DBT/BIRAC with the national biopharma mission to promote innovation and self-sufficiency in the biotechnology sector, strives to reduce any social and environmental risks in its activities. As the Product developments and related components for creation of robust innovation ecosystem in the biotech sector is the primary focus of I-3 Program, the following elements become inevitable such as compliance to corresponding environmental legislations, good practices in research and development methods, enhanced awareness on social and environmental risk management procedures, adherence to bioethics principles, capacity building of key stakeholders. So Environment, Occupational Health and Safety Management Framework (EMF) (https://birac.nic.in/nbm/uploads/2019/08/emf.pdf) is developed
Components in the Environment, Occupational Health and Safety Management EHRMP of grantee
Objectives of Environment, Occupational Health and Safety Management Framework
As per the Environment, Occupational Health and Safety Management Framework (EMF) the following activities are required from Organisations/Research institutions/Academia associated with the mission for technological and product development capabilities and operation of shared facilities in biopharmaceuticals including vaccines, biologics, medical devices and diagnostics but not limited to.
- Complying with biotechnology, environment and Safety regulations of GoI and World Bank Group
- Follow Good Laboratory Practices (GLP), Good Industry Practices (GIP) and Good Manufacturing Practices (GMP)
- Submission of Environmental and Health Risk Management Plan (EHRMP) specific to the activity. The EHRMP shall be prepared based on a review of the proposed activity vis-à-vis environmental issues.
- Obtain all applicable environmental authorizations specific to the activity
- Responsible for overall implementation of EHRMP
Following is the strategy developed for fulfilling the requirement:
- Guidance for filling and submission of Environment, Occupational Health and Safety Management plan (EHRMP)
- Conducting Site Inspection/Audit by Environment expert followed by report submission.
- Conducting Training on Regulatory compliance/EMF by Environment expert
- Obtaining response report and Quarterly reports for the initial inspection report
- Conducting Annual review yearly by Environment expert followed by report submission
Glimpses during environment & safety inspection and training the grantee on applicable legislations & polices at Yenapoya University
Since inception, 98 first time grantee visits with orientation training, 43 annual revisits were done till now. A strong framework is established for regular site-visits, feedback reports to grantee and receiving quarterly updates from grantee for environmental compliance.