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The Complex Factors that Influence Drug Prices

Pharmaceutical companies typically use a variety of factors to determine the price of their drugs, including: Development and production costs: Pharmaceutical companies invest significant amounts of money into the research, development, and production of new drugs. The cost of these activities, including clinical trials and obtaining regulatory approval, is factored into the price of the drug. Marketing and Distribution Cost: Marketing and distribution costs may also be considered by pharmaceutical companies when determining drug prices. These costs include expenses related to advertising, sales representatives, and distribution networks. Drug Uniqueness: If a drug is the first of its kind or represents a significant improvement over existing treatments, the pharmaceutical company may set a higher price for it. If a drug has many competitors or is like existing treatments, the company may have to set a lower price to remain competitive. Market demand: Companies also consider the dem
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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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