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Disinfectant Registration

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PHARMA - Disinfectant Registration

Regulations for Disinfectants

Disinfectants including surface disinfectants, wipes, sanitizers etc. in India, fall under the regulation of the Drug and Cosmetics Act, 1940 overseen by the Central Drugs Standard Control Organisation (CDSCO). Therefore, all regulations applicable to drugs and cosmetics must be adhered to when registering disinfectants. In India, pharmaceuticals, medical devices, cosmetic products and disinfectants are regulated by CDSCO.

Understanding the correct classification of disinfectants is crucial for manufacturers to make informed regulatory decisions tailored to specific markets.
Whether Disinfectants are classified as Drugs and Cosmetics or as an Insecticide in India?

Drugs and Cosmetics in India are regulated by Central Drugs Standard Control Organisation (CDSCO) and Insecticides in India are regulated by Central Insecticide Board and Registration Committee (CIBRC).

The term "Biocide" is not currently recognized in India, although discussions regarding guidelines for biocides are ongoing at CIBRC (Central Insecticide Board and Registration Committee). The regulatory authority that will oversee disinfectants, surface cleaners, toilet cleaners and germicidal formulations once biocide guidelines are implemented in the future remains uncertain. Interdepartmental discussion is necessary to assess whether any active substance falls within the scope of specific departments like CIBRC, CDSCO among others.

As on today, Disinfectants (including surface disinfectants, wipes, sanitizers etc.) are regulated by CDSCO in India, which comes under the purview of drugs. Disinfectant is deemed as “Drugs” u/s 3 (b)(ii) of the Drugs and Cosmetics Act, 1940. The standards for disinfectant products are categorized under Schedule 'O' of the Drug and Cosmetics Act, 1940.

Disinfectants with a product labelling claim like “kill germs” or “kills 99.9% germs” etc., will be considered as a drug.

CLASSIFICATION OF DISINFECTANTS

IN DIFFERENT COUNTRIES

The classification of disinfectants in different countries is based on variety of factors like claims, physical forms, end-use and the product type.
  • As Pesticide- Canada and the US markets categorise surface disinfectants as pesticides.
  • Drugs and Cosmetics- Products intended for hand and skin having soft claims like hygiene is classified as cosmetic product. US markets categorise human skin disinfectant formulations as drug products.India also categorises the same way.
  • Biocide- Europe and Korea classifies all types of disinfectant formulations as Biocide.
  • No classification- Some countries lack regulatory framework for products like disinfectants whether hand or surface. Here, the manufacturers modify some claims to fit in the cosmetic category or launch the product as per the local standards.

How
Mind Sync
Can Help?

At Mind Sync we provide a range of regulatory services for the drugs and cosmetics industry, customized to suit the requirements of large enterprises, small to medium-sized businesses, and micro-enterprises. Our team of Regulatory Experts has a proven track record in assisting applicants with expert guidance for thorough reviews of product formulations, labelling evaluations, claims analysis, and registration processes in India. We ensure precise documentation that complies with Indian regulations, offering comprehensive support for various process-related services.

Do you have any queries?

This information is in summary form and is therefore intended for general guidance only. It is not intended to be a substitute for detailed research or the exercise of professional judgment. Mind Sync does not accept any responsibility for loss occasioned to any person acting or refraining from action as a result of any information provided herein. On any specific matter, reference should be made to the appropriate advisor.

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