How to Start A Pharmaceutical Company? Procedure, documents, license, qualification for starting pharmaceutical company.

If you have experience in Pharmaceutical market and want to start your own pharma business then we are going to explain here about one of the best option i.e. Starting pharma marketing company. It could be best option for you. Worry about how to start pharmaceutical company! Here we are providing few quick steps that can help you during this process. Along with pharma marketing company, many other business opportunities is available in healthcare and pharma sector. Have a quick look at other business opportunities in Pharma Sector:

Every State of India has almost same form of formalities. Only minor requirement could vary state to state. You should first confirm to Drug Inspector office about starting pharma marketing company.

You can view this video for knowing how to start Pharmaceutical Marketing Company in Hindi audio where as content is in English.

Documentations and Licences:

First three documents is must for starting. You need to get issued drug license number for whole sale, stock, purchase, sale, exhibition and distribution of drug. For Whole sale drug license number, you have to visit to your local drug control or drug inspector office. Goods and Service Tax identification number is issued by tax authorities.

Important Step:

  • Take Experience and/or training to start Pharmaceutical Marketing Company
  • Write a Business Plan
  • 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.
  • Finance Source (Own Saving, Bank Loan, Investment etc.)
  • Research and Prepare list of all molecule and combinations, you want to launch in market.
  • 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 become 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.
  • Company Registration under Company Act
  • Appointment of registered experience person or registered pharmacist as per norms. ( In case if you or any of partner are not EP or Pharmacist)
  • Wholesale Drug License Number Registration.
  • Registration of company under Goods and Service Tax
  • Finalized all vendors i.e. manufacturers, printer etc.

Procedure and Sequence: 

Along with applying for above registrations, you can move upward with following steps. Following work, you should finished before issuing registration certificates, so you can save your time and you can meet with your deadlines.

Now you have products with your own brand names and your company name. Have a quick look at documents required for particular registration and licenses:

Requirements 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

Requirements for Drug License Number:

  • Local drug inspector/drug selling authority office can provide you full details of requirement for a whole sale license. Few we are describing here. Procedure and details for applying for D.L. number can be change according to government policies.
  • Application will be submitted in form no. 19 with other detailed information forms.
  • You or your partner (if any) should be a registered pharmacist or 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.

After submission of documents, inspection will be carried out by local drug authority for accuracy and correctness of detail submitted with the application. Drug authority reserves the right to approve or reject your application if not satisfy with application.

After issuing of drug license number for sale of drugs for which you have applied will be granted. List of licenses and forms you can check here. Now you are permitted to sale, purchase, or get manufactured drugs with your marketed by address.

Qualification and Eligibility for EP or competent person:

  • Person Should have one of the below qualification or eligibility to be EP or competent person:
  • Registered pharmacist under state pharmacy council or
  • Minimum one and half year experience at registered wholesale drug licensed firm after graduation and name is registered as EP at Drug Office or
  • Minimum four year experience as salesman in registered drug licensed firm after senior secondary examination and name is registered as EP at Drug Office.

Requirements for Goods and Service Tax Registration (GST):GST is essential in India for doing any type of business/trading but below 25 lac annual turnover, there is no requirement of gst registration. GST registration is compulsory to obtain within 30 days after exceeding turnover above 25 lac. Unlike VAT, GST is valid in all states. It can be applied through portal provided by state government or center government. Here we are describing few most common requirements for Goods and Service Tax:
For applying for GST Registration, you can follow following Steps.

  • 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 as mentioned in Provisional registration form

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

Read Related: What is Good and Service Tax (GST)? How to file return under GST?

These are steps for starting Pharma Marketing Company in India.

If you want to sell and purchase nutraceuticals or food products along with pharmaceutical products, you have to get registration certificate from food and drug department issued by FSSAI.
Click below links to read procedure and documents required for next two registrations

If you have started the procedure for setting up above steps, mean while start art work and packing designing and other office decoration work, finalizing the vendors, trade mark of Company name, brand names etc. Issuing of D.L. no. and TIN takes nearly one months or less or depends upon many other factors.

Read Here: How can you establish your pharma company?

Different types of companies you can start with below procedure:

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

Related post:

59 Replies to “How to Start A Pharmaceutical Company? Procedure, documents, license, qualification for starting pharmaceutical company.”

  1. You can't do this. It's a crime. You could be prosecuted in counterfeit and fake drugs act.

    You have to follow whole procedure to get manufacturing products at your company name.

  2. I'm a doctor and I wish to enter into Pharma marketing business to launch my own OTC medicine. I have gone through your website and want to meet and discuss the same more.
    I'm in delhi.
    Can I have your contact details?

  3. Please guide me to start a pharma trading company in Bihar.and what is the all registration process,how much its cost.where I can contract for manufacturing of medicine.

  4. Registration process you can check by click at Trade mark or private limited company link available at above article..
    Copy and paste following link to know estimated budget for your new marketing pharma company: http://www.pharmafranchisehelp.com/2015/11/i-want-to-know-budget-for-starting-pharma-company.html

    You can search at third party manufacturers at google and can contact manufacturers after their contact detail at their websites or at business portals.
    If you are interested we can provide you third party manufacturing facility through our known manufacturers.

  5. sir I would like to start with itraconazole and elovera 10% with vitamin e acetate cream and lotion so I would like to know what will be the investment.

  6. sir actually im thinking to setup a company which makes narcotic drugs legally like morphine
    can you just tell me
    is this business going to be profitable or just selling raw opium is more profitable

  7. Dear Vijaya Murthy ji,

    Initial step that is to be taken by you is to complete research about how you can start pharma manufacturing business, premises where you want to set-up plant, machinery required, which section you want to set-up like tablet, capsule, lactum, beta-lactum, syrup etc.

    After finalizing all thing, you should meet to local drug controller office regarding all formalities and procedure. They will instruct you all details.

    Send your mail at pharmafranchiseehelp@gmail.com for more detail..

  8. Hi,
    I have experience of medical representative and at managerial level in pharma companies. Will my experience will be considered/counted as Experience person to issue drug licence ? I am planning to launch pharma company.
    Please reply and guide.

    Regards,
    Surinder

  9. I have a retail drug license to start my own brands manufacturing I have to apply only wholesale license or a New drug wholesale, license.

  10. You have to apply for whole sale drug license for manufacturing of your own brands. You can apply new or add wholesale in your retail license

  11. Please provide information about following countries:
    How to start pharma company in United States of America (USA)
    How to start pharma company in Britain and other European Union countries

  12. सर मैं 12 वी पास हूं मैं खुद की फार्मा कम्पनी खोलना चाहता हूं कितना खर्चा आऐगा और मुझे क्या करना होगा और मैं आपसे मिलना चाहता हूं

  13. i want to do marketing of ayurvedic product with my own brand name. Please let me know what type of documents are required? For TIN and Company registration to whom i can contact?

  14. I have worked with pharma companies but was in Regulatory Affairs Department. Now I want to start my own trading company and in future my own pharma manufacturing unit.
    I target in first phase to decide my brand names of products. My question is how to select the product to launch first, I have no experience in marketing at all. And to get approval of products how to decide formula for that product because I don't have manufacturing experience.

    I will be more than happy , if you could answer my above queries.

  15. For selecting products to launch, first you have to check which molecule or combinations are in good demand at your target area. You have to do some research about molecules if you don't have prior knowledge of that area.

    For pharma products, formula of medicines are almost same for particular molecules. You can get manufactured same formula as of other companies if your manufacturing company will have approval of that formula.

    Products approval is work of manufacturer from which you will get manufactured your products. You will have not to do any work for products approval…

  16. I am —– Location Latur maharashtra.. i am a pharama graduate. Uli wanted to start pharma marketing company. I just wanted to know about the steps in an oredr . So kindly help me… what are requirements. And brand trade DL number know overall things but i want squence pls co oprate and help me i am waiting…

  17. Sequence:
    Choose Company Name
    Choose molecules and Brand Names
    Designing of Company Logo and Printing/Promotional Material
    Search Premises
    Apply for Drug License and Sale Tax Number
    Company Registration (You can do it before drug license or after drug license application)
    Search for third party manufacturer
    Place Order to manufacturer you will finalize
    Make an agreement/contract
    Complete payment and other formalities (Generally 25% Advance and 75% against performa invoice)
    Finalize Packaging Design and Drug Approvals
    Then all work will be done by Manufacturer
    When products will be ready, manufacturer will inform you and will send performa invoice (Time taken for new products is approximately 30 to 45 days)
    After remaining payment manufacturer will dispatch the product to your billing address
    Transportation
    Receive
    Now you have products with your own brand names and your company name

  18. Sir,
    I have my team of expertise and highly skilled people who are having experience of facing USFDA(twice) and WHO-GMP(more than twice) and successfully getting the certification. How can I get contacts of Pharma companies whom we can help them with their documentation and testing part, so that they can also get certification or licenses.plz help

  19. The question which bother's me is if even i started a pharmaceutical industry but what are the chances of getting sale my product?
    Cause there are many pharmaceutical companies or industries which are manufacturing the same (generic) products which all pharma industry are manufacturing.

  20. Hi Sir,
    Greetings,
    I am Mangesh Satpute Having a R&D experience near about 5 years and i want to start pharma business, Please guide me regarding Loan licence and third party manufacturing.
    which one is better for initial start.

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