Food for Special Medical Purposes (FSMP) intended for infants is a specialized category of food products designed to meet the unique nutritional needs of infants with specific medical conditions or dietary requirements. These products are formulated under strict guidelines to provide essential nutrients in appropriate quantities and proportions, tailored to support the growth, development and health of infants with medical conditions such as allergies, metabolic disorders, gastrointestinal disorders or other health issues.
FSMP for infants may come in various forms such as powdered formula, liquid formula or semi-solid preparations, depending on the specific requirements of the infant and the nature of their medical condition. These products undergo rigorous testing and evaluation to ensure safety, efficacy and compliance with regulatory standards. They are typically available by prescription or under the guidance of a healthcare professional to ensure appropriate use and monitoring.
All types of food for special medical purposes intended for infants have been included in the mandatory ISI Certification Scheme under IS 17945: 2022.
This standard specifies the types, criteria, testing methods and sampling procedures for food for special medical purposes intended for infants, including substitutes for preterm infants, lactose-free options and hypoallergenic formulas.
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.
The following documentation is required to get an ISI certification:
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There are two approaches for Indian manufacturers to become certified with the ISI Mark:
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
Step 2: Submission of the Application Form
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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
Step 2: Sample Testing
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The process of obtaining ISI Mark Certification for Foreign Manufacturers typically includes the following steps:
Step 1: Application
Step 2: Query Raised (If Any)
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Brand Liaison provides helpful support for achieving ISI Mark Certification. Among our offerings are:
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