What is Drug License? Different types of Drug Licenses?

Drug License:

Pharmaceutical Business in India is regulated business and there is requirement of licenses and registrations to do any business related to drugs and pharmaceutical products. Pharmaceutical business is regulated through Drug and Cosmetic Act & Rules in India. Drug and Cosmetic Acts & rules details the provisions to regulate the import, manufacture, distribution and sale of drugs and cosmetics (Including ayush drugs). Licenses require to conduct drug business is known as Drug License. 

Definition of Drug License:

Drug license is defined as the license or permission provided by Licensing authority appointed by concern state drug department to conduct business related to drugs and pharmaceutical products in that state.
There is different type of business activities related to drugs like import, manufacture, distribution and sale. Each type of business requires different types of permission or license. For importing, import permission is required. For manufacturing, drug manufacturing license is required. For distribution and wholesale, wholesale drug license and for retail drug business, retail drug license is required.

Requirements for Drug License:

Every type of drug license has specific requirements and needs. Most common requirements are:
Useful links for requirements and documents required for different license:

General documents needed for drug license:

  • Blue print/Master site file of premises
  • Proof of constitution of Firm e.g. Proprietor’ affidavit/partnership deed/Memorandum and Article of association which is applicable.
  • Academic, professional and approval details of competent person/s whatever application
  • Proof of ownership/Rent Agreement of premises where business is going to be conducted
  • List of Equipment and Machinery installed for manufacturing and testing of drugs with complete detail (in case of manufacturing business)

Types of Drug Licenses:

As we have discussed above, every drug business requires license for starting and doing. Licenses are issued in a format which is known as Form. Forms are numbered to differentiate each licensed form from other. Schedule A of drug and cosmetic act & rules defines the all licenses, certificates, memorandum, application and renewal formats of forms. Below we are providing form detail at which a particular type of license is issued.

List of Licences for Import of Drugs:

  • Form 10: Licence to import drugs (excluding those specified in Schedule X)
  • Form 10A: Licence to import drugs specified in Schedule X.
  • Form 11: Licence to import drugs for the purposes of examination, test or analysis
  • Form 11A: Licence to import drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients
  • Form 12B: Permit for the import of small quantities of drugs for personal use
  • Form 41: Registration Certificate to be issued for import of drugs into India
  • Form 43: Registration Certificate to be issued for import of cosmetics into India
  • Form 45: Permission to import Finished Formulation of a New Drug
  • Form 45A: Permission to import raw material (new bulk drug substance)

List of Licenses for Retail business of drugs:

  • Form 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 20F: Licence to sell, stock or exhibit for sale or distribute by retail drugs specified in Schedule X.
  • Form 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.

List of licenses for wholesale and distribution business of drugs:

  • 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 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

List of licenses for manufacturing business of drugs

  • 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 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 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 sale or for distribution of 2[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 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 46: Permission / Approval for manufacture of new drug formulation
  • Form 46A: Permission/ Approval for manufacture of raw material (new bulk drug substance)

List of licenses for retail business of homoeopathic medicines:

  • Form 20-C: Licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines by retail

List of licenses for wholesale and distribution business of homoeopathic medicines:

  • 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

List of licenses for manufacturing business of homoeopathic medicines:

  • Form 25C: Licence to manufacture for sale or for distribution of Homoeopathic medicines
  • Form 26C: Certificate of renewal of licence to manufacture for sale of Homoeopathic medicines
Check detail about starting homoeopathic Business in India (Retail, wholesale, marketing company and manufacturing unit)

List of licenses for manufacturing business of ayush medicines:

  • Form 25D: Licence to manufacture for sale of Ayurvedic (including Siddha) or Unani drug
  • Form 25E: Loan Licence to manufacture for sale Ayurvedic (including Siddha) or Unani Drugs
  • Form 26D: Certificate of renewal of licence to manufacture for sale of Ayurvedic / Siddha or Unani drugs
  • Form 26E: Certificate of renewal of loan licence to manufacture for sale of Ayurvedic / Siddha or Unani Drugs
  • Form 26 E-I: Certificate of Good Manufacturing Practices (GMP) to manufacture of Ayurveda, Siddha or Unani drugs
  • Form26E2-I: State Drug Controller or Licensing Authority for Ayurveda, Siddha and Unani Medicines-Free sale certificate
  • Form 26E2-II: State Drug Controller or Licensing Authority for Ayurveda, Siddha and Unani Medicines-free sale certificate
  • Form 26E3: State Drug Controller or Licensing Authority for Ayurveda, Siddha and Unani Medicines- Non-Conviction Certificate
  • Form 48: Approval for carrying out tests or analysis on Ayurvedic, Siddha and Unani drugs or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of Ayurvedic, Siddha and Unani drugs
  • Form 49: Certificate of renewal for carrying out tests or analysis on Ayurvedic, Siddha or Unani drugs or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of Ayurvedic, Siddha or Unani drugs
Useful links:

List of licenses for manufacturing business of cosmetic products:


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