How to start Ayurvedic Manufacturing Unit/Company? (Also Covered Unani and Siddha Systems of Medicines)

In previous article, we have discussed about how you can start own Ayurvedic Marketing Company. Read to get more detail about How to start Ayurvedic Marketing Company?

In this article, we will cover about How to start Ayurvedic Manufacturing unit/Company. Ayurvedic marketing company requires less amount and documents to start whereas ayurvedic manufacturing company require starting a comparatively large amount and documentation.

For Starting manufacturing of Ayurvedic and Herbal products, one must have Ayurvedic Manufacturing License for Ayush department of concern state. Every state has a department who look after licensing and other things related to Ayurvedic, Unani, and Siddha system of treatment. Manufacturing of herbal, Ayurvedic, Unani and Siddha products without a valid manufacturing license is criminal offence.

Here we are going to discuss about process, procedure, documents, licenses and required competent staff to start Ayurvedic, Unani and Siddha’s products manufacturing unit. Throughout article, you will know the requirement to start manufacturing business in alternative systems of medicines.

Step-wise procedure to Start Ayurvedic Manufacturing Unit:

1. Make a Business Plan
2. Search for Company Name
3. Financial Arrangement e.g. Own Saving/Fund, Bank Loan, Investment etc
4. Prepare a list of machinery and lab equipment, List of medicines, documents, area required, technical persons etc
5. Search for a premises fulfil criteria required and follow Schedule T specifications to start ayurvedic manufacturing unit. Premises may be owned or rented.
6. Arrange Technical persons i.e. Manufacturing Chemist and Analytical Chemist.
7. Prepare a Site Master file for your manufacturing unit and set-up premises for applying for manufacturing license
8. Go for Company Registration and Trademark Registration (Voluntary)
9. Purchase Machinery and Lab equipment
10. Prepare a file containing all documents (discussed below)
11. Apply for Ayurvedic Manufacturing License
12. Now Ayush officer will inspect premises
13. Granting of manufacturing license number if approved
14. Start manufacturing procedure like procurement of packaging material, raw material, manufacturing of products etc
15. Sell through Own Marketing, Third Party manufacturing, Contract manufacturing or loan licensing basis.

Documents required to Start Ayurvedic, Unani and Siddha Manufacturing Company:

1. Application Form
2. Prescribed Fee Challan
3. Details of proprietor, partners or directors whatever applicable and their identification and residential proof
4. Premises possession proof i.e. rent agreement in case of rented premises and ownership proof in case of owned premises
5. List of technical persons i.e. manufacturing chemist and analytical chemist along with educational and technical supporting documents, and identification proof
6. Premises Site Master File or Blue print of premises
7. List of machinery and lab equipments
8. List of medicines to be manufactured along with Product details includes brand name, herbs  and their parts used, reference book page number of each herb, form used (like powder or extract etc), preservatives used, prescribed indications of product etc
9. Electricity supply details e.g. electricity bill
10. NOC if any
11. Other documents that would be asked by concern officer at time of inspection and application filing

Minimum Area required for premises to be approved for Ayurvedic Manufacturing Unit:

Minimum Area required for starting ayurvedic manufacturing unit is 1200 Square Feet. If both unani and Ayurvedic medicines are manufacturing in space premises then 400 square feet additional area is required. Section wise partition should be done to avoid any contamination and follow Good Manufacturing Practice (GMP) standards. Each section should further require minimum space requirement to get approval under schedule T. Schedule T is a schedule prescribed under Drug and Cosmetic Act & Rules to advocate GMP standards and encourage hygienic conditions for manufacturing units and maintain efficacy, quality and accuracy of herbal, ayurvedic, unani and siddha products. Checkout: Schedule T: Good manufacturing Practice for Ayurvedic, Sidha and Unani Medicines
Check out: Area wise partition for Ayurvedic, Unani and Siddha Manufacturing unit by clicking here

Technical Persons Qualification Detail:

For Manufacturing/Production Chemist, a person should posses either of one qualification mentioned below:

1. BAMS for Ayurvedic Manufacturing/BUMS for Unani manufacturing/Siddha degree for siddha manufacturing ; or
2. Diploma/Degree in Ayurveda, Ayurvedic Pharmacy, Siddha and Unani system of medicine; or
3. Pharmacy graduation/Graduation in Chemistry/Botony/Pharmaceutical chemistry/ with atleast two year of experience ayurvedic/unani/siddha manufacturing unit; or
4. Registered Hakim/Vaid with at least four year of experience in ayurvedic manufacturing unit; or
5. A Ayurvedic (Siddha) and Unani pharmacist with at least eight year of experience in ayurvedic manufacturing unit

For Analytical/Quality Control Chemist, a person should possess at least

1. Minimum of graduation in Pharmacy, Chemistry, Pharmaceutical chemistry, Botany etc.

Related:

• List of Machinery Required
• List of Laboratory Equipments required
• Qualification of competent persons
• How to take approvals for medicine manufacture?
• Minimum area required

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