D. pharma license Uttar Pradesh-2023

Pharmacy Council of India

Uttar Pradesh Drug License-2023

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. In this article, we look at the procedure and various other aspects to obtain Uttar Pradesh Drug License for sales and manufacture in detail.

Fees

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.

License Conditions – 2022,2023

• 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.”
  

  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

Requirements for Uttar Pradesh Drug Sales License

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

Renewal of Drug Sales License

Renewal of Sale license should be made on the application form same as the form submitted during the grant of the new license along with the necessary fee. The Fee for the renewal of the license is same as the grant of license. The late fee for the renewal of the license is as follows that is applicable up to six months.

Documents Required for Renewal

• Copy of last renewal
• Affidavit of Pharmacist and current rent agreement
• Address proof of the authorized proprietor/applicant
• Affidavit of the liable person for day-to-day working and for any violation of drug laws

Uttar Pradesh Drug License for Manufacture

Types of Manufacturing License

Late fee for Renewal

Per month

Documents Required

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

1. Affidavit of the following attested by Public Notary:-
   • Proprietor of the applicant firm, in case the firm is proprietorship firm.
   • All the partners, in case the firm is a partnership firm.
   • The person duly authorised by the Board of Directors of the Private Limited or Limited Company.
2. In case the applicant Company is a Private Limited or Limited Company, a copy of minutes of the Board of Directors
3. 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.
4. Attested copy of registration certificate from District Industries Centre if the applicant firm is a Small Scale Unit.
5. Partnership deed copy if partnership firm.
6. Address proof of the authorised applicant/proprietor ( Voter I.D, Driving license)
7. Documents for Manufacturing Chemist Employed (not applicable if the license is required on Form 37 for a testing laboratory):
   • Affidavit duly attested by Public Notary
   • Attested copies of educational certificates, experience certificates.
   • Attested copy of the letter of approval by State Drugs Controller.
   • Copy of consent letter, appointment letter or joining letter.
   • Medical certificate from a registered medical practitioner along with the eye fitness certificate.
   • Four photographs per applied license
   • Address proof
8. Documents related to Analytical Chemist Employed:
   • Affidavit duly attested by Public Notary
   • Attested copies of educational certificates, experience certificates
   • Attested copy of the letter of approval by State Drugs Controller
   • Copy of consent letter, appointment letter or joining the letter
   • Medical certificate from a registered medical practitioner along with the eye fitness certificate.
   • Four photographs per applied license
   • Address proof
   • Attested copy of the consent of Approved testing laboratory that tests those raw materials and finished products which require sophisticated instruments for analysis
   • Three copies of the Plan of Premises showing all the sections and dimensions.
   • 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
   • Copy of No Objection Certificate from Pollution Control Board.
   • 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).
   • Copy of test report of water from a Government Approved Laboratory regarding its portability and freedom from pathogenic microorganisms

Processing Time

The license will be issued within 15 days from the date of submission of application online.

Application Procedure

The Food Safety and Drug Administration Department of Uttar Pradesh provides its citizen with the facility for applying online for Uttar Pradesh Drug License.

Easily register a company online through India Filings at just

Diploma in Pharmacy (Part-I and Part-II):-

    “5[Minimum qualification for admission to Diploma in Pharmacy Part-I course -A pass in any of the following examinations with Physics, Chemistry and Biology or Mathematics.

(1)     Intermediate examination in Science;

(2)      The first year of the three year degree course in Science,

(3)      10+2 examination (academic stream) in Science;

(4)   Pre–degree examination;

(5)    Any other qualification approved by the Pharmacy Council of India as equivalent to any of the above examination.

 Provided that there shall be reservation of seats for Scheduled Caste and Scheduled Tribes candidates in accordance with the instructions issued by the Central Govt. /State Govts./Union Territory Adman’s. as the case may be from time to time]

6. Duration of the course:-

The duration of the course shall be for two academic years with each academic year spread over a period of not less than one hundred and eighty working days in addition to 500 hours practical training spread over a period of not less than 3 months.

7.Course of study:-

The course of study for Diploma in Pharmacy Part-I and Diploma in Pharmacy Part-II shall include the subjects as given in the Tables I & II below. The number of hour devoted to each subject for its teaching in Theory and Practical, shall not be less than that noted against it in columns 2 and 3 of the Tables below.

The syllabi for each subject of study in the said Tables shall be as   specified in   Appendix A to these regulations.

9. Approval of the authority conducting the course of study:-

The course of regular academic study prescribed under regulation 7 shall be conducted in an institution, approved by the Pharmacy Council of India under sub-section (1) of Section 12 of the Pharmacy Act, 1948.

Provided that the Pharmacy Council of India shall not approve any institution under this regulation unless it provides adequate arrangements for teaching in regard to building accommodation, equipment and teaching staff as specified in Appendix-B to these regulations.

10. Examinations:-

There shall be an examination for Diploma in Pharmacy (Part-I) to examine students of the first year course and an examination for Diploma in Pharmacy  (Part-II) to examine students of the second year course . Each examination may be held twice every year. The first examination in a year shall be the annual examination and the second examination shall be supplementary examination of the Diploma in Pharmacy (Part-I) or Diploma in Pharmacy (Part-II), as the case may be. The examinations shall be of written and practical (including oral) nature, carrying maximum marks for each part of a subject, as indicated in Table III and IV below: –

*Internal assessment

11. Eligibility for appearing at the Diploma in Pharmacy Part-I examination:-

Only such candidates who produce certificate from the Head of the Academic institution in which he /she has undergone the Diploma in Pharmacy Part-I  course,  in proof of his /her having regularly and satisfactorily undergone the course of study by attending not less than 75% of the classes held both in theory and in practical separately in each subject shall be eligible for appearing at the Diploma in Pharmacy (Part-I) examination.

12. Eligibility for appearing at the Diploma in Pharmacy   Part-II examination:-

Only such candidates who produce certificate from the Head of the academic institution in which he/she  has undergone the Diploma in Pharmacy Part-II  course , in proof of his /her having regularly and satisfactorily undergone the Diploma in Pharmacy Part-II course by attending  not less than 75% of the classes held both in theory and in practical separately in each subject shall be eligible for appearing at the Diploma in Pharmacy (Part-II) examination.

13. Mode of examinations:-

1. 1. (1)  Each theory and practical examination in the subjects mentioned in Table-III & IV shall be of three hours duration.
   2. (2)  A Candidate who fails in theory or practical examination of a subject shall re-appear both in theory and practical of the same subject.
   3. (3)  Practical examination shall also consist of a viva-voce (Oral) examination.

14.³ [Award of Sessional   marks and maintenance of records::-

(1)  A regular record of both theory and practical class work and examinations conducted in an institution  imparting  training  for diploma in Pharmacy Part-I and diploma in Pharmacy Part II courses, shall be maintained for each student in the institution and 20 marks for each theory and 20 marks for each practical subject shall be allotted as sessional.

(2)   There shall be at least two periodic sessional  examinations during each academic year .The highest aggregate of any two performances shall form the basis of calculating sessional marks.

(3)   The sessional marks in practical’s shall be allotted on the following basis:-

(i) Actual performance in the sessional examination                 10marks

(ii) Day to day assessment in the practical class work              10marks.

15. Minimum marks for passing the examination: A student:-

shall not be declared to have passed Diploma in Pharmacy examination unless he /she secures at least 50% marks in each of the subject separately in the theory examinations, including sessional marks and at least 50% marks in each of the practical examinations including sessional marks. The candidates securing 60% marks or above in aggregate in all subjects in a single attempt at the Diploma in Pharmacy (Part-I) or Diploma in Pharmacy (Part-II) examinations shall be declared to have passed in first class the Diploma in Pharmacy (Part-I) or Diploma in Pharmacy (Part-II) examinations, as the case may be. Candidates securing 75% marks or above in any subject or subjects shall be declared to have passed with distinction in the subject or those subjects provided he/she passes in all the subjects in a single attempt.

16. Eligibility for promotion to Diploma in Pharmacy (Part-II):-

All candidates who have appeared for all the subjects and passed the Diploma in Pharmacy Part-I examination are eligible for promotion to the Diploma in Pharmacy Part-II class. However, failure in more than two subject shall debar him/ from promotion to the Diploma in Pharmacy Part-II class.

17. Improvement of sessional marks:–

Candidates who wish to improve sessional marks can do so, by appearing in two additional sessional examinations during the next academic year. The average score of the two examination shall be the basis for improved sessional marks in theory .The sessional of practical’s shall be improved by appearing in additional practical examinations. Marks awarded to a candidate for day to day assessment in the practical class can not be improved unless he /she attends a regular course of study again.

18.  Approval of examinations:-

The examinations mentioned in regulations  10 to 13 and 15 shall be held by an authority herein after referred to as the Examining Authority in a State , which shall be approved by the Pharmacy Council of India under sub-section (2) of section 12 of the Pharmacy Act, 1948. Such approval shall be granted only if the Examining Authority concerned fulfills the conditions as specified in Appendix-C to these regulations.

19. Certificate of passing  examination   for Diploma in Pharmacy  (Part-II):-

Certificate to having passed the examination for the Diploma in Pharmacy Part II shall be granted by the Examining Authority to a successful student.

TABLE-I

Diploma in Pharmacy (Part- I)

TABLE-II

Diploma in Pharmacy (Part-II)

No. of

hours of

Theory

No. of hours

of  Practical

75

100

100

75

75

50

50

–

75

–

75

    450

50

+275   =  725

² TABLE –III

DIPLOMA IN PHARMACY (PART-I) EXAMINATION

² TABLE-IV600

DIPLOMA IN PHARMACY (PART-II) EXAMINATION

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