Licensing & Certifications
Licensing & Certifications
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1. FSSAI Registration & License (Food Safety and Standards Authority of India)
- Description: Mandatory registration/license for operating any food business legally in India, ensuring food safety standards.
- Compliance: Mandatory for food manufacturing, trading, storage, transportation, catering, etc. Must maintain hygiene and food safety norms
- Use: All food businesses — Manufacturers, Traders, Restaurants, Food Storage Units, Caterers, Exporters, Importers, Online Food Businesses.
- Validity: 1 to 5 years (renewable).
- Department: Food Safety and Standards Authority of India (FSSAI).
2. Halal Certification
- Description: Certifies that products comply with Islamic dietary laws and are permissible (halal).
- Compliance: Raw materials, manufacturing processes, and finished goods must meet Islamic standards.
- Use: Food Products, Restaurants, Cosmetics, Pharmaceuticals — especially for exports to Muslim-majority countries.
- Validity: 1 year (renewable).
- Issuing Authority: Various recognized Halal Certification Bodies (approved by Islamic Councils).
3. Kosher Certification
- Description: Certification for food and ingredients compliant with Jewish dietary laws (Kashrut).
- Compliance: Ingredients, equipment, and processes must meet Jewish dietary standards.
- Use: Food, Beverages, Pharmaceuticals exporting to Jewish markets (USA, Israel, etc.).
- Validity: 1 year (renewable).
- Issuing Authority: Certified Kosher Agencies (e.g., OK Kosher, OU Kosher, Star-K).
4. FDA Certification (Food and Drug Administration - USA)
- Description: Certification allowing products to be sold legally in the United States, ensuring compliance with US food, drug, and health safety laws.
- Compliance: Strict product labeling, manufacturing, and quality assurance requirements.
- Use: Food Products, Drugs, Medical Devices, Cosmetics exported to the USA.
- Validity: Generally no expiry but facility registrations must be renewed every 2 years.
- Department: United States Food and Drug Administration (FDA).
5. HACCP Certification (Hazard Analysis and Critical Control Point)
- Description: A systematic preventive approach to food safety addressing physical, chemical, and biological hazards during production.
- Compliance: Identify critical control points, hazard analysis, documentation, and verification processes.
- Use: Food manufacturing units, processing plants, catering services, packaging industries.
- Validity: 3 years (subject to surveillance audits).
- Issuing Authority: Accredited Certification Bodies (approved by NABCB, etc.).
6. Drug License
- Description: A Drug License is a mandatory authorization issued by the government that allows businesses to legally manufacture, distribute, stock, or sell pharmaceuticals, medicines, and cosmetics. It ensures that the entity complies with the Drugs and Cosmetics Act, 1940 and rules framed under it, maintaining public health and safety standards.
- Premises must meet standard conditions (clean, hygienic, appropriate storage facility). Appointment of a qualified person (registered pharmacist or person having a degree/diploma with relevant experience). Maintenance of proper records for procurement and sale. Display of license prominently at the business premises. No sale of drugs without prescription where mandatory (Schedule H, H1, X drugs).
- Use: Wholesale or retail sale of medicines and drugs. Online pharmacy operations. Manufacturing and distribution of pharmaceutical products. Storage and sale of medical devices and cosmetics.
- Validity: Generally valid for 5 years (renewable thereafter). Renewal application must be filed before the expiry date to avoid penalties. Subject to periodic inspections by Drug Inspectors.
- Issuing Authority: State Drugs Control Department (for Retail and Wholesale Drug Licenses) Central Drugs Standard Control Organization (CDSCO) (for specific categories like bulk drugs, new drugs, and critical pharmaceuticals)
Types of Drug Licenses:
Type | Purpose |
|---|---|
Retail Drug License (RDL) | Sale of drugs directly to consumers (Pharmacy shops) |
Wholesale Drug License (WDL) | Sale of drugs to other businesses (distributors, retailers) |
Manufacturing Drug License | Manufacturing of allopathic, homeopathic, ayurvedic medicines |
Import License | Import of drugs from other countries |
Loan License | Manufacture of drugs using another manufacturer’s facility |
Blood Bank License | Collection, storage, and sale of blood and blood components |
7. AGMARK Certification (Agricultural Marketing)
- Description: Certification mark assuring that agricultural products conform to a set of standards approved by the government.
- Compliance: Agricultural products must pass quality and grading standards.
- Use: Sellers and exporters of grains, fruits, vegetables, edible oils, etc.
- Validity: 5 years (renewable).
- Department: Directorate of Marketing and Inspection (DMI), Ministry of Agriculture and Farmers Welfare, Government of India.
8. BIS Certification (Bureau of Indian Standards)
- Description: Ensures products meet Indian standards for quality, safety, and reliability.
- Compliance: Testing of products as per BIS guidelines and standards.
- Use: Electrical products, kitchen appliances, cement, steel, food products, etc.
- Validity: 2 years (renewable).
- Department: Bureau of Indian Standards (BIS), Government of India.
9. APEDA Registration (Agricultural and Processed Food Products Export Development Authority)
- Description: Mandatory registration for businesses exporting scheduled agricultural products from India.
- Compliance: Businesses must adhere to export standards and product packaging guidelines.
- Use: Exporters of fruits, vegetables, dairy products, meat, cereals, and floriculture.
- Validity: Lifetime (subject to updates and compliance with export guidelines).
- Department: APEDA, Ministry of Commerce and Industry, Government of India.
10. Spices Board Registration
- Description: Registration required for exporters dealing in Indian spices.
- Compliance: Good manufacturing practices (GMP) and quality standards to be followed.
- Use: Exporters of spices like pepper, turmeric, cumin, cardamom, etc.
- Validity: 3 years (renewable)
- Department: Spices Board India, Ministry of Commerce and Industry.
CE Certification (Conformité Européenne)
- Description: CE marking is a mandatory conformity mark for products sold within the European Economic Area (EEA). It certifies that a product meets the European Union’s health, safety, and environmental protection standards. CE marking also enables the free movement of products within the European market.
- Compliance: Product testing according to EU Directives and Regulations (like Low Voltage Directive, EMC Directive, Machinery Directive, Medical Devices Regulation, etc.). Risk Assessment and Conformity Assessment. Technical Documentation Preparation. Declaration of Conformity (DoC). Product Labelling and Marking.
- Use: Electronics and Electrical Appliances. Machinery and Industrial Equipment. Toys, Medical Devices, Construction Products. Personal Protective Equipment (PPE). All products intending to be sold in Europe.
- Validity: Valid until there are no changes in the EU Directives or changes in the product design or intended use. Surveillance audits may be conducted based on product category and regulation. In most cases, self-certification is allowed after meeting conformity requirements, but third-party notified bodies are necessary for certain high-risk products.
- Issuing Authority: Notified Bodies (For products requiring mandatory third-party assessment). Manufacturer (For self-declaration products after internal compliance).
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