AYUSH License
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An Overview of Ayush license
AYUSH, short for Ayurvedic, Yoga & Naturopathy, Unani, Siddha, and Homeopathy, represent ancient forms of medicine popular in India. Pre-2014, these therapies were unregulated until the establishment of an AYUSH Ministry. This Ministry introduced a regulatory framework for AYUSH businesses in manufacturing, selling, marketing, and exporting products domestically and internationally. AYUSH licenses are now a crucial aspect of this framework, with unlicensed businesses prohibited from operating in India. These licenses are granted by the state AYUSH Ministry under which the business operates, following provisions in the Drugs and Cosmetics Rules, 1945, business involving import/export, drugs, or cosmetics requires compliance with the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945. Any company dealing with herbal, Unani, or ayurvedic products must obtain an AYUSH License. Ancient Indian doctors treated patients with ayurvedic and Unani medicines, known for their lack of side effects, which has contributed to their global popularity over allopathic or homeopathic alternatives.
AYUSH License
Types of AYUSH License
1. AYUSH Manufacturer License: The business applicant needs a GMP Certified manufacturing facility on industrial land, with a minimum land area of 1200 square feet for making one product. More products require more land. They must have 2 Ayurvedic experts and pharmacists and all necessary machinery installed.
2. AYUSH Retail & Wholesale License: In order to get an AYUSH Retail or wholesale license, the shop must be 10 square meters in size and meet the height requirements of the National Building Code, 2005. For both AYUSH Retail and Wholesale license, the shop must be 15 square meters in size and compliant with the National Building Code, 2005.
3. AYUSH Loan License: The business lending its manufacturing unit must hold an AYUSH manufacturing license. The unit being lent must be located on industrial land, with separate rooms for raw material storage, finished product storage, and office space. Having pharmacies or Ayurvedic Experts is not necessary for the loan license holder. The license must be renewed periodically.
4. AYUSH Contract or Third-Party Manufacturing License: This particular license is acquired when an individual lacks both a license and a manufacturing unit. In this scenario, a third-party manufacturer handles the marketing aspect while the manufacturer takes care of the remaining compliances and liaison work. The third-party manufacturer is not responsible for meeting compliance requirements. The manufacturer's license is used, and approval from authorities is required for all drugs and products. The third-party manufacturer can supply raw materials if desired, otherwise it is the manufacturer's responsibility to procure them. This type of license is also referred to as white-label manufacturing or product-to-product manufacturing.
Documents Required
1. MoA or AoA
2. Photo ID Proof
3. Address Proof
4. Compliance Affidavit MPD 2021
5. Appointment Letter
6. Director’s Biodata
7. Copy of manufacturing license (if the applicant manufactures AYUSH products).
8. Plan and layout of the premises showing the installation of Machinery and Equipment.
9. Attested copies of documents relating to the ownership/ rent/ lease.
10. Detailed list of Manufacturing and Analytical Equipment as required for formulations applied.
11. Detail of the technical staff such as name, experience and qualification.
12. List of equipment to be used for manufacturing.
13. Water & HVAC system diagram.
14. KYC details of the applicant.
15. Constitution document of the business.
16. Proof of safety & effectiveness as per the rule of 158B of Drugs & Cosmetics Rules, 1945.
17. Undertaking in case of absence of non-herbal ingredients, applicable in case of herbal products.
How to Get AYUSH License
You may follow the given step by step instructions for Company to get AYUSH LICENSE:
Step 1: GMP Certificate
The World Health Organisation has set out rules for Good Manufacturing Practices to oversee the production of drugs/cosmetics and their quality. India and other countries adhere to these guidelines. Drugs/cosmetics made in India must also meet these standards and receive a GMP Certificate from the Drug Controller General of India, which can be obtained through the relevant state's Drug Control Department. This certificate is required when applying for an AYUSH license.
Step 2: COPP Certificate
The WHO has created the Certificate of Pharmaceutical Products to confirm drug quality when they are exported. It is typically requested by the National Health Authorities of the importing nation, and exporters must obtain it in their country. AYUSH manufacturers planning to distribute products globally must include this certificate when applying for an AYUSH license. Similar to the GMP Certificate, the COPP is issued by the Drug Controller General of India, with applications accepted by the Drug Control Department of the relevant state.
Step 3: Application Form for AYUSH License
After ensuring you have all required documents, you can start the online application process for an AYUSH License. Form 24D is required for AYUSH manufacturing license, while Form 25E is needed for AYUSH loan license, as per Rule 153 of Drugs and Cosmetics Rules, 1945. The state-specific application can be downloaded from the e-aushadhi portal.
Step 4: Documents
The process of AYUSH Registration in India is done online through an application. The AYUSH License form must be submitted with all required documents in the correct format and with current information. Mistakes in document submission could result in application rejection, so it is advised to gather all necessary documents before starting the application process.
Step 5: Submission of Application
After downloading the application form, you must manually enter required information such as business location, product details, and staff information. Once completed, scan the application form and submit it on the Department's website with the necessary documents and application fees.
Step 6: Verification of Application
The Department will carefully review and validate all provided information. Additionally, the AYUSH Department’s commissioner will inspect your workplace/establishment/factory in person and create a report. The Department will make a decision on your application based on the commissioner's report.
Step 7: Grant of the License
After reviewing the application and visiting the business's main office/manufacturing facility, the Department will issue the AYUSH license in Form 25D. Typically, it takes about 60 days for the Department to complete the online AYUSH Certificate application form processing.
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FAQs
What’s AYUSH License certification?
An AYUSH license certification is mandatory for traditional medicine practitioners in India, issued by the Ministry of AYUSH to confirm that they have completed the required training and meet the standards to practice traditional medicine in the country.
What types of drug get AYUSH License?
The medications eligible for an AYUSH License are specified in Section 33 B of the Drug and Cosmetic Act, 1940, including Ayurvedic, Unani, and Siddha products, as well as herbal products, drug products, and cosmetics.
Who can sell ayurvedic medicine in India?
One who has the AYUSH Retail License has full authority to sell ayurvedic medicine, if found selling of such ayurvedic medicine without license then he shall liable to such penalties.
What’s the full form of AYUSH?.
AYUSH stands for Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy.
How to get AYUSH License?
You have the option to submit your AYUSH License application digitally on the e-aushadhi platform. Simply download the appropriate form, complete it, upload the scanned copy, and include the required attachments and fees.