Introduction
A drug license is authorization granted by the government to any person or business that intends to use drugs for the purpose of cosmetics or medicine. If you plan to handle, store, or even administer medications in UP, you must have this license. This license guarantees that you conduct business in accordance with the regulations set out by the 1940 Drugs and Cosmetics Act.
Drug License Registration in UP
A drug license in Uttar Pradesh is used to sell, stock and contain the medicines in the state. It authorizes and maintains the manufacturing of medicines in the market.
Benefits of Drug License Registration in UP
· Helps in regulating the activities of the pharmaceutical company.
· Maintains the integrity of health sector
· Helps in maintaining the manufacturing and circulation of medicines in the market.
Requirement to get a Drug License Registration in UP
· Any medication produced by the licensee should be directly and personally supervised by a qualified pharmacist.
· A minimum of four years of hands-on experience in drug distribution is required of the licensee.
· A registered pharmacist should inspect the retail supply of any medication recommended by a certified medical professional.
· At the time of provision, the drug’s retail supply ought to be noted in a register.
· The medications listed in Schedules H or X are only good for two years and should only be provided to hospitals, dispensaries, nursing homes, and certified medical professionals upon a signed written order.
· The purchase record of medications meant for retail sale or planned for sale should be kept up to date by the licensee.
· After the expiration date, the licensee is not allowed to stock or sell any medications.
· Any medications that are meant to be given away as free samples to the medical community should not be kept on the licensee’s property.
· “Not for human use _ for treatment of animals only” should be the label on any medication used to treat animals in a retail establishment.
Documents Required for Drug License Registration in UP
The prerequisites for applying for a drug sales license under the Uttar Pradesh Drug License are the following documents.
· Public notary-attested affidavit:
1. Of Proprietor, in the event that the applicant company is a proprietorship.
2. If the company is a partnership, then all of the partners.
3. Of the individual duly permitted by the Private Limited Company’s Board of Directors
· A copy of the partnership firm’s deed
· Address evidence of the applicant or authorized proprietor (driver’s license or voter ID document)
· Affidavit of the person responsible for daily operations and any drug-related infractions.
· Pharmacist-related documents include
1. An affidavit properly attested by a public notary.
2. Copies of certificates attesting to educational qualifications
3. A certified copy of the U.P. Pharmacy Council’s registration certificate and its renewal.
4. Each licensing application requires two photos.
5. Letters of appointment and joining
6. Address Proof
· Records pertaining to the qualified individual (for wholesale license):
1. Certified copies of credentials of educational attainment
2. Certificate of experience on the affidavit
3. Each licensing application requires two photos.
4. Letter of appointment and, if relevant, letter of joining
5. Three copies of the planned property’s layout.
· Documentation proving the prospective premises’ ownership or renting status
1. If the property is rented, a photocopy of the rental agreement is required.
2. A certified copy of the landlord’s proof of ownership for the rented space.
· Two pictures of the owner, partners, or authorized individual.
· A certified copy of the refrigerator’s purchase invoice
· Documents for Manufacturing Chemists Employed (not relevant if a testing laboratory’s Form 37 requires a license):
1. A properly attested affidavit from a public notary certified documents of experience and education credentials.
2. A certified copy of the State Drugs Controller’s permission letter.
3. A copy of a letter of membership, appointment, or consent.
4. Both the eye fitness certificate and a medical certificate from a licensed practitioner are required.
5. Each licensing application requires four photos.
6. Proof of address
· Records pertaining to the Analytical Chemist in Use:
1. A properly attested affidavit from a public notary
2. Certified documents of experience and education credentials
3. A certified copy of the State Drugs Controller’s approval letter
4. A copy of the letter of consent, appointment, or joining
5. Both the eye fitness certificate and a medical certificate from a licensed practitioner are required.
6. Each licensing application requires four photos.
7. Proof of address
8. An attested copy of the approved testing laboratory’s consent to test raw materials and final products that need complex analytical tools
9. The Plan of Premises, which includes all the divisions and dimensions, is in three copies.
10. Documentation proving the proposed location’s ownership or renting status. If the space is rented, a copy of the leasing agreement is required. A certified copy of the rental property’s ownership verification from the property owner
11. A copy of the Pollution Control Board’s No Objection Certificate.
12. Attested copies of the Pollution Control Board’s air and water consent are required for license renewals (not relevant if the manufacturing unit is exempt for the same).
13. A copy of a government-approved laboratory’s test report on the water’s portability and lack of harmful microorganisms
Fee for Drug License Registration in UP
When submitting an offline application, the fees must be paid at the State Bank of India Government Treasury or Government Branch in the district where the license is needed. The application must be presented with the original Treasury Challan.
Duration – 14-17 days
|
Type of Sales License
|
Fees |
|
Wholesale License |
Rs. 1500 + 1500 = Rs. 3000.00 |
|
Retail License |
Rs. 1500 + 1500 = Rs. 3000.00 |
|
Restricted License |
Rs. 500 + 500 = Rs. 1000.00 |
|
Medications listed in Schedule X (wholesale) |
Rs. 500 |
|
Medications listed in Schedule X (Retail) |
Rs. 500 |
Procedure for Drug License Registration in UP
Residents can use the online application process to apply for a new medication license. Here’s how:
1. Register Online: To begin with, register on the FSDA’s official website.
2. Complete the Form: Complete the online form and include all the documentation they ask for.
3. Await Their Check: The FSDA will confirm that they have your paperwork and form.
4. They Might Visit: Occasionally, they might stop by to see how things are doing at your house.
5. Get Your Answer: The FSDA will let you know if you are eligible for the license.