Drug License
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For ensuring the good health of the people of the country drugs (medicines) are essential. The quality and composition of medicines can affect the health of a country, so it becomes necessary to regulate the manufacture as well as the trade of medicines at every stage. In India, the manufacture & sale of drugs is governed by the Drugs and Cosmetics Act, 1940 and Rules framed thereunder.
Drug License is issued for manufacturing, wholesale trade as well as retail trade of drugs by the state drug control department. Drug License is a state matter, so the procedures and fee for obtaining the Drug License may vary from state to state. In this article, we are covering the procedure, documents required and eligibility to obtain Drug License in Delhi.
Types of Licences issued for the sale of Drugs
Documents required Fresh Application of Retail/Wholesale license
- System-generated application in Form 19/19A/19C as applicable.
- Site plan and key plan of the premises.
- Constitution of the firm viz: Memorandum and Articles of Association and Copy of the resolution passed, in case of company. Partnership deed, duly attested by Notary Public, in case of the partnership firm. Trust deed, in case of trust/society.
- Photo ID proof of proprietor/partner/director of the firm.
- Affidavit regarding non-conviction of Prop./Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940.
- Affidavit regarding the compliance of MPD 2021, if the premises are located on DDA residential flat/plot/building
- 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-used road/street.
- Affidavit from the Regd. pharmacist/competent person (System Generated).
- For Retail Sale Registered Pharmacist: Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets, Registration of Delhi Pharmacy Council, Appointment Letter and Bio-data
- For Wholesale Licence Competent person: Proof of qualification i.e. final degree certificate / provisional a certificate with mark sheets, Experience Certificate, Appointment Letter and Bio-data.
- If Premise is owned: Either Regd. Sale Deed / Regd. GPA / Conveyance Deed in the name of the owner or Unregistered Sale Deed / Unregistered GPA supported with Electricity Bill / Water Bill / property tax receipt. In the case of the village, Khasra Khatauni documents will be considered.
- If Premise is rented: Rent Receipt and either Regd. Rent Agreement or Unregistered Rent Agreement along with ownership documents of the landlord, as stated above. In the case of the village, Khasra Khatauni documents will be considered.
- Online fee deposit receipt.
Documents required for application of Retail/Wholesale license due to Change in Constitution (CC) /Change in Premises (CP)
- System generated application in Form No. 19/19A/19B/19C as applicable.
- Documentary evidence w.r.t. change in constitution / A request letter for shifting of premises, as applicable.
- Site plan and key plan of the premises.
- Constitution of the firm viz: Memorandum and Articles of Association and Copy of the resolution passed, in case of company. Partnership deed, duly attested by Notary Public, in case of the partnership firm. Trust deed, in case of trust/society.
- Photo ID proof of proprietor/partner/director of the firm.
- Affidavit regarding non-conviction of Prop./Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940.
- Affidavit regarding the compliance of MPD 2021, if the premises are located on DDA residential flat/plot/building
- 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-used road/street.
- Affidavit from the Regd. pharmacist/competent person (System Generated).
- For Retail Sale Registered Pharmacist: Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets, Registration of Delhi Pharmacy Council, Appointment Letter and Bio-data.
- For Wholesale Licence Competent person: Proof of qualification i.e. final degree certificate / provisional a certificate with mark sheets, Experience Certificate, Appointment Letter and Bio-data.
- If Premise is owned: Either Regd. Sale Deed / Regd. GPA / Conveyance Deed in the name of the owner or Unregistered Sale Deed / Unregistered GPA supported with Electricity Bill / Water Bill/property tax receipt. In the case of the village, Khasra Khatauni documents will be considered.
- If Premise is rented: Rent Receipt and either Regd. Rent Agreement or Unregistered Rent Agreement along with ownership documents of the landlord, as stated above. In the case of the village, Khasra Khatauni documents will be considered.
- Online fee deposit receipt.
Documents required for application of additional Retail/Wholesale license
- System generated application Form No. 19/19A/19B/19C as applicable.
- Affidavit regarding non-conviction of Prop./Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940.
- For additional Retail Sale license:
- For Retail Sale Registered Pharmacist: Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets, Registration of Delhi Pharmacy Council, Appointment Letter and Bio-data.
- For Wholesale Licence Competent person: Proof of qualification i.e. final degree certificate / provisional a certificate with mark sheets, Experience Certificate, Appointment Letter and Bio-data.
- System-generated affidavit.
- Online fee deposit receipt.
Documents required for application of renewal of Retail/Wholesale license
- System generated application Form No. 19/19A/19B/19C as applicable.
- 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-used road/street.
- Online fee deposit receipt.
Documents required for change in registered pharmacist
- Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets of Registered Pharmacist.
- Registration of Delhi Pharmacy Council.
- Appointment letter and biodata.
- System-generated affidavit.
Documents required for change in the competent person
- Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets.
- Experience certificate.
- Appointment letter and biodata.
- System generated affidavit by Competent Person.
Revised documents required for addition or reduction in the premises
- If Premise is owned: Either Regd. Sale Deed / Regd. GPA / Conveyance Deed in the name of the owner or Unregistered Sale Deed / Unregistered GPA supported with Electricity Bill / Water Bill/property tax receipt. In the case of the village, Khasra Khatauni documents will be considered.
- If Premise is rented: Rent Receipt and either Regd. Rent Agreement or Unregistered Rent Agreement along with ownership documents of the landlord, as stated above. In the case of the village, Khasra Khatauni documents will be considered.
- Revised site plan.
Note:
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 retail license, the premises are of an area of not less than 10 square meters.
- For grant of a wholesale license, the premises are of an area of not less than 10 square meters.
- The clear height of the premises of the sale should be in accordance with the National Building Code of India, 2005 as amended from Time to Time.
No drug license is granted in premises situated on a DDA allotted residential plot/land or flat unless it meets with the requirements of MPD-2021.
To Obtain Drugs Licence for manufacturing of drugs
- Application form.
- Online payment of fee for license Rs. 6000/- and inspection fee Rs. 1500/-.
- Declaration form.
- Proof of constitution of the firm in case of Partnership/LLP/Pvt. Ltd./Trust.
- Affidavit regarding non-conviction of Prop./Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940.
- 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 and Rent Agreement (Notarised) and Self Occupied.
- Proof of ownership: Copy of Registered GPA/Sale Deed/Property Tax Receipt.
- List of equipments and machineries provided for manufacturing.
- List of equipments 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 thereunder” for more information.
- At present, as per the department policy “Licences are being granted in Industrial Area only”.
Guidelines issued by the department for filing the application
- The applicant has to obtain a User ID and Password by giving request online with the details of the firm.
- All the documents should be scanned in 100 dpi & black and white and then should be uploaded using the said ID and Password at the space provided for the purpose.
- The applicant should show all the original documents to the inspector at the time of inspection.
- Be sure that, all the information is filled in precisely for the 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.
- The licensing authority may ask for any other specific documents if required.
- The guidelines are subject to change as and when required and will be notified from time to time.
- Every application needs to be ‘e-send’, or it will not be inwarded to the office.
- If the proprietor/ partner is changed, it will be treated as ‘change in constitution’ and applicant will have to obtain a fresh license.
- After grant or rejection of your application, the applicant will receive an SMS about the same.Take a printout 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.
- Registered Pharmacists are also required to update their details by obtaining a separate password.
- These are only guidelines. The Provisions of Drugs and Cosmetic Act 1940 and Rules 1945 will always prevail.