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Ayush License

An AYUSH license is an official document issued by the Indian governments Ministry of AYUSH. It covers products and practices from Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy.

Originally, the Act covered only allopathic (modern) medicines but was later expanded to include AYU
Licensing: Businesses must get a valid license before making or selling any AYUSH products.
Approved Ingredients: Only approved ingredients can be used. These must be listed in official texts
Labeling and Packaging: Products need to have batch numbers, expiry dates, and usage instructions.
GMP Compliance: Manufacturers must follow Good Manufacturing Practices (GMP) to keep the products cl

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What is AYUSH License??

An AYUSH license is an official document issued by the Indian governments Ministry of AYUSH. It covers products and practices from Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy. This license is mandatory for any business in India that wants to produce, sell, or promote traditional medicines. It applies to all types of businesses, from large manufacturers to small clinics and shops.

Indias traditional medicine sector is experiencing rapid growth, creating new opportunities for entrepreneurs. According to a report by PIB Delhi, the AYUSH market expanded from US$2.85 billion in 2014 to US$43.4 billion in 2023. If you want to make or sell Ayurvedic, Unani, Siddha, or Homeopathic products, having the right license is essential. This license is your key to legally entering this trusted wellness market. It shows regulators and customers that your products are safe, effective, and meet all legal standards.

The Drugs and Cosmetics Act of 1940 governs the rules for obtaining an AYUSH license. This law ensures that all AYUSH products released into the market are safe, effective, and properly labeled. Without this license, businesses cannot legally operate in the traditional medicine sector in India.

The Drugs and Cosmetics Act, 1940, is Indias main law for controlling drugs and cosmetics. It covers everything from importing to selling these products.

How Does the Act Ensure Safety?

Penalties for Breaking the Rules

Originally, the Act covered only allopathic (modern) medicines but was later expanded to include AYUSH products.
Licensing: Businesses must get a valid license before making or selling any AYUSH products.
Approved Ingredients: Only approved ingredients can be used. These must be listed in official texts by the Ministry of AYUSH.
Labeling and Packaging: Products need to have batch numbers, expiry dates, and usage instructions.
GMP Compliance: Manufacturers must follow Good Manufacturing Practices (GMP) to keep the products clean and safe.
Product Seizure: Authorities may take the products away.
Requirements

Eligibility Criteria

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Manufacturers

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Produce products in their factories Hire others to make products for them

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Produce products in their factories

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Hire others to make products for them

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Herbal medicines Supplements Cosmetics with health claims

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Herbal medicines

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Supplements

8

Cosmetics with health claims

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Marketers

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Retailers and Wholesalers

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AYUSH Practitioners and Clinics

Paperwork

Documents Required

Business Registration Proof: This includes a Memorandum and Articles of Association, partnership deed , or proprietorship documents.
PAN and Aadhaar Card: These are required for the proprietor or director.
Premises Proof: Provide ownership documents, a rent agreement, or a lease agreement.
Site Layout: A detailed blueprint of the manufacturing unit is needed. It should show partitions and equipment placement. This must comply with GMP standards as defined in Rule 157, which outlines requirements for hygiene, ventilation, and adequate space for processes like raw material storage, production, and quality testing.
GMP Certificate: This is a mandatory compliance certificate for manufacturing units.
COPP Certificate: This is required if applicable, especially for export ambitions.
Technical Staff Documents: Include appointment letters, biodata, academic qualifications, experience certificates, and passport-size photos.
Product Details: Provide a list of medicines, formulations, ingredients, quantities, uses, and references to authoritative texts (for classical drugs). Clinical trial reports are needed for proprietary drugs. Draft labels for sales packaging are also required.
Affidavit of Non-Resemblance: This confirms no similarity with other products in name, formulation, or packaging.
Compliance Undertakings: These relate to the Drugs and Cosmetics Act and the Drugs & Magic Remedies Act of 1954.
Equipment List: A comprehensive list of all manufacturing and analytical equipment is necessary.
Process Validation Report: This report is required for at least three batches of products, especially for herbal products.
No Objection Certificate (NOC): From local authorities, if required.
Self-addressed Envelope: Include this with sufficient postal stamps for registered posts.
Step by Step

Registration Process

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Step 1: Get Your Documents Ready

Start by collecting all required paperwork for the application. You will need documents such as proof of premises (ownership or lease) and a detailed layout of your manufacturing unit. For the full list, scroll down to the "Documents Required for AYUSH License Application" section above.

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Step 2: Visit the e-Aushadhi Portal

Go to the official website e-aushadhi.gov.in to start your AYUSH license application. However, the process is not fully centralized across India. Some states, like Maharashtra, Tamil Nadu, and Karnataka, use their own state-level portals or offline procedures. Before applying, always check your states specific process and requirements.

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Step 3: Fill and Submit the Correct Application Form

Download and fill out the correct form with accurate business details.

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Step 4: The Official Verification and Site Inspection

After submission, the AYUSH department commissioner reviews the application. This includes verifying all submitted documents. They may also inspect the manufacturing facility. This ensures full compliance with regulatory standards including GMP norms, staff qualifications, cleanliness, and equipment.

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Step 5: Receiving Your AYUSH License

If the verification and inspection are satisfactory, the AYUSH license is granted. It is typically issued in Form 25D. This grants legal permission to operate. The maximum time for granting a license has been reduced to two months.

Pricing

Fees & Charges

Fee ComponentAmount
Government Fees for AYUSH LicenseContact for pricing
Professional FeesContact for pricing
Other CostsContact for pricing
Product testing in certified laboratories Legal agreements for contract or loan manufacturing Equipment and layout planning for GMP complianceContact for pricing
Product testing in certified laboratoriesContact for pricing
Legal agreements for contract or loan manufacturingContact for pricing
Equipment and layout planning for GMP complianceContact for pricing
Benefits

Key Advantages

Legal Recognition

Having an AYUSH license means your business is legally approved to operate. It helps you avoid penalties and ensures your business follows all regulatory rules. It makes your business a recognized, lawful operator, which adds to your credibility.

Enhanced Credibility

An AYUSH license is a sign of quality and compliance. It boosts your businesss reputation with both customers and authorities. This increases customer trust, as they know your products are safe and effective.

Regulatory Compliance

A valid AYUSH license shows that your business follows the Drugs and Cosmetics Act and related rules. This ensures you meet all safety standards, helping you avoid legal problems.

Export Opportunities

With an AYUSH license, you can apply for a Certificate of Pharmaceutical Product (COPP). This opens the door to international markets, creating more business opportunities and higher profits.

Business Expansion

An AYUSH license makes it easier to work with distributors and retailers. It helps your business expand into new markets and scale operations smoothly. It also makes it easier to register products across different states.

Government Incentives

Businesses with an AYUSH license may qualify for government grants, subsidies, and support schemes. These can help your business grow and innovate while also reducing operating costs.

Consumer Confidence

Having an AYUSH license reassures customers that your products are safe and effective. This builds brand loyalty and encourages repeat sales.

Common Questions

Frequently Asked Questions

An AYUSH license is a government-issued certificate. It allows businesses to manufacture, market, or sell Ayurvedic, Unani, Siddha, or Homeopathic products. This license ensures product safety, quality, and legal compliance, building trust among consumers and protecting public health.
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