How can a BAMS Doctor Start Ayurvedic Manufacturing Company?

One of our youtube viewer asked us about How a BAMS doctor can start Ayurvedic Manufacturing Company. Requirement for starting a ayurvedic manufacturing company is same as we have discussed in our article: How to start Ayurvedic Manufacturing Company?

but this article is specific for Bachelor of Ayurveda, Medicine and Surgery (BAMS) doctors.

An Ayurvedic Manufacturing unit requires two technical persons to handle overall manufacturing and quality. For manufacturing, a manufacturing chemist is required and for quality control, an analytical chemist is required. BAMS doctors are pre-approved manufacturing chemists for Ayurvedic manufacturing Unit under drug and cosmetic act. So they only require analytical chemist as another technical person.

(In case of Siddha and Unani Medicines, technical person related to Siddha and Unani will be required)

Application for licence to manufacture Ayurvedic (including Siddha) or Unani drugs:

  1. An application for the grant or renewal of a licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 24-D to the Licensing Authority along with prescribed Fee.
  2. Subject to the conditions of Rule 157 under Drug and Cosmetic Act & Rule being fulfilled, a licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25-D. The licence shall be issued within a period of three months from the date of receipt of the application

Plant Specifications:

Plant should compile with conditions as specify in Schedule T under Drug and Cosmetic act & Rules.

Documents Required:

  • Application Form (Form 24-D).
  • Prescribed Fees
  • Requirement of schedule ‘T’ are to be fulfilled for which Departmental Inspection Team will conduct the inspection and submit its report on the prescribed Performa.
  • Technical Persons qualification documents. One is of BAMS doctor and One is of Quality section as discussed above.
  • Master Site Plan
  • Power Availability Certificate from Electricity Department.
  • List of Machinery/Lab. Equipments.
  • List of medicine to be manufactured.
  • Project Report.
  • Ownership proof or rent agreement

AYUSH department team will inspect premises as per norms prescribed in Schedule T. If all requirements are fulfilled, manufacturing license will be issued.

Area Required:

Area Required for setting up manufacturing unit is 1200 Square feet covered area with separate cabins or partitions for each activity. If Unani medicines are manufactured in same premises an additional area of 400 sq. feet will be required.  You can read in detail at our article: How much Area required to start ayurvedic manufacturing plant.

Machinery and Equipment:

All the machinery and its part used in ayurvedic manufacturing is made-up of stainless steel. Machinery are in SS-304 and contact part should be in SS-316. To know in detail about machinery read our article: List of machinery used in Pharmaceutical and Ayurvedic Sector.

Laboratory Equipment:

An Ayurvedic manufacturing unit either establish own testing laboratory or unit can get testing done at government approved laboratories. Complete detail of laboratory equipment know here

Hope above information is helpful to you…

Requirements for Ayurveda, Sidha and Unani Quality Control Section: Equipment, Area etc.

Every Ayurvedic, Sidha and Unani manufacturing unit is required to set-up own quality control section or testing should be done through government approved testing laboratory. Tests should be conducted at per Ayurveda, Sidha and Unani pharmacopoeial standard. If tests are not available, tests should be performed under in-house specification or other information available. Work of quality control section is to verify all the raw materials, monitor in-process quality checks and control the quality of finished product being released to finished goods store/warehouse. Preferably for such quality control there will be a separate expert.

Quality Control/Analytical Chemist: Quality control section will have a minimum of :

  • Expert in Ayurveda or Sidha or Unani medicine who possesses a degree qualification recognized under Schedule II of Indian Medicine Central Council Act 1970;
  • Chemist, who shall possess at least Bachelor Degree in Science or Pharmacy or Pharmacy (Ayurveda), awarded by a recognized University; and
  • Botanist (Pharmacognosist), who shall possess at least Bachelor Degree in Science (Medical) or Pharmacy or Pharmacy (Ayurveda) awarded by a recognized University

The quality control section shall have the following facilities:–

  • Area for Quality control section should be minimum of 150 sq. feet.
  • For identification of raw drugs, reference books and reference samples should be maintained.
  • Manufacturing record should be maintained for the various processes.
  • To verify the finished products, controlled samples of finished products of each batch will be kept till the expiry date of product for 3 years.
  • To supervise and monitor adequacy of conditions under which raw materials, semi- finished products and finished products are stored.
  • Keep record in establishing shelf life and storage requirements for the drugs.
  • Manufacturers who are manufacturing patent and proprietary Ayurveda, Siddha, and Unani medicines shall provide their own specification and control references in respect of such formulated drugs.
  • The record of specific method and procedure of preparation, that is, Bhavana, Mardana and Puta and the record of every process carried out by the manufacturer shall be maintained.
  • The standards for identity, purity and strength as given in respective pharmacopoeias of Ayurveda, Siddha and Unani systems of medicines published by Government of India shall be complied with.
  • All raw materials will be monitored for fungal, bacterial contamination with a view to minimize such contamination.

List of equipment required for Laboratory in Ayurvedic Manufacturing Units.

(Alternatively, unit can get testing done from the Government approved laboratory)

CHEMISTRY SECTION

  • Alcohol Determination Apparatus (complete set)
  • Volatile Oil Determination Apparatus
  • Boiling Point Determination Apparatus
  • Melting Point Determination Apparatus
  • Refractometer
  • Polarimeter
  • Viscometer
  • Tablet Disintegration Apparatus
  • Moisture Meter
  • Muffle Furnace
  • Electronic Balance
  • Magnetic Stirrer
  • Hot Air Oven
  • Refrigerator
  • Glass/Steel Distillation Apparatus
  • LPG Gas Cylinders with Burners. Water Bath (Temperature controlled)
  • Heating Mantles/ Hot Plates
  • TLC Apparatus with all accessories (Manual)
  • Paper Chromatography apparatus with accessories
  • Sieve size 10 to120 with Sieve
  • Shaker
  • Centrifuge Machine
  • Dehumidifier
  • pH Meter
  • Limit Test Apparatus

PHARMACOGNOSY SECTION

  • Microscope Binoculor
  • Dissecting Microscope
  • Microtome
  • Physical Balance
  • Aluminium Slide Trays
  • Stage Micrometer
  • Camera Lucida (Prism and Mirror Type)
  • Chemicals, Glassware etc

License required to manufacture Diabetic Powder

Query:

Hi there

I have just seen your video on youtube on Ayurvedic manufacturing etc., which is very helpful

The reason I am writing to you is to enquire about a different kind of a licence and requirement. I will explain in detail so you can advice me.

Well, I have made a Ayurvedic churn for Diabetes, this churna is not manufactured by me, what i have done is taken different  powders/churans in exact ratios and made one churan which is found to be beneficial in curing Diabetes. These different powders are bought from local market and all i do is mix them in specific ratio and make my churan for diabetes.

I am doing this process for a long time for the family, domestic purpose and not for commercial purpose. But now I want to do it on commercial basis, as I have read this is completely a safe medicine

My purpose will be to outsource the raw products (Churans/powder) from the market, mixing, packing in good quality packing and sell them in the market on a very nominal rate.

I am from ahmedabad, gujarat, and I have been to the local Ayush office here, but it was useless visit as they could not explain anything, but only explain something about loan/third party licence.

I read on google about this Loan//Third party licence, i think i would need such licence but do not know how to get one and from where to proceed.

Please if you can help in advising about —

  1. This loan/third party licence and also
  2. if I need to have a unit/shed from where I should be operating? As I am not manufacturing only mixing and assembling powers/churans.
  3. ALso on how can I get such and licence and what all douments etc is required

I would be highly grateful if you answer my questions

 

Response:

After reading your mail, we have concluded two option for you…

  1. Either you can make your as Food Supplement

or

  1. you can make it as Ayurvedic Product

For in both case you need to take manufacturing license. For food supplement, you need FSSAI license and for ayurvedic product, you need ayurvedic manufacturing license.

Read requirements and how you can take licenses by clicking at below link:

How to start Food Supplement Company?

How to start Ayurvedic Company?

As you mention, you are only mixing. That come under manufacturing process. When you take different ingredients and mix these into a finished preparation, that fall under manufacturing process and you will need a manufacturing license for it.

As you asked by Loan licensing and Third party manufacturing, these both processes involve when you get manufactured your product from another manufacturer but brand name and company name belong to you…

In simple words, product will have your company name and your brand name but will be manufactured by an another manufacturing unit which have a valid manufacturing license number.

Read About Third Party Manufacturing by clicking here

Hope above information is helpful to you…..

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Kaise Ayurvedic Company Suru Kre?

Query:
Sir main BAMS doctor hu main 2-3 products register kra kr marketing krana chata hu. kis terha se register krau aur kis terha se work start kru

Response:

Product registration do trah ka hota hai: Ek brand name registration or dusra product composition ka registration..Humare article: Where to register ayurvedic products(click here) me aap complete detail pd skte hai.

Apne brand launch krne ke liye apko company registration (optional) krana pdega aur GST number lena padega. Uske bad aap kisi bhi ayurvedic manufacturer se contact krke apne brand name se product bnwa skte hai..

Umeed krte hai apko humara suggestion acha lga…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

How and Where approach for Ayurvedic Manufacturing license?

Query:I would like to share my query regarding , how and where approach for manufacturing licence?
Suppose, I have a seeds from a plant or tree to make herbal medicine (intake ). What I need to do from there?
Whether I need to test any laboratory first or need to register the company first? I need to know from scratch , that’s why requesting this query.
If they need test , then where to do the test (Kerala) and what will b the formalities . I need to start with small quantity and no need to plan for manufacturing unit now. Can invest in that once the business is good . I need to do with third party manufacturing . The product should be powdered and capsule form. Please advice from where to start?

Response:

You have to approach State Ayurvedic and Indian System of Medicines Control Officer in Kerala or any concerned department of state for applying for manufacturing license. Most of states have appointed AYUSH Department for providing manufacturing license to Ayurvedic manufacturing license. Ayush department headquarter for most of states at Capital Region. Read in detail about Ayurvedic Manufacturing Company here

If you have seeds from a plant or tree, first you have to study about particular use and medicinal effects of that seed by studying at Ayurvedic Reference books like Ayurvedic Pharmacopoeia of India, Charaka Samhita, Pharmacognosy books or any other books. If that seeds has any medicinal effects then only these can be used for preparation of Ayurvedic Medicines. Testing laboratories are already situated inside manufacturing units. Read in detail about registration of an Ayurvedic Product before launching in india?

If you don’t have plan to launch own manufacturing unit, you can start by getting manufactured your products at third party or contract manufacturing basis. Read about Ayurvedic Third party Manufacturing here

At third party manufacturing, either you can use preparations that are already used by Ayurvedic manufacturers or if you have special composition of preparation, manufacturer will make arrangement for it approval…

Hope above information are useful for you..

For any query and suggestion, mail at pharmafranchiseehelp@gmail.com

How to start Ayurvedic Manufacturing Company?

Query:

We are doing distributions and sale FMCG product tamil nadu. We want start Ayurved manufacturing company. Only – soap, shampoo, hair oil, conditioner we want manufacture first. Can you help. How much first cost will be. What procedure steps.

Response:

For starting Ayurvedic Manufacturing company, you need to complete all requirements as discussed in our Article: How to start Ayurvedic Manufacturing Company?

In above linked article, we discussed about machinery used in Liquid manufacturing, tablet and capsule manufacturing etc. For Ayurvedic Soap, Samphoo, Hair oil and Conditioner you have to use different manufacturing method and machinery but requirements for license will be same.

For Oil, Shampoo and conditioner, you will require mainly mixing and preparation tanks, filling machine etc. For soap, you will require soap dies along with other equipement.

Cost will be depend at machinery: Filling machine cost is approximately —–, tanks cost is approx. —–/- per tank and could require more than two tanks. Documentation and approval cost may be nearly fifty thousands.

Procedure for starting:

  • First finalize a premises where you want to start
  • Finalize machinery and equipements
  • Complete all documentation and requirements
  • Apply for Ayurvedic Manufacturing License
  • After manufacturing license start manufacturing

Hope this information will be helpful to you…

For any query and Suggestion, mail us at pharmafranchiseehelp@gmail.com

How to Register Ayurvedic Products before Launching in Market?

Query:

My Name is ———- and I have been researching on ayurvedic medicines from last two years. I have come up with a solution for problem related to stress, low energy, low libido in men. I want to manufacture this product and sell this product in market. I have been told that one needs clinical trails at government hospital to get the drug manufacturing licence. Can you please help me here, following are the areas i need help.
1) Is it true that without government clinical trails you can’t get drug manufacturing licence?
2)if yes then how do i get these clinical trails done.
3) My product is very simple in nature it few roots dried and mixed together, there no chemical and no other compound it totally plant based. I want to start on small scale and gradually grow. How do I meet the requirements of machinery in drug licence.
4) I can even make these medicines from home can I sell like this?
5) How do the get the required technical staff on board as required for drug manufacturing licence.

Kindly help me with this. thanks a lot



Response:

There is certain formalities to manufacture ayurvedic products.

1) You will not need for any clinical trial report for ayurvedic medicine to get approval from ayush department of concern state. You just need to fulfill medicine detail with herbs, quantity with reference book etc. Read: How to Register Ayurvedic Products before Launching in Market?
2) N/A
3) Most of ayurvedic products is manufactured by using herbs or plant parts. If you want to sell it as a Ayurvedic Medicine, you will need to take Ayurvedic Manufacturing License. Read complete procedure for Ayurvedic Manufacturing License Here
4) You can’t manufacture any ayurvedic medicines at home for commercial use except in some conditions. You can get manufactured these products from other manufacturers at third party manufacturing basis.
5) You have to hire technical staff i.e. manufacturing chemist and analytical chemist. Certain Job placement agencies can help in finding staff for you.

Hope Above information is useful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

What is the process and procedure for Ayurvedic Manufacturing Unit?

Query:

Support to get manufacturing of Ayurvedic product. Dear sir i want to make a Ayurvedic manufaturing unit want to make:
1. Ayurvedic dental lotion
2. Trifola dust.
3. Pain bam and others more
What is the process and procedure please guide me

Response:

You will need to complete all documents and licenses manufacture all Ayurvedic preparations: Read all requirements about ayurvedic manufacturing unit

Hope this information will be helpful to you…

Ayurvedic medicines manufacturing plant in partnership

Query:

I am going to start a ayurvedic medicines manufacturing plant in partnership, what all legal formalities I have to comply with and also I want to know on what basis I should make an partnership deed?

Response:

Read all legal formalities about Ayurvedic Medicine Manufacturing at our article:

How to start Ayurvedic Manufacturing Company?

Partnership deed basis should be mutual understanding of Partners. Some considered point should be:

  • Partners Details
  • Investment per person
  • Profit Share
  • Work responsibilities
  • Authorized Person
  • Compensation in case of leaving etc.

Hope this information will be helpful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

How to start Ayurvedic Manufacturing Unit?

Query:
I want to start small Ayurvedic product manufacturing unit ,what is the posses of start business please guide me.

Response:

For starting Ayurvedic Manufacturing company, you need to take manufacturing license from Ayush department. You can read all documentation and procedure of starting Ayurvedic Manufacturing Company hereMachinery and minimum requirements for all section for Ayurvedic Products, you can read at our article: Area and Machinery required for starting Ayurvedic Manufacturing unit …

Hope above information was useful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com