Designing BSL Labs as per WHO Guidelines: Importance in India's Research, Diagnostics, and Hospital Ecosystem

Biosafety Level (BSL) laboratories play a crucial role in safeguarding public health by studying and containing dangerous pathogens. Following the World Health Organization (WHO) BSL guidelines is essential to ensure the highest level of safety and prevent the spread of infectious diseases. In the Indian research, diagnostics, and hospital ecosystem, adherence to WHO BSL standards is of paramount importance. This blog explores the significance of designing BSL labs according to WHO guidelines and highlights the role of BSL3 and BSL4 labs in recent outbreak containment, including lassa fever, Nipah virus, bat virus, and bird flu. Biosafety and biosecurity are critical considerations in biomedical and medical settings worldwide. The importance of implementing biosafety measures has increased due to concerns regarding the potential dual use of microbial pathogens and the growing awareness of laboratory-associated infections (LAI). In India, prominent bodies such as the Indian Council of Medical Research (ICMR), Council of Scientific and Industrial Research (CSIR), Department of Biotechnology (DBT), Indian Council of Agricultural Research (ICAR), and Department of Science and Technology (DST) play vital roles in biomedical research and public health. These agencies have been instrumental in developing codes of conduct, ethics, and biosafety practices.

Under the Indian Environment (Protection) Act of 1986, the government has the authority to take necessary safety measures to protect and improve the quality of the environment, prevent and control environmental damage, and establish procedures and safeguards for handling hazardous substances. Rules were enacted in 1986 to regulate the manufacture, use, import, export, and storage of hazardous microorganisms, genetically engineered organisms, or cells. Competent authorities have been designated to ensure compliance with these provisions and provide guidelines on the ethical and social responsibilities of scientists, institutions, and industries involved in biological sciences research. Various committees and committees such as the Recombinant DNA Advisory Committee (RDAC), Institute Biosafety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM), and Genetic Engineering Approval Committee (GEAC) have been established under the Ministry of Environment, Forest and Wildlife. Guidelines on safety by the Department of Biotechnology (1990), the Drug Policy of 2002, and the National Seeds Policy, 2002, have been formulated to ensure that biomedical research and genetically engineered crops/varieties undergo testing for environmental safety and biosafety before commercial release. India also has controls in place for the export of Special Chemicals, Organisms, Materials, Equipment, and Technologies (SCOMET), including microorganisms/toxins. Specific conditions are specified for the export of SCOMET items, requiring a license. The Department of Biotechnology (DBT) has developed ethical policies on the human genome, genetic research, and services, while the Indian Council of Medical Research has established a code of conduct for scientists engaged in biomedical research. These ethical guidelines are in line with the principles of autonomy, privacy, justice, and equity outlined in the Declaration of Helsinki.

ICMR laboratories play a significant role in supporting public health and hospital care settings in India by establishing better diagnostic facilities for the detection of emerging diseases. ICMR focuses on early detection and research of emerging, re-emerging, and newly emerging highly pathogenic infectious diseases. Its regional laboratories are actively involved in combating endemic diseases, outbreak situations, and national emergencies related to highly infectious and zoonotic diseases of public health significance.

The Department of Health Research (DHR) has initiated a program to establish a network of 160 virology laboratories across the country in the 12th Five Year Plan. ICMR and other institutes supported by the DHR have already established sixteen BSL-2/BSL-3 laboratories to handle various pathogenic agents of public health importance. As part of the XII Plan document (2012-2017), ICMR and several other leading institutes are in the process of establishing multiple biosafety level-3 (BSL-3) laboratories at strategic locations. These laboratories will require trained scientific, technical, and engineering staff with a thorough understanding of biosafety principles and practices.

Establishing BSL-3 laboratories follows a phased approach, encompassing the design, validation, and functionality of the facility. Such facilities not only reduce the risk of occupational exposures to pathogenic materials but also contribute to a safe environment by enabling the early detection of high-risk groups for emerging infectious diseases. In conclusion, biosafety and biosecurity measures are crucial in biomedical and medical settings, and India has implemented various guidelines, rules, and committees to ensure the safe conduct of research and protection of the environment. The establishment of BSL-3 laboratories is a significant step in enhancing biosafety practices and early detection of emerging infectious diseases.