Manufacturers
Producing Food for Special Medical Purpose intended for Infants in India
Quality Control Order (QCO) Update

Quality Control Order (QCO) Update
The Government of India issues this Quality Control Order to ensure safety, reliability, and standardization of Food for Special Medical Purpose intended for Infants across the country.
Important update regarding Indian Standard applicable to all existing Licence holders/ New applicants/ manufacturers/ importers/ product sellers for Food for Special Medical Purpose intended for Infants.
Producing Food for Special Medical Purpose intended for Infants in India
Importing Food for Special Medical Purpose intended for Infants into India
Selling or distributing Food for Special Medical Purpose intended for Infants in India
Existing license holders and new applicants
On August 31, 2022, the Food Safety and Standards Authority of India (FSSAI) issued a notification for the Food Safety and Standards (Prohibition and Restrictions on Sales) First Amendment Regulations, 2022. This amendment reinforces quality and safety standards for specific food products, specifically Food for Special Medical Purpose intended for Infants, to ensure compliance with Indian regulations and elevate food safety.
If you are engaged in manufacturing, importing, or selling Food for Special Medical Purpose intended for Infants, this amendment directly impacts your business operations. Issued under the provisions of the Food Safety and Standards Act, 2006, this regulation mandates adherence to standards developed by the Bureau of Indian Standards (BIS) and is set forth to protect public health and consumer safety.
Key Provisions of the Food Safety and Standards (Prohibition and Restrictions on Sales) First Amendment Regulations, 2022
1. Title and Implementation Timeline
Officially named the Food Safety and Standards (Prohibition and Restrictions on Sales) First Amendment Regulations, 2022, this regulation will come into force as of April 1, 2023. Compliance requirements are universal for businesses of all sizes to ensure consistent quality in the food sector.
2. Mandatory BIS Certification for Food for Special Medical Purpose intended for Infants
The central provision of this amendment is the requirement for all Food for Special Medical Purpose intended for Infants to bear the BIS Standard Mark (ISI Mark). Products must conform to Indian Standard IS 17945: 2022, ensuring they meet strict quality and safety standards.
· Manufacturers must obtain a BIS license to use the ISI Mark, demonstrating compliance with essential health and safety standards for Food for Special Medical Purpose intended for Infants.
· This certification requirement applies to products sold within the domestic market, with exemptions for items produced exclusively for export.
3. BIS as the Certifying Authority
The Bureau of Indian Standards (BIS) is designated as the sole certifying authority for this amendment. BIS will be responsible for certifying and enforcing compliance to ensure that only products meeting Indian standards reach consumers, maintaining public safety and integrity in food quality.
4. Penalties for Non-Compliance
Entities failing to comply with the requirements of this amendment will face strict penalties as per the provisions of the Food Safety and Standards Act, 2006. This measure underscores the government’s dedication to enforcing high food safety standards and holding non-compliant businesses accountable to protect consumer health.
This amendment represents a significant step toward strengthening food quality standards for essential dairy products in the Indian market. It reflects FSSAI's commitment to consumer protection and industry compliance, aligning with the government’s goal of elevating food safety standards across India.
Stay compliant and prepare your business for these important regulatory changes to continue operating within the guidelines of the industry!
3. BIS as the Certifying Authority
| Title | Issue Date | View Order |
|---|---|---|
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| Extension Order | — | Click Here |

If you are engaged in manufacturing, importing, or selling Food for Special Medical Purpose intended for Infants, this amendment directly impacts your business operations. Issued under the provisions of the Food Safety and Standards Act, 2006, this regulation mandates adherence to standards developed by the Bureau of Indian Standards (BIS) and is set forth to protect public health and consumer safety.
Key Provisions of the Food Safety and Standards (Prohibition and Restrictions on Sales) First Amendment Regulations, 2022
Applicable Standard: IS 17945: 2022
1. Title and Implementation Timeline
Officially named the Food Safety and Standards (Prohibition and Restrictions on Sales) First Amendment Regulations, 2022, this regulation will come into force as of April 1, 2023. Compliance requirements are universal for businesses of all sizes to ensure consistent quality in the food sector.
2. Mandatory BIS Certification for Food for Special Medical Purpose intended for Infants
The central provision of this amendment is the requirement for all Food for Special Medical Purpose intended for Infants to bear the BIS Standard Mark (ISI Mark). Products must conform to Indian Standard IS 17945: 2022, ensuring they meet strict quality and safety standards.
· Manufacturers must obtain a BIS license to use the ISI Mark, demonstrating compliance with essential health and safety standards for Food for Special Medical Purpose intended for Infants.
The Bureau of Indian Standards (BIS) is designated as the sole certifying authority for this amendment. BIS will be responsible for certifying and enforcing compliance to ensure that only products meeting Indian standards reach consumers, maintaining public safety and integrity in food quality.
4. Penalties for Non-Compliance
Entities failing to comply with the requirements of this amendment will face strict penalties as per the provisions of the Food Safety and Standards Act, 2006. This measure underscores the government’s dedication to enforcing high food safety standards and holding non-compliant businesses accountable to protect consumer health.
This amendment represents a significant step toward strengthening food quality standards for essential dairy products in the Indian market. It reflects FSSAI's commitment to consumer protection and industry compliance, aligning with the government’s goal of elevating food safety standards across India.
Stay compliant and prepare your business for these important regulatory changes to continue operating within the guidelines of the industry!

Manak Bhawan 9, B.S. Zafar Marg,
New Delhi - 110002
+91-11-23231903
med@bis.org.in
To be announced
The contents provided in this update are solely meant for general informational purposes. Before you make decisions or take action based on the information provided, it is advised to seek professional legal consultation.