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 In order to assure and enhance the standards and quality of biological resource management in India, the National Accreditation Board for Testing and Calibration Laboratories (NABL) has taken a significant stride with the launch of biobanking accreditation programme based on the international standard of ISO 20387: 2018.
NABL is a constituent board of the Quality Council of India (QCI).
This move is poised to elevate Indian biobanks to global standards assuring the integrity and reliability of biological materials essential for cutting edge scientific research and personalised medicine.
Biobanking is a cornerstone for advancing Indian biomedical research especially in addressing India’s profound genetic diversity and complex disease burden. This is done by systematically collecting processing and storing high quality biological materials (like tissue, blood and DNA, plant genomes, wormseeds, microorganisms etc.) and their associated clinical or biological data. By doing this, bio banks provide the essential raw material for large scale genomic, proteomic, and epidemiological studies.
Initiatives such as the Phenome India National Biobank are critical for enabling precision medicine, allowing researchers to identify population-specific biomarkers, understand the unique progression of diseases like diabetes and cancer in the Indian context, and develop targeted therapies that are more effective for the varied ethnic and geographic populations across the country.
Ultimately, the robust and ethical infrastructure provided by accredited biobanks, like those aligning with ISO 20387:2018, ensures the integrity of samples, drives scientific innovation, and strengthens India’s capacity for global research collaboration and public health preparedness.
ISO 20387:2018, titled “Biotechnology – Biobanking – General requirements for biobanking” is the first international standard specifically dedicated to biobanking. It establishes a comprehensive framework for the competent, impartial, and consistent operation of biobanks.
A biobank is a legal entity or part of one that performs the process of acquisitioning and storing defined biological material such as human, animal, plant, fungal, microbial or wormseeds samples along with their associated data, for research and development purposes.
The standard covers the entire spectrum of biobanking operations, focusing on both the management system and the technical operations, including collection/acquisition to ensure appropriate sourcing and consent, preparation, preservation and protocols for maintaining sample quality and long-term viability (e.g., cryopreservation).
It also covers storage and traceability by giving requirements for storage facilities, equipment, and maintaining an auditable chain of custody. Besides this, it covers testing and analysis by giving procedures for assessing the quality of the biological material. It defines the distribution aspect giving the protocols for the safe and secure transportation and sharing of materials and associated data.
It also defines ethical and legal compliance towards adherence to confidentiality, ethical standards, and biosecurity/biosafety measures.
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