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

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.

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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 12th?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)

Compiled by:

Rakesh Dahiya,?SDCO cum Licensing Authority,?FDA Haryana

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