Ayurvedic products in India are regulated under multiple frameworks to ensure quality, safety, and public health. Two primary licenses govern the production and sale of these products: the AYUSH licence and the FSSAI licence. Each serves a distinct purpose and is issued by different authorities, impacting how businesses operate and manufacture Ayurvedic items. Proper adherence to licensing requirements is essential for obtaining an Ayurvedic Medicine Manufacturing Licence in West Bengal.
1. Defining AYUSH and FSSAI Licences
- AYUSH Licence: Issued by the Ministry of AYUSH, this licence regulates the manufacture, sale, and distribution of Ayurvedic medicines. It ensures compliance with Good Manufacturing Practices (GMP) and authentic formulation standards.
- FSSAI Licence: Issued by the Food Safety and Standards Authority of India, this licence governs food products, including Ayurvedic health supplements that are consumed as dietary items. It focuses on safety, hygiene, labeling, and nutritional compliance.
The choice between these licences depends on the type of product being manufactured or sold.
2. Regulatory Authorities
- AYUSH Licence: Controlled by the AYUSH department of the state, in West Bengal, by the State AYUSH Authority.
- FSSAI Licence: Managed by the FSSAI, which operates at both the central and state levels.
Both authorities maintain strict inspection protocols to ensure compliance.
3. Scope of Products Covered
The licences differ in the type of products they regulate:
Licence TypeProducts CoveredAYUSHClassical Ayurvedic medicines, proprietary formulations, herbal remedies, oils, tablets, capsulesFSSAINutraceuticals, herbal supplements, fortified foods, Ayurvedic health drinks, and food items with medicinal claims
4. Manufacturing Standards
- AYUSH Licence: Focuses on Good Manufacturing Practices (GMP) specific to Ayurveda, including herbal ingredient sourcing, storage, and formulation protocols.
- FSSAI Licence: Emphasizes food safety management systems, hygiene, labeling, permissible additives, and shelf-life stability.
Adherence to these standards ensures safe products and smooth approval during inspections.
5. Documentation Requirements
For obtaining an Ayurvedic Medicine Manufacturing Licence in West Bengal, documentation varies by licence:
AYUSH Licence Documentation:
- Application form with product details and manufacturing process
- Proprietor or company identity proof
- Factory layout and GMP compliance certificate
- List of qualified Ayurvedic doctors or pharmacists on staff
- NOC from local authorities and a fire safety certificate
- Details of raw material sourcing
FSSAI Licence Documentation:
- Application form for food safety registration
- Company registration and identity proof
- Ingredient specifications and sourcing details
- Food safety management plan and hygiene protocols
- Labeling format and nutritional information
Preparing documentation accurately reduces the risk of rejection or delays.
6. Fee Structure
Licence fees differ depending on product type, scale of operations, and manufacturing volume:
- AYUSH Licence: Generally ranges from ₹5,000 to ₹50,000 depending on manufacturing capacity and classification.
- FSSAI Licence: Fees depend on turnover, with central licences required for companies with a turnover above ₹12 lakh and state licences for lower turnover, ranging from ₹2,000 to ₹7,500.
Timely payment of fees ensures smooth processing.
7. Inspection and Verification
Both licences require physical verification:
- AYUSH Licence: Authorities inspect manufacturing units for GMP compliance, personnel qualification, and product authenticity.
- FSSAI Licence: Inspection focuses on food safety, hygiene, labeling, and adherence to ingredient standards.
Successful inspections are mandatory for final approval.
8. Validity and Renewal
- AYUSH Licence: Typically valid for 5 years and renewable upon submission of updated documents and compliance reports.
- FSSAI Licence: Valid for 1–5 years based on turnover and licence type, with renewal required before expiry.
Maintaining validity ensures uninterrupted production and sales.
9. Penalties for Non-Compliance
Operating without proper licensing invites strict consequences:
- Fines and penalties as per the Drugs and Cosmetics Act (AYUSH) or the Food Safety and Standards Act (FSSAI)
- Seizure of unlicensed products or equipment
- Possible legal proceedings against owners or management
- Suspension of operations until compliance is achieved
Adhering to licensing requirements prevents financial and legal risks.
10. Advantages of Holding Both Licences
Some businesses manufacture products that fall under both regulatory frameworks. Benefits of holding both licences include:
- Legal authority to manufacture classical medicines and herbal supplements
- Expanded product portfolio, including food-based Ayurvedic items
- Increased market access across the pharmaceutical and food sectors
- Enhanced credibility with consumers, distributors, and regulatory authorities
Holding an Ayurvedic Medicine Manufacturing Licence in West Bengal helps businesses meet diverse market requirements.
11. Operational Planning for Compliance
Maintaining legal compliance requires proactive planning:
- Classify products accurately under AYUSH or FSSAI jurisdiction.
- Establish separate processes for medicinal and food-grade products if both licences are required.
- Maintain detailed records of production batches, ingredients, and testing reports.
- Conduct internal audits for GMP and food safety protocols regularly.
Well-structured operations reduce risk and facilitate licensing.
12. Common Mistakes to Avoid
Businesses often encounter delays due to:
- Misclassification of products under the wrong licence
- Incomplete or inaccurate documentation
- Non-compliance with GMP or hygiene standards
- Ignoring renewal timelines or inspection protocols
- Improper labeling or ingredient declaration
Avoiding these mistakes ensures faster approval and uninterrupted operations.
13. Benefits of Compliance
Holding an Ayurvedic Medicine Manufacturing Licence in West Bengal provides multiple advantages:
- Legal authority to operate without risk of fines or legal action
- Assurance of product quality and consumer safety
- Access to broader markets, including retail and e-commerce
- Enhanced credibility and trust with consumers and regulatory bodies
- Easier collaboration with distributors and healthcare institutions
Compliance establishes a strong foundation for long-term growth.
14. Strategic Considerations for Manufacturers
- Plan product lines according to licensing requirements.
- Maintain separate quality control processes for medicines and consumable supplements.
- Engage trained personnel familiar with regulatory requirements.
- Keep updated with amendments in AYUSH and FSSAI regulations.
Strategic planning ensures regulatory adherence and operational efficiency.
Conclusion
The AYUSH licence and FSSAI licence serve distinct purposes but are both essential for the safe and legal production of Ayurvedic products. For businesses in West Bengal, obtaining an Ayurvedic Medicine Manufacturing Licence in West Bengal ensures compliance with both medicinal and food safety standards. Proper licensing safeguards consumers, reduces legal risks, enhances credibility, and supports sustainable growth in the Ayurvedic sector.