Orthobiologic therapies in India: Current evidence, clinical practice, and regulatory challenges

Background: Orthobiologics are increasingly used as minimally invasive adjuncts in the management of musculoskeletal disorders. In India, their clinical application has expanded in response to the growing burden of osteoarthritis, sports injuries, and degenerative conditions. Objective: To review current evidence on commonly used orthobiologic therapies and assess their clinical relevance, guideline support, and regulatory considerations in the Indian context. Materials and Methods: A focused narrative review was performed on platelet-rich plasma (PRP), bone marrow aspirate concentrate (BMAC), stromal vascular fraction (SVF), mesenchymal stem cells (MSCs), scaffolds, and exosomes. International recommendations were evaluated alongside Indian clinical studies and the evolving national regulatory framework. Results: PRP has demonstrated modest clinical benefit in selected indications and is cautiously supported by international guidelines, whereas cell-based therapies remain investigational. In India, widespread use is marked by variability in preparation, administration, and outcome reporting. Limited high-quality trials, cost-related barriers, and regulatory ambiguity continue to restrict evidence-based adoption. Conclusion: Orthobiologics offer potential clinical value in Indian musculoskeletal practice; however, their routine use should be guided by standardized protocols, India-specific guidelines, robust multicentre trials, and strict regulatory compliance to ensure patient safety and reproducible outcomes.