FDA Wholesale License

The Food and Drug Administration (FDA) is a federal organization that was founded in 1906 when the Federal Food and Drugs Act was passed. Food, medicines, cosmetics, animal food, dietary supplements, medical devices, biological commodities, and blood products are among the departments that supervise the majority of the agency's responsibilities.

FDA/ Wholesale License

Wholesale License for sale or distribution of drugs under Drugs and Cosmetics Rules in Form 20B & 21B or its renewal in Form 21C is issued to the manufacturer (subsidiary office/representative of the parent company) or any other who want to sell, stock, exhibit or offer for sale or distribute drugs, by the State Licensing Authority in India.

Wholesalers are companies that purchase products in bulk and resell them at a discounted price to retailers, who, in turn, sell the products to the public. The wholesale company usually does not sell directly to the end user. Wholesalers often purchase large quantities directly from the manufacturer or importer.

Wholesale Drug license is issued in Form 20B and Form 21B. For issuance of this license, an application has to be filled as per the Drugs and Cosmetics Act, 1940 and Rules 1945.

Forms of Licenses to Sell Drugs

A license to sell, stock, exhibit or offer for sale or distribute drugs other than those specified in Schedules C, C (1) and X and by retail on restricted license or by wholesale, shall be issued in Form 20, Form 20-A or Form 20 –B, as the case may be.

A license to sell, stock, exhibit or offer for sale or distribute drugs specified in Schedule C and C (1) excluding those specified in Schedule X, by retail on restricted license or by wholesale shall be issued in Form 21, Form 21-A or Form 21-B, as the case may be.

A license to sell, stock, exhibit or offer for sale or distribute drugs specified in Schedule X by retail or by wholesale shall be issued in Form 20-G as the case may be.

Applications for the grant or renewal of a license to sell, stock, exhibit or offer for sale or distribute drugs, other than those included in Schedule X, shall be made in Form 19 or in the case of drugs included in Schedule X shall be made in Form 19-C.

Uttar Pradesh Drug License

Drug license is a legal permit issued by the Government for businesses that deal with drugs and cosmetics. The Food Safety and Drug Administration Department under the Government of Uttar Pradesh grants drug license to prevent the manufacture and sale of sub-standard, fake medicines and to implement the provisions of the Drugs and Cosmetics Act, 1940. Corpseed will help you complete the procedure and various other aspects to obtain Uttar Pradesh Drug License for sales and manufacture.

Uttar Pradesh Drug License for Sales

The drug sale license is applicable for both retail as well as the wholesale purpose for the distribution of the drug in India. The license for drug sale is issued based on the conditions subjected to the competent person dealing with drugs and the premises (area of pharmacy shop and storage facility).

Types of Drugs Sales License:

Uttar Pradesh Drug License for Manufacture

• A registered pharmacist should directly and personally supervise any drug made by the licensee.
• The licensee should have minimum four years of practical experience in the distribution of drugs.
• The retail supply of any drug prescribed by the registered medical practitioner should be under the inspection of a registered pharmacist.
• The retail supply of the drug should be recorded in a register at the time of supply.
• The drugs mentioned in Schedule H or Schedule X are valid for a period of two years and should be supplied to registered Medical Practitioners, hospitals, dispensaries and nursing homes only on the signed order in writing.
• The licensee should maintain the purchase record of the drugs intended for sale or sold by retail.
• The licensee should not sell or stock any drug after the expiry date.
• The licensee should not store or stock any drugs on his premises that are intended for distribution as a free sample to the medical profession.
• The medicine in a retail shop for the treatment of animals should be labelled as “Not for human use - for treatment of animals only.”
• Note: The expired drugs stored to claim a rebate from the income tax will not be considered an offence under the act unless not intended for sale.

The following documents are the pre-requisites for the application of Drug Sales License under Uttar Pradesh Drug License:

• Affidavit attested by Public Notary:

1. Of Proprietor, if the applicant firm is proprietorship firm.
2. Of all the partners, in case the firm is a partnership firm.
3. Of the person duly authorized by the Board of Directors of the Private Limited of Limited Company

• Copy of partnership deed if partnership firm
• Address proof of the authorized proprietor/applicant (copy of voter I.D., driving license)
• Affidavit of the liable person for day-to-day working and for any violation of laws pertaining to Drugs.
• Documents related to Pharmacist:

1. Affidavit duly attested by Public Notary.
2. Copies of educational qualification certificates (Attested)
3. Attested copy of registration certificate and its renewal issued by U.P. Pharmacy Council.
4. Two photographs per applied license.
5. Address proof.
6. Appointment letter and joining letter

• Documents related to qualified person (for Wholesale license):

1. Attested copies of educational qualification certificates
2. Experience certificate on the affidavit
3. Two photographs per applied license
4. Appointment letter and Joining letter if applicable
5. Three copies of the plan of proposed premises.

• Documentary proof of rental or ownership basis of the proposed premises

1. Photocopy of the rental agreement in case of rented premises.
2. Attested copy of ownership proof of rented premises from the landlord.

• Two photographs of Proprietor/Partners/Authorized person.
• Attested copy of purchase invoice of a refrigerator

Requirements for Uttar Pradesh Drug Manufacture License:

The following documents are the pre-requisites for the application of Drug Manufacture License under Uttar Pradesh Drug License:

• Affidavit of the following attested by Public Notary: -

1. Proprietor of the applicant firm, in case the firm is proprietorship firm.
2. All the partners, in case the firm is a partnership firm.
3. The person duly authorized by the Board of Directors of the Private Limited or Limited Company.

• In case the applicant Company is a Private Limited or Limited Company, a copy of minutes of the Board of Directors
• If Partnership firm, list of names and addresses of all partners. List of Board of Directors of Private Limited or Limited Company with full names and addresses of all directors.
• Attested copy of registration certificate from District Industries Centre if the applicant firm is a Small-Scale Unit.
• Partnership deed copy if partnership firm.
• Address proof of the authorized applicant/proprietor (Voter I.D, Driving license)
• Documents for Manufacturing Chemist Employed (not applicable if the license is required on Form 37 for a testing laboratory):

1. Affidavit duly attested by Public Notary
2. Attested copies of educational certificates, experience certificates.
3. Attested copy of the letter of approval by State Drugs Controller.
4. Copy of consent letter, appointment letter or joining letter.
5. Medical certificate from a registered medical practitioner along with the eye fitness certificate.
6. Four photographs per applied license
7. Address proof

• Documents related to Analytical Chemist Employed:

1. Affidavit duly attested by Public Notary
2. Attested copies of educational certificates, experience certificates
3. Attested copy of the letter of approval by State Drugs Controller
4. Copy of consent letter, appointment letter or joining the letter
5. Medical certificate from a registered medical practitioner along with the eye fitness certificate.
6. Four photographs per applied license
7. Address proof
8. Attested copy of the consent of Approved testing laboratory that tests those raw materials and finished products which require sophisticated instruments for analysis
9. Three copies of the Plan of Premises showing all the sections and dimensions.
10. Documentary proof of ownership or rental basis of the proposed premises. Copy of rental agreement in case of rented premises. Attested copy of ownership proof of rented premises from the property owner
11. Copy of No Objection Certificate (NOC) from Pollution Control Board.
12. In case of renewal of license attested copy Air and Water Consent from the Pollution Control Board (not applicable if the manufacturing unit is exempted for the same).
13. Copy of test report of water from a Government Approved Laboratory regarding its portability and freedom from pathogenic microorganisms

While applying offline, the fees should be paid in the Government Treasury or Government Branch of State Bank of India of the district where the license is required. The original of the treasury challan must be submitted with the application.