Understanding the Licensing Process for Ayurvedic Businesses

Introduction

AYUSH licences are granted by the Indian government to anybody wishing to launch a business selling Ayurvedic, Unani, Siddha, or similar products. These permits are granted by the Ministry of AYUSH. The Department of Indian System of Medicine and Homoeopathy (ISM&H), established in March 1995, was the previous name of the Ministry of AYUSH till its creation on November 9, 2014.

Ayurvedic medicine is the oldest medical system in the world, having been practiced in India for millions of years. Since it has no negative effects, it is gaining popularity abroad and is already being imported by a number of countries.

Key Points to Remember When Applying for an Indian AYUSH licence

• No individual or group may start or run a pharmaceutical or cosmetic business without first obtaining the required licensing.
• All kinds of drug companies, including those that sell herbal, homoeopathic, ayurvedic, unani, and allopathic medications, are protected under the Drug & Cosmetic Act of 1940.
• Before someone may start making Ayurvedic medicines, they must get a permit from the Ministry of AYUSH.

The benefits of obtaining an AYUSH licence

There are several benefits to obtaining an AYUSH licence.

• After receiving the AYUSH licence, the individual or organisation is permitted to operate in any state, regardless of the location of the manufacturing company.
• The individual or organisation that applied for the AYUSH licence is only responsible for the product’s marketing; the manufacturing company is in charge of all other product compliance needs.
• The Health Insurance Policy provides coverage for AYUSH licence benefits.
• Getting an AYUSH licence is essential to regulate and stop the misuse of Ayurvedic medication since Indian culture strongly promotes the use of herbal and Ayurvedic treatment.
• The government’s “go local” policy is also encouraging companies and consumers to use domestically produced goods, such as herbal and Ayurvedic remedies.
• Medications derived from natural herbs and ayurvedic resources have a small risk of side effects, and the AYUSH licensing helps to boost user confidence.

Various Types of AYUSH licences

The following manufacturing permits are issued by the Ministry of AYUSH:

Let us examine the many types of AYUSH licences in more detail, including the following:

licence to manufacture for AYUSH

It is acquired when a candidate wishes to get a licence and intends to produce and market both goods. In such a case, the producer has to set up his manufacturing facilities.

Each state has its own requirements for the construction of these industrial facilities. All of the demands made by the state administration of AYUSH must be agreed upon.

Under the AYUSH Act, you must fulfil the following conditions in order to be granted an AYUSH Manufacturing licence:

• Location of Unit
• Unit Minimum Size
• Certification of GMP
• Inspection
• Specifications of the Team
• Contract for Loan Manufacturing

The following details can be made clear:

• It is imperative that the manufacturing plant be situated in an industrial area.
• A manufacturing site must be at least 1200 square feet in size in order to generate a single medication.
• If you want to manufacture many drugs, you will ultimately need additional space, which will lead to the addition of new categories.
• The manufacturing unit must have a GMP certification.
• Make sure to include two chemists and two Ayurvedic specialists.
• All of the production and packaging equipment is at your disposal.
• Your manufacturing facility will undergo routine inspections by the drug inspector.

Licence for Unani Manufacturing

Unani medicine is regarded as both an art and a science of healing. It is an honourable profession to help individuals with their persistent issues. The Unani framework’s distinctive approach to sickness prevention and treatment makes it appealing to people. It is well known as one of the corresponding medical systems.

licence for Siddha Manufacturing

Maintaining balance between the mind, body, and spirit is the aim of the treatment. By giving the body, mind, and spirit equal weight, Siddha treatment seeks to restore the body’s numerous psychological and physiological functions to complete balance. Ayurvedic treatment includes yoga, meditation, diet, and lifestyle.

licence for AYUSH Loans

The applicant does not claim the manufacturing facility under this type of agreement. The third party is in charge of manufacturing the goods. A factory with GMP certification must apply for such a borrowing licence; the applicant organisation will then be granted it. The product must then be approved by the authorities.

Documents Required to Acquire an AYUSH licence

• Details of the applicant, including name, address, email, and phone number
• An official copy of the Manufacturing licence
• Complete product list and composition submitted for COPP issuance
• Layout of the Manufacturing Plant/Site Master file
• Send in the manufacturing process and the formula for production.
• Analysis methodology and the final product specification report
• List of authorised items
• Batch-based stability study analysis, together with the drug’s name, production date, expiration date, and stability study condition
• Validation report for three batches of processes
• List of technical personnel, including details about their background, credentials, and approval status
• List of tools and equipment that have been used or will be used
• Diagram for the Water System
• Diagram of the HVAC System
• Data from the previous two years should be exported, if COPP revalidation is necessary.
• A demonstration of efficacy and safety as required by Rule 158B of the 1945 Drugs & Cosmetics Rules

The process for acquiring an AYUSH licence

The Ministry of Ayurveda requires all producers of herbal or Ayurvedic goods to apply for a licence. Every state has a webpage dedicated to AYUSH. To be eligible for an AYUSH licence, an applicant must go to the state’s AYUSH website. The steps indicated below must be followed in order to obtain the licence:

Go to the website

Get the application for an AYUSH licence by going to the AYUSH website for each state. Additionally, the petitioner must submit the necessary COPP and GMP affidavits.

Filling out the Form

The application form must then be completed, submitted to the commissioner of the AYUSH Department for evaluation, and supported by the necessary documents.

The Commissioner’s endorsement

The commissioner will provide his permission within 15 days when he is satisfied.

Getting the licence

The licence for AYUSH will be mailed to the applicant.

Loan licence Holder Participation

The manufacturer can arrange for it from their sources as well, or the owner of the loan licence can provide the raw ingredients and packaging. The manufacturer produces the final product by working to transform such raw materials into it. The licence holder is permitted to reapply for a loan licence from a new producer who has earned GMP certification.

Fees Charged to the Loan licence Holder by the Manufacturer

Conversion costs, or the cost of producing the desired item on the manufacturer’s property, might be imposed by the manufacturer. Additionally, the manufacturer will request payment for the product approval.

In order to address it, a legal report involving your insights and the maker on your ownership of the item must be written. In the event of a disagreement, the legal document that has been thus draughted should be adequate to protect your rights. A provision stating that your business retains ownership of the goods under all circumstances must be included.

Read Our Blog – Crafting a Holistic Approach: A Guide to Establishing an Ayurvedic Medicine Manufacturing Venture