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 The National Accreditation Board for Testing and Calibration Laboratories (NABL) has released an amended version of its Specific Criteria for Accreditation of Biobank, marking a significant step toward standardizing and enhancing biobanking practices across India.
The revised criteria are specifically designed to align Indian biobanking systems with international standards, particularly ISO 20387:2018. This move reflects the growing global emphasis on quality, consistency, and ethical practices in the handling and storage of biological materials, which are foundational to scientific research and innovation.
A biobank, sometimes also referred to as a biorepository or repository, is a facility that acquires, stores, preserves, and sometimes analyzes biological specimens such as tissues, blood, plant materials, or microbes, along with their associated data. These specimens serve as crucial assets in diverse fields including agriculture, environmental studies, drug discovery, personalized medicine, and genomics.
Under the new amendment, a biobank seeking accreditation must include at least three defined activities in its operational scope like acquisition, storage, collection, preparation, preservation, testing, analysis, or distribution.
The amendment was introduced following recommendations from NABL’s technical committee. Key updates focus on improving risk assessment processes, reinforcing impartiality, and ensuring compliance with regional, national, and international ethical and legal standards.
Importantly, laboratories already accredited under ISO 15189 or ISO/IEC 17025 may also seek biobank accreditation if they fulfill the specific criteria outlined in ISO 20387. However, merely being accredited for testing purposes under the above standards does not substitute for full biobank accreditation.
The NABL emphasized that accredited biobanks will play a crucial role in ensuring the reliability of stored biological materials, enhancing research credibility, and enabling effective collaborations both nationally and internationally.
This latest development is aimed at elevating India’s scientific infrastructure and aligning with global best practices in biospecimen management and ethical data use.
It has to be noted that for biosafety and biosecurity, the biobank shall have a procedure and records for disposal of sample as per current Biomedical Waste Management Guidelines and Institutional Biosafety Committee (IBSC) approval. An IBSC approval is a mandatory requirement for institutions in India working with hazardous microorganisms, genetically engineered organisms (GEOs), or cells.
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