FSSAI License for Packaged Drinking Water: Fees & Rules

Key Takeaways

• FSSAI approval is mandatory for packaged drinking water businesses, classified as a high-risk food category.
• Packaged drinking water manufacturers can obtain Registration or a State/Central License based on current eligibility.
• BIS certification is no longer mandatory; FSSAI’s specific testing scheme applies from 1 January 2026.
• Manufacturers must meet prescribed quality, safety, packaging, labeling, and testing requirements.
• High-risk packaged drinking water units are subject to mandatory inspections and applicable food safety audits.
• Manufacturers must maintain required documents, testing records, hygiene controls, and recall procedures.

Why is an FSSAI License Important for Packaged Drinking Water?

An FSSAI license is required for food businesses handling packaged drinking water because FSSAI regulates the safety of food and beverages sold in India. Packaged drinking water falls under FSSAI’s high-risk food category, which brings additional inspection and compliance requirements for manufacturers. The license is important for the following reasons:

• It establishes regulatory compliance: Food businesses must obtain the applicable FSSAI license before starting food operations. Packaged drinking water manufacturers must therefore meet the licensing requirements applicable to their business.
• It subjects high-risk units to stricter oversight: FSSAI requires pre-license inspection for packaged drinking water manufacturers and processors. It also requires inspections once every year under the high-risk category.
• It supports water safety controls: FSSAI has introduced a specific testing scheme for packaged drinking water and mineral water. FBOs must follow this scheme from 1 January 2026.
• It requires ongoing compliance: A license does not replace operational controls. Manufacturers must continue meeting applicable requirements for water quality, processing, packaging, hygiene, and testing.
• It provides traceability: The FSSAI license number identifies the licensed food business and is displayed on the product label. Businesses can also use an FSSAI License Number Check to verify license details.

Important update on BIS certification: Older information often states that BIS certification is mandatory for packaged drinking water. FSSAI officially removed the mandatory BIS certification requirement for packaged drinking water and mineral water in October 2024. From 1 January 2026, FBOs must instead comply with FSSAI’s specific testing scheme for these products.

FSSAI Testing Frequency for Packaged Drinking Water

The specific testing scheme requires manufacturers to follow different testing frequencies for different parameters:

• Monthly microbiological testing: Manufacturers must test for coliforms, E. coli, fecal streptococci, Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella, Shigella, Vibrio, yeast, and mold.
• Quarterly chemical and physical testing: This covers parameters such as pH, turbidity, TDS, heavy metals, fluoride, nitrate, arsenic, and pesticide residues.
• Biannual packaging material testing: Manufacturers must test the packaging materials twice a year to verify compliance with the applicable requirements.

Which Category Applies to Packaged Drinking Water: FSSAI Registration vs. License

The required approval depends on the scale and nature of the business operations. However, packaged drinking water is a high-risk food category with additional inspection and testing requirements, so manufacturers should verify the applicable Kind of Business and current FoSCoS eligibility before applying.

• FSSAI Registration: This applies to eligible small-scale food businesses based on the current turnover and eligibility criteria.
• FSSAI License: Larger food businesses require a State or Central License based on the applicable turnover thresholds and other prescribed conditions.
  • State License: Generally applies to businesses with annual turnover above ₹1.5 crore and up to ₹50 crore.
  • Central License: Generally applies to businesses with annual turnover above ₹50 crore or where other conditions require Central licensing.

FSSAI Fees for Packaged Drinking Water

The FSSAI government fee for a packaged drinking water manufacturing unit depends on the applicable approval category and production capacity. Additional expenses may arise from laboratory testing, inspection and compliance requirements, professional services, and plant setup.

Cost component	Applicable fee/cost
Basic Registration Fee	₹100
State License for production below 1 MT/day	₹3,000
State License for production of 1–2 MT/day	₹5,000
Central License for applicable units	₹7,500
Laboratory testing	Additional, based on required tests
Inspection and compliance expenses	Additional, based on applicable requirements
Professional fee	Depends on the service provider
Plant and setup costs	Depends on production capacity and facility

The ₹3,000 and ₹5,000 fees apply to the relevant food manufacturing/processing categories based on production capacity, while the Central License fee is ₹7,500. The exact fee should be confirmed against the applicable Kind of Business and current FoSCoS eligibility before payment.

Packaged drinking water manufacturers must also follow FSSAI’s specific testing scheme effective from 1 January 2026.

Documents Required for FSSAI License for Packaged Drinking Water

The required documents depend on the Kind of Business and application type selected in FoSCoS. Manufacturers should also check whether FSSAI product approval applies to their product before applying. Common FSSAI documents include:

• Form B: Completed and signed by the proprietor, partner, or authorized signatory.
• Plant layout: A blueprint showing the processing areas and their dimensions.
• Equipment details: A list of Machinery with installed capacity and other prescribed specifications.
• Identity and address proof: Documents for the proprietor, partners, directors, or authorized signatory.
• Business constitution documents: Partnership deed, proprietorship declaration, or company incorporation documents, as applicable.
• Premises proof: Documents establishing possession of the manufacturing premises.
• Water analysis report: Chemical and bacteriological analysis of water used as an ingredient, where applicable.
• Pesticide residue report: FSSAI specifically lists a pesticide residue report for water used by packaged drinking water, packaged mineral water, and carbonated water units.
• Food Safety Management System plan or certificate: Where applicable.
• Responsible person details: Manufacturers must provide the prescribed details of the person responsible for regulatory and inspection-related activities.
• Recall plan: Where applicable.
• Local authority NOC: Where required by the application or state authority.

FSSAI also lists the requirement for a technically qualified person supervising production under its licensing documentation framework.

How to Apply for an FSSAI License for Packaged Drinking Water?

Businesses can apply through the FoSCoS portal, which FSSAI uses for food licensing and registration applications. Follow these steps:

Step 1: Identify the Applicable Kind of Business

Determine the exact activity, such as manufacturing or processing packaged drinking water. Then check the current FoSCoS eligibility criteria for the appropriate registration or license category.

Step 2: Prepare the Required Documents

Collect the plant layout, machinery details, business constitution documents, premises proof, water analysis reports, and other documents applicable to the manufacturing activity.

Step 3: Create an Application on FoSCoS

Open the official FoSCoS portal and select the option for a new License or Registration. Enter the business, premises, applicant, and manufacturing details requested by the portal.

Step 4: Upload Supporting Documents

Upload the documents specified for the selected Kind of Business and application category. Check each document before submission to avoid queries caused by incomplete or inconsistent information.

Step 5: Pay the Applicable Government Fee

Pay the prescribed FSSAI fee through the official FoSCoS payment facility. The applicable fee depends on the approval category and business activity.

Step 6: Complete Inspection and Verification

For packaged drinking water manufacturers, FSSAI’s high-risk framework requires the prescribed inspection before approval. Keep the manufacturing premises and compliance records ready for verification.

Step 7: Receive the FSSAI Approval

After the authority completes the applicable processing and approval, the FSSAI registration or license becomes available through the prescribed system.

Step 8: Maintain Ongoing Compliance

Continue product testing, source-water testing, packaging controls, hygiene practices, record maintenance, and other requirements applicable to the manufacturing unit.

What Happens if Packaged Drinking Water Fails a Required Test?

The manufacturer must take corrective action when testing identifies microbiological or other non-compliance.

For microbiological non-compliance, FSSAI requires the manufacturer to investigate the contamination, recheck available stock, and ensure conformity before releasing affected products. Production and dispatch should restart only after satisfactory corrective action and satisfactory microbiological results for five consecutive batches.

The manufacturer must also retain records of such incidents for at least 5 years for review by FSSAI.

Repeated non-compliance can trigger additional regulatory action, including risk-based inspection where the testing scheme provides for it.

Packaged Drinking Water Plant Compliance Checklist: What You Need?

Before setting up a packaged drinking water plant, plan for the following key compliance areas:

• Water source requirements: Identify a consistent water source and ensure it meets the applicable quality requirements before processing.
• Treatment and process controls: Plan the required treatment, filtration, disinfection, and other processing controls based on the source water quality.
• Packaging and container requirements: Use suitable sealed containers that are safe for direct consumption and comply with applicable packaging requirements.
• Laboratory and testing arrangements: Establish arrangements for the testing required under FSSAI’s packaged drinking water testing scheme and use laboratories meeting the applicable requirements.
• Technically qualified personnel: Arrange for the required technically qualified person to supervise production and related activities.
• Hygiene and sanitation: Maintain hygienic premises, equipment, food-contact surfaces, cleaning procedures, pest controls, and other applicable sanitation measures.
• Records: Maintain testing, production, hygiene, and corrective-action records required under the applicable compliance framework.
• Recall system: Maintain a procedure to identify and withdraw affected products when testing or other controls identify a safety issue.
• Product labelling: Ensure packaged water labels carry the information required under the applicable FSSAI labelling requirements.

Difference Between Packaged Drinking Water and Natural Mineral Water

Packaged drinking water and natural mineral water are separate product categories under the FSSAI framework.

Packaged drinking water is regulated under Regulation 2.10.8, while packaged natural mineral water falls under Regulation 2.10.7. FSSAI has separate testing schemes for the two products.

A business should therefore select the correct product category and Kind of Business when applying through FoSCoS. The manufacturer should not treat packaged drinking water and natural mineral water as interchangeable products for licensing or testing purposes.

Common Compliance Mistakes to Avoid While Operating a Packaged Drinking Water Plant

Packaged drinking water manufacturers should pay particular attention to the following compliance areas:

• Using outdated BIS information: Do not treat the earlier mandatory BIS certification requirement as the current FSSAI requirement.
• Using outdated turnover limits: The thresholds changed from 1 April 2026.
• Ignoring the high-risk classification: Manufacturers must account for the additional inspection and audit requirements.
• Skipping scheduled testing: The 2026 testing scheme specifies testing frequencies for different parameters.
• Using an unapproved laboratory: Follow the scheme’s requirements for FSSAI-notified, NABL-accredited laboratories.
• Changing the water source without testing: A new source must undergo the prescribed testing before regular production.
• Using damaged reusable containers: FSSAI prohibits the continued use of containers that become soiled, de-shaped, or mutilated.
• Failing to maintain records: Manufacturers must maintain testing, packaging, hygiene, and corrective-action records required under the applicable framework.