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Delhi Drug License

Last updated : December 17th, 2019 04:56 pm

Delhi Drug License

The Drugs Control Department regulates the manufacture and sales of drugs and Cosmetics. The Government has laid down various drug laws under which the State Drug Controller deals with the licensing of both manufacturing and sale premises of drugs & cosmetics. In this article, we look in detail the documents required, fees and the procedure for online payment to obtain Delhi Drug License.

Drugs and Cosmetics Act, 1940

Under the Drugs and Cosmetic Act, 1940, the competent authority is authorized to grant Drug license to carry out drugs/medicines or cosmetics relevant businesses.  As per the act, the license covers all kinds of drug or cosmetic businesses such as homoeopathic, allopathic excluding the ayurvedic and unani medicines. The manufacturer or seller of the drugs or cosmetics is responsible if any person using the product is affected due to the negligence of the same and is considered an offence under the act. Moreover, the act covers the penalty to be imposed on the licensee for non-renewal of the license after its expiry.

Delhi Drug License for Sale

The drug sale license is issued for both retail as well as wholesale purpose for the distribution of drug in India. The issuance of license for drug subjects to conditions attached with the competent person who deals with drugs and the premises (area of pharmacy shop and storage facility).

Pre-requisites for sale license:

An applicant applying for drug sale license under the Drugs & Cosmetics Act, 1940 and Rules should provide the following facilities.

For Retail/Whole sale of Drugs requires an independent premise with the minimum area of 10sq.m.and height of 2.75 m

To obtain the license for retail as well as wholesale of drugs, a premise of not less than 15 sq.m. with height of 2.75 m is necessary to be provided. In addition, the premises should possess adequate storage facilities like cold storage and deep freezer etc. for storage of general drugs as well as specific drugs.

Types of License for Sale:

Sale of drugs requires different types of license for specified drugs. The type of drugs for which the sales license is required and the relevant application form are listed below in the table.

S.N	Category	Sale Type	Application Form	License Form
1.	Drugs other than those specified in Schedule C&C (1)&X	Whole Sale	19	20-B
		Retail Sale	19	20
		Restricted (General Store)	19-A	20-A
2.	Drugs specified in Schedule C&C (1) but excluding those specified in Schedule ‘X’	Whole Sale	19	21-B
		Retail Sale	19	21
		Restricted (General Store)	19-A	21-A
3.	Drugs specified in Schedule ‘X’	Whole Sale	19-C	20-G
		Retail Sale	19-C	20-F
4.	Sale of Drugs from motor vehicles (1) Drugs other than those specified in Schedule C&C (1) (2) Drugs specified in Schedule C&C (1)	Whole Sale	19-AA	20-BB
		Whole Sale	19-AA	21-BB R-62- D R
5.	Homoeopathic Medicines	Whole Sale	19-B	20-D
		Retail Sale	19-B	20-C

Documents Required Drug Sale License

The necessary documents for drug sale license under Delhi Drug license are mentioned below.

Documents required for Fresh Application of Retail/Wholesale license:

1. System generated application form for relevant drug sale (19/19A/19B/19C as applicable).
2. Site plan and key plan of the premise
3. Constitution of the firm

• In case of company, memorandum and articles of association and Copy of resolution Passed,.
• In case of partner-ship firm – partnership deed, duly attested by Notary Public
• In case of trust / society – Trust deed.

4. Photo ID proof of proprietor / partner / director of the firm
5. Affidavit regarding non-conviction of Property/Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940.
6. Affidavit regarding compliance of MPD 2021, if the premises are located on DDA residential flat / plot /building
7. Online fee deposit receipts.
8. System generated affidavit from the registered pharmacist/competent person.
9. 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

10. For Wholesale License Competent person:

• Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets
• Experience Certificate
• Appointment Letter and Bio-data.

11. Premises:
12. a) If Owned:

Registered Sale Deed / Regd. GPA / Conveyance Deed in the name of owner or Unregistered Sale Deed / unregistered GPA supported with Electricity Bill / Water Bill / property tax receipt.

1. b) If Rented:

Rent receipt, registered rent agreement, unregistered rent agreement along with ownership documents of property owner.

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

Documents required for Application of additional Retail/Wholesale license:

1. System generated application form for relevant drug sale (19/19A/19B/19C as applicable).
2. Affidavit regarding non-conviction of Property/Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940.
3. For additional Retail Sale license:

• Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets of Registered Pharmacist.
• Registration of Delhi Pharmacy Council.
• Appointment Letter and Bio-data.
• System Generated Affidavit.

4. Online fee deposit receipts.

Documents required for Application of renewal of Retail/Wholesale license:

1. System generated application form for relevant drug sale (19/19A/19B/19C as applicable).
2. 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.
3. Online fee deposit receipts.

Documents required for Change in Registered Pharmacist:

1. Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets of Registered Pharmacist.
2. Registration of Delhi Pharmacy Council.
3. Appointment Letter and Bio-data.
4. System Generated Affidavit

Documents required for Change in Competent Person:

1. Proof of qualification i.e. final degree certificate / provisional certificate with mark   sheets
2. Experience Certificate.
3. Appointment Letter and Bio-data
4. Affidavit by Competent Person (System Generated)

Documents required for Addition / Reduction in premises :

1. Revised documents for premises
2. a) If Owned: Registered Sale Deed / Registered GPA or Unregistered Sale Deed / unregistered GPA    supported with Electricity Bill or Water Bill or property tax receipt.
3. b) If Rented: Rent receipt and either Regd. Rent Agreement or Un registered Rent Agreement along with ownership documents of landlord as stated above
4. 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 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 and
• For grant of licenses
  • In Form 20 or Form 21 or both, and
  • 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.

For a premises situated on a DDA allotted residential plot/land or flat, drug license is not issued unless it meets with the requirements of MPD-2021.

All the documents should be self-attested by the applicant/authorized person authenticity and to ensure confirmation of having submitted the same.

Delhi Drug License for Manufacturing

An applicant applying for grant of licenses for manufacturing of drugs/cosmetics should provide the premises in an approved industrial area and must comply with the relevant provisions of Drugs and Cosmetics Rules, 1945 as applicable for granting the  licenses for manufacture of particular type of drugs / cosmetics.

Types of Licenses:

Type of License

For manufacturing of drugs in license on Form 25

For manufacturing of drugs in license on Form 25A

For manufacturing of drugs in license on Form 25B

For manufacturing of drugs in license on Form 25C

For manufacturing of drugs in license on Form 25F

For manufacturing of drugs in license on Form 28

For manufacturing of drugs in license on Form 28A

For manufacturing of drugs in license on Form 28B

For manufacturing of drugs in license on Form 28C

For manufacturing of drugs in license on Form 28D

For manufacturing of drugs in license on Form 28DA

For manufacturing of drugs in license on Form 28E

For manufacturing of drugs in license on Form 29

For manufacturing of cosmetics in license on Form 32

For manufacturing of cosmetics in license on Form 32A

For approval of Testing Laboratories on Form 37

Requisites for Drugs License for manufacturing of drugs

The documents necessary for drug manufacturing license under Delhi Drug License are as follows.

• Application in the prescribed form
• Declaration form
• 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 constitution of firm in case of partnership / private limited/ trust.
• Copy of Resolution passed by Board of Directors.

• Proof of Ownership : Copy of registered 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, 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 along with 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.
• All industries seeking licenses for manufacturing of Drugs  should obtain a No Objection Certificate from Delhi Pollution Control Committee.
• Drugs Manufacturers Units applying licenses where the drugs involve the use of alcohol and other inflammable material in the processing should acquire a No Objection Certificate from Delhi Fire Services.

Note:  Currently, as per department policy licenses are being granted in industrial area only.

Online payment: License fee: Rs. 6000/- + Inspection Fees Rs. 1500/-

Competent Authority

• For Sales License: Licensing Authority of the concerned Zone
• For Manufacturing: Assistant Drugs Controller of the concerned Zone

Time Frame

For Sale License:

Process	Time Period
For grant of licenses for sale of drugs or for disposal of application. (if the conditions are satisfied)	35 days
Change addition/ deletion of Registered Pharmacist.	60 days
Change addition/ deletion of Competent Person.	90 days
For grant of sale licenses for Homoeopathic Medicines or for disposal of application. (if the conditions are satisfied)	90 days
For grant of sale licenses for Homoeopathic Medicines  or for disposal of application. (if the conditions are satisfied)	35 days
For grant of sale licenses for Schedule X Drugs Medicines or for disposal of application. (if the conditions are satisfied)	35 days

*The time period denotes from the date of receipt of application.

For Drug Manufacturing License:

The period for grant of licenses for manufacturing of Drugs / Cosmetics is 75 days from the date of receipt of application, if conditions are satisfied.

Application Procedure

3. Every application is required to be ‘e-send’ (ESEND is a service to make it easy for you to move files from one account to another account) as it will not be allowed in person to the office.
4. For this purpose, the applicant has to obtain the user ID and password by requesting online with the details of the firm.
5. All documents must be scanned in 100 dpi & black and white, and then uploaded using the generated user id and password.
6. All the original documents are necessary to be showed to the inspector at the time of inspection.
7. After the grant or rejection of the application, you will receive an SMS about the same.
8. 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.
9. You will receive licenses/approvals with the valid e-signature and official seal.

E-Payment for License

The applicant can make the payment of fee for the required license through the e-payment portal of the NCT Delhi.

Step 1: To make the requisite fee, visit the e-payment website of the Delhi government.

Step 2: Select the department as ‘Drugs Control’ and select the required license type for which the payment should be made.

Step 3: Enter the required payee details. The amount to be paid for each type of license appears.

Step 4: Click submit and proceed with the payment.