Compliances for AYUSH Manufacturing
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AYUSH Manufacturing & Import Registration
Introduction
AYUSH is an abbreviation for Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy medicines and also is used as a collective department name for the Ministry of AYUSH, Government of India.
Ayurveda is one of the most noted traditional systems of medicines that has maintained the relation of human body constitution and nature and survived and flourished for ages till date. In ancient times the knowledge of nature-based medicines was the only option to cure an ailment.
Ayurveda has a very old history since 2nd century BC, the foundation of Ayurveda was established by the ancient schools of Hindu Philosophical teachings named Vaisheshika and the school of logically named Nyaya.
The Ministry of AYUSH was formed on 9th November 2014 to ensure the maximum development and practical usage of AYUSH systems of health care. Earlier it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H) which was created in March 1995 and renamed as Department of Ayurveda, Yoga, and Naturopathy, Unani, Siddha, and Homoeopathy (AYUSH) in November 2003.
Benefits of AYUSH Manufacturer & Importer Registration
Under the Drugs and Cosmetics Act, 1940, it is illegal to manufacture, sell, or distribute AYUSH products without a valid license. Registration protects you from heavy penalties, seizures, and business closures.
2. Manufacturing Benefits
These registrations ensure legal operation, quality standards, and market growth for producing AYUSH products.
- Grants legal permission to manufacture and sell, avoiding penalties under the Drugs and Cosmetics Act.
- Boosts credibility by demonstrating adherence to Good Manufacturing Practices (GMP), building consumer trust.
Licensed units can access subsidies under schemes like AOGUSY (Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana) for upgrading labs and manufacturing tech.
How to Get AYUSH Manufacturer / Importer Registration?
The manufacturing unit must be set up according to the guidelines of the Ministry of AYUSH and comply with Good Manufacturing Practices (GMP) requirements, including proper infrastructure, machinery, and qualified technical staff.
2. Import Registration Process
Import of AYUSH products require state licensing authority approval; for import/export benefits, obtain RCMC from AYUSHEXCIL via DGFT.
- Submit business details, authorized reps, pay RCMC fee.
- Verification by council; receive RCMC certificate.
The manufacturer or importer must prepare detailed documentation related to:
- Product composition
- Ingredients used
- Manufacturing process
- Safety and quality standards
- Label and packaging details
- Quality control
- Product labeling
- Record maintenance
- Periodic renewals and compliance audits
Documents Required for AYUSH Manufacturing & Import Registration
- PAN Card of the company or proprietor
- Ownership/Lease Proof/Registered Rent Agreement
- List of qualified technical staff
- Technical staff details (names, BAMS/BHMS qualifications, experience certificates).
- Certificate of Incorporation / Partnership Deed
- Memorandum & Articles of Association (MOA & AOA)
- List of manufacturing machinery and equipment
- Import Export Code (IEC)
- Brand/Product List
What you get?
- SPCB CTE for AYUSH Products Manufacturing
- SPCB CTO for AYUSH Products Manufacturing
- AYUSH Registration as manufacturer / importer from Department of AYUSH
Common Questions
Frequently Asked Questions
AYUSH stands for Ayurveda, Unani, Siddha and Homeopathy. Any individual or a business entity desirous of manufacturing medicines of any of the types stated above need to have an AYUSH Registration.
- AYUSH Manufacturing Registration
- AYUSH Loan Registration / Third Party Manufacturing Registration
- AYUSH Import License
- To develop the ancient medicine system in India with more researched and documented evidence
- To provide the facility and infrastructure for development of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy medicines
- To preserve the culture of India and promote the ancient culture by way of ayurvedic medicines
- To regulate the manufacturing and Import of Indian Ayurvedic medicines
There is different Govt. fee for application for various Registrations under AYUSH Department. The fee also varies from one State to another. It is generally between Rs.1000 to Rs.2000, for most types of licenses.
- Firstly, we are required to get a layout plan/ Naksha of the facility prepared by a qualified architect, this layout plan should be compliant with the AYUSH laws of the respective State.
- Then, we need to get the layout plan/naksha of the facility approved by the District Health Officer/Chief Medical Officer of the District.
- After the layout plan is approved, we apply, online or offline, along with other documents, to the State AYUSH Department for the type of license as per our requirement.
- The concerned Government Official visits the site and performs site inspection.
- After the issues raised during site inspection are dealt with, the AYUSH Registration is issued.
- Covering Letter
- Fees (Challan)
- Authorization Letter
- Rent agreement/Property papers
- CIN/ Partnership deed
- List of technical staff
- Site Plan/Layout Plan/Naksha
- SPCB Pollution Registration
- Lab Report
- Details of Manufacturing Process
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