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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 Manufacturing License

For manufacturing of drugs and pharmaceutical products, drug authority issued a license which is known as Drug manufacturing License. Manufacturing unit that want to indulge into manufacturing of drugs and other pharmaceutical products has to take a manufacturing license.

Every Drug manufacturing License has a unique number which is known as drug manufacturing license number.

Types of Drug Manufacturing Licenses:
  • Form 24: Application for the grant of or renewal of a licence to manufacture for sale or for distribution of drugs other than those specified in Schedules C and C (1) and X
  • Form 24A: Application for grant or renewal of a loan license to manufacture for sale or for distribution of drugs other than those specified in Schedules C and C (I) and X
  • Form 24B: Application for grant or renewal of licence to repack for sale or distribution of drugs, being drugs other than those specified in Schedules C and C (1) excluding those specified in Schedule X
  • Form 24C: Application for the grant or renewal of a licence to manufacture for sale or for distribution of Homoeopathic medicines or a licence to manufacture potentised preparations from back potencies by licensees holding licence in Form 20C
  • Form 24F: Application for the grant or renewal of a licence to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedules C and C(1)
  • Form 25: Licence to manufacture for sale or for distribution of] drugs other than those specified in Schedules C and C(1) and X
  • Form 25A: Loan licence to manufacture for sale or for distribution of] drugs other than those specified In Schedules C and C (1) and X
  • Form 25B: Licence to repack for sale or distribution of drugs being drugs other than those specified in Schedules C and C (1) excluding those specified in Schedule X
  • Form 25C: Licence to manufacture for sale or for distribution of Homoeopathic medicines
  • Form 25F: Licence to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedules C and C(I)
  • Form 26: Certificate of renewal of licence to manufacture for sale of drugs other than those specified in Schedule X
  • Form 26A: Certificate of renewal of loan licence to manufacture for sale of drugs other than those specified in Schedule X
  • Form 26B: Certificate of renewal of licence to repack for sale or distribution of drugs being drugs other than those specified in Schedules C and C (1) excluding those specified in Schedule X
  • Form 26C: Certificate of renewal of licence to manufacture for sale of Homoeopathic medicines
  • Form 26F: Certificate of renewal of licence to manufacture for sale of drugs specified in Schedule X
  • Form 26H: Certificate of renewal of licence to manufacture for sale of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs specified in Schedules C and C(I) excluding those specified in Schedule X
  • Form 26J: Certificate of renewal of loan licence to manufacture for sale of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs specified in Schedules C and C(I) excluding those specified in Schedule X
  • Form 27: Application for grant or renewal of a licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding those specified in Part XB and Schedule X
  • Form 27A: Application for grant or renewal of a loan licence to manufacture for sale or for distribution of drugs specified in Schedules C and C(1) excluding those specified in Part XB and Schedule X
  • Form 27B: Application for grant or renewal of a licence to manufacture for sale or for distribution of drugs specified in Schedules C, C(I) and X
  • Form 27D: Application for grant or renewal of a licence to manufacture for sale or for distribution of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs excluding those specified in Schedule X
  • Form 27DA: Application for grant or renewal of a loan licence to manufacture for sale or for distribution of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs excluding those specified in Schedule X
  • Form 28: Licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding those specified in Schedule X
  • Form 28A: Loan Licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding those specified in Schedule X
  • Form 28B: Licence to manufacture for sale or for distribution of drugs specified in Schedules C, C(I) and X
  • Form 28D: Licence to manufacture for saleor for distribution of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs specified in Schedules C and C(I) excluding those specified in Schedule X
  • Form 28DA: Loan licence to manufacture for sale or for distribution of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs excluding those specified in Schedule X
  • Form 29: Licence to manufacture drugs for purposes of examination, test or analysis
  • Form 30: Application for licence to manufacture drugs for purposes of examination, test or analysis
  • Form 31: Application for grant or renewal of a licence to manufacture cosmetics for sale or for Distribution
  • Form 31A: Application for grant or renewal of loan licence to manufacture cosmetics for sale or for distribution
  • Form 32: Licence to manufacture cosmetics for sale or for distribution
  • Form 32A: Loan licence to manufacture cosmetics for sale or for distribution
  • Form 33: Certificate of renewal of licence to manufacture cosmetics for sale
  • Form 33A: Certificate of renewal of loan licence to manufacture cosmetic for sale
  • Form 44: Application for grant of permission to import or manufacture a New Drug or to undertake clinical trial.
  • Form 46: Permission / Approval for manufacture of new drug formulation
  • Form 46A: Permission/ Approval for manufacture of raw material (new bulk drug substance)

Condition of Drug Manufacturing License:
  • Factory premises should compile with the standards lay down in Schedule M
  • Premises should have adequate space, plant, machinery/equipment for manufacturing unit as recommended under schedule M.
  • Manufacture and testing of drugs to be conducted under supervision of fulltime competent technical staff i.e. drug manufacturing chemist and drug analytical chemist
  • Maintain adequate staff, premises and laboratory equipment for carrying out tests of the strength, quality and purity of the substances at a testing unit. Refer: Drug testing Laboratory
  • Adequate arrangements for the storage of drugs
  • Comply with the requirements of Good Manufacturing Practice as laid down under Schedule M

Qualification of Competent Technical Staff for Drug manufacturing License:
Manufacture of drugs to be conducted under the active direction and supervision of full time competent technical staff that possess either of following qualifications:
  • A graduate in Pharmacy or Pharmaceutical Chemistry with 18 months practical experience in manufacture of drugs after graduation
  • A graduate in Science with at least three years of practical experience in manufacture of drugs after graduation
  • A graduate in Chemical Engineering or Chemical Technology or Medicine with at least three years of practical experience in manufacture of drugs after graduation
  • holding any foreign qualification equivalent to above educations and practical experience

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