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Requirements For Granting Drugs Sales Licences

The Drugs Control Department grants following types (§) of Sales licence by the respective Jurisdictional delegated Licensing Authorities.

  1. Retail Drug licence in Form 20 and Form 21,
  2. Wholesale Drug licence in Form 20B and Form 21B,
  3. Licenses to sell drugs under Schedule X (in Form 20F for Retail and Form 21G for Wholesale)
  4. Restricted licenses in Form 20A and Form 21A and
  5. License to sell drugs from motor vehicle in Form 20BB

Details on Forms, fees and Additional Fees (Penalty) for sale licenses are listed separately for applicants use are mentioned in XLN India software.

The applicants are required to submit the documents for grant of Fresh Licenses as per the Check list given below for each type (§) of Licenses. After following the procedures mentioned in Steps 1 to 4 below, the licenses will be granted to the applicants.

In case of Change of premises (CoP), Change of Constitution (CoC), fresh licenses are required to be obtained and the licensees are expected to make their applications well in advance, by surrendering the existing licenses.

In case of renewal of Licenses, applicants are required to submit respective Form, fees prescribed, additional information sheet meant for renewal (Refer format given) along with a covering letter before the expiry of the Licenses.

If the application is made on Letter of Authority (LA) or the Power of Attorney (POA), the LA or POA original copy signed by the Director / Company Secretary / Owner supported with board resolution or by the Partner of the firm. The LA / POA Holder is required to submit his Photo & residential address proof with the application.

Checklist For Grant Of Fresh Licences

For Retail Drug Licence

Click here to know steps followed for the Grant of Retail drugs Licence

  1. Covering letter
  2. Form 19/Form 19C.
  3. Additional information sheet (AIS).
  4. Challan/ Payment Acknowledgement.
  5. Sketch of the premises (In duplicate)
  6. Rent agreement or lease deed
  7. Qualified person’s proforma.
    1. Registered Pharmacists affidavit as in XLN India software.
    2. Affidavit by the applicant on Constitution, tenancy, area of premises etc.
  8. Refrigerator invoice or declaration
  9. Proprietorship declaration or Partnership deed or memorandum of articles of association.
  10. Residential address proof - document like Election ID Card / Aadhar Card / Passport / Ration Card / Driving Licence of applicants (proprietor / Partner / Managing Director / Authorized Signatory POA / LA ) and pharmacists & or competent persons.
  11. Passport size photographs of applicants and pharmacists/competent persons

      Notes:


    1. Minimum floor area required in case of retail licences is 10 sq. Mts., in case of wholesale licences 10 sq. Mts. and in case an application is made for both wholesale and retail licences minimum floor area required is 15 sq. Mts.
    2. Maximum number of days to wait to get this service delivered is framed in the XLN India Software – Citizen’s Charter.
Work Flow of 30 working Days
StepDescriptionNo. of DaysDesignation
1.Receipt of Application2.00Licensing Authority / Assistant Commissioner
2.Inward Processing2.00Superintendent
3.Preliminary Processing3.00Licensing Authority
4.Inspection Report15.00Drugs Inspector
5.Final Processing3.00Licensing Authority / Assistant Commissioner
6.Preparation of Licence3.00Superintendent
7.Dispatch2.00Dispatcher

For Licenses Wholesale Drug Licence

Click here to know steps followed for the Grant of Wholesale Licence

  1. Covering letter
  2. Form 19/Form 19C.
  3. Additional information sheet (AIS).
  4. Challan/ Payment Acknowledgement.
  5. Sketch of the premises (In duplicate)
  6. Rent agreement or lease deed
  7. Competent person's proforma
  8. Competent persons experience certificate (Minimum 4 years in case of matriculate and one year in case of Recognized degree holder).
  9. Competent person’s qualification certificate.
    1. Competent persons affidavit as in XLN India software.
    2. Affidavit by the applicant on Constitution, tenancy, area and commercial nature of premises etc.
  10. Refrigerator invoice or declaration
  11. Proprietorship declaration or Partnership deed or memorandum of articles of association.
  12. Residential address proof - document like Election ID Card / Aadhar Card / Passport / Ration Card / Driving Licence of applicants (proprietor / Partner / Managing Director / Authorized Signatory POA / LA ) and pharmacists & or competent persons.
  13. Passport size photographs of applicants and pharmacists/competent persons

      Notes:


    1. Minimum floor area of premises required in case of wholesale licences 10 sq. Mts.
    2. The applicants are required to produce supportive documents to show that the proposed premise is of commercial in nature.
    3. Maximum number of days to wait to get this service delivered is framed in the XLN India Software – Citizen’s Charter.
Work Flow of 30 working Days
StepDescriptionNo. of DaysDesignation
1.Receipt of Application2.00Licensing Authority / Assistant Commissioner
2.Inward Processing2.00Superintendent
3.Preliminary Processing3.00Licensing Authority
4.Inspection Report15.00Drugs Inspector
5.Final Processing3.00Licensing Authority / Assistant Commissioner
6.Preparation of Licence3.00Superintendent
7.Dispatch2.00Dispatcher

For Grant OfLicences To Sell Drugs Under Schedule X

Click here to know steps followed for the Grant of Schedule-X drugs Licence

  1. Covering letter
  2. Form 19C.
  3. Additional information sheet (AIS).
  4. Challan/Payment Acknowledgement.
  5. Photocopy of licenses in Form 20, 21 and /or 20B and 21B
  6. Undertaking that schedule X drugs shall be kept under lock and key, to which only responsible persons have access;

As a policy licenses in Form 20F is granted only to such persons possessing valid licenses in Form 20, 21 and similarly 20G licenses to such persons possessing valid licenses in Form 20B and 21B.

For Grant Of Restricted Licenses In Form 20A And Form 21 A

Click here to know steps followed for the Grant of Restricted drugs Licence

  1. Covering letter
  2. Form 19A.
  3. Additional information sheet (AIS).
  4. Challan/ Payment Acknowledgement.
  5. List of drugs permitted to be sold [ separate for list for 20A and 21 A] (Refer format given)
  6. Sketch of the premises (In duplicate)
  7. Rent agreement or lease deed
  8. Proprietorship declaration or Partnership deed or memorandum of articles of association.
  9. Photo copies of address proof and photo I.D’s of applicants.
  10. Residential address proof - document like Election ID Card / Aadhar Card / Passport / Ration Card / Driving Licence of applicants (proprietor / Partner / Managing Director / Authorized Signatory POA / LA ).
  11. Passport size photographs of applicants.

      Notes:


    1. Maximum number of days to wait to get this service delivered is framed in the XLN India Software – Citizen’s Charter.
Work Flow of 30 working Days
StepDescriptionNo. of DaysDesignation
1.Receipt of Application2.00Licensing Authority / Assistant Commissioner
2.Inward Processing2.00Superintendent
3.Preliminary Processing3.00Licensing Authority
4.Inspection Report15.00Drugs Inspector
5.Final Processing3.00Licensing Authority / Assistant Commissioner
6.Preparation of Licence3.00Superintendent
7.Dispatch2.00Dispatcher

Steps Followed For The Grant Of Licence

The following steps are followed from the receipt of application of applicants till the grant of licenses.

Step-I

The applicants are required to submit the required statutory application in the prescribed Form, Fees, and other documents listed in the Check list for grant of Fresh Licenses. The applicants are instructed to use the suitable on line Form/s available in the website.

In case of additional grant of Licenses also the same procedure, document and fees are required from the licenses.

The Licencing Authority may call for any additional documents to ascertain the correctness of information furnished by the applicants.

Step-II

The application is verified by the section for the correctness of the list of documents submitted and is then processed and submitted to concerned Assistant Drugs Controller who in turn either scrutinize himself or forward to Drugs inspector working undewr him / her for scrutiny and inspection of proposed premises.

If the submitted application is not in order or requires any clarifications / information a compliance letter will be served to the applicant.

Step-III

If the submitted documents, area of premises and the facility for storage are found in order, after inspection based on recomendation the concerned Assistant Drugs Controller and delegated Licensing Authority will Grant the License.

Step-IV

The applicants will get computerized SMS alert to the provided mobile number in their application. The Granted licenses along with the original documents like KSPC Certificate will be delivered by post.

Click here to Register on-line application.

(Issued in the public interest by the Drugs Controller for the State of Karnataka, Bangalore)