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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.

Drug Testing Laboratory

Every drug manufacturing unit having a drug manufacturing license shall maintain a laboratory for carrying out tests on drugs or raw materials used in the manufacture for sale of drugs.

Types of Drug testing laboratory applications and Licenses:
  • Form 36: Application for grant or renewal of approval for carrying out tests on drugs/ cosmetics or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs /cosmetics
  • Form 37: Approval for carrying out tests on drugs/ cosmetics and raw materials used in their manufacture on behalf of licensees for manufacture for sale of drugs/cosmetics
  • Form 38: Certificate of renewal of approval for carrying out tests on drugs / cosmetics and raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs / cosmetics
  • FORM 39: Report of test or analysis by approved institution

Competent Technical Staff qualification:

The head of the testing unit shall possess a degree in Medicine or Science or Pharmacy or Pharmaceutical Chemistry of a University recognized for this purpose and shall have experience in the testing of drugs, which in the opinion of the licensing authority is considered adequate

For more detail follow schedule L

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