Quick Answer
Infant formula manufacturing and sale in India is among the most strictly regulated sectors under FSSAI. Products intended to replace breast milk for infants below 6 months require Central FSSAI License and must comply with FSSAI infant formula regulations and the IMS Act restrictions on promotion.
Who Needs FSSAI License for Infant Formula Business?
- Infant formula manufacturers
- Follow-on formula producers
- Specialty medical infant formula manufacturers
- Infant formula importers and distributors
💡 The 14-digit FSSAI License number must be displayed at your premises and on all packaging, menus, and bills.
Which License Type Do You Need?
| Annual Turnover | License Type | Issued By |
|---|
| Below ₹12 Lakh | Basic FSSAI Registration | State Food Authority |
| ₹12 Lakh – ₹20 Crore | State FSSAI License | State Food Authority |
| Above ₹20 Crore | Central FSSAI License | FSSAI Central Office |
⚠️ Multi-state businesses require a Central FSSAI License regardless of turnover.
Documents Required
- PAN & Company registration documents
- Manufacturing facility or import license proof
- Complete product formulations with nutritional analysis
- Clinical safety evidence
- IMS Act compliance documentation
- Central FSSAI License application
- HACCP-based FSMS documentation
- Labelling samples for regulatory approval
Step-by-Step Application Process
- Determine License Type — Based on annual turnover decide Basic, State, or Central.
- Register on FoSCoS Portal — Visit foscos.fssai.gov.in and create an applicant account.
- Fill Application Form — Complete Form A (Basic) or Form B (State/Central).
- Upload Documents — Attach all required documents in prescribed formats.
- Pay Government Fee — Pay online via UPI, net banking, or card.
- Await Inspection — An FSSAI officer may inspect your premises within 30 days.
- Receive License — Download your FSSAI License certificate from the FoSCoS portal.
Get Your FSSAI License for Infant Formula Business Fast
ClearlyComply experts handle the entire process. Most businesses get their license in 15–20 working days.
Talk to an Expert
💳 Apply & Pay — ₹2,499
Fees & Timeline
| License Type | Government Fee | Processing Time |
|---|
| Basic Registration | ₹100/year | 7–10 working days |
| State License | ₹2,000–₹5,000/year | 15–30 working days |
| Central License | ₹7,500/year | 30–60 working days |
Frequently Asked Questions
What is the IMS Act and how does it affect infant formula business?
The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 (IMS Act) strictly regulates advertising and promotion of infant formula. It prohibits advertising, free samples to mothers, and gifts to healthcare workers.
What FSSAI compositional standards apply to infant formula?
FSSAI specifies precise levels of proteins, fats, carbohydrates, vitamins, minerals, and other nutrients in infant formula. These are based on WHO Codex standards and are mandatory. Products not meeting these compositional standards cannot be sold as infant formula.
Can infant formula manufacturers advertise their products in India?
The IMS Act severely restricts advertising of infant formula. Advertising in public media is prohibited. Educational material must include breastfeeding promotion. Any promotional activity must be pre-approved and comply with IMS Act restrictions.
What is the minimum shelf life requirement for infant formula?
FSSAI requires infant formula to have adequate shelf life declared on packaging. The product must maintain its nutritional quality and safety throughout this period. Probiotic-containing infant formulas must maintain viable organism counts at end of shelf life.
Need help with FSSAI License for Infant Formula Business?
Our compliance experts will handle everything for you.
📱 WhatsApp Us
✉️ Email Us