Most water plant owners now know three things: the BIS mark is voluntary at the national level, FSSAI treats packaged drinking water as a high-risk food, and monthly testing under the Scheme of Testing has been compulsory since 1 January 2026. The fourth piece gets less attention: the third-party food safety audit. This guide explains where it comes from, who must have it, and how to prepare.
Where the audit requirement comes from
Two FSSAI instruments work together.
First, the Food Safety and Standards (Food Safety Auditing) Regulations, 2018. FSSAI announced them on 10 September 2018. Audits are done by private auditing agencies recognised by FSSAI. They check a food business against the hygiene and sanitary requirements in Schedule 4 of the licensing regulations. FSSAI decides which categories must be audited, and how often, based on risk.
Second, the FSSAI order dated 29 November 2024. It amended FSSAI's risk-based inspection policy of 2 May 2022 and added packaged drinking water and mineral water to the "High-Risk Food Categories". As reported by Lexplosion and Deccan Herald, the order brought in three things:
- inspection before a licence or registration is granted;
- inspection of these manufacturers at least once a year;
- an annual audit by an FSSAI-recognised third-party auditing agency for Central licence holders.
For more on how BIS and the high-risk rules fit together, see our explainer on BIS no longer being mandatory for packaged drinking water.
Who needs the audit
The yearly third-party audit applies to centrally licensed manufacturers in high-risk categories. From 1 April 2026, a Central licence applies to food businesses with turnover above Rs 50 crore. Units between Rs 1.5 crore and Rs 50 crore hold a State licence. (Some activities need a Central licence whatever the turnover, so check which licence you hold.)
A State-licensed water plant is not covered by the yearly third-party audit under the 2024 order. It still faces the pre-licence and yearly inspections. FSSAI's 2018 announcement also says businesses outside the mandatory list may choose a voluntary audit.
| Requirement | Applies to | How often | Basis |
|---|---|---|---|
| Pre-licence inspection | All PDW / mineral water manufacturers | Before licence or registration is granted | FSSAI order, 29 Nov 2024 |
| Risk-based inspection | All PDW / mineral water manufacturers | At least once a year | FSSAI order, 29 Nov 2024 |
| Third-party food safety audit | Central licence holders | Once a year | FSSAI order, 29 Nov 2024; Auditing Regulations, 2018 |
| Scheme of Testing | All PDW / mineral water manufacturers | Monthly microbiological tests; records kept 5 years | FSSAI order, 17 Dec 2025 |
How the audit affects inspections
FSSAI said in 2018 that satisfactory audits lead to less frequent regulatory inspections. A poor result can lead to more. Sampling by the licensing authority continues either way, and officials can still inspect after a complaint. A clean audit lowers your risk. It does not replace inspection.
Why this matters now
State food safety departments are actively checking water units. On 27 September 2026, Dynamite News reported that the J&K Food and Drug Administration sealed a packaged water unit in Pulwama. The licence printed on its bottles had been issued for fruit and vegetable trading, not water manufacturing. The report cited Section 63 of the FSS Act, under which running without the required licence can bring a penalty of up to Rs 10 lakh. Inspectors look first at licence scope and records, and an auditor checks the same things.
What this means for water plant owners
- Confirm your licence type and scope. The product category on your FSSAI licence must cover packaged drinking water or mineral water manufacture. See our FSSAI licence page.
- If you are a Central licensee, plan the audit date. Choose only an agency on FSSAI's recognised list, and book it well before the year ends.
- Prepare the Schedule 4 basics. Premises and layout, water treatment and sanitation, pest control, staff hygiene and medical records, cleaning logs, calibration, and traceability of batches.
- Keep testing records ready. Monthly microbiological reports, source-water reports from FSSAI-notified NABL labs, and 5 years of records under the Scheme of Testing.
- Keep other approvals current. Auditors and inspectors often ask for CGWA NOC and Pollution Control Board CTE/CTO documents too.
- Close the gaps quickly. Record corrective actions with dates. A documented fix carries more weight than a verbal promise.
Setting up a new unit? Our approval checklist for packaged drinking water plants lists every licence in order.
How ClearPath Compliance India can help
ClearPath Compliance India, based in Kota, Rajasthan, works with food, beverage and packaged drinking water plants on FSSAI licensing, BIS, CGWA NOC, Pollution Control Board consents, factory licence and fire NOC. For audit readiness, we can review your licence scope, run a mock Schedule 4 check, organise testing and hygiene records, and track corrective actions before the recognised agency or the inspector visits. Contact us to book a review.
Sources
- FSSAI press release, 10 Sep 2018: Food Safety Auditing Regulations, 2018
- Lexplosion: FSSAI order of 29 Nov 2024 adding packaged drinking water and mineral water to high-risk categories
- Deccan Herald: FSSAI reclassifies packaged drinking water as high-risk, mandates stricter checks
- Dynamite News, 27 Sep 2026: Pulwama water plant sealed over FSSAI licence
General information only, not legal advice. Rules are as reported on the dates stated and may change; check the latest FSSAI orders before acting. Brand and business names, if any, are trademarks of their owners and are used for identification only. This article is not sponsored or endorsed by any brand named.