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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.

Wholesale Drug License

Wholesale drug license is the license issued by drug authority to sell, stock or exhibit or offer for sale, or distribute drugs by wholesale. Every wholesale drug license has a unique number assigned to it which is known as wholesale drug license number.

Wholesale drugs sales mean sale to a person for purpose of selling again and includes sale to hospital, dispensary, medical, educational or research institution etc.

Types of Wholesale Drug Licenses:
  • Form 19: Application for grant or renewal of a licence to sell, stock or exhibit or offer for sale, or distribute of drugs other than those specified in Schedule
  • Form 19AA: Application for grant or renewal of a licence to sell, stock or exhibit or offer for sale by wholesale, or distribute drugs from a motor vehicle
  • Form 19B: Application for licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines
  • Form 19C: Application for grant or renewal of a licence to sell, stock, exhibit or offer for sale, or distribute of drugs specified in Schedule
  • Form 20B: Licence to sell, stock or exhibit or offer for sale, or distribute] by wholesale, drugs other than those specified in Schedules C, C(I) and X
  • Form 20BB: Licence to sell, stock or exhibit or offer for sale by wholesale, or distribute drugs other than those specified in Schedule C and Schedule C (1) to the Drugs and Cosmetics Rules, 1945 from a motor vehicle
  • Form 20D: Licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines by wholesale
  • Form 20E: Certificate of renewal of Licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines
  • Form 20G: Licence to sell, stock or exhibit or offer for sale, or distribute by wholesale drugs specified in Schedule X
  • Form 21B: Licence to sell, stock or exhibit or offer for sale, or distribute by wholesale drugs specified in Schedules C and C (1) excluding those specified in Schedule X
  • Form 21BB: Licence to sell by wholesale or to distribute drugs specified in Schedule C and Schedule C (1) to the Drugs and Cosmetics Rules, 1945 from a motor vehicle.
  • Form 21C: Certificate of renewal of licence to sell, stock or exhibit or offer for sale, or distribute drugs
  • Form 21CC: Certificate of renewal of licence to sell, stock or exhibit or offer for sale by wholesale, or distribute drugs from a motor vehicle

Conditions to be satisfied for taking wholesale drug license:

Premises area should not be less than ten square meters and all operations should be conducted under supervision of a competent person, who either is a Registered Pharmacist or has passed the matriculation examination or its equivalent examination from a recognized Board with four years 'experience in dealing with sale of drugs or holds a degree of a recognized University with one year‘s experience in dealing with drugs. 

Requirements for taking wholesale drug license:
Area: minimum of premises is 10 Square meter. Premises shall be designed, constructed, adapted and maintained to suit the wholesale operations so as to permit supply of drugs under hygienic conditions.
If licensee want to conduct wholesale plus retail business then minimum area should be 15 square meters.
Competent Person: Registered Pharmacist or person having 1 year experience after graduation

Documents required for taking Retail Drug License:

General Documents:
  • Application at Form 19, 19AA, 19B or 19C as per license required
  • Fee Challan receipt
Competent Person related Documents:
  • Registered Pharmacist or Competent person appointment letter if either of owner or partner is not a competent person.
  • Educational and Qualification proof copy i.e. registration certification of pharmacist at State Pharmacy council or competent person experience documents, diploma or bachelor degree certificates etc
  • Date of birth certificate or proof copy of competent person
  • Declaration Affidavit of competent person as prescribed by authority
  • Address proof of competent person
Premise and owner related Documents:
  • Shop possession proof (Ownership proof or rent agreement which is applicable)
  • Refrigerator purchase bill copy
  • Partnership deep/MOA/Registration copy if any
  • Affidavit of proprietor/partners/directors
  • Address proof of proprietor/partners/directors
  • Blue print/layout plan of shop in three copies
  • Any other documents asked by drug authority

Scope of Wholesale Drug License:

To whom a licensee can supply medicines with wholesale drug license?

A wholesale Drug license can supply drugs to only drug license holders i.e. pharmaceutical retailers (Medical Stores/Pharmacies), Hospitals, dispensaries and other institutions (educational or research), registered medical practitioners, online pharmacies, pharmacy chains etc. A wholesale drug licensee can’t dispense medicine to patient or its caretaker.

Check out: How to become a pharmaceutical distributor?

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