AYUSH License - A License For Ayurvedic Products

We are an action-oriented consultancy firm, who believe in providing 100% assistance to our clients by investing our sustain efforts in completing the AYUSH license immediately. 

To know more about how to get AYUSH license and its process, contact us immeditely.

What is AYUSH Manufacturing License?

Ayurveda, Yoga, and Naturopathy, Unani, Siddha, Sowa-Rigpa, and Homoeopathy (AYUSH) is a license under the Ministry of AYUSH (established on November 9, 2014), which is essential to acquire by manufacturer’s dealing in ayurvedic or herbal products. 

Moreover, these systems are based on specific medical philosophies and constitute a way of healthy living based on established concepts of anticipation of diseases and health promotion.

We - at JR Compliance will ensure to provide you indepth information regarding how to get AYUSH license to ensure that our clients can track their registration. 

What will happen if an applicant fails to comply with the conditions/undertakings of the AYUSH license?

If an applicant fails to comply with the conditions/undertakings prescribed by Nodal agencies/other departments/agencies of the AYUSH license must be convicted or punished as per legal provisions.

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Types of AYUSH License

1. Complete Manufacturing License

If a manufacturer desires to engage in the manufacturing and marketing of herbal products, you must obtain a Complete Manufacturing License. However, to obtain this license, you are required to establish your manufacturing unit.


Requirements to Fulfill Under AYUSH Act,

  • A manufacturing unit should be established in an industrial area.
  • There would be regular inspection of the unit by the Drug inspectors.
  • For a category of drug, the minimum size of the unit should be 12,000 square feet.
  • If you are manufacturing more than a drug, you will need more space.
  • You should acquire all the required manufacturing and packaging machinery.
  • The manufacturing unit should be mandatorily GMP certified.
  • Make sure that you have 2 Ayurvedic experts and 2 Pharmacists as part of your team members.
2. AYUSH Third-Party Manufacturing/Contract License

As the name suggests, the AYUSH manufacturing license of a third-party manufacturer is used to manufacture the product. However, the manufacturing unit doesn’t need to be owned by the applicant because the candidate/applicant only has to market the product.

On the contrary, the manufacturer is responsible for completing all the essential requirements and formalities. 

3. AYUSH Loan License

AYUSH loan license needs to be obtained by a third party. To be noted, the candidate/applicant is not responsible for manufacturing medicines, but a third party completes the manufacturing.

Moreover, the manufacturer should be GMP certified, and further, it will be issued to the candidate/applicant. 

Requirements to Fulfill Under AYUSH Act,

  • The manufacturing unit should be established in an industrial area.
  • The establishment should have the below-mentioned rooms,
    1. An office.
    2. A storage room for raw material.
    3. A storage room for finished products.
  • The loan license should be renewed as and when required.
  • The inspection of the establishment by the Drug Inspector is essential.
4. Siddha Manufacturing License

Siddha is the practice or treatment done to maintain the balance of the mind, body, and spirit system. Moreover, it gives equal importance to the body, mind, and spirit to restore psychological and physiological harmony of the body.

Moreover, the Siddha manufacturing license is issued to the establishments to provide equal importance to the mind, body, and spirit.

5. Unani Manufacturing License

Unani medicine is the science and craft of healing. Moreover, it is a rare approach that prevents and cures diseases. Consequently, to provide such service, you are required to obtain the AYUSH manufacturing license.

General Requirements to Fulfill Before Applying For AYUSH License

  • The establishments should be established to prohibit the open sewerage, drain, public lavatory, dust, smoke, etc.
  • The building for the drug production should obtain the permit for the production of the same by maintaining the hygienic conditions and free from cobwebs or insects, floor and walls should not be damp, etc.
  • If an establishment uses containers such as glass bottles, vitals, etc., there should be appropriate measures to wash, clean, and dry the containers.
  • Pure water should be pure and of portable quality. 
  • Proper measures should be taken to wash the premises. 
  • The wastewater and residue of laboratories and manufacturing sections should be disposed of after adequate treatment as prescribed by Pollution Control Authorities. 
  • Premises should have personal storage space for different purposes (raw material, packaged products, and final products). Thus, the storage room should have an adequate ventilation system and should not be damp.
  • Containers used to store a product should be appropriately labeled for identification, including the name of raw materials, source of supply, etc. Also, the status of raw material should be mentioned as “under test” or “approved” or “ rejected.”
  • The packaging material of a product should be appropriately stored in a clean and dried space.
  • The finished product should be stored in a particular area marked “quarantined.”
  • After laboratory quality control and expert examination/testing, the finished product will be moved to “approved finished goods stock.”
  • The workers should have a proper uniform, availability of sanitation facilities, personal cleanliness facilities, medical facilities, etc.
  • Medical exams should be conducted at the time of employment, along with periodic checkups.
  • For the production, the machinery and equipment should be available as per requirement.
  • Proper maintenance of records of batch manufacturing, distribution, and market complaints.
  • Availability of every license needed to provide a section of a facility of quality control.

Documents Required For AYUSH Manufacturing License

Submit the information regarding name, address, email, contact information, etc.

Replica of manufacturing license.

List of approved products.

List of products applied for issuing COPP and their composition.

The layout of the manufacturing unit or site master file.

Details of manufacturing process and manufacturing formula.

Specification report of finished product and method of analysis.

Process validation report of three batches.

Stability study analysis based on a batch, including manufacturing date, expiry date, stability study condition, and drug’s name.

Diagram of a water system and HVAC system.

List of technical staff, including details of experience, qualifications, and approval status.

Affix the export data of two years, wherever re-validation of COPP is applicable.

Evidence of safety and effectiveness as prescribed in Rule 158B of Drugs and Cosmetic Rule,1945.

Undertaking regarding compliance provisions of Domestic Regulation Drugs and Cosmetic Act,1940.

In the case of herbal products, undertakings concerning the absence of non-herbal (like metals, minerals, etc.) in products applied for WHO-CoPPs.

How to Get AYUSH License?

The details of GMP and COPP certificates will be mentioned in the application form.

After entering the information, the required documents will be affixed. Also, other documents will be sent  to the concerned authorities.

After reviewing the documents, a certificate will be issued within 15 days.

Lastly, an applicant will receive the license through the post.

Note - In the case of large industries, the commissioner possesses the authority to grant you a particular clearance. However, in the case of an MSME, the District Collector will give the specific consent. 

Our Role in AYUSH License Registration

We will guarantee to educate you regarding how to get AYUSH license.

We guarantee to provide you with complete support in the process of registration.

We guarantee to provide you with assistance in the process of documentation.

Our AYUSH license consultants will assist you in fulfilling the general requirements of registration.

We will coordinate with the officials to ensure proper coordination and to complete the registration timely.

Our AYUSH license experts will keep you informed regarding every step of the registration.

In case of any concerns, our experts will provide you with the finest solutions.

Logo of Ministry of AYUSH

Conclusion

To recapitulate, obtaining an AYUSH license could be tedious for an establishment because you must fulfill various general requirements or understand how to get AYUSH license before applying for the same. Moreover, the documentation process and registration process are also perplexing.

Consequently, an experienced and expert consultant can provide you with the most appropriate support to procure the AYUSH license. Thus, JR Compliance with the experience of 8+ years guarantees to make the process of AYUSH license registration effortless by providing 24*7 support to our clients.

Hence, contact us immediately to know more about how to get AYUSH license.

Have Questions? We've got answers.

What is GMP Certification?

Good Manufacturing Practice (GMP) certification is the certificate that assures that a product is persistently produced and controlled according to the WHO quality standards. Therefore, it minimizes the potential risk of pharmaceutical production. 

What of COPP?

CoPP is a document that indicates the authenticity of the treatment provided under the AYUSH license. Typically, it serves as proof of the authenticity of the license.

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