Chemical Registration 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 chemical Regulatory framework and hence are not classified separately. Disinfectant products in India are generally classified under the drug category and require approval from the Central Drug Standard Control Organization (CDSCO), whereas locally manufactured products can be placed in the market based on the state manufacturing license.
Detergents are considered as general consumer household products that do not require chemical 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 end-to-end scientific and chemical Regulatory services in India.
Table 1: Chemical Regulations in India
| Chemical Regulation | 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 (CDSCO) 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, etc. |
GHS is well accepted in India and the industry has developed a practice to follow GHS in terms of Safety Data Sheet (SDS) (SDS is a requirement as per schedule 9 of The Manufacture, Storage and Import of Hazardous Chemicals Rule, 1989”) and label preparation.
Freyr Expertise
- Product Classification and Regulatory Guidance.
- Regulatory Strategies for Market Access/Product Launch.
- Product Notification/Chemical Registration in India.
- Regulatory Applicability Review and Interpretation.
- Preparation of Technical Data Files (Specifications, MSDS, etc.) Including Chemical Registration/Notification Dossiers.
- Application Preparation and Submission for Relevant Introductions and Renewals.
- Sustainability and Packaging Solutions.
- Regulatory Intelligence (RI) Services for REACH Registration India.
Freyr Advantages
- Local presence in the market with relevant expertise and experience.
- End-to-end Regulatory consultation on REACH registration India.
- Easily navigate the complexities of REACH registration India.
- Support for region-specific Regulatory complexities.
- A structured and cost-effective approach to ensure compliance in multi-market scenarios.
- Quick turnarounds and faster time-to-market.
- Expert advice on chemical Regulatory services in India.
Our Location in India
Level 4, Building No. H-08,
Phoenix SEZ,
HITEC City 2, Gachibowli,
Hyderabad – 500081, India