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- BIS Certification for Food for Special Medical Purpose intended for Infants under IS 17945 is a voluntary type.
- Primarily, it creates a level of trust with the consumers while ensuring product safety, nutrition, and quality.
- Compliance with FSSAI is not the only thing that is ensured, rather, a trustworthiness layer is added.
- On top of that, the professionals can rest assured with the assistance of this, as they get to know it beforehand, thus, it is easy to persuade them.
- Always stay updated with BIS and FSSAI notifications.
Introduction
One year ago, a medium-scale Indian infant nutrition brand came to us with doubts about getting the BIS Certification for Food for Special Medical Purpose intended for Infants under IS 17945. Their products were fully FSSAI-compliant; however, the distributors and hospitals still requested the BIS mark as it provided them with additional reassurance. We see the situation over and over again: even if the certification is on a voluntary basis, it is still taken as one of the main factors of quality for the products made for infants with special medical needs.
What is BIS Certification for Food for Special Medical Purpose intended for Infants
BIS Certification to Food for Special Medical Purpose designed to meet the needs of Infants indicates that the product is a specialized and safe infant formula, in accordance with the intended nutritional and manufacturing standards of IS 17945. The certification, although not mandatory, creates goodwill among the healthcare fraternity, and consequently among them,the product becomes more easily accessible by the trade.Bureau of Indian Standards
Key Points:
- It ensures that the nutritional value and safety of FSMP in infants are correct.
- This certification is on a voluntary basis and it creates trust and goodwill among the users.
- It also alleviates concerns about nutritional requirements, microbial safety, labeling, and product quality.
What is IS 17945?
IS 17945 is an Indian Medical Standard for Food for Special Medical Purpose (FSMP) that sets forth the requirements for safety and quality of nutrition for infants. The document specifies the nutrient composition, the range of microbes allowed, labeling, and packaging, among others. Getting certified for this standard also certifies that the specialized infant formulas are the safest, the most reliable, and are suitable for the infants diagnosed with specific diseases.
Key Points:
- It sets the required nutrient compositions and safety measures for FSMP in infants.
- It outlines microbial safety, product labeling, and packaging in conjunction with nutrient provision.
- It confirms the safety and reliability of infant formulas when designed for medical cases.
- It is indicative of the voluntary BIS Certification standards.
- At the same time, it provides protection for infants with special medical needs.ISI MARK
Who need BIS Certification for Food for Special Medical Purpose intended for Infants
Acquiring a Food for Special Medical Purpose (FSMP) intended for infants with BIS approval is necessary only for the manufacturers, importers, and distributors of FSMP in India. A company that is involved in the production or distribution of FSMP for infants, suffering from conditions like metabolic disorders, allergies, or malabsorption, may demonstrate this certification as proof of their quality and safety, as per the compliance of IS 17945 standards.
Key Points:
- Manufacturers engaged in the production of infant FSMP products.
- The importers who bring the FSMP from foreign countries into India.
- Distributors and the brands which want to earn the confidence of the market.
- Companies that are focusing on hospitals, clinics, and healthcare providers.
- Any company that wants to be identified as the one which follows quality standards of IS 17945.
Key features of BIS Certification
- BIS certification will always be in compliance with IS 17945 which defines the safety, nutritional content, and quality aspects.
- BIS-approved laboratories perform document verification, factory inspection, and product testing.
- These provide the manufacturer with a BIS certificate and ISI mark, which is the brand value and the customer’s trust.
- The certificate renewal through the periodic surveillance and sample retesting is a must.
- This may be due to a manufacturer, an importer, or a distributor requesting quality assurance of the FSCM product.
- Demonstrates the adherence with good manufacturing practices in hygiene, labeling, and production of infant formula.
Step by Step process of BIS Certification for Food for Special Medical Purpose intended for Infants
Step 1: Check of Eligibility
- First of all, Check if the product is a Food for Special Medical Purpose (FSMP) for infants as per IS 17945.
- Establish that the product is food which is developed to fulfill the medical needs of the mentioned areas like allergies or metabolic disorders, etc.
- Moreover, ensure that the manufacturing and formulation details conform to the necessary regulatory standards.
Step 2: Application Submission
- With the technical dossier, the BIS application form is to be filed.
- Product specifications, composition, source of raw material, quality manuals, etc. are to be included.
- Provide all the documents in full so that the processing shall not be delayed.
Step 3: Document Review
- Bis checks whether all the documents that the applicants have submitted meet the IS 17945 standards.
- Examine the aspects of safety, nutrient content, correct labeling, and good production practices.
- Give an answer straight away to any hesitation or request for more information made.
Step 4: Factory Inspection
- BIS does a factory visit the same place where the goods are made.
- Check the factory for its cleanliness, standard calibration of instruments, and follow the Good Manufacturing Practice (GMP)
- Show the quality control and environmental monitoring that are taking place.
Step 5: Sample Testing
- Samples of the product are taken and tested in BIS-certified laboratories.
- Nutrient composition, microbial safety, shelf-life, and labeling accuracy are tested.
- Test results should also be checked that they fall within the limits and meet the requirements given in IS 17945.
Step 6: Evaluation & License Grant
- BIS evaluates the inspection and testing reports and then decides on the compliance status.
- The certification is awarded and the use of the ISI mark for the product as well as the facility is permitted.
- Part of the certificate and the conformity practice is hard-ended by the periodic surveillance.
Importance and Benefits of BIS Certification
Importance:
- Helps to be sure of the safety of nutrition and the quality of the product according to IS 17945 standards.
- Gives an indication of the organization’s behavior, covering cleanliness, and standard product.
- Allows to establish a connection with medical staff, who in turn recommend the product to patients as well as gather other Multisector partners for commercial distribution.
- Gives evidence of good management of regulations even if it is a voluntary certification.
Benefits:
- Strengthens brand image and increases market competition.
- Helps parents and pediatricians to feel more confident about product safety and nutrition provision.
- Quality is assured always through the results of surprise checks and sample testing.
- Contributes to foreign trade, building relations with medical institutions, and increasing the number of distribution points.
- Facilitates regulatory requirements and traceability with proper documentation.
Timelines, Costs, Validity & Renewal
| Aspect | Details |
| Timelines | Typically 30–60 days for domestic manufacturers; may be longer for foreign applicants due to audits and coordination. |
| Costs | Varies based on product type, number of variants, and factory size; includes application fee, inspection fee, and testing charges. |
| Validity | Certification is usually valid for 1–2 years, depending on BIS guidelines and product category. |
| Renewal | Renewal requires re-submission of documents, surveillance audit, and product sample testing before the validity expires. |
Why choose Diligence Certification
- Expert Guidance: Step-by-step guidance through IS 17945 standard and BIS processes is facilitated by an end-to-end support team.
- Streamlined Process: Makes the tasks of filing full dossiers, doing pre-audits, and coordinating with the BIS convenient and efficient thus reducing the waiting time.
- Compliance Assurance: Being the one to do all documentation, labeling, and quality systems in accordance with BIS standards makes a point of compliance assurance.
- Time and Cost Efficiency: It reduces the amount of interaction that is necessary between the authorities and the applicant and also helps to avoid the common mistakes.
- Ongoing Support: Being there for surveillance audits, renewals, and regulatory updates as well offers advantages of continuous support.
- Trusted Partner: Having a deep understanding of the infant nutrition market and the associated regulatory framework, the Diligence team is able to provide support and guidance to manufacturers, importers and distributors, instilling confidence and market acceptance.
Conclusion
BIS Certification in Food for Special Medical Purpose intended for Infants under IS 17945 standard is voluntary but it is an important quality benchmark that assures safety, nutrition, and quality. It adds to the credibility of the manufacturers, importers, and distributors, thereby, they will have access to healthcare professionals, caregivers, and distributors who are the end users of these products, while also adhering to strict standards in production and labeling.
The process becomes smooth and dependable when one goes with Diligence Certification. Expert guidance is a big help in preparing full dossiers, coordinating with BIS, and ensuring compliance to requirements thus making it easier for brands to gain trust, market acceptance, and long-term growth in the infant nutrition segment.
Frequently Ask Questions
Is BIS Certification for Food for Special Medical Purpose for Infants mandatory?
It is currently a non-mandatory program under IS 17945 but is majorly recommended as it gives an assurance of good safety and quality standards.
What does IS 17945 indicate?
IS 17945 is the Indian Standard that describes the nutrient composition, microbial safety, labeling, packaging, and production quality requirements of FSMP for infants.
Which category of people should look for the help of BIS Certification?
The manufacturers, importers, and distributors of specialized infant formulas that have as a target the infants with specific medical needs like allergy and metabolic disorder treatment,are those who should get help from the BIS certification.
What are the main assets that a BIS Certification can offer to you?
Among these, it includes product safety as the main reason for confidence among healthcare professionals, the brand gets more credibility and trust, quality is assured constantly, and it is easier to have a market positioning.
How much time will the process of BIS Certification take?
For Indian manufacturers, the procedure time is 30-60 days. The timelines for foreign applicants depend on the audits and coordination, so they can be different.
What are the documents needed for BIS Certification?
Usually, these documents are product specifications, technical dossiers, quality manuals, manufacturing flowcharts, labeling proofs, and raw material certificates.
How long is the BIS Certification valid for?
In general, the certification validity is for 1-2 years and depends on the product category and on the BIS guidelines.
Is there a need for Periodic Surveillance?
Yes, BIS does regular inspections and sampling as part of their routine procedure to ensure that the standards of IS 17945 are fully complied with.
Will BIS Certification be Facilitated in Exporting?
Yes, the answer is; certification makes the international market scenarios such as hospital tie-ups, exports, and foreign cooperation more straightforward as the partners abroad rest assured about the quality of the product.
How does the Diligence Certification contribute to the successful acquisition of BIS Certification?
Diligence Certification handles the full service provider role for each stage of the process, i.e. document preparation, mock audit, coordination with the BIS, and guidance for surveillance and renewal, thus making the process simple and trustworthy
