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

Updated on November 26, 2022 04:03:16 PM

For any Individual/Corporate/Partnership Firms etc , it is mandatory to obtain a valid Drug Licence from concerned State Authorities (Drugs Control Department). The provisions for this has been made in Drugs and Cosmetic Act 1940 and Rules 1945 applicable in India.

Basic pre-requisites for a Drug License

  • Minimum area of the Office/Shop.
  • Granted in the commercial premises or other premises independent of residence.
  • Refrigerator or Air Conditioner on the premises.
  • Needs to comply with the conditions of licence of the issuing Authority.
  • Displayed at premises of business.A technical staff :- A registered pharmacist or competent person with same line experienced as approved by the Department if Drug Control.

Drug License Certificate Sample

  • Form-20B
  • Form-21B
Drug License Certificate Sample
Drug License Certificate Sample

Conditions for obtaining Drug License in India

conditions for obtaining drug license in india

Minimum Area & Height of Premises

The minimum area of 10 square meter is required to start a medical shop or pharmacy or wholesale outlet. In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meter is required.
The clear height of the premises should be in accordance with the National Building Code of India, 2005 as amended from Time to Time.

Storage Facility

Must have refrigerator & air conditioner in the premises. According to the labeling specifications certain drugs like vaccines, Sera, Insulin Injections etc., are required to be stored in the refrigerator.

Phamacist / Competent / Technical Staffs

Manufacturing :- for an Drug manufacturing unit there must be Technical Staff at manufacturing and Technical Staff for testing as well.

Wholesale :– The sale of drug by wholesale shall be made either in the presence of registered pharmacist or in the presence of a competent person who shall be a graduate with 1 yr experience in dealing in drugs or a person who has passed S.S.L.C with 4 years experience in dealing in drugs, specially approved by the department of drug control for the purpose.

Retail :– The sale of drug by retail must be made in the presence of registered pharmacist approved by the department, Registered pharmacist is required throughout the working hours.

Commercial Premises

Licences for the sale of drugs can be granted only at premises that is commercial premises or premises independent of residence. For this purpose state drug office issues guidance which may be referred to.

Location Based License

If drugs are sold or stocked for sale at more than one place, a separate license is needed in respect of each such place. Similarly, in case of manufacturer, a separate license is required to manufacture same or different drugs but at different location

License for Each State

In case a business is operating in more than two states, it has to obtain drug licence in every state in which business is being carried on. Drug licence is location specific, and hence within state application, all site must be included.

Importer of Drugs or Cosmetics

Drugs and Cosmetic Act aims at ensuring safety, effectiveness and conformity of the drugs and cosmetics sold in India to the state quality standards. Drugs or cosmetics of schedule X can be imported into India only after obtaining a License

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Documents requirement for Drug License in India

  • The firm's constitution (MOA & AOA for Company and Partnership Deed for Firm/LLP)
  • For Retail & Wholesale license - Affidavit from the Regd. pharmacist/competent person
  • Property Paper ( Registry Deed/Lease Deed/POA in case of owned Property)
  • Board Resolution, List of Directors, Certificate of Incorporation ( in case of company)
  • The key plan and the site plan of the premises ( Blue Print).
  • One Invoice copy of Refrigerator/Air conditioner purchased for use
  • Copy of Rent agreement ( in case of rented premises)
  • Covering Letter stating purpose of the Application
  • ID proof of Directors/Partners/Proprietor
  • For Manufacturing - Affidavit from employer and or Technical Staff for full time working with the firm
  • For Manufacturing - List of Technical Staff and their proof of Education Qualification, Experience Certificate, Biodata, Appointment Letter, three photographs.
  • Incase of Retail License:- Registered Pharmacist's degree certificate, Registration certificate with State Pharmacy Council and Appointment Letter and Bio-data.
  • Incase of Wholesale License:- Competent person's degree certificate, Experience Certificate in medicine job and Appointment Letter and Bio-data.
  • For manufacturer - Affidavit of Non Conviction, List of Equipment and Machineries for manufacturing and List of Equipment Provided for Testing
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Drug License Registration process in India ( General Instruction)

process of drug license registration

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.

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Our Pricing

Drug License For Fees
Wholesale Rs. 39,999/-
Retail Rs. 44,999/-
Manufacturing Rs. 99,999/-

Get Free Consultation

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Our Service Package Inclusion in Drug License Registration

Consultation

First, Get Consultation from our Drug License Consultant to know the Drug License Rule, Documents Requirements, License Expenses, Renewal , Types of License applicability as per your business nature, etc.

Documentations

Drug License registration need various documents in support of application filing. Documents varies Region wise as well as business to business and type of Drug License. We prepare all required documents first.

Preparing Application

Once your documents is prepared, we starts preparing your application along.

our service package inclusion in drug license registration

Application Submission

Once your application is completed in all respect, we proceed to file with state Drug Control Authority.

Inspection assistance

We Assist client at the time of Inspection of premises by the Drug Inspector appointed by the Authority to check the Documents in Original and inspection of premises to ensure the particulars as mentioned in the applications is correct and premises fit for the drug business as per guidelines.

Registration Copy

The whole process of approval shall take upto 45 to 60 days by the Authority.

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Simple & Fast Process

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Process

Frequently Asked Questions (FAQs)

Is it necessary to obtain drug license prior to commencement of the drug business?

Yes, before you start any business dealing in drugs, whether it is Allopathic Drugs, Ayurvedic Medicine, Homeopathy or Unani, to manufacture, distribute or sell the drugs It is mandatory to obtain a license as per the nature of business by applying to the controller of the drugs and cosmetics

What are different types of Licenses Issued for the Pharmaceutical Business?

Based on the requirement of the pharmaceutical business, an applicant must apply for issue of specific drug license. There are various licenses, for example,

  1. Drug Manufacturing License,
  2. Wholesale Drug License,
  3. Retail Drug License,
  4. Import of Drugs or Cosmetics,
  5. Import of Medical Equipment,
  6. Export of Medicines etc.
Is it true that for grant of a drug license my shop must be located at a commercial premises?

Licenses for the sale of drugs can be granted only at premises which is commercial premises or other premises independent of residence, also known as mixed land use. For this purpose state drug office issues guidance which may be referred to.

Do I have to apply and seek separate drug license for Branches of My Pharmaceutical Business?

In case a business is operating in more than two states, it has to obtain drug license in every state in which business is being carried on. Drug licence is location specific, and hence within state application, all site must be included.

How to import Drugs or Cosmetics?

Drugs and Cosmetic Act aims at ensuring safety, effectiveness and conformity of the drugs and cosmetics sold in India to the state quality standards. Drugs or cosmetics of schedule X can be imported into India only after obtaining a License