AYUSH License Online in India

An AYUSH license is not just a legal requirement; it’s a key to business growth, trust, and international expansion.

• 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 business's 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.

In the AYUSH industry, certain businesses must have an AYUSH license to operate legally and safely. Here’s a breakdown of who needs it:

• Manufacturers

Businesses that make Ayurvedic, Unani, Siddha, or Homeopathic products must have an AYUSH manufacturing license. This applies to companies that:

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

This license is required for:

• • Herbal medicines
  • Supplements
  • Cosmetics with health claims

The Ministry of AYUSH ensures that all manufacturers follow rules to keep products safe and of high quality.

• Marketers

Even if a business doesn’t make AYUSH products, it still needs an AYUSH license if it sells or distributes them. The license ensures that all products meet safety standards, no matter who makes them. Marketers often work with certified manufacturers to sell their products.

• Retailers and Wholesalers

While the Central Drugs and Cosmetics Act mainly regulates manufacturers, most states require retailers and wholesalers to obtain a specific AYUSH retail or wholesale license. This license allows them to legally store and sell AYUSH products like Ayurvedic, Unani, Siddha, and Homeopathic medicines.

Having this license helps increase business trustworthiness by assuring customers of product quality. It also ensures compliance with legal requirements, reducing the risk of penalties.

Additionally, it helps avoid issues with state-level rules, which can vary. Thus, retailers and wholesalers benefit from obtaining an AYUSH license to operate smoothly and legally.

• AYUSH Practitioners and Clinics

Doctors and clinics that offer AYUSH treatments must obtain a state-specific AYUSH Clinic License. This ensures that only qualified professionals provide treatments and that patients are kept safe. The license is required if a clinic dispenses or recommends AYUSH medicines.

The Ministry of AYUSH provides several types of licenses. Each one is designed to match different business models in the traditional medicine sector.

1. AYUSH Manufacturing License

This license is for businesses that own and run their manufacturing units. It allows them to produce and sell AYUSH products. To get this license, companies must follow state-specific rules and ensure that their products meet proper quality standards.

2. AYUSH Loan License

This license is for businesses that don’t own a manufacturing unit. Instead, they use the premises, equipment, and staff of a licensed manufacturer. The third-party manufacturer handles the production. However, the applicant still needs to get product approval from the authorities.

3. AYUSH Contract Manufacturing License

In this case, the business doesn’t own a manufacturing unit or a license. They hire a third-party manufacturer to make the products. The business focuses only on marketing and selling the products. A legal contract is used to define who owns the product. This process is often called white-label manufacturing.

Note: The key difference is who holds the manufacturing license: with a loan license, you do; with contract manufacturing, the third-party factory does.

4. AYUSH Retail and Wholesale Licenses

These licenses are for businesses that sell AYUSH products.

• Retailers sell directly to customers.
• Wholesalers sell products in bulk to other businesses.

Before applying for an AYUSH license, every business must meet a few basic requirements. These conditions are essential to ensure your application gets approved without delays or rejections.

• A Legally Registered Business Entity: A business must be registered with the Government of India. This can be a sole proprietorship, partnership, or private limited company. Proper registration provides legal standing.
• A Compliant Manufacturing Premise: To get a manufacturing license, your production unit must be set up in an industrial area. The minimum required area is 1200 sq. ft. for making one type of product. If you plan to manufacture more product categories, you will need additional space.The premises must also be well-organized with separate sections for each of the following:
• • Office space
  • Raw materials storage
  • Finished goods storage
  • A quality control laboratory

These separate sections help maintain hygiene and prevent cross-contamination during production.

Note: In some states, you must also follow local municipal zoning laws and get a No Objection Certificate (NOC) from local authorities.

• Mandatory GMP Certification: Your unit must be certified under Good Manufacturing Practice as per Schedule T of the Drugs and Cosmetics Rules, 1945. This ensures your products are made in clean, safe, and controlled environments, following all safety and quality standards.
• Qualified Technical Staff: To ensure quality control, your unit must employ trained professionals. At least one Ayurvedic or Unani expert with a BAMS or BUMS degree must be on staff. Additionally, you must appoint one pharmacist with a D.Pharm or B.Pharm degree. These professionals supervise production and ensure that all work follows the required standards.
• The COPP Certificate (For Export Ambitions): If you wish to export your AYUSH products, you must also apply for a Certificate of Pharmaceutical Product (COPP). This document proves that your products meet global safety and quality standards. It supports your entry into international markets and is issued by CDSCO or the relevant State Licensing Authority. However, you can only get it after a successful WHO-GMP inspection.

Having all documents ready is crucial for a smooth application process. Here is a comprehensive list:

• 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.

The Ministry of AYUSH has simplified the application process by enabling online submissions through its official portal, making it easier and faster for businesses to apply for a license.

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.

Note: The required documents may vary from state to state. You might also need a testing lab agreement if your unit does not have an in-house lab.

Any errors or missing documents can lead to delays or rejection of your application.

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 state’s specific process and requirements.

Step 3: Fill and Submit the Correct Application Form

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

• Form 24D – For Manufacturing License
• Form 24E – For Loan License

Then,

• Attach all required documents
• Pay the application fee online
• Submit the form through the portal or the state-specific system (if applicable)

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.

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.

The shift to an online portal (e-Aushadhi), reduced processing time (from three to two months), and perpetual validity (discussed later) are clear indicators of the government's "ease of doing business" initiative.

Understanding the costs involved is important for proper budgeting. Fees generally include government charges, professional fees, and other operational costs.

• Government Fees for AYUSH License

The government fees for an AYUSH Manufacturing License were revised and took effect on October 1, 2021. The fee for any number of generic Ayurvedic, Unani, and Siddha (ASU) products increased from ₹1,000 to ₹2,000. For up to 10 proprietary ASU drugs, the fee increased to ₹3,000.

• Professional Fees

These are the charges taken by consultants or legal experts who help you with the license application. They assist in preparing documents, filling out forms, and making sure everything is done correctly.

Professional fees from consultants or agencies vary. These experts assist with documentation and navigating the application process, which can save time and reduce errors.

• Other Costs

Apart from government and professional fees, businesses may also face other expenses. These costs can include setting up a proper manufacturing unit that meets all the legal and safety standards.

You may also spend money on:

• • Product testing in certified laboratories
  • Legal agreements for contract or loan manufacturing
  • Equipment and layout planning for GMP compliance

If you are applying for a GMP certificate, there is a fee involved. Keeping the GMP certification valid over time also has a cost. You can renew it online by submitting a form along with a ₹1,000 renewal fee.

The Ministry of AYUSH has made major changes to simplify the license process. As per the Drugs (4th Amendment) Rules, 2021, effective from October 1, 2021, AYUSH manufacturing licenses now come with perpetual validity, replacing the earlier five-year term.

This means that once a license is granted, it remains valid for a lifetime. However, to keep the license active, businesses must meet certain conditions:

• Submit an annual self-compliance declaration online.
• Renew the Good Manufacturing Practices (GMP) certificate every 5 years.

These updates significantly reduce the paperwork and hassle of frequent renewals. Businesses can now focus on long-term planning without worrying about license expiration. The annual self-declaration helps maintain regular compliance, while the five-year GMP validation ensures ongoing product quality.

Overall, this change makes it easier to operate in the AYUSH sector and encourages sustained investment by reducing regulatory burdens.

Operating without a valid AYUSH license carries severe legal and business risks. It is not a viable option.

• Legal Consequences: Manufacturing or selling substandard AYUSH drugs can lead to product seizure. It can also result in license cancellation. Misbranding or making misleading claims attracts heavy fines and legal action. Selling adulterated or spurious drugs can result in imprisonment and business closure.
• Penalties: The Drugs and Cosmetics Act of 1940 imposes strict penalties for violating AYUSH product regulations. These include:
  • Fines up to ₹1,00,000 or more, depending on the severity of the offense
  • Imprisonment up to 3 years for serious violations such as selling spurious, adulterated, or misbranded products
  • Product seizure and immediate stop to manufacturing or selling
  • Cancellation of license, if applicable
• Business Reputation: Operating illegally severely damages a brand's credibility. It also erodes consumer trust. This can lead to a significant loss of market share. It can also result in long-term business failure.
• Consumer Protection: The Act protects consumers from harmful products. It empowers authorities to take corrective measures. Examples include product recall. Consumers can also file complaints if they suffer harm.

After your AYUSH license application is approved, you receive an official AYUSH License Certificate. This certificate is proof that your business is legally authorized to manufacture, sell, or promote AYUSH products.

How to Download an AYUSH License Certificate?

1. Visit the official AYUSH licensing portal (e-aushadhi.gov.in/).
2. Log in using your registered credentials.
3. Navigate to the “License” or “Certificate” section.
4. Find your approved application and click on the download link.
5. Save the certificate as a PDF for your records and display it at your business premises as required.

How to Check the Status of Your AYUSH License?

1. Go to the official AYUSH license application portal (e-aushadhi.gov.in).
2. Click on the “Application Status” or “Track Application” option.
3. Enter your application number or registered business details.
4. View the current status of your license application, including verification, inspection, or approval stages.
5. Contact the AYUSH department if you face delays or need further assistance.

These steps help you stay updated on your license progress and ensure you have the official certificate when needed.