Ayush Manufacturing License
What is AYUSH Manufacturing Registration?
AYUSH Manufacturing Registration is an approval issued by the State Licensing Authority that allows a business to set up and operate a unit for producing medicines and wellness products under Ayurveda, Siddha, Unani and Homeopathy (ASU&H).
This registration serves two important purposes.
First, it gives the manufacturer the legal right to produce classical formulations as well as customised/proprietary (unique or brand-specific) products. Second, it confirms that the unit follows the quality, hygiene and safety standards prescribed under the Drugs & Cosmetics Act, 1940, along with the Good Manufacturing Practice requirements listed in Schedule-T, which apply specifically to AYUSH facilities.
Since these products are used for therapeutic and preventive health needs, the government ensures that manufacturing takes place in a clean, controlled and compliant environment. AYUSH Registration acts as proof that the products are consistently prepared, tested and stored according to established standards.
Types of AYUSH Registrations in India
☑️ AYUSH Manufacturing Registration (Own Unit): This applies to businesses who set up their own manufacturing facility. It requires dedicated production space, machinery, storage areas, quality-control systems and qualified technical staff. It is ideal for companies planning large-scale production, multiple formulations or long-term market presence.
☑️ AYUSH Loan Licence Registration: This is for brands that want to launch products but do not wish to invest in a manufacturing unit immediately. Here, the production is carried out at a third-party factory already registered with AYUSH. It is a common choice for startups and early-stage brands.
☑️ AYUSH Retail / Wholesale Registration (Not Mandatory for Manufacturing): Businesses that are only involved in selling or distributing AYUSH products do not need a separate AYUSH retail or wholesale license. According to Section 33A of the Drugs and Cosmetics Act, 1940, the licensing requirements apply only to the manufacturing of AYUSH products, not to retail or wholesale activities.
☑️ AYUSH Export-Related Registrations (GMP / COPP): Manufacturers who plan to export may require additional certificates like GMP and COPP. These help prove international-grade quality to importing nations.
☑️ AYUSH Clinic Registration: Separate registration is available for clinics offering AYUSH treatments, covering practitioner qualifications and patient-care standards.
AYUSH Manufacturing Registration is an approval issued by the State Licensing Authority that allows a business to set up and operate a unit for producing medicines and wellness products under Ayurveda, Siddha, Unani and Homeopathy (ASU&H).
This registration serves two important purposes.
First, it gives the manufacturer the legal right to produce classical formulations as well as customised/proprietary (unique or brand-specific) products. Second, it confirms that the unit follows the quality, hygiene and safety standards prescribed under the Drugs & Cosmetics Act, 1940, along with the Good Manufacturing Practice requirements listed in Schedule-T, which apply specifically to AYUSH facilities.
Since these products are used for therapeutic and preventive health needs, the government ensures that manufacturing takes place in a clean, controlled and compliant environment. AYUSH Registration acts as proof that the products are consistently prepared, tested and stored according to established standards.
Benefits of AYUSH Manufacturing Registration
Getting an AYUSH Manufacturing Registration provides several important long-term benefits for any business in the AYUSH sector, the following are a few key advantages:
1️⃣ Legal and regulatory security: It protects the business from violations under the Drugs & Cosmetics Act.
2️⃣ Credibility in the market: Customers, distributors and pharmacies trust licensed products far more than unverified brands.
3️⃣ Eligibility for exports: Many countries require Indian exporters to hold AYUSH licenses and GMP/COPP certifications.
4️⃣ Participation in government tenders: Ministries and public procurement portals prefer licensed manufacturers.
5️⃣ Stronger brand image: Operating under regulatory control helps build long-term consumer trust.
6️⃣ Access to subsidies and AYUSH-specific schemes: Manufacturers often qualify for government support programs.
7️⃣ Better quality assurance: Schedule guidelines improve product stability, consistency and safety.
How to Apply for AYUSH Manufacturing Registration
Getting AYUSH Manufacturing Registration is done through an online process and involves a few clear steps. Below is the breakdown of the process.
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Prepare All Documents Before you start the application, make sure every document is complete, updated and arranged properly. Missing or incorrect paperwork is one of the most common reasons for delays or rejection.
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Apply for GMP Certification You must apply for a GMP certificate from the State Drug Controller. This certificate confirms that your manufacturing setup follows the required Good Manufacturing Practices and meets the quality standards set under the law.
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Apply for COPP (If You Plan to Export) For businesses that want to export AYUSH products, applying for a Certificate of Pharmaceutical Product (COPP) is necessary. This document shows foreign authorities that your products meet India’s quality and regulatory standards.
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Download the Correct AYUSH License Form Forms like Form 24D (for a manufacturing licence) or Form 25E (for a loan licence) are issued under Rule 153 of the Drugs & Cosmetics Rules, 1945. These forms are available on state AYUSH portals such as e-Aushadh
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Submit the Application Online Fill in all required details carefully, upload the supporting documents, and pay the application fee. Everything is done digitally on the state AYUSH portal.
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Factory Inspection by AYUSH Department Once your application is submitted, an AYUSH inspector will review your documents and visit your premises. They will check whether your facility, equipment, and processes meet the required standards. Their inspection report is crucial for approval.
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Issuance of the License If the inspection is successful and all details are verified, the authority issues the AYUSH Manufacturing License (usually in Form 25D). The usual processing time is around 60 days, depending on the state.
List Of Documents Required For Ayush Manufacturing License
Having the right documents ready in advance helps avoid delays. Here are the key documents you should be prepared with:
- Copy of existing manufacturing license (if any)
- Site layout of the manufacturing facility
- Manufacturing formula and process details
- Product specification reports
- List of products for COPP certification
- Validation reports for at least three product batches
- Technical staff details with qualifications
- Equipment list for manufacturing
- Diagrams of water and HVAC systems
- Proof of product safety and efficacy under Rule 158B
- Declarations for non-herbal ingredient absence (if applicable)
- Compliance undertakings with applicable acts
- KYC of applicant (PAN, Aadhaar)
- Address proof of premises (rent agreement or ownership documents)
- Business constitution documents (Partnership Deed, Certificate of Incorporation, etc.)
Validity And Renewal
The AYUSH Manufacturing Registration now follows updated rules that make the process easier and more stable for manufacturers:
- The manufacturing licence generally carries lifetime validity, as long as the manufacturer regularly submits the required self-compliance declarations to the authority.
- GMP and COPP certificates do not have lifetime validity. These usually need to be renewed every 5 years, after the regulatory team inspects and verifies the facility again.
- If the manufacturer fails to file the periodic compliance reports or violates any conditions, the authority can suspend or cancel the licence, even though it is otherwise lifetime-valid.
This system ensures smooth operations while maintaining quality and safety standards for AYUSH products.
Frequently Asked Question
You need AYUSH Manufacturing Registration, along with GMP certification and COPP if exporting.
On average 2-4 months, depending on documentation and inspection readiness.
Yes, Schedule-T GMP compliance is compulsory.
Yes, qualified doctors, pharmacists and QC personnel are required.
Yes, ELT prepares the complete documentation set and helps design the factory as per GMP norms.
Why Choose ELT Corporate?
ELT Corporate is a technology-based platform offering multiple services across India. We aim to deliver exceptional services to our clients& resolving their all business related issues in following ways.
Expert in Legal, Tax & Compliance
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Complete Setup Support for Foreign Companies
End-to-end assistance for entering and operating in India.
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