Drug License

Drug license refers to According to the Drugs and Cosmetic Act, all the medicines and devices that are made for the utilization of humans and animals internally and externally may be a drug. All those substances come under the drugs category that's used for diagnosis, treatment, and prevention of disease. Ayurvedic and Unani drugs were included within the Act in 1964 through an amendment.

Types of Drug License

To carry out a pharmaceutical business, you would like the subsequent sorts of licenses.

Manufacturing License
  • Businesses handling the manufacturing of allopathic and homoeopathic medicines are granted a producing license.
Sale License
  • Pharmacies handling the sale of the drugs are issued sale license. you'll get three sorts of sale license-wholesale drug license, Retail Drug license, and restricted drugs.
Loan License
  • This drug license is issued to a business that doesn't have its own manufacturing setup but uses the facilities of another licensee.
Import License
  • A license granted for the import of medicine is an import license.
Multi-Drug License
  • This drug license is given to the medical stores having many shops in various states with a standard name.

Requirements for Obtaining a Drug License

Pharmacist:
  • A pharmacist may be a professional with a degree in pharmacy. you would like to possess an affidavit from a registered pharmacist. Drug license for a medical store are often given to a competent person with a graduate degree and 1-year experience.
Space:
  • You would like to supply an area not but 15 square meters for getting a retail/wholesale drug license.
Storage:
  • Medicines need specific storage facilities. So you ought to have proper storage facilities like refrigerators and air conditioners.

Documents Required for The New Application of Retail/Wholesale Drug License

  • MOA for a company/partnership deed/LLP agreement
  • ID proof
  • Property papers or the rental agreement of the premises
  • Site plan
  • Proof of proper storage
  • Copy of Board resolution
  • Proof of depositing fee/Challan copy
  • Affidavit of non-conviction
  • Affidavit form a registered pharmacist
  • Pharmacist's proof of qualification, registration, and appointment letter in case of retail drug license
  • Pharmacist's proof of qualification, experience certificate, and appointment letter in case of retail drug license

Documents Required for The Application of Additional Retail/Wholesale License

  • Drug application form generated from the system for relevant drug sale
  • Affidavit of non-conviction
  • Proof of qualification of the pharmacist
  • Pharmacist's registration with Delhi Pharmacy council
  • Appointment letter and Bio-data of Pharmacist
  • A system-generated affidavit
  • Online drug license fee deposit receipt.

Documents Required for Application of Renewal of Retail/Wholesale License

  • A drug application form is generated from the system for a relevant drug sale.
  • Conversion charge receipt is given by MCD.
  • Online drug license fee receipt.

Documents Required for Change in Pharmacist

  • Certificate of qualification
  • Experience certificate
  • Appointment letter and Bio-data
  • Affidavit by a competent person

Documents Required for Addition/Reduction in Premises

  • Revised documents of the space
  • Registered sale deed for owned space
  • Rent receipt/agreement for rented space
  • Changed site plan
List of Drug License Application Form
Sr.No Form Purpose
1 Form 19 It is an Application for issuing or renewing a drug license to sell or distribute drugs. Drug license form 19 does not include the drugs listed in schedule X.
2 Form 19A It is an Application for issuing or renewing a restricted drug license to sell, stock, or distribute by retail. It is done by those dealers who don't engage the service of a qualified individual.
3 Form 19B It is an Application for a drug license to sell, stock or distribute Homoeopathic medicines.
4 Form 19C It is an Application for granting or renewing a drug license to sell, stock, and distribute drugs listed in Schedule X.
5 Form 24 It is an Application for granting or renewing a drug license to manufacture for sale or for distribution of drugs. The drugs listed Schedule C, C (1) and X cannot be sold.
6 Form 24A It is an Application for granting or renewing of a loan drug license to manufacture or distribute the drugs. The drugs listed Schedule C, C (1) and X cannot be sold.
7 Form 24B It is an Application for granting or renewing of a licensee to repack for sale or distribution. The drugs listed Schedule C, C (1) and X cannot be sold. 
8 Form 24C It is an Application for granting or renewing a drug license to manufacture and distribute homoeopathic medicines. 
9 Form 24F Application for permitting or renewing of a drug license to manufacture or distribute drugs listed in Schedule X. Drugs listed in Schedule C and C(1) cannot be sold. 
10 Form 27 Application for granting or renewing a drug license to manufacture or distribute drugs listed in Schedule C and C (1).
The Time Frame for Drug License Application Approval
Process Time Period
For grant of licenses for the sale of drugs or application disposal 35 Days
For change/ addition/deletion of a registered pharmacist 60 Days
For change/addition/deletion of competent person 90 Days
For grant of sale licenses for homoeopathic medicine of application disposal 90 Days
For grant of sale licenses for allopathic medicine or application disposal 35 Days
For grant of sale licenses for drugs listed in schedule X or application disposal. 35 Days
For Drug Manufacturing License
  • 75 days are required to grant a license for the manufacturing of drugs or cosmetics. The time frame is counted from the date of receipt of the application. 

How to Apply for A Drug License

You can apply for a drug license online. Follow these steps to fill the drug license application form.

  • Go to the food safety and drug administration website of the state. Register yourself with an ID and password. Now, login and fill the online drug license application form. Pay the government fee and upload scanned copies of the documents needed.
  • On receiving the application, the drug inspector will plan a visit to verify the documents and the premises.
  • If verification is successful and all the documents are found to be correct then the drug license is issued. 
  • Download drug license online with valid e-signatures and official seal from the website. 

E- Payment of Drug License

Step 1:
  • Visit the e-payment websites of the states. 
Step 2:
  • Select the department as drug control and select the type of license. 
Step 3:
  • Enter your details in the payment gateway.
Step 4:
  • Click the submit button and proceed with payment.  

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