India preserves a spirited heritage of herbal and Ayurvedic medicine, and obtaining a license for herbal products is mandatory for manufacturing in India. In recent years, India has become a revolutionary on an international level when it comes to the manufacturing of herbal products. Licenses for these products are issued by the Ministry of Ayush, which supervises Ayurveda, Yoga, Unani, Siddha, and Homeopathy. Companies engaged in herbal and Ayurvedic medicine must comply with regulatory standards to guarantee product safety and efficacy.
Regulatory Authority for Herbal Products in India
Herbal and Ayurvedic products in India are regulated under the Drugs and Cosmetics Act, of 1940, and the Drugs and Cosmetics Rules, of 1945. The authority responsible for regulating these products is the Ayush Ministry, which oversees Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy (AYUSH) medicines.
License Required for Manufacturing and Selling Herbal Products
Manufacturers and distributors of herbal & ayurvedic products need to obtain an Ayush License. Depending on the business activities you can apply for different types of Ayush licenses, such as:
1. Ayush Manufacturing License
Ayush manufacturing license is compulsory for businesses that manufacture herbal or ayurvedic products. This license is issued by the Ministry of Ayush after meeting the necessary standards.
Eligibility Requirements To Obtain Ayush License For Herbal Products:
- A manufacturing unit must adhere to hygiene and infrastructure standards.
- Comply with Good Manufacturing Practices (GMP) as per Schedule T of the Drugs and Cosmetics Act.
- Proper documentation of raw materials and formulations.
Documents Required For Ayush Manufacturing License:
- Application form as per state requirements.
- Company incorporation certificate.
- Site plan and layout of the manufacturing unit.
- Details of technical staff and their qualifications.
- List of herbal products with formulations.
- Proof of compliance with GMP norms.
2. Ayush Retail or Wholesale License
Ayush retail/wholesale license is required to sell herbal products in the market as a retailer or distributor.
Eligibility Requirements To Obtain Ayush Wholesale License:
- The business entity must be properly registered as Sole Proprietorship, Partnership, or Pvt. Ltd.
- A valid GST registration.
- Businesses must have adequate storage facilities for herbal products.
Documents Required:
- Business registration documents
- GST certificate
- Identity proof of the owner
- List of products to be sold
Eligibility Criteria for Herbal Product Certification in India
To obtain certification for herbal products in India, businesses must meet the following eligibility criteria:
Business Entity Registration For Herbal Products
- The applicant must be a registered business entity such as Sole Proprietorship, Partnership, or Pvt. Ltd.
- GST registration is required for tax compliance.
Obtain Manufacturing License For Herbal Products
- A valid Ayurvedic/Herbal Drug Manufacturing License from the State Licensing Authority (SLA) under the Ministry of Ayush is mandatory.
- If manufacturing herbal products in another manufacturing unit, a Loan License is required.
- To manufacture herbal and ayurvedic products businesses must have qualified technical staff.
GMP & Quality Compliance
- The manufacturing facility must comply with Good Manufacturing Practices (GMP) under Schedule T of the Drugs and Cosmetics Rules, 1945.
- WHO-GMP certification is recommended for better credibility and export compliance.
Approved Ingredients & Formulation For Herbal & Ayurvedic Products
- Herbal products should use ingredients listed in the Ayurvedic Pharmacopoeia of India (API) or recognized classical texts.
- Any proprietary formulation requires approval from the regulatory authority.
Documentation Requirements
- Application form with business details
- Manufacturing site details & GMP compliance proof
- List of ingredients & formulations
- Product testing reports (heavy metals, microbial load, stability, etc.)
- Packaging & cosmetic labeling compliance as per Ayush and FSSAI guidelines
Testing & Certification
- Products must pass safety and quality tests in NABL-accredited labs.
- Heavy metal, microbial, and pesticide residue testing is mandatory.
- Certifications such as ISO 9001, HACCP, Organic Certification, and AYUSH Premium Mark can enhance credibility.
Labeling & Claim Compliance
- Labels must follow Ayush & FSSAI guidelines, with accurate ingredient lists and dosage instructions.
- Misleading therapeutic claims are strictly prohibited.
Export Certification (If Applicable)
- Businesses planning to export must obtain a Free Sale Certificate (FSC), WHO-GMP, Certificate of Analysis (COA), and compliance with international standards (USFDA, EU, etc.).
How To Get An Ayush License For Herbal Products?
There are multiple steps involved while applying for an Ayush license, including application, submission, document verification, and compliance. The following steps are explained below:
Step 1: Documentation
The primary step is proper documentation that is needed while applying for a license for herbal products.
Step 2: Apply For A GMP Certificate
The next step after gathering documents is to apply for a GMP certificate If you are a manufacturer.
Step 3: Apply For A Copp Certificate, If Applicable
If you are planning to export herbal products outside the country then the next step is to apply for a COPP certificate.
Step 4: Download the form for the Ayush License Certificate
After getting the necessary certificate download the form for the Ayush license certificate from the Ayush portal to apply for an Ayush license online.
Step 5: Fill Out & Submit The Application
After downloading the Ayush license application form from the AYUSH portal, fill it out with the correct and valid information and apply.
Step 6: Verification By Ayush Department’s Commissioner
Ayush license document verification will take place after the submission of the form. They also visit your office or manufacturing unit to physically examine the place.
Step 7: License For Herbal Products Granted
After ensuring that offerings and manufacturing units meet the necessary standards, the authorized department grants the AYUSH certificate.
How Much Does a Herbal Product License Cost In India?
The cost of obtaining a license for herbal products varies depending on the state and type of license. Manufacturing licenses generally have a higher fee, while retail and wholesale licenses may have a lower cost. Additionally, Good Manufacturing Practice (GMP) certification can incur extra expenses.
Validity Of License For Herbal Products
The validity of a license for herbal products was 5 years before the 4th amendment of Drugs Rule, 2021 & required renewal. Now the validity is extended to a lifetime and requires online submission of a self-compliance declaration every year or unless it can be revoked.
Key Consideration Before Applying For a License For Herbal Products
Here are the following key points you must consider while applying for an Ayush license for herbal products:
- A person or entity cannot start a manufacturing & distribution business of Ayurvedic & herbal products without an Ayush license.
- To start a business in the herbal and ayurvedic industry one must comply with the Drugs and Cosmetics Act, of 1940, and the Rule, of 1945.
- Complying with these regulations ensures the safety, quality, and efficacy of herbal products.
- If the business involves activities under section 33B of the Drugs and Cosmetics Act 1940 then it is mandatory to obtain an Ayush license.
- The Ministry of Ayush issues the Ayush license.
What Is Ayush Certified Products?
Products that meet the quality, safety, and efficacy standards set by the Ministry of Ayush are AYUSH-certified products. These products are made with traditional medicine systems like Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homoeopathy.Â
Do Herbal Cosmetics Require CDSCO Approval?Â
Herbal cosmetics don’t need approval from CDSCO unless they are imported; in that case, registration with Form 42/43 is essential. State authorities oversee these products as cosmetics.
How Are Herbal Products Classified in Indian Regulations?Â
A herbal product is categorized as a cosmetic when used externally, as an Ayurvedic medicine if it makes therapeutic claims, and as a nutraceutical when intended for oral use.
Are Herbal Cosmetics Governed by the Drugs and Cosmetics Act of 1940?Â
Indeed, herbal cosmetics products are regulated under the Drugs and Cosmetics Act of 1940, which necessitates compliance with labeling, manufacturing, and BIS standards; however, they do not require drug approval unless they claim medicinal properties.
