DRUG LICENSE
About Drug License- Licensing is mandatory to do business in Drugs & Cosmetics in India. The provisions for this has been made in Drugs & Cosmetics Act, 1940 which is applicable to whole of India.
In case a business is operating in more than two states, it has to obtain drug licence in every state in which business is being carried on. Drug licence 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.
Types of Drug License:-
1. Manufacturing License2. Sale License-:
• Wholesale License
• Retail License
• Restricted License (General Stores)
3. Loan License
Conditions for obtaining Drug Licence for Retail/Wholesale:-
1. For Retail/Whole sale of Drugs requires an independent premise with the minimum area of 10sq.m.and height of 2.75 m2. 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.
Procedure for applying for Drug License:-
1. Every application is required to be ‘e-send’ (E-SEND 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.
2. For this purpose, the applicant has to obtain the user ID and password by requesting online with the details of the firm.
3. All documents must be scanned in 100 dpi & black and white, and then uploaded using the generated user id and password.
4. All the original documents are necessary to be showed to the inspector at the time of inspection.
5. After the grant or rejection of the application, you will receive an SMS about the same.
6. 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.
7. You will receive licenses/approvals with the valid e-signature and official seal.
Documents required for Drug License for Sale:-
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:
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.
b) If Rented- Rent receipt, registered rent agreement, unregistered rent agreement along with ownership documents of property owner.
12. In case of village, Khasra Khatauni documents will be considered.
Documents required for Drug License for Manufacturing purpose:-
1. Application in the prescribed form
2. Declaration form
3. Key plan and site plan in blue print / ammonia print.
4. Proof of Possession:
a) Rented: rent receipt & rent agreement. (Notary Attested)
b) Self-occupied
5. Proof of constitution of firm in case of partnership / private limited/ trust.
6. Copy of Resolution passed by Board of Directors.
7. Proof of Ownership : Copy of registered GPA / sale deed / property tax receipt
8. Affidavit of Non Conviction as per format given in Guide Line Booklet.
9. List of Equipment And Machineries Provided For Manufacturing.
10. List of equipment provided for testing.
11. 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.
12. 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.
13. Affidavit from employer and or technical staff for full time working with the firm as per format given in Guide Line Booklet.
14. 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.
15. Consent of approved testing laboratory for sophisticated testing.
16. All industries seeking licenses for manufacturing of Drugs should obtain a No Objection Certificate from Delhi Pollution Control Committee.
17. 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.