategies. 

Policy-Level Support for HACCP in Biosimilars 

To promote biosimilar excellence, Indian regulatory and industry bodies can: 

This ecosystem-level support will strengthen India’s biosimilar sector holistically, making it both self-sufficient and export-ready. 

Conclusion: The Next Frontier, Safely Managed 

India’s rise in biosimilar manufacturing marks a defining moment in the country’s pharmaceutical journey. But this rise must be anchored in quality, predictability, and regulatory alignment. 

HACCP gives Indian companies the tools to: 

By embedding HACCP into biosimilar production, India not only accelerates its Make in India goals but also strengthens its position in Atmanirbhar Bharat—as a country capable of producing world-class biologics with homegrown systems, talent, and integrity. 

???? Bibliography  

Dhiman, K., & Dadwal, N. (2025). Implementation of hazard analysis and critical control points (HACCP) in Indian biopharmaceutical industries: A field study. Environment Conservation Journal, 26(1), 84–90. https://doi.org/10.36953/ECJ.28512885