Regulatory Services for Chemical Products & Mixtures in India

Overview

Cleaning and disinfectant products are called/identified and regulated differently across countries and regions, making it very challenging for the industry to place these products in different markets.  

In India, these products are not regulated under a consolidated, separate Regulatory framework and hence are not classified separately. Disinfectant products in India are generally classified under the drug category and require approval from the CDSCO, whereas locally manufactured products are allowed to place in the market based on the state manufacturing license.

Detergents are considered general consumer household products which do not require registration/ notification from any authority.

In addition to the above, chemicals associated with such formulation/ mixture are regulated under other chemical acts like Manufacture, Storage and Import of Hazardous Chemical (Amendment) Rules, 1989, 1994, 2000 & Ozone-Depleting Substance (R&C) Rules (2000). Further, India is prepared and making progress in bringing the new chemical legislation - “Chemical Management and Safety Rules” - into force. As the framework is similar to the EU REACH, the industry also refers to this regulation as India REACH, where the main objective of the rules is to ensure a high level of protection for human health and the environment.

Keeping abreast with the stringent and changing global Regulatory dynamics for chemical products, Freyr can extensively support and provide the end-to-end scientific and chemical Regulatory Services in India.

Categories

Biocide/ Disinfectant

Detergents

/Cleaning products

General Consumer Products

Chemicals

Regulation

Drug and Cosmetics Act

IS 4955: 2001

Consumer Protection Act

Manufacture, Storage and Import Of Hazardous Chemical (Amendment) Rules, 1989, 1994, 2000

Ozone-Depleting Substance (R&C) Rules (2000)

In the future to be regulated by the CSMR Act.

Registration Requirement

Yes

NO

NO

Yes

Process in Brief

In the case of imported formulation, the importer must obtain Drug registration via the Central Drug standard control organization fulfilling various requirements, whereas, in the case of local manufacturing, products are allowed to be placed in the market on the basis of local state manufacturing license.

N/A

N/A

Technical dossier

Local Representative

Yes

N/A

N/A

Yes

Key Data Requirements

Efficacy studies

Safety Summary

CoA

Stability study

 

 

Active alkalinity,

Total phosphates,

Ash built-up, Safety Information about the product and Use

Safety Information about the product and Use

Registration dossier as per Schedule   VII, Toxicological information

Quantity,

MSDS

Timeline

18 – 24 months

N/A

N/A

N/A

H.S. Code

38089400

3401 and 3402

Multiple

Multiple

Examples:

3903, 29, 38

GHS is well accepted in India and the industry has developed a practice to follow GHS in terms of SDS (SDS is a requirement as per schedule 9 of The Manufacture, Storage and Import of Hazardous Chemicals Rule, 1989”) and label preparation.

Expertise

Freyr Expertise

  • Product classification and Regulatory guidance
  • Regulatory strategies for market access/product launch
  • Product notification/registration strategies
  • Regulatory applicability review and interpretation
  • Preparation of technical data files (specifications, MSDS, etc.), including chemical registration India/notification dossiers
  • Application preparation and submission for relevant introductions and renewals
  • Sustainability and packaging solutions
  • Regulatory intelligence
Freyr Advantages
Advantages

Freyr Advantages

  • Local presence in the market with relevant expertise and experience
  • End-to-end Regulatory consultation
  • Easily navigate complexities of Regulatory authorities.
  • Support for region-specific Regulatory complexities
  • A structured and cost-effective approach to ensure compliance in the multi-market scenario
  • Quick turnaround and faster time-to-market
  • Expert advice on Regulatory services for chemicals in India