Indo-U.S. Workshop on Challenges of Emerging Infections and Global Health Safety Summary of a Workshop (2016) / Chapter Skim
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5 Laboratory Regulatory Oversight: Finding the Balance
5 Laboratory Regulatory Oversight: Finding the Balance
Pages 105-128
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From page 105... ...
While drafting and preparing these guidelines, the review committee considered local factors, such as resistance to infection, the host-parasite burden in the community laboratory environment, and chances of survival and growth of altered organisms under tropical conditions. Prior to that, in 1986, the Indian government enacted environmental protection rules and regulations defining procedures for handling genetically modified organisms (GMOs)
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From page 106... ...
The IBSC evaluates any potential danger associated with the work. It also evaluates the biological containment plan and facilities as per the recombinant DNA safety guidelines, and determines whether additional expertise should be considered.
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From page 107... ...
Next, Jain described the DBT RCGM, which functions in the Department of Biotechnology, and is responsible for reviewing the reports of all approved/ongoing projects involving the high risk category and control field experiment research in four areas: human and animal healthcare, agriculture, industry, and environmental management. This committee is empowered to visit the experimental facilities where projects with biohazard potential are being pursued prior to the commencement of research to ensure that adequate safety measures are taken as per the recombinant DNA safety guidelines.
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From page 108... ...
Then, in 2012, DBT issued Guidelines on Synthetic Similar Biology and Regulatory Requirements for Marketing Authorization in India. Issues related to genetic engineering of human embryos and the use of embryos or fetuses in research and human germline gene therapy are excluded from the scope of the 1990 Recombinant DNA Safety Guidelines.
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From page 109... ...
Examples of Category III research include all toxin gene cloning experiments producing LD50 less than 50 micrograms per kg of body weight of vertebrates or large scale growing, research including cultured human cells of recombinant DNA molecules containing complete genes of potentially oncogenic viruses or transformed cellular genes, experiments involving the use of infectious animal and plant viruses in a tissue culture system, experiments
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From page 110... ...
A participant asked if Jain could clarify the qualifications of a biosafety officer on the IBSC. Jain replied that this person is to have medical qualifications, specifically the person is to be a practicing doctor (MBBS)
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From page 111... ...
S Rao added that when the biosafety guidelines were initially created, DBT nominated the biosafety committee members.
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From page 112... ...
There is self-closing double door access, and personal protective equipment must be worn inside that air-lock or anteroom. Biosafety cabinets are used inside the facility, and waste and clothing are decontaminated at the exit and removed through a second door.
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From page 113... ...
The essential issue for personnel safety is "training, training, and more training." All personnel must have protective equipment, and basic laboratory training. They need to be recertified periodically and all of them must be vaccinated and educated.
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From page 114... ...
Another participant followed up on the ISO 15189. The National Accreditation Board trains assessors in India, however, none of them has access to BSL-3 facilities, therefore, in the participant's view, a third party should be involved in the assessment and accreditation of these labs.
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From page 115... ...
The biosafety officer atthe Holland lab assisted in preparing the architectural drawings for the Indian lab along with an architect from Delhi. It took nearly five years to complete the requirements on paper.
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From page 116... ...
In particular, it is important to consider how these labs fit into the global community of well-operating, -managed, -maintained, -certified laboratories. One of the outcomes of this meeting, if it is useful to the Indian government, may be for Indian National Science Academy and the National Academy of Sciences to produce background papers that could provide information on existing animal health and human health laboratories, and on which regulatory structures exist and where gaps still remain.
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From page 117... ...
becoming the regulatory agency that established the RAC, issued the NIH Guidelines for Research Involving Recombinant DNA Molecules, and provided assistance to local committees in the application of those guidelines Asilomar also led to the Biosafety in Microbiological and Biomedical Laboratories (BMBL) regulations and guidelines.
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From page 118... ...
The BMBL is now used as a regulation, although it was clearly developed as a guideline. Under the Select Agent Act, laboratories must be inspected every three years.
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From page 119... ...
A great deal of effort is expended to certify that this material remains inside the laboratory where the individuals themselves are protected by very rigorous use of personal protective equipment. There are also secondary safety barriers in facility design.
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From page 120... ...
Ksiazek returned to personnel reliability measures. The Select Agent Act requires that researchers working with Tier 1 agents obtain a security clearance prior to obtaining permission to conduct their experiments.
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From page 121... ...
With the advent of the Select Agent Act, the BMBL shifted from being standards to being a regulatory mechanism. An Indian participant noted that when Indian experts studied the classification of biocontainment labs by biosafety level, there were initially just a few parameters taken into account: an agent's capability to infect the person working with the organism, the risk posed to the community by the agent, and the availability of preventive and therapeutic measures.
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From page 122... ...
ICMR-DBT jointly released guidelines for probiotic research and ICMR recently posted the Code of Conduct for people conducting life-science research online. Another recent development is the ICMR ethics bill, soon to be released.
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From page 123... ...
Muthuswamy then turned to biosafety, biosecurity, and human health safety issues for workers and research participants. The ICMR/GCLP guidelines issued in 2008 are clinical laboratory practice guidelines pertaining to specimen collections and pre-analytical collections.
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From page 124... ...
The aim of codes of conduct for scientists is to ensure that all research activities involving microbial or other biological agents or toxins, whatever their origin or method of production, are only of the types and quantities justified by preventative research or other peaceful purposes. In order to prevent the use of scientific research for purposes of bioterrorism or biowarfare, all persons and institutions engaged in any aspect of scientific research should abide by their codes of conduct.
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From page 125... ...
International collaboration on bioethics and biosafety issues warrant focused attention. Muthuswamy concluded by underscoring that guidelines need constant updating, new ones must be formulated, and legislation is needed to regulate these guidelines.
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From page 126... ...
There are some institutes, such as the Institution of Science, where directors have the authority to send some material without the Steering Committee's approval. Sample exchanges by DST and DBT do not require approval.
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From page 127... ...
Laboratory Regulatory Oversight: Finding the Balance 127 based on the experience of CDC. He proposed the designation of two Americans and two Indians to develop concrete recommendations.
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