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First step need to take For Starting a Pharmaceutical Company

Query: I am a veterinarian by profession. Have been going through your website from past 1 year and have planned now to give a start to my own pharma company. Please let me know what will be the first step I need to take.  Answer: First Step you need to prepare yourself for Pharmaceutical Company:  Preparation means Choose marketing type, Choose molecules want to launch, Location where you want to launch product, Choose Company, Products Name, Budget available...  Choose marketing type: As number of marketing and selling types present in pharmaceutical market. i.e. Branded Marketing , Generic Marketing , OTC Marketing, Franchise Marketing etc. You need to select any one from above.  Choose Molecule: Once you have selected which marketing type is best suitable for you then you need to select at which segment and molecules you want to work. Check out: How to choose products/service for business? Location: You can't launch your pharmaceutical company all over India or at broad area.

What all documents needed to start generic own pharma?

First we will discuss about licenses and after that documents required for different types of generic own pharma businesses. In generic pharma, you have different types of pharma business like
  • Generic pharma manufacturing company
  • Generic Pharma marketing Company
  • Generic Pharma Distribution and Wholesale
  • Generic Pharma Pharmacy store and Chemist Shop

Licenses required for Different generic pharma businesses:

For Manufacturing:


For Marketing:

  • Wholesale Drug License
  • GST Number

For Distribution and Wholesale:

  • Wholesale Drug License
  • GST number (above 40 lakh annual turnover)

For Pharmacy Store and Chemist Shop:


Documents Required for Generic Own Pharma:

Documents for drug manufacturing license:

Application for grant or renewal of licence to manufacture for sale or for distribution of drugs shall be made to the licensing authority appointed by the State Government.

List of Documents:
  • Application form in Form 24B
  • Fee Deposit Slip
  • Proof of possession of manufacturing premises
  • Manufacturing Unit Site Plan
  • Blue print of premises
  • Firm or Company Details
  • List of machinery and documents in manufacturing unit
  • List of equipment in testing laboratory
  • List of drugs to be manufactured
  • Affidavit
  • List of technical staff i.e. Approved manufacturing chemist and analytical chemists along with their certificates and approval copies
  • NOC if required
  • Other documents asked by drug licensing authority

Documents for Wholesale drug license:

The State Government appoint Licensing Authorities for granting wholesale drug license which is generally District Drug Control Officer.

List of Documents:
  • Application form in Form 19
  • Fee Deposit Slip
  • Proof of possession of premises
  • Firm or company detail
  • Competent person detail (Experience Certificate or Pharmacist Registration copy) along with educational and professional certificates
  • Affidavits
  • Blue print of premises
  • Refrigerator purchase bill
  • Other documents asked by department if any

Documents for Retail Drug License:

The State Government appoint Licensing Authorities for granting retail drug license which is generally District Drug Control Officer.

List of Documents:
  • Application form in Form 19
  • Fee Deposit Slip
  • Proof of possession of premises
  • Firm or company detail
  • Registered Pharmacist detail (Registration copy, academic certificates documents etc)
  • Affidavits
  • Blue print of premises
  • Refrigerator purchase bill
  • Other documents asked by department if any

Documents for GST Number:

A person can apply for gst number online through gst portal i.e. www.gst.gov.in.

List of Documents:
  • Address Proof of Business Entity
  • Proprietor/Partners/Directors Address Proof
  • Aadhaar Card, PAN and Image etc
  • Ownership Proof or Rent agreement
  • Firm or company detail
  • Back Statement and Bank Detail

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