Know the Complete List of Items for Drug License

Know the Complete List of Items for Drug License
| Updated: Feb 12, 2021 | Category: Drug, Government

In India, if any individual wants to start a business in Drugs and Cosmetics, then it is mandatory to get a Drug License, but before applying for a Drug License, you must know the complete list of items for Drug license such as essential documents, prerequisites, list of application forms, procedure, etc. The registration process for drug license is done under the Drugs and Cosmetics Act, 1940. The provisions of this Act deals with the Drug License and other rules & regulations regarding such business, and this License is needed based on the business transaction of a specific business. Scroll down to check more information regarding the complete list of items for Drug License in India.

What are the Features and Classification of Drug License?

Following is the list of different features of Drug License in India:

  • This License is compulsory for Drugs and Cosmetics Business in India.
  • This License should be displayed at the noticeable place of premises.
  • License for the sale of drugs can be allowed in the commercial areas or other areas independent of residence.
  • Every Cosmetic and Drug business require to comply with the conditions of the License.

Following is the classification of Drug License:

classification of Drug License

Drug License is divided under five different categories, and you can check the same below:

  • Sale License: This License is issued for the drugs sale, and it has the following bifurcations:
  1. Retail Drug License.
  2. Wholesale Drug License.
  3. Restricted Drugs.
  • Import License: This License is only for the import of the drug.
  • Manufacturing License: This License is issued to a business who manufactures drugs inclusive of Homeopathy or Allopathic Medicines.
  • Loan License: This License is issued to a business that doesn’t own the manufacturing unit but uses the manufacturing facilities of another license.
  • Multi-Drug License: That License is for those businesses who own a pharmaceutical shop in multiple states with a similar name.

Also, Read: Complete Process to Apply for Wholesale Drug License in India

Requirements for Obtaining a Drug License: List of Items for Drug License

This also comes in the complete list of items for Drug license; without this, you are not able to apply for a license:

  • Storage Facility: Some drugs need to be stored in a low temperature, air conditioners, and refrigerators are a must.
  • The requirement for Space: The other important requirement for obtaining a drug license is space that is the area of the unit or pharmacy:
  1. For Retail License and Wholesale License – 15 square meters required.
  2. In all other situations- 10 square meters required.
  3. The height of the sale premises should be as per the guidelines prescribed under the National Building Code of India, 2005.
  • Pharmacist Individual: The Pharmacist must be well-educated or qualified in the case of a retail business where in case of wholesale business, the individual must be an undergraduate with four years of experience or graduate with one year of experience.

What are the Essential Documents Required for Obtaining a Drug License in India?

When it comes to the complete list of items for Drug License, the documents come in the first place without any proper documentations nobody can attain a Drug License in India:

  • Submit a copy of MOA (Memorandum of Association), AOA (Articles of Association) for a company.
  • Submit Partnership Deed, LLP Agreement in case of LLP and Partnership.
  • Submit any Identity proof of all the proposed director or partner or proprietor such as Aadhar Card, Voter’s Id, Passport, PAN Card, Driving License, etc.
  • Submit a copy of ownership proof or property or a rental agreement in case of rented premises.
  • Layout and key plan of the premises.
  • Submit a copy of Board Resolution allowing obtaining a license.
  • Availability proof of storage space such as refrigerator, cold storage, etc.
  • For a pharmacist at a retail sale and wholesale:
  1. Qualification Proof.
  2. Appointment Letter.
  3. Registration of Local Pharmacy Council.
  • An affidavit from the registered Pharmacist.
  • Copy of challans as proof of depositing fee.
  • Affidavit regarding non-conviction of proprietorship or director or partner and the firm.

Documents Related to registered Pharmacist:

  • Copy of Certificate of Registration from Pharmacy Council.
  • Original affidavit of Pharmacist.
  • Latest passport size photographs.
  • Proof of electricity accessibility on the premises.
  • Copy of Diploma Pharmacy. Copy of Renewal of Registration if applicable.
  • Submit the original certificate of experience in dealing with drugs from authorized persons.
  • Copy of Joining Letter and Appointment Letter.
  • Copy of education certificate including High School Certificate.

Different Types of Application Forms

There are several types of application forms, and this also comes under the complete or essential list of items for Drug License:

  • Form 19.
  • Form 19A.
  • Form 19B.
  • Form 19C.
  • Form 24.
  • Form 24A.
  • Form 24B.
  • Form 24C.
  • Form 24F.

Process of Obtain a Drug License in India

Following is the process to obtain a Drug License and to complete the list of all the items for Drug License:

  • An individual must apply for the License online as per the business requirements for which he or she must have a valid contact number and email Id.
  • After that, the applicant must keep all the essential documents updated.
  • Then you need to upload all the vital documents and the form along with the application fees.
  • Once you completed the online process, an inspector will go to the site and verify all the document’s validity.
  • Once you have finished all the steps, the authority will issue the drug license certificate.

Conclusion

Drug license is essential in the pharmaceutical business of India. All its prerequisites are to be fulfilled in order to get this License. Operating without this can invite penal actions; therefore, the above mentioned Complete List of Items for Drug License should be adhered to. If anyone wants to establish or start a business-related Drugs and Cosmetics in India, then you can call Swarit Advisors. Our experts will help you obtain drug licenses and explain all the complete list of items for drug license.

Also, Read: How to get a Drug Distribution License in India?

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A legal writing enthusiast, a wanderer, and a zealous reader. After gaining a lot of knowledge about the diverse legal topics and developing research skills, Karan joined the league of legal content writers to deliver quality-rich blogs.

 

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