Understanding the Drug License: A drug license is an official authorization provided by the government to entities engaged in the commerce of pharmaceuticals and cosmetics. It is the Food Safety and Drug Administration Department of the Government of Uttar Pradesh that issues such licenses. The primary aim is to thwart the production and distribution of inferior or counterfeit medications and to enforce the regulations set forth in the Drugs and Cosmetics Act of 1940. This article delves into the detailed process and various facets involved in securing a Drug License in Uttar Pradesh for both sales and manufacturing purposes.

• A registered pharmacist must directly and personally supervise any drug produced by the licensee.
• The licensee must have a minimum of four years of practical experience in drug distribution.
• The retail supply of any drug prescribed by a registered medical practitioner must be inspected by a registered pharmacist.
• The retail supply of the drug must be recorded in a register at the time of supply.
• Drugs listed in Schedule H or Schedule X are valid for two years and should only be supplied to registered medical practitioners, hospitals, dispensaries, and nursing homes upon a signed written order.
• The licensee must maintain purchase records for drugs intended for sale or sold by retail.
• The licensee must not sell or stock any drug after its expiry date.
• The licensee must not store or stock any drugs on the premises intended for distribution as free samples to the medical profession.
• Medicines in a retail shop for the treatment of animals must be labelled as “Not for human use – for treatment of animals only.”

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

1. Affidavit attested by Public Notary:
   • Of Proprietor, if the applicant firm is proprietorship firm.
   • Of all the partners, in case the firm is a partnership firm.
   • Of the person duly authorized by the Board of Directors of the Private Limited of Limited Company
2. Copy of partnership deed if partnership firm
3. Address proof of the authorized proprietor / applicant (copy of voter I.D., driving license)
4. Affidavit of the liable person for day-to-day working and for any violation of laws pertaining to Drugs.
5. Documents related to Pharmacist:
   • Affidavit duly attested by Public Notary.
   • Copies of educational qualification certificates (Attested)
   • Attested copy of registration certificate and its renewal issued by U.P. Pharmacy Council.
   • Two photographs per applied license.
   • Address proof.
   • Appointment letter and joining letter
6. Documents related to qualified person (for Wholesale license):
   • Attested copies of educational qualification certificates
   • Experience certificate on the affidavit
   • Two photographs per applied license
   • Appointment letter and Joining letter if applicable
   • Three copies of the plan of proposed premises.
7. Documentary proof of rental or ownership basis of the proposed premises
   • Photocopy of the rental agreement in case of rented premises.
   • Attested copy of ownership proof of rented premises from the landlord.
8. Two photographs of Proprietor/Partners/Authorized person.
9. Attested copy of purchase invoice of a refrigerator