Companies already holding licences must now undergo annual audits and risk-based inspections to ensure continued compliance with stricter safety and quality standards, they said.
The shift follows FSSAI’s decision to classify packaged drinking water as a “high-risk” food category. Under the regulator’s revised Risk Based Inspection Scheme, companies must now meet hygiene and safety standards before securing a licence and will face more stringent oversight, including mandatory inspections and annual third-party audits.
High-risk food products include items with a high potential for contamination, such as milk, dairy products, meat, eggs, and certain ready-to-eat foods. Pre-licence inspections are standard practice for these categories, aligning bottled water with broader public health measures.
The move is significant because the government dropped the requirement for mandatory Bureau of Indian Standards (BIS) certification for packaged and mineral water in October 2024, simplifying compliance and consolidating regulatory authority under FSSAI.
Previously, manufacturers had to submit a BIS certificate as part of their FSSAI licence application, with BIS responsible for primary inspections.
Queries sent to the health ministry spokesperson and FSSAI on Monday remained unanswered till press time.
Quality clampdown
The new rules apply across the board—from small local firms to major brands such as Bisleri, Kinley (Coca-Cola), Aquafina (PepsiCo), and Himalayan (Tata).
India’s bottled water market, worth an estimated $9.5 billion in 2024-25, houses over 200 brands and is projected to reach $29.7 billion by 2033, growing at a compound annual growth rate (CAGR) of 12.45%, according to a report by IMARC Group.
The policy was discussed at a recent meeting of FSSAI’s Central Advisory Committee in Bhubaneswar, where state food safety commissioners were told to enforce the inspection requirement, according to the people cited earlier. The measure is aimed at ensuring rigorous quality control, a responsibility that previously sat with the BIS.
“FSSAI’s officials will now conduct pre-inspections of the plant before issuance of the license to the company. They will check the water’s source, the cleanliness of the plant, the equipment used, and the labelling of the bottles. The food commissioner in all the states/UTs have been directed to follow this new rule,” said one of the officials cited earlier.
The other official said that the move responds directly to complaints about unauthorized sellers refilling bottles with untreated water at home.
According to a Lok Sabha reply on 9 February 2024, India has 6,244 BIS-licensed manufacturers for packaged drinking water and 32 for mineral water. There is no official count of unauthorized plants, but industry estimates suggest the unorganized segment accounts for a significant portion of the market.
Under the Food Safety and Standards Act, 2006, operating without a licence can result in a fine of up to ₹5 lakh or imprisonment for up to six months.
India’s packaged water business has been buoyed by rising incomes, urbanization, and health concerns, factors that have fuelled a proliferation of new entrants. That rapid growth has also raised safety concerns.
The FSSAI’s action is crucial for protecting public health and ensuring that every bottle of water on the market is safe to drink. The new regulations will bring greater accountability to an industry that has seen rapid expansion, according to the officials.
Industry leaders were quick to welcome the tighter oversight.
Angelo George, CEO of Bisleri International, said, “Any initiative aimed at strengthening public health and safety will positively impact the sector, especially in combating the menace of counterfeit bottled water in the market.”
George added that Bisleri has always been proactive in maintaining high standards through regular internal and third-party audits and monthly sample analyses. “These measures reflect our unwavering commitment to delivering safe, high-quality drinking water and maintaining the trust of our consumers.”
“At PepsiCo India, food safety and quality are core to everything we do. Our brand Aquafina, part of the Packaged Drinking Water (PDW) category, fully complies with all applicable Indian food regulations. Each bottle reflects our steadfast commitment to delivering safe, high-quality drinking water to consumers,” said a PepsiCo India spokesperson.
A Tata Consumer Products spokesperson said the company welcomes FSSAI’s new quality and safety initiatives. All its brands, including Himalayan mineral water bottled at the Shivalik source, undergo stringent checks in a NABL-accredited lab for physio-chemical, microbiology, and packaging standards. The company remains fully compliant with FSSAI rules and continues voluntary BIS certification.
Medical experts also supported the changes.
Dr. Sawan Bopanna, a senior consultant in gastroenterology and hepatology Sri Balaji Action Medical Institute, Delhi, said unsafe drinking water remains a major cause of illnesses like typhoid and cholera. “Such pre-inspection measures allow authorities to not only verify the purity of the source water but also assess the hygiene standards maintained during the bottling and packaging process.”
Bopanna added that the move could reduce the risk of contaminated water reaching consumers and increase public confidence.