Procedure to obtain license for Medical Store / Pharmacy

How to start Medical Store / Pharmacy: Procedure

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Pharmacist Medical Store Pharmacy
Picture: Pixabay
SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
Rakesh Dahiya

Last Updated on January 3, 2024 by The Health Master

Sale Licenses – Drug and Homoeopathic

To download draft notification for e-Pharmacy, click here

Must read article for Registered Pharmacist (RP) : Crucial role of pharmacists in health care

Also read the article : How to keep your medicines safe

How to obtain license for Retail and/or Wholesale for Drugs and Homoeopathic medicines

Medical Store Pharmacy Medicine Pharmacist
Picture: Pixabay

For obtaining license for Retail and/or Wholesale for Drugs and Homoeopathic medicines, the list of documents required is provided below. Download the pdf file and prepare the documents accordingly.

List of Forms & Fee for obtaining the said licenses is provided below. Download the pdf file and prepare the Form accordingly and submit the required fee.

Forms

Download the below pdf files for various Forms which suits your requirement

Procedure for obtaining drug sale license

To download the procedure, how to obtain drug sale license, click below link

Submit your application (Online and / or hard copy) to Licensing Authority of your area after completing all the required documents. Procedure of submission of application may vary from State to State)

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License conditions for allopathic drugs

Conditions of licenses is to be maintained after obtaining the required licenses for Drugs. Download the pdf file for ready reference.

License conditions for Homeopathic medicines

Conditions of licenses is to be maintained after obtaining the required licenses for Homoeopathic medicines. Download the pdf file for ready reference.

Note: Requirements of some of documents and procedure for submission of application may vary from State to State


Schedule H, H1 & H2 drugs

Also read Schedule H, Schedule H1 & Schedule H2 drugs, click below links:

Schedule-H

Schedule-H1

Schedule-H2



Fee structure: All types of drugs licenses:

Download the pdf file for the license fee structure for all licenses under the Drugs and Cosmetics Act 1940 and the Rule framed thereunder. Click below link


Fees for various kinds of drugs Licenses under Drugs and Cosmetics Act 1940 & Rules 1945

Types of LicensesApplication Form License on Form FeeRenewal / Retention fee Late fee Duplicate licenseFee per item
Drug Sale Licenses
Whole Sale1920-B & 21-B3000/-  3000/-2%  300/-
Retail sale1920 & 21-do--do--do--do-
Homeopathic (WSDL)19-B20-D250/-20-E50/-150/-
Homeopathic (RSDL)19-B20-C250/-20-E50/-150/-
Sch. X (WSDL)19-C20-G500/-500/-2%  150/-
Sch. X (RSDL)19-C20-F500/-500/-2%150/-
Drug Manufacturing Licenses
Manufacturing (Non- Biological)24257500/-7500/-2%  1000/-300/-
Manufacturing (Biological)27287500/-7500/-2%  1000/-300/-
Manufacturing Schedule X24 F25 F7500/-7500/-2%1000/-300/-
License for Test / Analysis2930250/-Valid for 3 years. Renewal for 1 year
Loan License (Biological)27-A28-B7500/-7500/-2%  No300/-
Loan License (Non- Biological)24-A25-B7500/-7500/-2%  No300/-
LVP27-D28-D7500/-7500/-2%  No300/-
Cosmetics Manufacturing Licenses
ManufacturingCOS 5COS 810,000/10,000/-  2%500/-
Loan LicenseCOS 6COS 910,000/10,0002% 500/-
LaboratoryCOS 22COS 231,000/-1,000/-2%100/-
Additional Section10,000/
Free SaleNo fee
Medical Devices Manufacturing Licenses
Medical Devices (A& B)MD-3MD-55000/-5000/-2%500/-
Medical Devices (Loan License) (A& B)MD-4MD-65000/-5000/-2%500/-
Medical Devices (C& D)MD-7MD-850,000/-50,000/-2%1,000/-
Medical Devices Loan License (C& D)MD-9MD-1050,000/-50,000/-2%  1,000/-
Registration of Medical Devices LaboratoryMD-39MD-4020,000/-20,000/-2%
Sale LicenseMD-41MD-423,000/-3,000/-2%
Free Sale certificate  1,000/- for each category    
Other Licenses
Blood Centre27-C28-C7500/-26-G1000/-No300/-
Homeopathic Mfg License24-C25-C300/-26-C100/-50/-50/-
Approval of Commercial testing Lab36377500/-7500/-2%
Repacking Non-Biological24-B25-B700/-700/-2%1000/-100/-

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Change of name of Medical Store / Pharmacy

If you want to change the name of a Medical Store / Pharmacy (Retail sale or wholesale), you have to apply to Licensing Authority of your area.

To download specimen performa for applying for change of name of Medical Store / Pharmacy, Click below link:

License Retention Fee for Medical Store / Pharmacy

To download specimen performa for informing Licensing Authority regarding License Retention Fee for Medical Store/ Pharmacy, Click below link:

Change of premises of Medical Store / Pharmacy

If you want to change the premises of a Medical Store / Pharmacy (Retail sale or wholesale), you have to obtain new sale drug license before change the premise. You have to shift the drugs at new premises after obtaining the license.

Change in constitution of Medical Store / Pharmacy

If any change in constitution takes place of your Medical Store / Pharmacy (Retail sale or wholesale), you have to obtain new sale drug license within three months of the said change in constitution.

What is 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

No need to obtain new license in following situation:

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

For cancellation of license

If you want to cancel, your license of Medical Store / Pharmacy (Retail sale or wholesale), you have to write to License Authority of your area.

Documents required for cancellation of license:

  • Cancellation request letter
  • Original copies of licenses

To download a specimen letter for cancellation of license, click below link:

Procedure for disposal of drugs after cancellation of licence

Rule 66A.

1. After cancellation of license, he / she shall apply in writing to the licensing authority of the area for disposal of drugs, giving the following details, namely:

(a) the name and address of the firm to whom the drugs are proposed to be sold or supplied

(b) the names of drugs together with their quantities, batch numbers, the names and addresses of their manufacturers and the dates of their expiry

2. The licensing authority may, after examination of the particulars, if necessary, after inspection by an Inspector of the premises where the drugs are stocked, grant the necessary permission for their disposal.

How to change Pharmacist at Medical Store

How to change pharmacist at medical store, click here


Record keeping at Medical Store

Record keeping for Medical Store / Pharmacy, click here

Jan Aushadhi Store

How to start Jan Aushadhi Store: Procedure

Click below link to know the procedure How to start Jan Aushadhi Store

How to start Jan Aushadhi Store: Procedure

How to obtain retail drug license

How to obtain Jan Aushadhi License

How to change pharmacist at medical store

Good storage practice of medicines at Medical Store

Record keeping for Medical Store / Pharmacy

Self inspection of Medical Store :105 points

Duties of Retail Chemists / Medical Store / Pharmacy

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



Compiled by:
Rakesh DahiyaSDCO cum Licensing Authority, FDA Haryana


Expiry and shelf life of medicine: Must read

FAQs – on Notification: Marketer of drugs

FAQs – On ‘Good Night’, ‘All Out’, ‘Hit’ and ‘Harpic’ etc.

Crucial role of pharmacists in health care

Self audit of Medical Store :105 points

Record keeping for Medical Store / Pharmacy

How to change Pharmacist at Medical Store

Good storage practice of medicines at Medical Store

Duties of Retail Chemists / Medical Store / Pharmacy

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

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