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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.

Retail Drug License

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

Retail sale means a sale whether to a hospital, or dispensary, or a medical, educational or research institute or to any other person other than a sale by way of wholesale dealing.

Types of Retail 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 19A: Application for the grant or renewal of a restricted licence to sell, stock or exhibit or offer for sale, or distribute drugs by retail by dealers who do not engage the services of a registered pharmacist
  • 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
  • From 20: Licence to sell, stock or exhibit or offer for sale, or distribute drugs by retail other than those specified in Schedules C, C(1) and X]
  • Form 20A: Restricted Licence to sell, stock or exhibit or offer for sale, or distribute drugs by retail other than those specified in Schedules C, C (1) and X for dealers who do not engage the services of a registered pharmacist
  • Form 20C: Licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines by retail
  • Form 20E: Certificate of renewal of Licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines
  • From 20F: Licence to sell, stock or exhibit for sale or distribute by retail drugs specified in Schedule X
  • From 21: Licence to sell, stock or exhibit or offer for sale,or distribute by retail drugs specified in Schedules C and C (1) excluding those specified in Schedule X
  • Form 21A: Licence to sell, stock or exhibit or offer for sale, or distribute] by retail drugs specified in Schedule C (1)excluding those specified in Schedule X for dealers who do not engage the services of a registered pharmacist
  • Form 21C: Certificate of renewal of licence to sell, stock or exhibit or offer for sale, or distribute drugs

Conditions of retail Drug License:

Premises area should not be less than ten square meters and all operations (Compounding, Dispensing, supply against prescription of a registered medical practitioner) should be conducted under supervision of a registered pharmacist only. The supply of any drug on a prescription of a Registered Medical Practitioner shall be recorded at the time of supply in a prescription register specially maintained for the purpose and the serial number of the entry in the register shall be entered on the prescription. 

Requirements for taking Retail Drug License:
Area: minimum of premises is 10 Square meter. Premises shall be designed, constructed, adapted and maintained to suit the pharmacy operations so as to permit dispensing of drugs under hygienic conditions.
If licensee want to conduct Retail plus wholesale business then minimum area should be 15 square meters.
Competent Person: Registered Pharmacist

Documents required for taking Retail Drug License:

General Documents:
  • Application at Form 19, 19A, 19B or 19C as per license required
  • Fee Challan receipt
Competent Person related Documents:
  • Registered Pharmacist appointment letter if either of owner or partner is not registered pharmacist
  • Educational and Qualification proof copy i.e. registration certification at State Pharmacy council, diploma or bachelor degree certificates etc
  • Date of birth certificate or proof copy of pharmacist
  • Declaration Affidavit of pharmacist as prescribed by authority
  • Address proof of pharmacist
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

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