ISI / BIS Certification for Infant milk substitutes

Often referred to as infant formula, infant milk substitutes are carefully prepared goods meant to nourish babies who are not breastfed or who receive insufficient breast milk. The goal of these alternatives is to closely mimic the nutritional makeup of breast milk in order to promote babies' healthy growth and development. 

Under IS standard IS 14433: 2022, all infant milk substitutes are now covered by the required ISI Certification Scheme. 

Without the ISI Mark, this product cannot be marketed, imported, or exported into the Indian consumer market.

About ISI / BIS Certification

Indian Standards Institute, or ISI was renamed the Bureau of Indian Standards (BIS) in 1987. The official mark that the Bureau of Indian Standards provides for manufacturers of various goods is the ISI Mark. It is used to indicate compliance with Indian standards (IS) set by the Bureau of Indian Standards (BIS) and has been used as a conformity marking for industrial products. Manufacturers received permission from BIS to use the ISI Mark on items that comply with relevant Indian requirements through the product certification program. 

Only manufacturers (domestic or foreign) who produce the finished product will be awarded ISI Certification. This will not be given to any product importers, traders, dealers, or distributors.

Documents Required for ISI / BIS Certification

The following documentation is required to get an ISI certification:

• Main Application Form V
• Address Proof of Manufacturing Unit
• Details of Manufacturing Process
• Test Report of products

For more detailed information, please click here.

Process of ISI / BIS Certification

There are two approaches for Indian manufacturers to become certified with the ISI Mark:

• Regular Procedure
• Simplified Procedure 

Regular Procedure

With the possible exception of cases deemed "All India first," which might take up to 180 days, the licensing procedure is expected to be finished in 120 days. This timeline starts on the day the application is received, assuming that at different points in time the documentation, unit assessment, and product conformance are all deemed acceptable.

Step 1: Manufacturing Unit Customization in Compliance with Applicable Indian Standards

• Identifying the applicable Indian Standard
• Establishing in-house testing facilities as per the Standard's requirements

Step 2: Submission of the Application Form

• Preparing an Internal Test Report for the product by the relevant Indian Standard
• Compiling all necessary documents
• Completing the Online Application Form
• Online payment of application fees directly to BIS
• Submitting hard copies of the Application Form with all enclosures to the relevant Branch Office (BO) of BIS

For more detailed information, please click here.

Simplified Procedure

This is a much faster process than the standard procedure. After a factory inspection is deemed satisfactory and the initial evaluation establishes that the sample complies with the applicable Indian Standard(s), the license application process is expected to be finished in 30 days.

Step 1: Adapting the Manufacturing Unit to Comply with the Relevant Indian Standard

• Identifying the applicable Indian Standard
• Establishing in-house testing facilities to meet the Standard's requirements

Step 2: Sample Testing

• Obtaining the necessary certificate for raw materials (Material Test Certificate - MTC)
• Conducting product sample testing at a BIS-recognized testing laboratory

For more detailed information, please click here

ISI Mark Certification Process for Foreign Manufacturers

The process of obtaining ISI Mark Certification for Foreign Manufacturers typically includes the following steps:

Step 1: Application

• Compile all the required documents.
• Submit the documents along with the Application Fee.
• An Application Number will be allotted.
• Scrutiny of the Application will be conducted within a specified time frame.​

Step 2: Query Raised (If Any)

• If any documents are missing or there is non-compliance, you will be informed.
• You need to submit a reply within the given timeframe.

​For more detailed information, please click here.

Why choose Brand Liaison?

Brand Liaison provides helpful support for achieving ISI Mark Certification. Among our offerings are:

•  Expert guidance
•  Streamline process
• Comprehensive support
• Cost-effective solutions
• Time efficient

Please click here to get in contact with our team of specialists for a deeper explanation of the paperwork and steps needed to get ISI Mark Certification.