Articles -Pharma & Cosmetics

FAQs – on Medical Store / Pharmacy (Retail sale or Wholesale)

Rakesh Dahiya

November 13, 2021

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Rakesh Dahiya

SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com

FAQs – on Medical Store / Pharmacy (Retail sale or Wholesale)

Q 1. What is the area required for Medical Store / Pharmacy (Retail sale or Wholesale) ?

Ans: Ares required for Medical Store / Pharmacy (Retail sale or Wholesale):
Not less than 10 Sq. Mtr : For Retail sale or Wholesale (any one)
Not less than 15 Sq. Mtr : For Retail sale and Wholesale both
Note: This area means carpet area of the premises only, walls not included in it.

Q 2. If Retail sale license is already there, can wholesale license be obtained at the same premises ?

Ans: Yes, Wholesale license can be obtained at the firm already having Retail sale license if area is 15 Sq. Mtr.

Q 3. Is separate license for Homoeopathic is required if Retail sale license is already there ?

Ans: No. Separate license for Homoeopathic medicine is not required if Retail sale is already there at the firm.

Q 4. Is separate license for Homoeopathic is required if Whole sale license is already there ?

Ans: Yes. Separate license for Homoeopathic medicine is required if Whole sale is already there at the firm.

Q 5. Whether Experience person may be considered as Registered Pharmacist ?

Ans: No. Experience Person is only for Wholesale only. Registered Pharmacist is for both Wholesale or Retail sale.

Q 6. What is Qualification and experience for approval of Experience Person ?

Ans:
Matriculation or equivalent: Four years experience in dealing with sale of drugs.
Degree (Graduation): One year experience in dealing with drugs.
Note: If anyone is 12^th pass or in between matric and Graduation, then four years experience in dealing in sales of drugs is required.

Q 7. When Registered Pharmacist resigns, then what is the time limit for appointing a new Registered Pharmacist ?

Ans: New Registered Pharmacist should be appointed immediately after resignation of Registered Pharmacist of the frim.
Note: However the information may be given in the Drug office of your area within one month of such change)

Q 8. Is it mandatory to display “Chemist and Druggist” on a Medical Store ?

Ans: Yes. It is mandatory to display “Chemist and Druggist” on a Medical Store.

Q 9. Can drugs be shifted after applying for change of premises of Medical Store / Pharmacy (Retail sale or Wholesale) ?

Ans: No. Drugs can be shifted only after obtaining license after change in premises

Q 10. What is mean by change in constitution of Medical Store / Pharmacy ?

Ans: If any change in constitution takes place of your Medical Store / Pharmacy (Retail sale or wholesale), it is called change in constitution and a new sale drug license is to be obtained within three months of the said change in constitution.

It is considered to be a change in constitution, if following situation occurs:

Proprietorship firm to Partnership firm or Pvt. Limited firm or Limited firm
Partnership firm to Proprietorship firm or Pvt. Limited firm or Limited firm
Pvt. Limited firm to Limited firm
Note: In case of death of proprietor, new license is to be obtained

Q 11. Is there any need of applying for new drug license when change of Registered Pharmacist or change of any director ?

Ans: No. There is no need to apply for a new drug license in following situations:

In case of change of Registered Pharmacist
In case of change of Directors at Pvt. Limited or Limited firm

Q 12. What are the mandatary records to be maintained at Medical Store / Pharmacy (Retail sale or Wholesale) ?

Ans: The following records are mandatary:

Schedule H1 register (Retail sale)
Cash / credit memo (Retail sale and Whole sale)
Purchase record file (Retail sale and Whole sale)
(Must be maintained in chronological order)
Correspondence file (Retail sale and Whole sale)
(It is advised to maintain separate files for ready reference for each correspondence done with various departments, companies etc.)

Q 13. For how many time the records should be preserved at Medical Store / Pharmacy (Retail sale or Wholesale) ?

Ans: Sale / purchase records of drugs at Medical Store / Pharmacy (Retail sale or Wholesale) shall be preserved for a period not less than two years. Schedule H1 register shall be preserved for three years from the date of last entry.

Q 14. What is format for schedule H1 register ?

Ans; The following details must be there in the schedule H1 register:

Sr. No.
Date
Name and address of Prescriber
Name Customer / Patient
Name of drug
Batch no. of drug
Quantity of drug
Invoice No.

Q 15. What is format for cash / credit memo for Retail sale?

Ans; The following details must be there in the cash / credit memo:

Name of the firm
Address of firm
License No.
GST no. (if required),
Name & Address of Customer / Patient
Name & Address of Prescriber with Registration no. of Registered Medical Practitioner (RMP),
Sr. No. of memo
Date
Quantity of drug
Name of drug,
Batch no. of drug
Expiry date of drug
Name of manufacturer
Subtotal
Grand total
Signature of Registered Pharmacist.

Q 16. What is format for Sale cash / credit memo for Whole sale?

Ans; The following details must be there in the cash / credit memo:

Name of the firm
Address of firm
License No.
GST no. (if required),
Name & Address of the licensee / RMP / Institution
License No. of the licensee / Regn. No. of RMP
Name & Address of Prescriber with Registration no. of Registered Medical Practitioner (RMP)
Sr. No. of memo
Date
Quantity of drug
Name of drug,
Batch no. of drug
Expiry date of drug
Manufacturing company name
Subtotal
Grand total
Signature of Competent Person
(Registered Pharmacist or Experience Person)