The Role of Product Certification and Licensing in the Dairy Industry

Every time you pick up a packet of ghee, a carton of milk, or a tin of infant formula in India, there’s a good chance you’ll spot a small logo – ISI, AGMARK, or an FSSAI number. These aren’t just symbols. They represent a system of product certification and licensing that ensures what you’re consuming has been tested, inspected, and verified to meet defined quality and safety standards. For dairy producers, these certifications are not optional formalities – they are the backbone of quality assurance in a sector that directly impacts public health.

What product certification means in the dairy industry 🔗

Product certification is the process by which an independent authority verifies that a dairy product consistently meets a defined set of standards – covering composition, hygiene, purity, and safety. A dairy manufacturer cannot simply claim their milk powder or ghee is of a certain quality; that claim must be backed by documented testing, facility inspections, and an official mark issued by a recognized certifying body.

Licensing, on the other hand, is the legal authorization granted to a food business to manufacture, process, store, or sell dairy products. Without the appropriate license, a dairy unit cannot legally operate. Together, certification and licensing create a two-layered system – one that sets the quality bar, and another that ensures every business operating in the sector clears it.

The key certifying bodies for dairy products in India 🔗

Three major organizations govern product certification and licensing for the dairy sector in India: the Bureau of Indian Standards (BIS), the Directorate of Marketing and Inspection (DMI) under the Ministry of Agriculture, and the Food Safety and Standards Authority of India (FSSAI). Each has a distinct scope, and understanding the difference between them is essential for anyone working in dairy quality assurance.

Bureau of Indian Standards (BIS) and the ISI mark 🔗

BIS is India’s national standards body, originally established as the Indian Standards Institution (ISI) in 1947 and restructured under the BIS Act, 1986. Its core function is to formulate national standards for products – both food and non-food – and to certify that manufacturers comply with those standards through the ISI Mark Scheme.

Among dairy products, BIS/ISI standards cover most processed milk products. Ghee and creamery butter are covered separately under AGMARK, while the rest fall under BIS/ISI jurisdiction. Although BIS certification was historically voluntary, in 1987, BIS made it mandatory for certain items, including food colors and additives, milk powder, and condensed milk.

The Conformity Assessment Scheme for Milk and Milk Products – jointly developed by BIS and the National Dairy Development Board (NDDB) – provides a comprehensive approach to quality assurance in the dairy sector. It covers product certification for milk and milk products, food safety management system (FSMS) certification, and process certification aligned with NDDB’s quality mark guidelines.

AGMARK and the Directorate of Marketing and Inspection 🔗

AGMARK stands for Agricultural Marketing and is governed by the Directorate of Marketing and Inspection (DMI) under the Agriculture Produce (Grading and Marketing) Act, 1937. AGMARK certifies the quality and purity of agricultural products – including dairy, fruits, vegetables, spices, and edible oils – and assures consumers of hygiene and quality.

For dairy products, ghee and creamery butter are covered under AGMARK. The certification process involves drawing three samples – one is analyzed by the AGMARK chemist, one is sent to the central control lab, and the third is held by the manufacturer for future reference. Labels are issued only after the chemist confirms the product meets the specifications fixed under AGMARK standards.

As of now, 213 agricultural products come under AGMARK certification. AGMARK certification deals with chemical tests, microbiological experiments, pesticide residue analysis, and Aflatoxin levels. Importantly, AGMARK is granted for the product, not for an individual farmer or manufacturer.

FSSAI: the primary licensing authority 🔗

FSSAI – the Food Safety and Standards Authority of India – was established under the Food Safety and Standards Act, 2006 and operates under the Ministry of Health and Family Welfare. Unlike BIS and AGMARK, which are primarily certification bodies, FSSAI functions as a licensing and regulatory authority. Every food business operator dealing in dairy units – including milk chilling units – is required to be licensed or registered under FSSAI. One cannot deal in milk and milk products without a valid FSSAI license.

The type of FSSAI license depends on the scale of the dairy operation. A state license is required for dairy units handling between 500 and 50,000 litres of milk per day. A central license is required for units handling more than 50,000 litres of liquid milk per day or 2,500 MT of milk solids per annum.

For medium and large dairy operators, a site inspection is a mandatory part of the FSSAI approval process. Authorities verify sanitation in processing units, storage conditions, temperature controls for perishable goods, employee hygiene standards, and labeling compliance. If gaps are identified, an improvement notice is issued, directing the business to resolve issues within a fixed timeframe.

How the BIS certification process works 🔗

The BIS certification process for dairy manufacturers follows a structured sequence involving application, inspection, testing, and ongoing surveillance. The process involves two main stages: the licensing process and the surveillance process. In the licensing stage, the manufacturer submits an application, a BIS officer visits the factory for a preliminary inspection, product samples are collected and tested, and a final result is derived.

During the on-site factory audit, information including factory layout, quality control procedures, staff details, testing and manufacturing equipment, and process flow are physically validated. A requisite number of random samples are sealed and sent to a BIS-recognized laboratory in India for independent testing. Once positive results are received, the manufacturer receives a CM/L number to use the ISI mark on the product. This number, along with the ISI logo and the corresponding Indian Standard number, must be marked on the product before it is sold in the market.

Once certified, the manufacturer’s obligations do not end. After grant of licence, BIS can conduct surprise factory surveillance inspections to verify that the manufacturer continues to maintain the required manufacturing infrastructure, process controls, quality control systems, and product conformity to the applicable Indian Standard. BIS also carries out market surveillance through purchase of ISI-marked products from the market, which are then sent for third-party laboratory testing.

BIS certification is usually valid for two years, after which it must be renewed. The typical process takes between four and six months, depending on the scheme and product category.

Significance of these certifications for quality assurance 🔗

Certification and licensing serve a very direct purpose: they prevent substandard and adulterated dairy products from reaching consumers. Each mark functions as an independent quality signal backed by testing and inspection, not just manufacturer self-declaration.

For the dairy industry specifically, the stakes are high. Milk and milk products are perishable, consumed across all age groups, and frequently targeted for adulteration – whether through added water, foreign fats in ghee, or incorrect composition in milk powders. Certifications like ISI and AGMARK create accountability at the manufacturing stage by setting measurable benchmarks and verifying compliance before a product can bear the mark.

One key advantage of the BIS Conformity Assessment Scheme for dairy is that it provides single-point quality certification covering all elements of a food safety management system in accordance with IS/ISO 22000, product certification per relevant Indian Standards, and process certification aligned with NDDB guidelines. This integrated approach reduces gaps that could otherwise exist when product quality, process quality, and food safety management are assessed separately.

Recent regulatory changes: streamlining the framework 🔗

India’s dairy certification landscape has undergone significant changes in recent years, all aimed at reducing regulatory duplication while keeping consumer protection intact.

In February 2024, FSSAI approved amendments removing the requirement for BIS, ISI, and AGMARK certifications for certain food products. These changes, known as the Food Safety and Standards (Prohibition and Restrictions on Sales) First Amendment Regulations, 2024, came into force on 17th October 2024. Under the new framework, the FSSAI license is now the only mandatory certification for most food products, simplifying the regulatory process and reducing compliance costs for dairy businesses.

However, some key categories remain under mandatory BIS or ISI certification. BIS certification is still required for infant milk food, infant formula, milk cereal-based weaning food, and follow-up formula. ISI certification remains mandatory for sweetened condensed milk, milk powder, and skimmed milk powder. These products are retained under stricter certification requirements due to their direct impact on vulnerable consumer groups, particularly infants and young children.

This shift reflects the government’s “One Nation, One Commodity, One Regulator” policy – the intent being that FSSAI becomes the single authority for food safety regulation in India, eliminating the need for dairy manufacturers to pursue multiple parallel certifications.

Why certification and licensing matter beyond compliance 🔗

For dairy businesses, obtaining the right certifications is not simply about regulatory compliance – it directly affects market access, consumer confidence, and business credibility. Certified dairy products can be supplied to government institutions, export markets, and organized retail chains, where non-certified products would be outright rejected.

The removal of mandatory BIS and AGMARK requirements for several dairy categories is expected to ease operational costs and reduce bureaucratic requirements for food producers, while ensuring FSSAI remains the single regulatory body overseeing food safety standards. For small and medium dairy enterprises, this simplification reduces both cost and time to market.

At the same time, voluntary certifications like AGMARK for ghee or ISI marks for specific milk products remain valuable market differentiators. A product carrying the AGMARK seal signals that its quality and purity have been independently verified – something that builds trust in both domestic and export markets where adulteration concerns are persistent.

What do you think? With FSSAI now positioned as the single mandatory regulator for most dairy products, do you think the voluntary BIS and AGMARK certifications will still carry weight with consumers? And should stricter mandatory certification be extended to more dairy product categories beyond infant formula and milk powders?

References

1. https://www.bis.gov.in
2. https://www.fssai.gov.in
3. https://bis.gov.in/about-bis/bis-act-rules-and-regulations/
4. https://agmarknet.gov.in
5. https://www.fssai.gov.in/home/about-fssai/about-authority.html