Drug License Retail & Wholesale

 Drug License Retail & Wholesale Eligibilty Crieteria:

Drug License Retail & Wholesale is permission granted by the government authorities to the business to deal with drugs. It is mandatory to procure a drug licence Retail & Wholesale before starting a drug business. The term drug is defined under section 3(b) of The Drugs And Cosmetics Act, 1940.

  • Pharmacist/ Competent Individual: The pharmacist must be qualified in the case of a retail business. In case of a wholesale business, the individual must be a graduate with 1-year experience or an undergraduate with 4 years experience.
  • Space Requirement: The other important requirement is space, that is the area of the pharmacy/unit. – For both wholesale and retail license – 15 square meters. -In all other cases – 10 square meters. – The clear height of the sales premises shall be as per the guidelines laid down under the National Building Code of India, 2005.
  • Storage Facility: The other important requirement is storage facility since some drugs require to be stored in low temperatures, refrigerators and air conditioners are a must.

Application Procedure for a Drug License Retail & WholeSale

The following are the steps to be taken for obtaining the drug license:

  • The applicant must apply online for the license as per the line of business, for which he/she must have a valid email id and contact number.
  • The next step is to keep all the documents updated.
  • Next is to upload the documents and the form along with the applicable fees.
  • Upon completion of the online process, an inspector will visit the site and verify the validity of documents.
  • If all the above steps have been duly complied with, the authority will issue the drug license.

List of Essential Documents For Obtaining a License

The documents essential for obtaining a sale license are:

  • Constitution of the entity – Memorandum of Association (MOA), Articles of Association (AOA) for a company, partnership deed, LLP agreement in case of partnership and LLP.
  • ID proof of partner/director/proprietor.
  • Documents related to premises – Copy of ownership documents of property or rental agreement as the case may be.
  • Site plan and key plan of the premises.
  • Copy of Board resolution permitting obtaining of a license.
  • Proof of availability of storage space as cold storage, refrigerator, etc.
  • Copy of challan as a proof of depositing fee.
  • Affidavit regarding non-conviction of proprietor/partner/director and the firm.
  • The affidavit from the registered pharmacist/competent person.
  • For a pharmacist at a retail sale: – Proof of qualification – Registration of local pharmacy council – Appointment letter
  • For a pharmacist at a wholesale sale:: – Proof of qualification – Experience certificate – Appointment letter

List of Application Forms

Sr. No Form No Purpose
1 Form 19 Application for grant or renewal of a license to sell, stock, exhibit or offer for sale, or distribute drugs apart from those specified in Schedule X.
2 Form 19A Application for granting or renewing a restricted license to sell, stock, exhibit or offer for sale, or distribute drugs by retail via dealers who don’t engage the service of a qualified individual.
3 Form 19B Application for license to sell, stock or exhibit or offer for sale, or distribute Homoeopathic Medicines.
4 Form 19C Application for grant or renewal of a [license to sell, stock, exhibit or offer for sale, or distribute] drugs specified in Schedule X.
5 Form 24 Application for either the grant of a license or for the renewal of a license or to manufacture for sale or for distribution of drugs other than those which are specified in [Schedule C, C (1) and X].
6 Form 24A Application for either the grant of a loan license or renewal of a loan license to manufacture for sale or distribution of drugs other than those specified in Schedule C, C (1) and X.
7 Form 24B Application for grant or renewal of a licensee to repack for sale or distribution of drugs, being drugs other than those specified in Schedule C and C (1) excluding those specified in Schedule X.
8 Form 24C Application for the grant or renewal of a license to manufacture for sale [or for distribution] of Homoeopathic medicines or a license to manufacture potentized preparations from back potencies by licensees holding a license in Form 20-C
9 Form 24F Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedule C and C(1).
10 Form 27 Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule C and C (1) excluding those specified in part XB and Schedule X
Drug License Retail & Wholesale– Application, Documents, Registration, & Forms