Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on November 29, 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
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)
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:
Fee structure: All types of drugs licenses:
License fee structure for all licenses
| Types of Licenses | Application Form | License on Form | Fee | Renewal / Retention fee | Late fee | Duplicate license | Fee per item |
| Drug Sale Licenses | |||||||
| Whole Sale | 19 | 20-B & 21-B | 3,000/- | 3,000/- | 2% | 300/- | – |
| Retail sale | 19 | 20 & 21 | 3,000/- | 3,000/- | 2% | 300/- | – |
| Homeopathic (WSDL) | 19-B | 20-D | 2,000/- | – | – | – | – |
| Homeopathic (RSDL) | 19-B | 20-C | 2,000/- | – | – | – | – |
| Sch. X (WSDL) | 19-C | 20-G | 500/- | 500/- | 2% | 150/- | – |
| Sch. X (RSDL) | 19-C | 20-F | 500/- | 500/- | 2% | 150/- | – |
| Drug Manufacturing Licenses | |||||||
| Manufacturing (Non- Biological) | 24 | 25 | 7,500/- | 7,500/- | 2% | 1,000/- | 300/- |
| Manufacturing (Biological) | 27 | 28 | 7,500/- | 7,500/- | 2% | 1,000/- | 300/- |
| Manufacturing Schedule X | 24 F | 25 F | 7,500/- | 7,500/- | 2% | 1,000/- | 300/- |
| License for Test / Analysis | 29 | 30 | 250/- | Valid for 3 years. Renewal for 1 year | – | – | – |
| Loan License (Biological) | 27-A | 28-B | 7,500/- | 7,500/- | 2% | No | 300/- |
| Loan License (Non- Biological) | 24-A | 25-B | 7,500/- | 7,500/- | 2% | No | 300/- |
| LVP | 27-D | 28-D | 7,500/- | 7,500/- | 2% | No | 300/- |
| Cosmetics Manufacturing Licenses | |||||||
| Manufacturing | COS 5 | COS 8 | 10,000/ | 10,000/- | 2% | – | 500/- |
| Loan License | COS 6 | COS 9 | 10,000/ | 10,000 | 2% | 500/- | |
| Laboratory | COS 22 | COS 23 | 1,000/- | 1,000/- | 2% | 100/- | – |
| Additional Section | – | – | 10,000/ | – | – | – | – |
| Free Sale | – | – | No fee | – | – | – | – |
| Medical Devices Manufacturing Licenses | |||||||
| Medical Devices (A& B) | MD-3 | MD-5 | 5,000/- | 5,000/- | 2% | – | 500/- |
| Medical Devices (Loan License) (A& B) | MD-4 | MD-6 | 5,000/- | 5,000/- | 2% | – | 500/- |
| Medical Devices (C& D) | MD-7 | MD-8 | 50,000/- | 50,000/- | 2% | – | 1,000/- |
| Medical Devices Loan License (C& D) | MD-9 | MD-10 | 50,000/- | 50,000/- | 2% | – | 1,000/- |
| Registration of Medical Devices Laboratory | MD-39 | MD-40 | 20,000/- | 20,000/- | 2% | – | – |
| Sale License | MD-41 | MD-42 | 3,000/- | 3,000/- | 2% | – | – |
| Free Sale certificate | 1,000/- for each category |
| Other Licenses | |||||||
| Blood Centre | 27-C | 28-C | 7,500/- | 26-G | 1,000/- | No | 300/- |
| Homeopathic Mfg License | 24-C | 25-C | 2,000/- For any no. of single ingredient | – | – | – | 200/- Per product of combination |
| Approval of Commercial testing Lab | 36 | 37 | 7,500/- | 7500/- | 2% | – | – |
| Repacking Non-Biological | 24-B | 25-B | 700/- | 700/- | 2% | 1,000/- | 100/- |
Compiled by:
Lalit Kr. Goel, DSDC, FDA Haryana
Rakesh Dahiya, SDCO, FDA Haryana
Download fee structure
Click below link to download the fee structure of all types of drug licenses
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 Dahiya, SDCO 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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