Obtaining Ayush manufacturing license for herbal products in India is mandatory for manufacturing the ayurvedic or herbal products in India. In recent years, India has become a pioneer on the global level when it comes to the manufacturing of herbal products. Talking about the current scenario in which COVID-19 exists, the demand for herbal or Ayurvedic products has increased across the nation due to the fact that these natural products can fulfill the objectives of improvement in immunity level and serve several other health benefits as well.
AYUSH stands for Ayurveda, Yoga, Unani, Siddha, and Homeopathy. Ministry of AYUSH is the responsible body that regulates AYUSH License.
Types of Ayush Manufacturing License for Herbal Products in India
The three types of Ayush Manufacturing License for herbal products in India are given below.
Complete Manufacturing License
Obtaining a complete Ayush manufacturing license for herbal products in India is necessary if you are interested in conducting the manufacturing as well as marketing activities of products. Another term for this license is a full-fledged manufacturing license. You should own a manufacturing unit as it is the eligibility criteria for acquiring this license. You need to follow up with the requirements of the state authority of AYUSH and fulfill all of them. Requirements for Ayush manufacturing license for herbal products in India vary from state to state.
You need to act in accordance with the requirements prescribed by the respective state authorities of AYUSH.
The essentials for complete manufacturing license is mentioned below in the points-
- The manufacturing unit must be Good manufacturing practice certified.
- The location for your manufacturing unit must be an industrial site.
- The minimum size of your manufacturing unit must be 1200 sqft. It is only for one single category of drugs. Furthermore, you should increase the space if you feel like adding more drug categories in your wishlist.
- You must arrange all machinery needed for the purpose of manufacturing and packaging.
- You need to get 2 Pharmacists along with 2 Ayurvedic experts.
- The drug inspector will be readily available to inspect the premises.
- Other additional paperwork
- After the fulfillment of the requirements as mentioned earlier, you can get go to apply for FSSAI registration.
Read our article: Provisions Related to Ayurvedic, Siddha and Unani (ASU) Drugs
Ayush Loan License
- In order to obtain this loan license, there is no need to be the manufacturing unit owner. You can go ahead for a finance loan to a manufacturing plant of a third party manufacturer.
- Applying for a loan license is possible with a GMP certified manufacturer, and issuance of it would take place for your company registration.
- Hereafter, the responsible authorities would grant you approval with respect to your products. After that, you can give your nod to the manufacturing of your products in the manufacturer factory.
- On the one hand, you will be looking to provide the packaging material and raw materials. On the other hand, the manufacturer will be finding out the ways to arrange it from his sources.
- Eventually, you will be getting finished products from the manufacturer’s end.
- If you wish to change the manufacturer, then you should apply for a loan license again this time with a new GMP certified manufacturer.
- The manufacturer will be charging the amount concerning the conversion charges. These charges reflect the cost of product manufacturing in his facility.
- The product label won’t be revealing anything regarding the manufacturer with whom you have collaborated. The product label would affirm that the manufacturing and marketing of the product are done by your company.
Given below are the requirements for this license-
- There must be at least three rooms within the premise (manufacturing plant). The requirement is of one storage room for raw materials, one storage room for finished goods, and one room for office setup.
- On a regular basis, the renewal of a loan license must take place.
- In this case of this license, there is no requirement for Pharmacists and Ayurvedic experts.
- Drug inspectors would visit your premises for inspection regularly.
- Your company must get registered in the same state as the manufacturing unit.
- Various other paperwork
- Once the requirements, as mentioned above, get fulfilled, you can proceed ahead for applying for an FSSAI license for herbal products.
White Label Manufacturing/Third Party Manufacturing/Contract Manufacturing
- Third-Party Manufacturing License or White Label Manufacturing License is a license where you will go ahead for utilizing the manufacturing license of a third-party manufacturer for the product manufacturing.
- You have only the authority to market the product. Owning a manufacturing unit and obtaining any permit is not mandatory in this case. The manufacturer will be looking after the essentials and formalities with the Ministry of Ayush office[1].
- In this case, the manufacturer needs to look for approval from concerned authorities concerning your product as the manufacturer’s Ayush manufacturing license for herbal products in India would get used by you. Either you will be contributing packaging materials or raw materials or arrangements of the same would happen from the manufacturer part from these varied sources.
- After that, finally, you would receive the final product from the manufacturer. The label inscribed on the product which shows that company name, which has managed the manufacturing along with marketing of the product.
- The manufacturer will not only charge the conversion charges for product manufacturing, but also he will charge the approval fees of the product. It is vital to prepare a legal document that must represent that you are the owner of the product.
- The legal document must ensure that your company would continue to be the product owner if any dispute happened. Most of the big companies are involved in contract manufacturing. For instance, one manufacturer looks after the five or six brands that manufacture chyawanprash.
- The brands are only into the marketing part and outsource the manufacturing in this case.
Take Away
Acquiring an Ayush manufacturing license for herbal products in India is a prerequisite for manufacturing the Ayurvedic or Herbal products in India. Herbal or Ayurvedic products have become the need of the hour amid the COVID-19 pandemic. We, at Corpbiz, would help you in obtaining Ayush license and FSSAI License as well.
Read our article:Drug Distribution, Sale and Manufacture under Drugs and Cosmetics Act
