Food and Drug Licence in India: FSSAI Registration and Drug License Guide

A food and drug licence is an umbrella term commonly used for legal permissions required to operate a food business, pharmacy, medical store, drug wholesale business, medicine manufacturing unit, or related enterprise in India. However, food registration and drug licensing are governed by different laws, authorities, portals, and compliance requirements.

For food businesses, the applicable approval is generally an FSSAI Registration or FSSAI Licence. For medicine and pharmaceutical businesses, the requirement is usually a drug licence issued by the relevant State Drug Control Department under the Drugs and Cosmetics framework. Do not confuse Indian food and drug licences with U.S. FDA registration: the US Food and Drug Administration (US FDA) regulates products entering or sold in the United States, while FSSAI and Indian drug-control authorities regulate domestic Indian compliance.cdsco+1

Food and Drug Licence Meaning

A food and drug licence means the statutory approval needed to legally handle regulated food or drug products. In practical terms, it may refer to one or both of the following:

Food registration or FSSAI licence for restaurants, home kitchens, food manufacturers, online food sellers, caterers, bakeries, cloud kitchens, distributors, importers, and packaged-food brands.
Drug licence for pharmacies, chemists, medical stores, wholesalers, drug distributors, pharmaceutical manufacturers, and certain cosmetics businesses.

The food segment is governed by the Food Safety and Standards Act, 2006, and administered by the Food Safety and Standards Authority of India (FSSAI). The drug segment operates under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945, with central oversight from the Central Drugs Standard Control Organisation (CDSCO) and licensing functions performed by State Governments and State Drug Control Departments.cdsco+1

A business selling only food normally needs FSSAI approval, not a drug licence. A medical store selling only medicines normally needs a drug sale licence, not an FSSAI licence. But a business dealing in both regulated foods and pharmaceutical products may need separate approvals.

Food Registration for Food Businesses

Food registration is mandatory for Food Business Operators (FBOs) in India. An FBO includes a person or entity involved in manufacturing, processing, packaging, storage, distribution, transportation, sale, or import of food.

Examples include:

Home-based bakers and tiffin services
Tea stalls, juice shops, sweet shops, and snack vendors
Restaurants, dhabas, cafés, and cloud kitchens
Grocery stores and supermarkets
Food manufacturers and repackers
Online food sellers and marketplace brands
Caterers and event-food suppliers
Warehouses, cold-storage operators, distributors, and transporters
Food importers and exporters

Since 1 April 2026, FSSAI has revised the turnover-based categories for many food businesses:

Food registration category	Annual turnover threshold	Typical applicant
FSSAI Registration	Up to ₹1.5 crore	Small food seller, home kitchen, petty food business
State FSSAI Licence	Above ₹1.5 crore to ₹50 crore	Restaurant chain, manufacturer, distributor, medium food business
Central FSSAI Licence	Above ₹50 crore	Large food business, subject to applicable business criteria

FSSAI also uses specific eligibility criteria for certain categories, including dairy units, slaughterhouses, food transporters, importers, exporters, and businesses operating in more than one state. Therefore, turnover is important but is not the only factor when choosing an FSSAI licence.fssai+1

Food and Drug Licence Difference

The term “food and drug licence” can create confusion because food approval and drug approval are not interchangeable. The following table explains the basic difference.

Point	Food registration / FSSAI licence	Drug licence
Main regulator	FSSAI	State Drug Control Department and CDSCO framework
Main law	Food Safety and Standards Act, 2006	Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945
Covers	Food, beverages, ingredients, packaged foods, food services	Medicines, pharmaceutical products, certain cosmetics
Common applicants	Food vendors, restaurants, manufacturers, importers	Pharmacies, wholesalers, distributors, manufacturers
Main application platform	FoSCoS	State drug-control portal or relevant state licensing authority
Key focus	Food safety, hygiene, labelling, storage, quality	Qualified staff, premises, storage, product control, sale/manufacture compliance

Every Food Business Operator in India must obtain the appropriate FSSAI registration or licence. Meanwhile, the Drugs Rules provide for licensing authorities appointed by state governments for sale, stocking, distribution, and other regulated drug activities.fssai+1

Food and Drug Administration in India

The phrase Food and Drug Administration is often searched by people looking for the government department that regulates food and medicines. In India, the structure differs from the US Food and Drug Administration.

For food, the central regulator is FSSAI. It sets food-safety standards, oversees licensing and registration, regulates labelling, and supports enforcement through state and local food-safety authorities.

For drugs, CDSCO functions under the Ministry of Health and Family Welfare and is responsible for functions including drug approvals, clinical trials, standards, and regulation at the central level. State Drug Controllers and state licensing authorities manage many operational licensing matters, including retail and wholesale drug licences.

Some states use the name Food and Drug Administration or Food Safety and Drug Administration for their departments. For example, the Uttar Pradesh Food Safety and Drug Administration provides food licensing and drug/cosmetics application services through its official department portal.

Food and Drug Licence Types

A food and drug licence can include several distinct approvals depending on the business model.

Food and Drug Licence: FSSAI Registration

FSSAI Registration is generally intended for small food businesses. It is suitable for petty manufacturers, small retailers, hawkers, temporary stalls, home-based food ventures, and other small operators that meet the eligibility criteria.

Under the revised 2026 classification, businesses with annual turnover up to ₹1.5 crore fall under FSSAI Registration for the relevant categories.fssai

Food and Drug Licence: State FSSAI Licence

A State FSSAI Licence usually applies to eligible medium-sized food businesses operating within a state. This can include restaurants, food manufacturers, warehouses, distributors, caterers, and retailers whose operations exceed registration-level limits but do not require a Central Licence.

Food and Drug Licence: Central FSSAI Licence

A Central FSSAI Licence may be necessary for large food businesses, importers, exporters, businesses supplying government departments, operators working across multiple states, and specific categories defined by FSSAI eligibility conditions.

Food and Drug Licence: Retail Drug Licence

A retail drug licence is needed to sell medicines directly to consumers through a pharmacy, chemist shop, or medical store. The applicant must comply with applicable premises, storage, and competent-person requirements prescribed under the Drugs Rules and state-level procedures.

Food and Drug Licence: Wholesale Drug Licence

A wholesale drug licence is relevant for businesses that stock and distribute medicines to retailers, hospitals, pharmacies, or other authorised buyers rather than selling directly to end consumers.

Food and Drug Licence: Drug Manufacturing Licence

A drug manufacturing licence is required for businesses manufacturing pharmaceutical products. This category involves significantly more detailed technical, quality-control, facility, documentation, and inspection requirements than a retail or wholesale sale licence.

Food Registration Documents Required

Food registration documents vary according to the FSSAI category and nature of the business. Common documents may include:

Passport-size photograph of the applicant
Aadhaar card, PAN card, or other identity proof
Address proof of the proprietor, partners, or directors
Proof of business premises, such as rent agreement, ownership proof, or utility bill
Food product list or food-category details
Partnership deed, certificate of incorporation, or business constitution document
Layout plan of the processing or manufacturing unit, where applicable
List of machinery and equipment for manufacturing units
Water-analysis report where required
Food-safety management system plan or declaration, where applicable
Import Export Code for food importers or exporters, where applicable

Apply only through the official FoSCoS portal or use qualified professional support that gives you transparent access to your own application credentials and documents. FSSAI identifies FoSCoS as its official Food Safety Compliance System.foscos.fssai+1

Food and Drug Licence Application Process

The food and drug licence process should begin by identifying the exact activity of the business. Applying for the wrong category can delay approval, lead to modification requirements, or create compliance gaps.

For food registration, follow these steps:

Identify whether you need FSSAI Registration, State FSSAI Licence, or Central FSSAI Licence.
Check the applicable business category, turnover threshold, production capacity, and location criteria.
Create an account on the official FoSCoS portal.
Complete the applicable application form and upload the required documents.
Pay the prescribed government fee.
Respond promptly if the authority seeks clarification or additional documents.
Cooperate with inspection requirements, where applicable.
Download and display the issued FSSAI certificate at the business premises.

For drug licensing, the broad process is different:

Determine whether the business needs a retail, wholesale, manufacturing, loan, or other drug licence.
Apply to the competent state licensing authority or through the applicable state portal.
Upload ownership, premises, technical-person, storage, and business documents.
Ensure qualified personnel and storage arrangements meet the relevant requirements.
Facilitate inspection by the Drug Inspector or authorised official.
Receive the licence only after the licensing authority is satisfied with compliance.

Do not start selling prescription medicines merely because you have applied for a licence. Operating conditions, approvals, and state-level requirements must be met before commencing the regulated activity.

Food and Drug Licence Compliance

Obtaining a food and drug licence is only the first stage. Continuous compliance is essential.

For food businesses, compliance commonly includes:

Maintaining hygienic premises and safe water arrangements
Preventing contamination during preparation, storage, and transport
Using accurate food labels and ingredient declarations
Maintaining bills, supplier records, and traceability records
Displaying the FSSAI licence or registration number as required
Avoiding misleading health, therapeutic, or disease-cure claims
Renewing, modifying, or updating approvals when required under the applicable regulatory system

For drug businesses, compliance commonly includes:

Selling medicines only through authorised channels
Maintaining required storage conditions, including refrigeration where applicable
Keeping purchase and sale records
Employing required competent technical personnel
Following prescription, labelling, batch, expiry, and stock-control requirements
Avoiding sale of spurious, expired, misbranded, or improperly stored medicines

A food business should not market a normal food product as a treatment for diabetes, thyroid disorders, sexual conditions, cancer, or other diseases unless the claim is specifically permitted under applicable law. Similarly, supplements, nutraceuticals, and medicines are not automatically governed by the same licence category.

Food and Drug Licence FAQs

Food and Drug Licence: What is it?

A food and drug licence is a general term used for approvals connected with food and pharmaceutical businesses. In India, food businesses usually need FSSAI Registration or an FSSAI Licence, while medicine businesses need the appropriate drug licence from the competent state authority.

Food Registration: Is FSSAI mandatory?

Yes. FSSAI states that every Food Business Operator in India must be licensed or registered under the Food Safety and Standards Act, 2006. FSSAI registration guidance fssai

Food and Drug Licence: Do I need both approvals?

You need both only if your business genuinely handles both regulated food products and regulated drugs. A bakery usually needs FSSAI approval; a pharmacy usually needs a drug sale licence.

Food Registration: Which FSSAI category applies to small businesses?

For applications made under the revised thresholds effective from 1 April 2026, FSSAI Registration generally applies up to ₹1.5 crore annual turnover, subject to the applicable business category and eligibility conditions. FSSAI revised threshold FAQ fssai

Food and Drug Licence: Can a home baker apply for FSSAI Registration?

Yes, a home baker or home-based food seller may apply for the applicable FSSAI Registration or Licence based on the business category, turnover, and operational details.

Food and Drug Administration: Is FSSAI the same as US FDA?

No. FSSAI regulates food safety in India. The US Food and Drug Administration is a U.S. federal agency that regulates products in the United States.fssai+1

Food and Drug Licence: Where can I apply for FSSAI?

Apply through the official FoSCoS portal. It is FSSAI’s online system for licensing and registration services.foscos.fssai

Food Registration: What documents are required?

Common documents include identity proof, address proof, premises proof, business details, product list, and category-specific documents. Manufacturing, importing, dairy, meat, and other specialised businesses may need additional documentation.

Food and Drug Licence: Can I sell medicines with only an FSSAI licence?

No. An FSSAI licence does not authorise the sale of medicines. A pharmacy or medicine seller requires the appropriate drug licence under the applicable drug-control framework.

Food and Drug Licence: Who issues a drug licence?

Drug licences are generally issued by the competent state licensing authority or State Drug Control Department, while CDSCO performs central regulatory functions under the Drugs and Cosmetics framework. CDSCO official website cdsco

Food and Drug Licence: Is a pharmacist required for a medical store?

Retail drug licensing involves requirements relating to competent technical personnel, premises, and storage. The exact eligibility should be checked with the relevant State Drug Control Department because requirements and procedures can vary by licence type and state.

Food Registration: How long is an FSSAI licence valid?

FSSAI’s 2026 FAQ states that licences and registrations issued under the revised framework have perpetual validity unless they are suspended, cancelled, or surrendered. Existing businesses should check their FoSCoS account and official notices for migration or transition instructions.fssai

Food and Drug Licence: Can I use the word “FDA approved” on my food label?

Do not use “FDA approved” casually or misleadingly. In particular, U.S. FDA food-facility registration does not mean FDA has approved a facility’s products, labels, or claims.ecfr+1

Food and Drug Administration Registration: Is US FDA registration required for Indian food exports?

It may be required for facilities that manufacture, process, pack, or hold food intended for U.S. consumption, unless an exemption applies. Foreign facilities typically need a U.S. agent. FDA food-facility registration page fda

Food and Drug Licence: Can I apply without a physical shop?

A food business may operate from a home or commercial kitchen if it meets applicable FSSAI requirements. A drug licence, however, has separate premises, storage, and personnel requirements; an online medicine business cannot assume that a standard home setup qualifies.

Food Registration: What happens if I operate without FSSAI approval?

Operating a food business without the applicable registration or licence can expose the business to enforcement action and may also create problems with marketplaces, delivery platforms, distributors, customers, and inspections.

Food and Drug Licence: How do I check official updates?

Use official portals rather than relying only on agents or unofficial blogs: FSSAI, FoSCoS, CDSCO, and the relevant State Food Safety or Drug Control Department.

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