ONLINE CA SERVICES LOGO

Drug License Registration in India

629382e030fb025780ee2963

Get Free Consultation

Drug License Registration in India at glance - Process, Documents Required

For individuals, corporations, or partnership firms engaging in the sale or distribution of drugs, it is mandatory to secure a valid Drug License from the respective State Authorities, such as the Drugs Control Department. The legal framework for this requirement is established under the Drugs and Cosmetics Act of 1940 and the Rules of 1945 in India.

To obtain a Drug License, certain fundamental prerequisites must be met:

1. Sufficient Office/Shop Area: The premises where the business operates should have an adequate space to accommodate the storage, sale, and distribution of drugs.

2. Commercial Premises: The office or shop should be situated in a commercial area, separate from residential spaces.

3. Refrigeration or Air Conditioning: The premises must have appropriate refrigeration or air conditioning facilities to maintain the required temperature for storing temperature-sensitive drugs.

4. Compliance with Licensing Conditions: The business must adhere to the terms and conditions specified by the issuing drug control authority.

5. Display of Drug License: The valid Drug License must be prominently displayed at the business premises for easy identification and verification by the concerned authorities.

6. Technical Staff: Employing a registered pharmacist or a competent person with relevant experience, approved by the Drug Control Department, is necessary to ensure proper management and adherence to regulatory guidelines.

Meeting these basic requirements and obtaining a Drug License from the State Drugs Control Department is crucial for adhering to legal obligations and maintaining the quality and safety of drugs in the market.

Form 20B

Conditions for obtaining Drug License in India

To establish a pharmacy or medical shop, adhere to the following requirements:

1. Minimum Premises Area: A minimum area of 10 square meters is required for a medical shop or pharmacy, while a combined retail and wholesale business needs at least 15 square meters.

2. Clear Height: The premises should meet the clear height requirements as per the National Building Code of India, 2005, as amended from time to time.

3. Storage Facility: Ensure your premises have refrigerators and air conditioners to store drugs as per labeling specifications. Certain drugs, like vaccines, Sera, Insulin Injections, etc., must be stored in refrigerators.

4. Technical Staff:

a. Manufacturing: Employ both technical staff for manufacturing and technical staff for testing.
b. Wholesale: Conduct sales in the presence of a registered pharmacist or a competent person with at least one year of experience in dealing with drugs or a person with an S.S.L.C. degree and four years of experience in dealing with drugs, approved by the Drug Control Department.
c. Retail: A registered pharmacist must be present throughout the working hours.

5. Commercial Premises: Obtain licenses for drug sales only at commercial premises or premises independent of residential spaces. Refer to the guidance issued by the state drug office for clarification.

6. Location-Based License: If your business operates at multiple locations, secure a separate license for each place.

7. State-Wise Licensing: In case your business operates in more than two states, obtain a drug license in every state where operations are carried out. Drug licenses are location-specific, and within-state applications should include all sites.

8. Import License: For importers of drugs or cosmetics, the Drugs and Cosmetics Act ensures the safety, effectiveness, and conformity of products to state quality standards. To import Schedule X drugs or cosmetics into India, obtain a license specifically for this purpose.

Documents requirement for Drug License in India

Drug License Registration process in India ( General Instruction)

Login ID and Password

Applicant has to obtain user ID and Password by giving request letter in person with the details of the firm.

Online Application

Please be sure that, all the information is filled precisely for respective application mentioned below and only then e-send the application. In case of rejection of your application for incomplete information, the fees once paid will be forfeited.

Upload Documents

All the documents should be scanned in 100 dpi & black and white, and then should be uploaded using the said ID and Password at space provided for the purpose. The licensing authority may ask for any other specific documents if required.

Physical Inspection

Show all the original documents to the inspector at the time of inspection. Inspector may ask you any further documents relevant to your application.

Approval/Rejection

After grant or rejection of your application, you will receive an SMS about the same. Take a print out of the approval/rejection from ‘Print License’ option for fresh license and renewal and click ‘MISC approvals’ for other approvals within 3 days. You will receive licenses/approvals with the valid e-signature and official seal.

Change in constitution

If the proprietor/ partner are changed, it will be treated as ‘change in constitution’ and applicant will have to obtain a fresh license.

Separate Password for Pharmacists

Registered Pharmacists are also required to update their details by obtaining separate password.

Our Pricing

Drug License ForFees
WholesaleRs. 24,999/-
RetailRs. 34,999/-
ManufacturingRs. 49,999/-

Note: The aforementioned Fees is exclusive of GST.

Why Taxvilla

g1

Complete Digital

g2

Free Expert Assistance

g3

Best Price Guarantee

g4

4.9/5 Google Rating

g5

Money Back Guarantee

g6

Simple & Fast Process

Scroll to Top