Indian Standard for Safe Handling of Biotherapeutic Products Used in Homoeopathy: Guidelines

Biotherapeutic products used in Homoeopathy are derived from biological sources of human, animal, microbial and other origins and include pathological and non-pathological preparations such as nosodes and sarcodes. Owing to the biological nature of these materials, their safe handling, preparation, storage, testing and documentation require systematic controls to protect personnel, the public and the environment. The Indian Standard `IS 19901:2026, Safe Handling of Biotherapeutic Products Used in Homoeopathy — Guidelines', provides a comprehensive framework for risk assessment, biosafety classification, containment, determination of first safe dilution (FSD), safety and efficacy evaluation, quality assurance, formulation, dispensing and documentation. The standard also establishes requirements for source identification, regulatory authorization, storage and disposal of biological materials, personnel training and institutional compliance. This article reviews the major provisions and significance of IS 19901:2026, highlighting its role in establishing a structured biosafety and quality-assurance framework for biotherapeutic products used in Homoeopathy.