Ayurvedic medicine can be manufactured only by a firm/company having valid ayurvedic manufacturing license which is issued by state ayush department. So if you want to manufacture ayurvedic medicine then first you need to take ayurvedic manufacturing license and have to fulfill its requirement i.e. 1200 sq feet area, two technical person will be required - one for manufacturing and one as analytical chemist and will require machinery, product approval for the products you want to manufacture. So, when you fulfill all formalities, after that you can start manufacturing of ayurvedic medicines. Want to know more about ayurvedic sector click here
How to start Ayurvedic Manufacturing Unit/Company? (Also Covered Unani and Siddha Systems of Medicines)
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. Same procedure and step is applicable for Siddha and Unani Medicine Manufacturing License.
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?
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.
Check out: Area wise partition for Ayurvedic, Unani and Siddha Manufacturing unit by clicking here
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?
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:
- Make a Business Plan
- Search for Company Name
- Financial Arrangement e.g. Own Saving/Fund, Bank Loan, Investment etc
- Prepare a list of machinery and lab equipment, List of medicines, documents, area required, technical persons etc
- Search for a premises fulfil criteria required and follow Schedule T specifications to start ayurvedic manufacturing unit. Premises may be owned or rented.
- Arrange Technical persons i.e. Manufacturing Chemist and Analytical Chemist.
- Prepare a Site Master file for your manufacturing unit and set-up premises for applying for manufacturing license
- Go for Company Registration and Trademark Registration (Voluntary)
- Purchase Machinery and Lab equipment
- Prepare a file containing all documents (discussed below)
- Apply for Ayurvedic Manufacturing License
- Now Ayush officer will inspect premises
- Granting of manufacturing license number if approved
- Start manufacturing procedure like procurement of packaging material, raw material, manufacturing of products etc
- Sell through Own Marketing, Third Party manufacturing, Contract manufacturing or loan licensing basis.
Ayurvedic medicine manufacturing unit requirements (Including Unani and Siddha):
- Manufacturing Licence
- Goods and Service Tax Identification Number
- Company Registration (If want to register under company act)
- Trademark Registration (Voluntary but essential for protecting intellectual property)
- IEC and Free Sale Certificate (For Export Purpose)
- Testing and Analysis Laboratory Approval
- Approval of Medicines to be manufactured
Documents required to Start Ayurvedic, Unani and Siddha Manufacturing Company:
- Application for grant of a licence to manufacture ayurvedic, siddha or unani drugs (Form 24D for New License and Form 24E for Loan License)
- Prescribed Fee Challan
- Details of proprietor, partners or directors whatever applicable and their identification and residential proof
- Premises possession proof i.e. rent agreement in case of rented premises and ownership proof in case of owned premises
- List of technical persons i.e. manufacturing chemist and analytical chemist along with educational and technical supporting documents, and identification proof
- Premises Site Master File or Blue print of premises
- List of machinery and lab equipment
- 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
- Electricity supply details e.g. electricity bill
- NOC if any
- 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 MedicinesCheck 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:- BAMS for Ayurvedic Manufacturing/BUMS for Unani manufacturing/Siddha degree for siddha manufacturing ; or
- Diploma/Degree in Ayurveda, Ayurvedic Pharmacy, Siddha and Unani system of medicine; or
- Pharmacy graduation/Graduation in Chemistry/Botony/Pharmaceutical chemistry/ with atleast two year of experience ayurvedic/unani/siddha manufacturing unit; or
- Registered Hakim/Vaid with at least four year of experience in ayurvedic manufacturing unit; or
- A Ayurvedic (Siddha) and Unani pharmacist with at least eight year of experience in ayurvedic manufacturing unit
- Minimum of graduation in Pharmacy, Chemistry, Pharmaceutical chemistry, Botany etc.
Licenses Required:
List of licenses for manufacturing business of Ayurvedic
(including Siddha) or Unani Drugs:
Form 25D: License to manufacture for sale of Ayurvedic (including Siddha) or Unani drug
Form 25E: Loan License to manufacture for sale Ayurvedic
(including Siddha) or Unani Drugs
Form 26D: Certificate of renewal of license to manufacture
for sale of Ayurvedic / Siddha or Unani drugs
Form 26E: Certificate of renewal of loan license to manufacture
for sale of Ayurvedic / Siddha or Unani Drugs
Form 26 E-I: Certificate of Good Manufacturing Practices
(GMP) to manufacture of Ayurveda, Siddha or Unani drugs
Form26E2-I: State Drug Controller or Licensing Authority for
Ayurveda, Siddha and Unani Medicines-Free sale certificate
Form 26E2-II: State Drug Controller or Licensing Authority
for Ayurveda, Siddha and Unani Medicines-free sale certificate
Form 26E3: State Drug Controller or Licensing Authority for
Ayurveda, Siddha and Unani Medicines- Non-Conviction Certificate
Form 48: Approval for carrying out tests or analysis on
Ayurvedic, Siddha and Unani drugs or raw materials used in the manufacture
thereof on behalf of licensees for manufacture for sale of Ayurvedic, Siddha
and Unani drugs
Form 49: Certificate of renewal for carrying out tests or
analysis on Ayurvedic, Siddha or Unani drugs or raw materials used in the
manufacture thereof on behalf of licensees for manufacture for sale of
Ayurvedic, Siddha or Unani drugs
ASU (Ayurvedic, Siddha and Unani) medicines manufacturing process:
Different types of ASU (Ayurvedic, Siddha and Unani) medicines manufacture at different procedures.
Classical ASU (Ayurvedic, Siddha and Unani) medicines are manufactured with procedure as per old ayurvedic, siddha and Unani books and literatures like Charaka Samhita, Sushruta Samhita, Bhaishajya Ratnavali , Sharngadhara
Samhita, Bhava Prakasha, Bhaishajya Ratnavali etc.
Patent and Proprietary ASU (Ayurvedic, Siddha and Unani) medicines are manufactured using self made formulae of herbs or their extract considered effective for particular indication or disease.
Machinery and Equipment:
For manufacturing of ASU (Ayurvedic, Siddha and Unani) medicines depending on the size of operation and the nature of product manufactured, suitable equipment either manually operated or operated semi-automatically (Electrical or steam based) or fully automatic machinery shall be available. These may include machines for use in the process of manufacture such as crushing, grinding, powdering, boiling, mashing, burning, roasting, filtering, drying, filling, labelling and packing etc. To ensure ease in movement of workers and orderliness in operations a suitably adequate space will be ensured between two machines or rows of machines. These equipment have to be properly installed and maintained with proper cleaning.
Marketing Types and Selling of Ayurvedic Medicines:
If you are in business of manufacturing of ayurvedic, unani and siddha medicines then you will require to market and sell your products. So, here we will describe some marketing types through which you can market and sell your ASU (Ayurvedic, Siddha and Unani) medicines.
Manufacturing for ASU marketing Companies
Own Brand Marketing and Selling:
- Online Selling of ASU (Ayurvedic, Siddha and Unani) medicines
- Prescription Marketing
- Distribution through retailers, chemist and pharmacies
- Ayurvedic Franchise Business
- Door to Door marketing
- Direct selling / MLM marketing
- Tele-marketing
- Counter selling outside Yoga classic or park or crowded places
- Ayurvedic Medical Store (Retail counter at good location)
Related Articles
- Qualification of competent persons
- How to take approvals for medicine manufacture?
- Minimum area required
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