Guidelines For Grant of Licences for Sale of Drugs Under

Drugs & Cosmetics Act, 1940 and Rules thereunder

 

INTRODUCTION

 

            Drugs are essential for ensuring good health of a Nation. Drugs are different from other commodities and because of that the Government has laid down stringent law. Regulation governing manufacture & sale of drugs are given in the Drugs and Cosmetics Act, 1940 and Rules framed thereunder. Control is exercised over drugs from the raw material stage during manufacture, sale, distribution and upto the time it is passed-on to a patient or consumer by a Pharmacist in retail Pharmacy, Hospital or a Dispensary.

GENERAL INSTRUCTIONS

 

1.      Applicant has to obtain user ID and Password by giving request online on  with the details of the firm.

2.      All the documents should be scanned in 100 dpi & black and white, and then should be uploaded using the said ID and Password at space provided for the purpose.

3.      Please show all the original documents to the inspector at the time of inspection.

4.      Please be sure that, all the information is filled precisely for respective application mentioned below and only then e-send the application. In case of rejection of your application for incomplete information, the fees once paid will be forfeited.

5.      The licensing authority may ask for any other specific documents if required.

6.      These guidelines are subject to change as and when required and will be notified from time to time.

7.      Every application needs to be ‘e-send’, or it will not be inwarded to the office.

8.      If the proprietor/ partner are changed, it will be treated as ‘change in constitution’ and applicant will have to obtain a fresh license.

9.      After grant or rejection of your application, you will receive an SMS about the same.

Take a print out of the approval/rejection from ‘Print License’ option for fresh license and renewal and click ‘MISC approvals’ for other approvals within 3 days. You will receive licenses/approvals with the valid e-signature and official seal.

10.  Registered Pharmacists are also required to update their details by obtaining separate password.

11.  These are only guidelines. The Provisions of Drugs and Cosmetic Act 1940 and

Rules 1945 will always prevail.

 

  

Types of Licences issued by the Department for sale of Drugs and documents required:-

A.    Different types of licence required for the sale of drugs (the required number of application form for a particular licence is  mentioned in the bracket) are given hereunder:-

(i)     Licence on Form 20 is issued for the sale of Allopathic drugs by retail other than those specified in Schedule C, C(1) and X. (Form-19)

(ii)   Licence on Form 20-A is issued  for the sale of restricted Allopathic drugs by retail other than those specified in schedule C, C(1) and X. (Form-19A)

(iii) Licence on Form 20-B is issued for wholesale of Allopathic drugs other than those specified in Sch C, C(1) and X. (Form-19)

(iv) Licence on form 20-C is issued for sale of Homoeopathic medicines by retail. (Form-19B)

(v)   Licence on Form 20-D is issued for sale of Homoeopathic Medicines by wholesale.(Form -19B)

(vi) Licence on Form 21 is issued for retail sale of Allopathic drugs specified in Sch C & C(1).(Form-19)

(vii)   Licence on Form 21-B is issued for wholesale of Allopathic drugs specified in Sch C & C(1).   (Form-19)

(viii)  Licence on form 21-A is issued for retail sale of restricted Allopathic drugs specified in Schedule C (I). (Form-19A)

       (ix) Licence on Form 20-F is issued for retail sale of drugs specified in Sch. 'X'. (Form-19-C).

        (x)   Licence on Form 20-G is issued for wholesale of drugs Specified in Sch. 'X'.    (Form-19-C)

 

(B)    Documents required Fresh Application of Retail/Wholesale license :

       (i) Online fee deposit receipts.

(ii)      Application Form No. 19/19A/19B/19C as applicable (System Generated)

(iii)    Site plan and key plan of the premises.

(iv)    Constitution of the firm viz: Memorandum and articles of association and Copy of resolution Passed, in case of company. Partnership deed, duly attested by Notary Public, in case of partner-ship firm. Trust deed, in case of trust / society.

(v)      Photo ID proof of proprietor / partner / director of the firm.

(vi)    Affidavit regarding non-conviction of Prop./Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940.

(vii)  Affidavit regarding compliance of MPD 2021, if the premises are located on DDA residential flat / plot /building

(viii)                   Conversion charge receipt issued by MCD with relevant documents in support of commercial use as per MPD 2021 viz; copy showing the Name of notified commercial / mixed use road/street.

(ix)    Affidavit from the Regd. pharmacist/competent person (System Generated).

(x)      For Retail Sale Registered Pharmacist:

a)      Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets.

b)      Registration of Delhi Pharmacy Council,

c)      Appointment Letter and Bio-data

(xi)    For Wholesale Licence Competent person:

a)      Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets

b)      Experience Certificate,

c)      Appointment Letter and Bio-data.

(xii)  Premises : a) If Owned:

either Regd. Sale Deed / Regd. GPA / Conveyance Deed in the name of owner,

or Un regd. Sale Deed / un regd. GPA supported with Electricity Bill / Water Bill / property tax receipt.

b) If Rented:

Rent Receipt and

either Regd. Rent Agreement,

or Un registered Rent Agreement along with ownership documents of landlord, as stated above.

* In case of village, Khasra Khatauni documents will be considered.

 

(c) Documents required for Application of Retail/Wholesale license due to Change in Constitution (CC) /Change in Premises (CP) :

  (i) Fee deposit receipts.

(ii)     Application Form No. 19/19A/19B/19C as applicable (System Generated)

(iii)   Documentary evidence w.r.t. change in constitution / A request letter for shifting of premises. (as applicable)

(iv)   Site plan and key plan of the premises.

(v)     Constitution of the firm viz: Memorandum and articles of association and Copy of resolution Passed, in case of company. Partnership deed, duly attested by Notary Public, in case of partner-ship firm. Trust deed, in case of trust / society

(vi)   Photo ID proof of proprietor / partner / director of the firm.

(vii) Affidavit regarding non-conviction of Prop./Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940.

(xiii)                    Affidavit regarding compliance of MPD 2021, if the premises are located on DDA residential flat / plot /building

(xiv)                   Conversion charge receipt issued by MCD with relevant documents in support of commercial use as per MPD 2021 viz; copy showing the Name of notified commercial / mixed use road/street.

(viii)   Affidavit from the Regd. pharmacist/competent person (System Generated).

(ix) For Retail Sale Registered Pharmacist:

a)         Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets.

b)         Registration of Delhi Pharmacy Council.

c)         Appointment Letter and Bio-data

(x) For Wholesale Licence Competent person:

a)         Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets

b)         Experience Certificate.

c)         Appointment Letter and Bio-data.

(xv)  Premises : a) If Owned:

either Regd. Sale Deed / Regd. GPA / Conveyance Deed in the name of owner,

or Un regd. Sale Deed / un regd. GPA supported with Electricity Bill / Water Bill / property tax receipt.

b) If Rented:

Rent Receipt and

either Regd. Rent Agreement,

or Un registered Rent Agreement along with ownership documents of landlord, as stated above.

* In case of village, Khasra Khatauni documents will be considered.




 (D) Documents required for Application of additional Retail/Wholesale license :

 (i) Fee deposit receipts.

(ii)     Application Form No. 19/19A/19B/19C as applicable (System Generated)

(iii)   Affidavit regarding non-conviction of Prop./Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940.

(iv)       For additional Retail Sale licence :

a)         Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets of Registered Pharmacist.

b)         Registration of Delhi Pharmacy Council.

c)         Appointment Letter and Bio-data.

d)        System Generated Affidavit.

 

(E) Documents required for Application of renewal of Retail/Wholesale license :

         (i) Fee deposit receipts.

(ii)   Application Form No. 19/19A/19B/19C as applicable (System Generated)

(iii)  Conversion charge receipt issued by MCD with relevant documents in support of commercial use as per MPD 2021 viz; copy showing the Name of notified commercial / mixed use road/street.

 

(F) Documents required for Change in Registered Pharmacist:

a)      Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets of Registered Pharmacist.

b)      Registration of Delhi Pharmacy Council.

c)      Appointment Letter and Bio-data.

d)     System Generated Affidavit

 

             (G) Documents required for Change in Competent Person:

                                a)      Proof of qualification i.e. final degree certificate / provisional certificate with                                         mark   sheets

                                 b)      Experience Certificate.

c)      Appointment Letter and Bio-data

d)     Affidavit by Competent Person (System Generated)

 

(H) Documents required for Addition / Reduction in premises :

i.)                  Revised documents for premises a) If Owned:

            either Regd. Sale Deed / Regd. GPA or Un regd. Sale Deed / un regd. GPA    supported with Electricity Bill or Water Bill or property tax receipt.

           b) If Rented:

Rent Receipt and either Regd. Rent Agreement or Un registered Rent Agreement along with ownership documents of landlord as stated above

ii.)                Revised Site Plan

 

Note :

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

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

b)      For grant of a licence in form 20-B or form 21-B or both, the premises are of an area of not less than 10 square metres and

c)      For grant of licences

(i)   In Form 20 or Form 21 or both, and

(ii) In Form 20-B or Form 21-B or both, the premises should be of an area of not less than 15 square metres.

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.

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

For the sake of authenticity and to ensure confirmation of having submitted the same, all the documents are required to be self-attested by the applicant/authorized person.

        (I) . To Obtain Drugs Licence for manufacturing of drugs

• Application Form
• Online payment : Fees of Lic. Rs. 6000/- + Inspection Fees Rs. 1500/-
• Declaration Form
• Proof of Constitution of Firm in case of Partnership / Pvt. Ltd./ Ltd. /Trust.
• Copy of Resolution passed by Board of Directors.
• Key Plan and Site Plan in Blue Print / Ammonia Print.
• Proof of Possession: A) Rented : Rent Receipt & Rent Agreement. (Notary Attested)

                                                       B) Self Occupied.

• Proof of Ownership : Copy of Regd. GPA / Sale Deed / Property Tax Receipt
• Affidavit of Non Conviction as per format given in Guide Line Booklet.
• List of Equipment and Machineries Provided for Manufacturing.
• List of Equipment Provided for Testing.
• List of Technical Staff for manufacturing along with their Self Certified photocopies w.r.t. Certificates of Education Qualification, Experience Certificate, Biodata on Proforma, Appointment Letter, three photographs.
• List of Technical Staff for testing along with their Self Certified photocopies w.r.t. Certificates of Education Qualification, Experience Certificate, Biodata on proforma, Appointment Letter, three photographs.
•  Affidavit from employer and or Technical Staff for full time working with the firm as per format given in Guide Line Booklet.
• List of Formulations to be permitted alongwith product information separately for each drug and affidavit about owner / user of the trade name applied for.
• Consent of Approved Testing Laboratory for Sophisticated Testing.
• Kindly refer “Drugs and Cosmetics Act, 1940 and Rules made there under” for more information.
•  At present, as per department policy “Licences are being granted in Industrial Area only”.

HOW CAN YOU HELP US?

Before submitting applications for the grant of licences, the applicants should ensure that they submit the correct application forms and attach all the requisite documents as listed in the booklet “guidelines for obtaining licences under Drugs and Cosmetics rules or listed under the check list of documents.