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

Authors

• Kumar Vivekanand, Central Council for Research in Homoeopathy, New Delhi, India AND Ayush Department, Bureau of Indian Standards, New Delhi, IndiaFollow
• Indra Gaurav Saxena, Central Council for Research in Homoeopathy, New Delhi, India AND Ayush Department, Bureau of Indian Standards, New Delhi, India
• Divya Taneja, Central Council for Research in Homoeopathy, New Delhi, India
• Shailendra K. Saxena, King George's Medical University, Lucknow, India
• Shrishti Dixit, Ayush Department, Bureau of Indian Standards, New Delhi, India
• Raj Kumar Manchanda, Ayush Department, Bureau of Indian Standards, New Delhi, India

Author ORCID Identifier(s)

Kumar Vivekanand: https://orcid.org/0000-0001-9105-3383

Indra Gaurav Saxena: https://orcid.org/0000-0001-8802-9577

Divya Taneja: https://orcid.org/0000-0003-1606-6576

Raj Kumar Manchanda: https://orcid.org/0000-0001-5589-9170

Corresponding Author

Kumar Vivekanand

Keywords

Biotherapeutics, BIS standard, IS 19901:2026, Homoeopathy, Biosafety, Biological materials, Risk assessment, Quality assurance, First safe dilution (FSD)

Article Type

Discussion

Abstract

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.

Digital Object Identifier

10.53945/2320-7094.2805

Publisher

Central Council for Research in Homoeopathy

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 4.0 International License.

How to cite this article

Vivekanand K, Saxena IG, Taneja D, et al. Indian Standard for Safe Handling of Biotherapeutic Products Used in Homoeopathy: Guidelines. Indian J Res Homoeopathy. 2026;20(3):435–44.