top of page
Search

AYUSH License | AYUSH License In India | How to Get AYUSH License



Ayurveda is an ancient healing science is gaining popularity day by day. Herbal and Ayurvedic are the backbone of treating a patient. Such medicines are in great demand and so many big and commercial houses are entering the Ayurvedic manufacturing field. Ayurvedic drugs and herbs industry has an estimated 500 crore turnover all over the world. There is a huge demand for Ayurvedic and herbal medicine in developed countries. United States, Canada, Russia, and the European Union are the biggest importers of Ayurvedic products from India.

However, it mandatory to take the consent of the government to partake in the manufacturing of Ayurvedic. This consent is given in the form of a license called the Ayush License. Under the section 33P of the Drugs and Cosmetics Act 1940, Ministry of Ayurveda, Yoga, Unani, Sidha and Homeopathy directs state regulatory authorities to grant Ayush license for the manufacturing of ayurvedic products.

All the manufacturers of Ayurvedic drugs and medicines in India are required to register for the Ayush license. The Ministry of Ayush was established in 2014 earlier it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H) which was created in March 1995.


Types of Ayush license issued by Ministry of Ayush

  1. Complete manufacturing license

  2. Ayush loan license

  3. Ayush third party/ contract manufacturing license


1. Complete manufacturing license:

Manufacturing license is required if you plan to do both manufacturing and marketing. It is a full-fledged in manufacturing license. Therefore to be eligible for a manufacturer license, you will have to set-up your own manufacturing unit. Any person who wants to apply for the manufacturing license needs to comply with the specific requirements issued by the Ayush state authority. Each state has its own set of conditions and requirements for the Ayush manufacturing license. The applicant has to abide by the requirements led down by the respective state authorities of the Ayush. Listed below are the detailed requirements for manufacturing license:


The manufacturing unit must be located in an industrial license.

  • Each drug category should have at least a minimum of 1200 sqft of manufacturing area.

  • GMP certificate is also mandatory for the manufacturing plant.

  • The should be a team of 2 Pharmacies and 2 Ayurveda experts.

  • The applicant must have all the machinery required for manufacturing.

  • The Drug Inspector shall carry out regular inspections at the manufacturing unit.


2. Ayush loan license:

In Ayush loan license the manufacturing unit is not owned by the applicant. The products are manufactured by third-party manufacturers. A manufacturer with a GMP certificate can apply for this license which can be issued in the name of his company. It is required to obtain product approval from the authorities. Below are some of the requirements for Loan license of Ayurvedic medicines

  • Loan License has to be renewed regularly

  • Regular inspection of your premises.

  • No Ayurvedic experts and Pharmacist is required.

  • The company must be registered in the same state as the manufacturer.


3. Ayush third-party/Contract manufacturing license:

The applicant only involves in the marketing of the business in this case and manufacturing is not under him. The manufacturer has to get approval from concerned authorities. Manufacturer takes care of all the liaison and compliance work The applicant can provide packaging material and raw material to the manufacturer or they can be sourced by the manufacturer himself.


Documents required for Ayush license:

Following are the documents that are required for Ayush license registration-

  • ID proof of the directors

  • Photographs

  • Business registration proof

  • Application form in prescribed format

  • Site plan

  • Challan fee for obtaining this license

  • Copy of documents like purchase bills like [refrigerator, air-conditioner electricity bills.

  • Declaration form in the format prescribed

  • Ownership proof of the premises

  • Rent agreement of the premises, (if rented)

  • MoA and AoA

  • Appointment letter by registered pharmacist

Procedure of Ayush license registration:

  1. Go to the individual state site of the Ayush

  2. Download the requisite form, attachments for Ayush license

  3. List the documents which may include affidavits and other certification such as GMP and CoPP as the case may be.

  4. Apply for GMP and CoPP if applicable.

  5. Submit it before the Directorate of AYUSH, falling under the jurisdiction of that

Comments

bottom of page