Drug Licence

Drug Licence

DRUG LICENSE (DL)

To start the Pharma business, a drug license is required. The central drugs standard control organization and state drugs standard control organization issue the drug license in India.

The provisions for this has been made in Drugs & Cosmetics Act, 1940 which is applicable to whole of India. It is an Act to consolidate all the laws relating to drugs & cosmetics, which established the Drugs Control Department. In 1964, the Act was amended to include Ayurvedic & Unani drugs. However a particular business entity may require different types of drug license based on their business. Normally, the drug control organization issues two types DL one is Retail drug license which is issued to a person who runs a chemist shop and another one is a Wholesale drug license which is issued to a person who wants to sell drugs on a wholesale level. In case a business is operating in more than two states, it has to obtain drug license in every state in which business is being carried on. Drug license is location specific. If drugs are sold or stocked for sale at more than one place, application shall be made, and license shall be issued, in respect of each such place except migrant vendors.

Once the license is granted to the business, all such License must ensure that all the condition in the drug license are compiled at all the time during the course of the business. All the records /registers /Forms must be maintained in the manner specified by the licensing authorities and authorities shall be kept informed for all the changes or modification in the business activities.

NOTE: In some states, retail drug license is issued only to that person who possesses the degree or diploma in Pharma from the recognized university.

WHAT ARE DIFFERENT TYPES OF LICENSES ISSUED FOR THE PHARMACEUTICAL BUSINESS?

Based on the requirement of the pharmaceutical business, an applicant must apply for the issue of a specific drug license. There are various licenses, for example:

  • Drug Manufacturing License
  • Wholesale Drug License
  • Retail Drug License
  • Import of Drugs or Cosmetics
  • Import of Medical Equipment

THE REQUIREMENT FOR OBTAINING DRUG LICENSE

Following are the requirements for obtaining a Drug License:

  • Area –The minimum area required to start a Pharmacy, Medical shop or Wholesale outlet is 10 square meter and for wholesale and Retail minimum 15 square meters is required.
  • Storage facility – Certain drugs such as vaccines, sera, insulin injection etc. need to be stored in the refrigerator. So it is mandatory that there must have a refrigerator and air conditioner in the premises.
  • Technical Staff – 
    • Wholesale – The sale of the drug by wholesale shall be made either in the presence of registered pharmacist or in the presence of a competent person who shall be a graduate with 1 year experience in dealing in drugs or a person who has passed S.S.L.C with 4 years’ experience in dealing in drugs, specially approved by the department of drug control.
    • Retail – The sale of the drug by retail must be made in the presence of registered pharmacist approved by the department, a registered pharmacist is required throughout the working hours.

Documents required to obtain Drug License

Following documents are required with application form no.19 to be submitted in a prescribed form:

  • Constitution of the firm (MOA/AOA)
  • Photo ID proof of proprietor/partner/director
  • Copy of Property paper (If owned property)
  • Copy of Rent agreement (If rented property)
  • Site Plan and key plan of the premises
  • Refrigerator invoice and details
  • Affidavit regarding compliance of MPD 2021 (if premises are located on DDA residential flat/ plot/ building)

LIST OF DOCUMENTS FOR NEW RETAIL DRUG LICENSE

 (Drug License No. 20, 21)
 (Proprietor + Regd. Pharmacist)

  • Form No.19
  • Challan Rs.3000/-
  • Affidavit of the proprietor on stamp paper of 20 Rs.
  • Educational certificate copies of the proprietor (Self-attested)
  • Self-attested copies of Identity proof of proprietor ( Domicile/ Driving license/ Voter ID card)
  • Affidavit of Regd. Pharmacist.
  • Educational certificate copies of Regd. Pharmacist (Self-attested)
  • Self-attested copies of Identity proof of Regd. Pharmacist ( Domicile/Driving license/ Voter ID card)
  • Blueprint of Plan layout of proposed area/ premises.
  • Electricity bill of proposed area/ premises.
  • Copy of Refrigerator bill.
  • Rent agreement ( 50 Rs. Stamp paper)
  • Ownership document of the premises including the copy of tax receipt of proposed area/ premises.
  • Covering letter.
  • Photo 5-5 each of Regd. Pharmacist and proprietor.

                                            

LIST OF DOCUMENTS FOR NEW WHOLESALE DRUG LICENCE

 (Drug License No. 20B, 21B)
 (Proprietor + Competent person)

  • Form No. 19
  • Challan Rs.3000/-
  • Affidavit of the proprietor on stamp paper of 20 Rs.
  • Educational certificate copies of the proprietor (Self-attested)
  • Self-attested copies of Identity proof of proprietor ( Domicile/ Driving license/ Voter ID card)
  • Affidavit of Competent person.
  • Educational certificate copies of Competent person (Self-attested)
  • Self-attested copies of Identity proof of Competent person

(Domicile/Driving license/ Voter ID card)

  • Experience certificate of a competent person. (Experience certificate of 4 years after 12th or experience certificate of 2 years after graduation in original)
  • Blueprint of Plan layout of proposed area/ premises.
  • Electricity bill of proposed area/ premises.
  • Copy of Refrigerator bill.
  • Rent agreement ( 50 Rs. Stamp paper)
  • Ownership document of the premises including the copy of tax receipt of proposed area/ premises.
  • Covering letter.
  • Photo 5-5 each of competent person and proprietor.

NOTE: ALL DOCUMENTS IN PDF FORMAT SCANNED IN GRAY SCALE.

After the documents are submitted the inspection is carried by the local drug authority for the accuracy and correctness of detail submitted with the application.

Conditions for obtaining Drug License:

The applicant has to provide an independent shop with the adequate area for grant of retail/wholesale licenses as per details given below:

For grant of a license in Form 20 or Form 21 or both, the premises are of an area of not less than 10 square meters.

For grant of a license in form 20-B or form 21-B or both, the premises are of an area of not less than 10 square meters.                                  

   For grant of licenses:

  • In Form 20 or Form 21 or both,
  • In Form 20-B or Form 21-B or both, the premises should be of an area of not less than 15 square meters.
  • The clear height of the sales premises should be in accordance with the National Building Code of India, 2005 as amended from Time to Time.

 Note: No drug license is granted in a premises situated on a DDA alloted residential plot/land or flat unless it meets with the requirements of MPD-2021.

QUALIFICATION AND ELIGIBILITY TO GET THE RETAIL & WHOLESALE DRUG LICENSE.

A person who applies for drug licenses should possess one of the following qualifications

  • Registered pharmacist under the state Pharma council
  • Minimum 1 year experience as a salesman in a registered wholesale drug licensed firm after graduation or
  • Minimum 4 year experience as a salesman in a registered drug licensed firm after senior secondary examination.
  • Professional fees :

  • 44999/-

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