How to Start Pharmaceutical Company (Marketing & Manufacturing)?

Starting a Pharmaceutical company is a dream project for every pharma professional. But most of us haven’t start own pharmaceutical venture due to lack of knowledge and procedure to start pharmaceutical company. Here we will try to help you to start your own pharmaceutical company. This article we cover complete detail that is necessary to start pharmaceutical company.

We can divide pharmaceutical companies in two parts:

  1. Pharmaceutical Manufacturing Company
  2. Pharmaceutical Marketing Company

These are two basic types of pharmaceutical companies. These can be further divided into following parts based upon their marketing, sale and work basis irrespective of marketing and/or manufacturing type.

  1. Pharmaceutical Branded/Ethical Company
  2. Pharmaceutical Generic Company
  3. Pharmaceutical Franchise Company
  4. Pharmaceutical Pcd Company
  5. Pharmaceutical Specialty company e.g. Derma, ophthalmic, cardiac etc
  6. Pharmaceutical Export Company
  7. Pharmaceutical Import Company
  8. Pharmaceutical OTC company
  9. Pharmaceutical Distribution Company
  10. And many more

A manufacturing company can be marketing company at same time if they are doing own marketing also along with manufacturing. Manufacturing company also require to fulfill marketing company licenses and requirements to market, sell and distribute products.

There are different procedures to start marketing and manufacturing pharmaceutical company. In this article we will cover licences, procedure, documents, qualifications and requirements to fulfill criteria for marketing company and manufacturing company. First we will discuss about requirements, licenses required and Licencing authority for granting licenses for manufacturing company. Later in article will discuss about marketing/distribution/trading company.

How to start Pharmaceutical Manufacturing Company

Requirements:

  • Plant and Building (As per WHO:GMP and/or Your Country Law like in India, As per Drug and Cosmetic Act)
  • Technical Staff i.e. Approved Manufacturing Chemist and Approved Analytical Chemist
  • Machinery and Lab Equipment
  • Office Accessories
  • Machine Men and Workers
  • Electricity Supply
  • Water Supply
  • HVAC unit
  • List of medicines to be manufactured
  • Non Objection Certificate if required

Licences Required:

  • Company Registration (in case proprietorship you may skip this process)
  • Manufacturing License
  • Laboratory License
  • Wholesale Drug License
  • Goods and Service Tax Number

Licensing Authority for Manufacturing License:

Licensing Authority is a department and/or authorized person by government to grant, renew, issue and suspend license for any manufacturing unit. In case of manufacturing unit Drug Control Officer of concern state is a licensing authority for pharmaceutical manufacturing unit. Licensing Authority office is generally located at State Capital and/or Zonal basis for big states. You have to apply to licencing authority for granting of manufacturing license.

For new drugs, blood and blood products, IV fluids, vaccines and sera in India approval and licensing, Licensing authority is Drug Controller General of India.

How to apply?

Once you have completed all requirements and documents, you can visit to state drug control office for submitting your file for granting of manufacturing license. Most of state has started online application submission and/or some states still use manual file submission. You may have to visit number of times to licensing authority for it. Once you have submitted your application. Licensing Authority will intimate inspection schedule for your manufacturing unit through mail, phone and/or manually as applicable.

Inspection:

Inspection is conducted by joint team of State Drug Control Office and District Drug control office and/or with central drug authority. All facilities, technical staff detail, machineries and particulars are inspected according to submitted application and as per Drug and Cosmetic Act & Rules.

In case, all requirements and documents are find to be satisfactory, a license is issued by concerning drug authority for manufacturing of medicines in enclosed list with manufacturing license application.

 

Only Manufacturing License and Laboratory License processes are different for Pharmaceutical Manufacturing Company from Pharmaceutical Marketing Company. Remaining processes are same for both types of companies. Manufacturing Company also require wholesale drug license. Wholesale Drug License Procedure we have discussed in how to start pharmaceutical marketing company section below.

Remaining processes we will discuss later in article. Documents also we will discuss in end. You can skip to end to read documents required for each process. One of main critical step is trade mark registration. Trade Mark registration is important for protection of company name and brand names.

How to Start Pharmaceutical Marketing Company

Requirements:

  • Premises (Cemented and well furnished floor and walls, concrete roof etc)
  • Competent Person i.e. Pharmacist or Experience Person
  • Office Accessories
  • Freeze and Air conditioner if asked for
  • Electricity Supply

Licences Required:

  • Company Registration (in case proprietorship you can skin this process)
  • Wholesale Drug License
  • Goods and Service Tax Number
  • FSSAI Registration (In case of selling Food and Dietary Supplements also)

License Authority for Wholesale Drug License:

Licensing Authority is a department and/or authorized person by government to grant, renew, issue and suspend license for wholesale drug licence. In case of wholesale drug license Senior Drug Inspector and/or Drug Inspector of concern district is a licensing authority for pharmaceutical marketing company. Licensing Authority office is generally located at District Head quarter and/or combined for two or more districts in some regions. You have to apply to licencing authority for granting and issuing of wholesale drug license.

How to apply?

Once you have completed all requirements and documents, you have to visit District drug control office in your district for submitting your file for granting of wholesale drug license. Most of state has started online application submission and/or some states still use manual file submission. You may have to visit number of times to licensing authority for it. Once you have submitted your application online, you still need to submit your uploaded documents physically at licencing authority office . Licensing Authority will intimate inspection schedule for your premises inspection through mail, phone and/or manually as applicable.

Inspection:

Inspection is conducted by District Senior Drug Inspector and/or Drug Inspector. All facilities, competent person details and other particulars are inspected according to submitted application and as per Drug and Cosmetic Act & Rules.

In case, all requirements and documents are find to be satisfactory, a license is issued by concerning drug authority for sale, stock, exhibit and distribute of medicines for wholesale.

How to Register Company in India (Company Registration)?

There are four types of pharmaceutical companies mostly registered under Company Act.

  • One Person Company
  • Private Limited Company
  • Limited Liability Company
  • Public Limited Company

Each type of company has different requirements and eligibilities. There are certain criteria fixed by Government of India for registration your company in any type. Ministry of corporate affair regulated company registration through Company Act 1956, 2013 and allied Acts. You can register your company through ministry of corporate affairs website.

Most of us will not take burden to apply for company registration by own self if we can get company registration consultants easily. Most of Chartered Accounts and Sale Tax/income Tax Advocates do this work with small consultancy fees. Search for CA and other agencies that deal in company registration nearby you and apply for company registration.

If you want to apply your own then you can visit at http://www.mca.gov.in/ and follow the process to apply for company registration.

How to apply for Goods and Service Tax Identification Number:

GST is essential in India for doing any type of business/trading but below 20 lac annual turnove, there is no requirement of GSTIN registration. GST registration is compulsory to obtain within 30 days after exceeding turnover above20 lac. Unlike VAT, GST is valid in all states. It can be applied through portal provided by state government and/or center government.

Like company registration, you can outsource work of for GSTIN registration through CA and other agencies. If you want to apply for GSTIN by own then Go to www.gst.gov.in. There will be the two options: New User and Existing User. Click at New User, Enter your detail for apply GST, Enter you mobile number and Email Address of the authorized signatory of the business entity. This number and e-mail will be used for all future communication from the GST portal.

You will receive a OTP at mobile number and e-mail id you entered in previous step. Enter this OTP. After that follow all steps and enter information and scanned images of documents as mentioned in Provisional Registration form. After completion of this process, you have been successfully applied for GSTIN registration.

We will recommend you to let your CA do this work for you. They will charge some fees but it worth for work, they know better than you and us.

How to apply for Food Safety and Standards Authority of India (FSSAI) Registration

If you want to market food and dietary supplements along with medicines and drug then you also have to apply for FSSAI registration. This is a simple registration process which you need to apply online by visiting at FSSAI website. After applying application online, you also have to submit your documents manually at FSSAI officer’s office appointed by FSSAI department at district head quarter or at specific location. Office detail can be found at FSSAI website and/or contact number provided at their website.

This is applicable for marketing and selling of food & dietary supplements only. If you are a manufacturing food & dietary supplements then you have to apply for Food and Dietary Supplement manufacturing license at FSSAI website. This process is also online and has to submit documents at food officer’s office.

Documents and requirements are different for license and registration process. There are three type of categories under FSSAI.

  • Central License
  • State License
  • Registration

You can apply as per your need. If you are marketing, only registration could be ok but if you have large turnover you have to take state license from FSSAI. For manufacturing, you can opt for state license and/or central license as per your requirement.

Note: For granting FSSAI manufacturing license separate building and premises is necessary.

What will be Procedure and sequence to proceed for Starting Pharmaceutical Company

Important Step in starting Pharmaceutical Company

  • Taking Experience in pharmaceutical sector by doing job and/or indulge with any already established company/firm.
  • Take training if you don’t have experience in pharmaceutical sector
  • Choose Location of Business. Search for shop/building/premises for office, licenses and stock. It may be rented or owned but there should be adequate space as per government norm.
  • Research and Prepare list of all molecule and combinations, you want to manufacture and/or marketing.
  • Finalize Company Name and Brand Names of all products. Be sure these don’t resemble to any other company or brand already working in Market. Due to presence of thousand of brands and companies, it becomes difficult to choose unique name but you should try your best. Already registered or in process Trade Name and Company Name you can search at http://ipindiaonline.gov.in/tmrpublicsearch/frmmain.aspx. Trade name in class 5 and Company name at class 35.
  • Appointment of Technical and competent staff

Now we will discuss about documents required for licenses we have discussed above.

Documents Required:

Documents Required for Pharmaceutical Manufacturing License:

List of Documents required to obtain pharmaceutical manufacturing drug license: (May vary state to state):

  • Covering Letter including introduction of applicant with address of the Plant and Administration office
  • Prescribed forms duly filled and signed by the Proprietor / Managing Partner / Managing Director
  • Fees challan in original remitting the required amount of fee in the Head of Account or Original Treasury Challan
  • Documents related to ownership of firm (Proprietorship/Partnership/Company)
  • Affidavit of Proprietor / Partners / Directors etc (Notarized)
  • Address Proof copy duly attested
  • Attested copy of ownership proof/rent agreement/lease deed
  • Affidavit of applicants, manufacturing chemist and quality control chemist
  • List of all technical staff along with photocopy of educational qualification and experience.
  • Blue print of Plan and layout of the premises showing the installation of Machinery and Equipment.
  • Design and layout of HVAC systems if applicable
  • List of medicines intend to be manufactured in manufacturing unit
  • Water Analysis Report
  • Electricity Connection Documents
  • NOC from competent Local Authority like Gram Panchayat , Nagar Nigam or Nagar Palika if applicable
  • Detailed list of Manufacturing Machinery and Lab Equipment with copies of purchase Bills. (As per Format)
  • Permission obtained from the Municipal Authorities/ Panchayat authorities / Certificate in conformity with Factories Act for construction and starting the Unit
  • Permission from the Health Authorities / Pollution Control Board clearance of the area for setting up the manufacturing facility
  • Clearance from Drugs Controller General (India), New Delhi in case of new drugs (Either Bulk drug or Formulation)
  • Site Master File. (Refer para 29 of part I of Schedule M)

Affidavit formats, blue print format and other formats you can ask from drug control office

Documents Required for Wholesale Drug License:

Senior drug inspector and/or Drug Inspector can provide you full details of requirement for a whole sale drug license. Procedure and details for applying for D.L. number can be change according to government policies. Important documents are:

  • Application will be submitted in form no. 19 with other detailed information forms.
  • You or your partner (if any) either should be a registered pharmacistor Experienced Person (Duly registered under local authorities) or competent person. If you don’t have any of above qualification than you can appoint or hire a registered pharmacist or EP (Experienced Person) and make him authorized to handle all work on your behalf (Appointment letter will be submitted with application)
  • Premises size should have minimum of 10 square meter area (requirement of area may vary) and should have single premises.
  • Affidavits
  • Fees ( mode of fee and prescribed fee may vary)
  • Blue print or layout of Premises
  • Freeze purchase bill copy with complete address
  • Air Conditioner if applicable
  • Ownership or Rent agreement deed of premises.
  • Electricity bill of premises.
  • Affidavit of proprietor, partner, pharmacist, EP etc.
  • Firm registration receipt in case private limited firm. List of directors, address proof, article of association etc is also to submit with application form
  • Partnership deed if any
  • Any other documents as asked by local drug controller etc.

 

Documents for Company Registration:

  • DSC (Digital Signature Certificate)
  • DIN (Director Identification Number)
  • PAN (Permanent Account Number) Card
  • TAN (Tax Deduction and Collection Number)
  • Identity Proof (Electronic ID / Aadhar Card / Passport / Driving License)
  • Passport Photo
  • Address Proof (Bank Statement / Mobile Bill / Telephone)
  • Rent Agreement (Notarised: For rented property) or Ownership proof
  • Latest Electricity Bill
  • MOA(Memorandum Of Association) or/andAOA (Article Of Association)
  • NOC if required

Documents required for applying for GSTIN:

  • Digital Signature Certificate (Class II)
  • Address Proof of Business Entity
  • Proprietor/Partners/Directors Address Proof
  • Aadhaar Card, PAN and Image etc
  • Ownership Proof or Rent agreement
  • Partnership deed or memorandum of association/certificate of incorporation
  • Back Statement and Bank Detail

Qualification for Competent/Technical Staff:

Qualification of Technical Staff for Manufacturing Company

Manufacturing Chemist:

Minimum of Bachelor in Pharmacy with one and half year of experience in pharmaceutical manufacturing unit under supervision of approved manufacturing chemist

Or

Minimum of Bachelor in Sciences with three year of experience in pharmaceutical manufacturing unit under supervision of approved manufacturing chemist

Analytical Chemist:

Minimum of Bachelor of Pharmacy

Or

Minimum of Bachelor in Science with three year of experience in Laboratory of pharmaceutical manufacturing unit under supervision of approved analytical chemist.

Qualification and Eligibility for EP or competent person for Marketing Company

Person should have one of the below qualification or eligibility to be EP or competent person:

  • Registered pharmacist under state pharmacy council or
  • Minimum of one experience at registered wholesale drug licensed firm after graduation with salary in bank account and appointment letter, resignation letter & experience letter at firm’s letter head with duly stamped and signed

If you want to know about Investment then Read our Article: How much Investment requirement required to Start these Companies?

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

Have a quick look at other business opportunities in Pharma Sector:

 

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

Clinical Pharmacist and Qualification required to be Clinical Pharmacist

Clinical Pharmacist means a person who is a registered pharmacist as defined in Pharmacy Act, 1948 and working toward providing patient care to optimize the use of medication and promote health, wellness and disease prevention.

Clinical pharmacists care for patients in all health care settings. Clinical pharmacists often collaborate with physicians and other healthcare professionals

Minimum Qualification (Either of):

  • D. Pharmacy
  • B. Pharmacy
  • Pharma D

Hospital Pharmacist and his key Responsibilities

‘Hospital Pharmacist’ mean a person who is a registered pharmacist as defined in Pharmacy Act, 1948 and who are working in a hospital pharmacy service (Public/Private sector) as a pharmacist.

Responsibilities:

  • Hospital Pharmacists are responsible for ensuring the safe, appropriate and cost-effective use of medicines.
  • Hospital pharmacists use their specialist knowledge to dispense drugs and advise patients about the medicines which have been prescribed in Registered Medical Practitioner’ prescription.
  • They work collaboratively with other health care professionals to devise the most appropriate drug treatment for patients.
  • Some pharmacists are also involved in manufacturing required drug treatments.

Minimum Qualification (Either of):

  • D. Pharmacy
  • B. Pharmacy
  • Pharma D

Scope of Hospital Pharmacist:

  • Senior Pharmacist
  • Chief Pharmacist

Salary Structure:

Salary Based upon experience.

Related: How to start Hospital Pharmacy?

Top Ayurvedic Companies in India

How can a Doctor Start Pharma Company?

Query:
I’m looking to start my own pharmaceutical marketing company and I need your expertise in clarifying few areas of concern.
1. I am a doctor by profession and I run a nursing home in my home town so if I am looking forward to start a new company can I start in my own hospital premises preferably top floor or do I need to find a new place/rented one i.e is it okay to start in hospital premises(note:I don’t have any other office space as of now)
2. Can the ownership be made in my name or do I need to nominate any other person since I am a doctor

P.S: kindly revert to me back via mail and I ask you not to disclose my query in any other forum/3rd party clients

Response:

1. There is condition for Drug License (Wholesale/Distributor/Stockist Drug License) that premises should be a separate and independent. You can start your company at Top floor (preferably first or second) and take drug license but that floor should fulfill minimum requirement for wholesale drug license.
2. You can be owner of pharmaceutical marketing company irrespective of your Doctor profession but you will need to hire a registered pharmacist for taking wholesale drug license.

We don’t disclose our any reader information to any third party or forum. We only use our reader’s query (without disclosing identity or personnel information) to post at our blog with answer so our other readers can be benefited with it.

Hope above information is helpful to you…
For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Query related to online b2b pharma company Portal

Query:

It  was very enlightening to have read your article. I am a founder of
an online b2b pharma company that sells medicines in terms of credits to retailers from wholesalers instead of cash. After reading from your article I guess that the money spent on marketing and sales by wholesalers can be effectively reduced by using my website. Now being from a non pharma I have a very big issue in determining the profit margins of the 5 players in distribution hierarchy.
So,
1. Can you please send the price list of all medicines currently
available and their margins to each player?
2. I find very difficult to settle on a ecommerce margin that can be
collected from wholesalers. Can you please suggest a margin?
3. Should I collect different margins for different medicines or a
uniform margin for all medicines?
4. How would I know the profit margins if I were to fix different
prices for different medicines?

Thanks in advance.

Response:

Congrats for your B2B Portal for retailer and wholesaler. Before proceeding further, please conduct complete research in pharma market, so it become easy to acquire market.

Wholesale to retail transaction is already in credit, No Pharmacy and Chemist give payment in cash to wholesaler in India. Payment term is 30 to 45 days. In many cases, it crosses 45 days mark. You need to keep in mind this aspect to associate retailers and wholesalers with you.

Second aspect, wholesaler, distributor and stockist doesn’t spend at marketing. It’s company responsibility to spend at marketing and sale.

Retailers and wholesalers are key costumer only in case of generic medicines. If you also want to sell branded and ethical medicines, Retailers and wholesalers are not key costumers to decide price and margin.

  1. Margins and prices vary according to company and its marketing type, so it’s not possible to send price list of all available medicines and their margins.
  2. A wholesale charge generally 10 percent margin. A wholesaler can give your margin from this 10 percent margin. You can decide 1%, 2% or maximum of 3% that can be afford by a wholesaler against your services.
  3. You can charge differently for different type of margins according to market demand and market competition.
  4. You margin will vary according to market demand and competition. You have to fix it accordingly.

Hope above information is helpful to you…

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

Related: Best Ayurvedic Herbal Products Online

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

How to start Online Pharmacy in India?

Query:

What is the procedure to open a online pharmacy in India?

 

Response:

In India, There is no special provision or act present that can describe, regulate and specify online pharmacy. Online Pharmacies also follow drug and Cosmetic Act and Rules made there under. Along with Drug and Cosmetic Act, it should also follow the rule and regulation mentioned under Information Technology Act.

For setting-up online pharmacy, you will require to either set-up own online pharmacy website/mobile app or need to create seller account at existing online pharmacy portals.

Before setting-up own online pharmacy website/app or making seller account at existing online pharmacy portal, you need to set-up a physical pharmacy as in case of traditional pharmacy. Requirement and document will be same for online pharmacy as we have discussed in our article: How to start Pharmacy in India?

You will require a pharmacist at your online pharmacy for receiving and processing prescription uploaded by patient or his care taker. Offline Pharmacy set-up is mandatory for selling medicine online with complete documents and procedure.

Here we take a short look at documents and necessities for starting Offline Store First and then sell medicine online.

Licenses required:

  • Retail Drug License
  • GST number

Retail Drug License:

Retail drug license is issued by District Drug Control Officer who provide drug license as per guidelines issued by State Drug Control Officer. You need to visit district drug control office for applying retail drug license number. Procedure for applying retail drug license may be online or offline as per state policy, you are going to apply.

Requirement and documents for Setting UP Online Pharmacy:

  • Area required: Minimum of 100 square feet
  • Registered Pharmacist: All related documents photocopy will be attached along with Drug License application form
  • Rent agreement or ownership proof of premises
  • Blue print of premises (3 copies)
  • Address Proof of Premises
  • Refrigerator and Air conditional Purchase Bill

Goods and Service Tax Number (GST):

GST is mandatory for firm having annual turnover above 20 lac but in case of online sale GST may be compulsory for all firms/persons having any amount of annual turnover. Read complete detail about applying Goods and Service Tax Identification Number here

After taking retail drug license and GST number, you need to set-up online presence. Online presence could be set-up by either building own e-commerce pharmacy website/app or creating a seller account at already present online pharmacy websites/apps.

Completing above step, you can start selling medicines and drugs online.

What’s coming new:

Government is in process to regulate online sale of medicine by making amendment in Drug and Cosmetic Act and Rule. For knowing new regulations and amendments, we have to wait for new government policy.

Online Pharmacies could have to follow following provisions:

  • Requires a valid Prescription
  • Online Pharmacy should have Physical Address so drug authority can inspect quality and standards of online pharmacy store
  • Government is planning to launch a common portal where all online pharmacies must have registered their self.
  • Online Pharmacy License will be issued by State Drug Control Authority.
  • Presence of Pharmacist is must for collecting prescription and answering the questions of the consumers.
  • Pharmacy can’t dispense habit forming medicines and schedule X drugs.
  • Prescription Drugs (Schedule H and Schedule H1) can only be sell out against a valid doctor prescription.
  • Online Pharmacies have to comply with e-commerce standards covered under IT act, 2000.

Hope above information is helpful to you…

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

Steps involved to register the herbal medicine

Query:

This is with regards to the herbal products and registration. I would like to know to steps involved to register the herbal medicine.

Response:

Herbal Medicines and Ayurvedic Medicines are synonyms in Indian Market. Herbal Medicines are manufactured by same way and under same manufacturing license as of Ayurvedic Medicines. Herbal Medicines could be manufactured only with proper manufacturing license issued by AYUSH department.

Two type of registration could be for herbal medicines. One for Registration of herbal medicine for manufacturing and second for its Brand Name/Trade Name registration.

A herbal medicine combination for manufacturing can be registered only by Herbal Medicine Manufacturer having Ayurvedic/Unani/Sidha Medicine manufacturing licence but Brand Name/Trade Name can be registered by its owner i.e. any person/marketed company/manufacturing company

For registering Herbal Medicine for manufacturing, you first need to take Herbal medicine manufacturing license under AYUSH department. Read Procedure to take Herbal medicine license here

Along with applying manufacturing license, you can file herbal medicines or any time after receiving manufacturing license, you can apply for herbal medicine registration.

Some herbal products (not medicines) also manufactured under Food and Dietary supplements under FSSAI license. Herbal Cosmetic Products are manufactured under both type of manufacturing license i.e. ayurvedic manufacturing license and Cosmetic Manufacturing License.

Only BAMS/BUMS doctors are allowed to manufacture herbal medicines for only their own patients without manufacturing license and medicine registration.

Read our detailed article about How to register Ayurvedic and Pharma Product before launching in Market?

Hope above information is helpful to you….

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