Sale Licenses – Drug and Homoeopathic

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Last Updated on May 13, 2024 by The Health Master

Sale Licenses – Drug and Homoeopathic

Apply online on ONDLS, click here

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.

Documents-required-for-obtaining-license-for-sale-of-drugs

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.

Form-and-Fee-for-obtaining-license-for-sale-of-drugs

Forms

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

Form 19

Form 19A

Form 19 AA

Form 19B

Form 19 C

Click for all other application forms

Procedure for obtaining drug sale license

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

Procedure-for-obtaining-drug-sale-license

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-Allopathic-Drugs

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.

License-conditions-for-Homeopathic-Medicines

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

Apply online on ONDLS, click here

Schedule H, H1 & H2 drugs

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

Schedule-H

Schedule-H1

Schedule-H2

To read / download all Schedules

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

License fee structure for all licenses

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

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	3000/-	3000/-	2%	300/-	–
Retail sale	19	20 & 21	-do-	-do-	-do-	-do-	–
Homeopathic (WSDL)	19-B	20-D	250/-	20-E	50/-	150/-	–
Homeopathic (RSDL)	19-B	20-C	250/-	20-E	50/-	150/-	–
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	7500/-	7500/-	2%	1000/-	300/-
Manufacturing (Biological)	27	28	7500/-	7500/-	2%	1000/-	300/-
Manufacturing Schedule X	24 F	25 F	7500/-	7500/-	2%	1000/-	300/-
License for Test / Analysis	29	30	250/-	Valid for 3 years. Renewal for 1 year	–	–	–
Loan License (Biological)	27-A	28-B	7500/-	7500/-	2%	No	300/-
Loan License (Non- Biological)	24-A	25-B	7500/-	7500/-	2%	No	300/-
LVP	27-D	28-D	7500/-	7500/-	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	5000/-	5000/-	2%	–	500/-
Medical Devices (Loan License) (A& B)	MD-4	MD-6	5000/-	5000/-	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	7500/-	26-G	1000/-	No	300/-
Homeopathic Mfg License	24-C	25-C	300/-	26-C	100/-	50/-	50/-
Approval of Commercial testing Lab	36	37	7500/-	7500/-	2%	–	–
Repacking Non-Biological	24-B	25-B	700/-	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:

Specimen-performa-for-name-change-of-the-firm

License Retention Fee for Medical Store / Pharmacy

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

Specimen-perform-for-information-of-submitting-License-Retention-Fee

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:

Specimen-letter-for-cancellation-of-license

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.