DISINFECTANT REGISTRATION SERVICES

In India, disinfectants (including surface disinfectants, wipes, sanitizers etc.) are regulated under Drug and Cosmetics Act by The Central Drugs Standard Control Organisation (CDSCO) and all regulation applicable to drugs need to be followed for registering disinfectants. The disinfectant product standards are classified under Schedule ‘O’ of Drug and cosmetic Act.
CDSCO under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
The purpose of product and potential or intentional exposure of humans determine the regulatory body in India. Pharmaceuticals (drugs), medical devices, cosmetics and disinfectants are regulated by the Central Drugs Standard Control Organization (CDSCO).
Now, the term biocides does not exist in India although guidelines for biocides are under discussion at CIBRC (Central Insecticide Board and Registration Committee). It is uncertain which regulatory body will regulate disinfectants, surface cleaners, germicidal formulations, toilet cleaners once guidelines for biocides enter into force in the future. In India interdepartmental communication is needed to evaluate if any active substance is falling in certain departments such as CIBRC, CDSCO, and Indian Medical Association (IMA).
Applications for an import license require a number of legal, technical and regulatory Documents.

Key Services

• Data generation support
• Support in Legal documents
• Advice and assistance for technical documents
• Over all support for regulatory documents
• Covering Letter guidance
• Authorization Letter guidance
• Preparation support for product labels.
• Support in claims to be submitted
• Support in Product Registration Certificate