 |
» Regulatory Toxicology
Overview
Safety of human health and environment is the primary concern of the world. The adequacy and quality of safety data allows regulatory decisions for the production, marketing, transport, storage, categorization/labeling and usage of a vast variety of industrial chemicals, agro-chemicals, pharmaceuticals, cosmetic products and food/feed additives, etc that have an overriding influence on the sustainment and quality of our life and environment. Creation of a competent and competitive facility for regulatory toxicology studies is, therefore, the most desirable application of scientific knowledge for service to society, service to industry and sustainable development around the world.
The advent of genetically modified/engineered organisms, crops and drugs, also called bio-technologically-derived products, gene-therapy, stem-cell therapy, nano-materials, etc have ushered-in a new dimension to highly beneficial yet potentially hazardous substances in contact with humans and environment that must be evaluated to assure that their intended application does not entail any untoward effect on human health and environment.
Regulatory toxicology is, therefore to assure the wellbeing of our populace, validating the product specifications and helping regulatory decisions to support Indian industry in global positioning of their equally credible products. The scientific expertise, technical competence and suitable data base on standard reference materials and model test substances, will serve as ?Referral Centre? for other R&D institutions, industry, etc. venturing in designing, formulation, production and/or marketing their products. A whole new cadre of scientific and technical manpower in the country shall emerge from this effort because of unique analytical and biological approaches applicable to the safety evaluation of bio-technologically-derived products, gene-therapy, stem-cell therapy, nanomaterials, etc. as against conventional toxicology for synthetic drugs and chemicals.
Compliance to Good Laboratory Practices (GLPs) is the key to international acceptance of safety data/reports on industrial and consumable products. Harmonized protocols and test procedures with compliance to Good Laboratory Practices (GLPs) improve mutual acceptance of data/reports and avoid technical barriers to the international trade. It eliminates the ground for expensive repetitions and expedites regulatory decisions which in-turn benefits both the society and the industry. Regulatory toxicology capability with GLP compliance is the global requirement and upcoming R&D based venture considering its costeffectiveness in India.
Mission: Protection of human health and environment
Goals:
Objectives:
Safety of human health and environment is the primary concern of the world. The adequacy and quality of safety data allows regulatory decisions for the production, marketing, transport, storage, categorization/labeling and usage of a vast variety of industrial chemicals, agro-chemicals, pharmaceuticals, cosmetic products and food/feed additives, etc that have an overriding influence on the sustainment and quality of our life and environment. Creation of a competent and competitive facility for regulatory toxicology studies is, therefore, the most desirable application of scientific knowledge for service to society, service to industry and sustainable development around the world.
The advent of genetically modified/engineered organisms, crops and drugs, also called bio-technologically-derived products, gene-therapy, stem-cell therapy, nano-materials, etc have ushered-in a new dimension to highly beneficial yet potentially hazardous substances in contact with humans and environment that must be evaluated to assure that their intended application does not entail any untoward effect on human health and environment.
Regulatory toxicology is, therefore to assure the wellbeing of our populace, validating the product specifications and helping regulatory decisions to support Indian industry in global positioning of their equally credible products. The scientific expertise, technical competence and suitable data base on standard reference materials and model test substances, will serve as ?Referral Centre? for other R&D institutions, industry, etc. venturing in designing, formulation, production and/or marketing their products. A whole new cadre of scientific and technical manpower in the country shall emerge from this effort because of unique analytical and biological approaches applicable to the safety evaluation of bio-technologically-derived products, gene-therapy, stem-cell therapy, nanomaterials, etc. as against conventional toxicology for synthetic drugs and chemicals.
Compliance to Good Laboratory Practices (GLPs) is the key to international acceptance of safety data/reports on industrial and consumable products. Harmonized protocols and test procedures with compliance to Good Laboratory Practices (GLPs) improve mutual acceptance of data/reports and avoid technical barriers to the international trade. It eliminates the ground for expensive repetitions and expedites regulatory decisions which in-turn benefits both the society and the industry. Regulatory toxicology capability with GLP compliance is the global requirement and upcoming R&D based venture considering its costeffectiveness in India.
Mission: Protection of human health and environment
Goals:
- Develop and demonstrate the capability to address contemporary challenges and answer future emergencies through R&D and application of new knowledge in Regulatory Toxicology
- Harness the full potential of scientific and technological revolution and economic benefits of India becoming a preferred destination of safety evaluation of industrial and environmental chemicals/products
- Offer technologically up-to-date and economically competitive services (safety evaluation, analytical characterization, hazard identification, risk assessment, remediation, and knowledge-based consultancy) for chemicals, biologicals and environmental pollutants
- Implement the principles of Good laboratory Practice (GLP) for mutual acceptance of data/reports towards regulatory considerations and avoid technical barriers to the international trade
Objectives:
- To conduct non-clinical safety/toxicity and analytical studies on industrial and environmental chemicals, etc.
- To undertake environmental monitoring, risk assessment and remediation studies on air, water and soil borne domestic, industrial and environmental pollutants.
- To develop mathematical models of hazard identification and remediation of water and waste-water borne domestic, industrial and environmental pollutants.
- To develop human resource in safety/toxicity screening, environmental impact assessment, water and waste-water technologies, and bioremediation of industrial and environmental chemicals and pollutants.
- To serve as ?National Referral Centre? for regulatory toxicology issues.
- Development of newer analytical methods for characterization and quantification of chemicals.
- Mathematical modeling for analytical method development and predictive purposes.
- Toxicological evaluation of chemicals and products.
- Toxico-pathological investigations on chemicals and products.
- Maintenance and supply of healthy laboratory animals for R&D
programs.
- Mathematical/Statistical/Chemometric modeling
- Various analytical techniques
- Short and long term toxicity studies
- Geno-toxicity studies
- Reproduction toxicity studies
- Inhalation studies
- Genetic characterization of laboratory animals.
- Toxico-pathological evaluation of multiple organs from variousspecies of laboratory animals.
- Exploratory and Predictive modeling
| « Back | Next » |