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.
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|