BIOCIDES REGULATION SERVICES

In India, currently the biocide regulation is not yet defined. However, the import/manufacturing of biocides for different uses (including paints, coatings, textile etc.) are regulated by CIBRC (Central Insecticide Board and Registration Committee) and Central Drugs Standard Control Organisation (CDSCO) depending on the active substance status in India.

Auxilife provides technical and regulatory support to register biocides and biocidal products (Manufacturing Use Products) in India as per the respective regulation (i.e. CIBRC and CDSCO). Due to the absence of comprehensive guidelines in India, determining the implications and requirements for importing and registering biocidal claim products often necessitates a case-by-case investigation and strategic approach.

 


Key Services

• Strategic advice & guidance
Auxilife by leveraging their expertise helps navigate the complex world of regulatory compliance. The team of experts monitor regulatory updates and changes to ensure safety, efficacy, and environmental concerns are addressed.

• Advice on data requirements and Data Gap Analysis
This service is structured to optimize the utilization of existing data requirements by addressing data gaps, preparing data waivers, and formulating bridging arguments, ultimately minimizing testing expenses.

• Literature review
We offer specialized technical and regulatory assistance tailored to meet the rigorous demands, our team stands ready to provide unparalleled support in the systematic review of literature and scientific assessment processes.

• Selection of the best testing laboratory and Constant monitoring of the laboratories data generation
Auxilife offers consultancy services with valuable expertise and support throughout the data generation, study monitoring, GLP studies and study plans in collaboration with GLP laboratories worldwide.

General services

• Advice on testing strategy.
• Selecting the best testing laboratory.
• Preparation of product labels.
• Preparation of MSDSs.
• Liaison with Regulatory Authorities.