Drug License

If you are planning to start a pharmaceutical business, the first thing you need to proceed with is a drug license. The government of India has strict laws for granting drug licenses to drug and cosmetic manufacturers and sellers. A drug license is a grant given by the authority under the Drugs and Cosmetics Act 1940. There are two types of licenses a pharmacy owner can apply for. They are retail drug licenses and wholesale drug licenses. With this drug license, you can sell a wide range of drugs that includes allopathic, homoeopathic, ayurvedic, and Unani drugs. 

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Meaning of Drugs

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

Types of Drug License

To carry out a pharmaceutical business, you need the following types of licenses. 

Manufacturing License

Businesses dealing with the manufacturing of allopathic and homoeopathic medicines are granted a manufacturing license. 

Sale License

Pharmacies dealing with the sale of the drugs are issued sale license. You can get three types of sale license-wholesale drug license, Retail Drug license, and restricted drugs. 

Loan License

This drug license is issued to a business that does not have its own manufacturing setup but uses the facilities of another licensee. 

Import License

A license granted for the import of drugs is an import license.

Multi-Drug License

This drug license is given to the medical stores having many shops in various states with a common name.

Requirements for Obtaining A Drug License

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

Documents Required for The Application of Additional Retail/Wholesale License

Documents Required for Application of Renewal of Retail/Wholesale License

Documents Required for Change in Pharmacist

Documents Required for Addition/Reduction in Premises

List of Drug License Application Form

SR.FormPurpose
1Form 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.
2Form 19AIt 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.
3Form 19BIt is an Application for a drug license to sell, stock or distribute Homoeopathic medicines.
4Form 19CIt is an Application for granting or renewing a drug license to sell, stock, and distribute drugs listed in Schedule X.
5Form 24It 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.
6Form 24AIt 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.
7Form 24BIt 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. 
8Form 24CIt is an Application for granting or renewing a drug license to manufacture and distribute homoeopathic medicines. 
9Form 24FApplication 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. 
10Form 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

ProcessTime Period
For grant of licenses for the sale of drugs or application disposal35 Days
For change/ addition/deletion of a registered pharmacist 60 Days
For change/addition/deletion of competent person90 Days
For grant of sale licenses for homoeopathic medicine of application disposal90 Days
For grant of sale licenses for allopathic medicine or application disposal35 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.

  1. 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.
  2. On receiving the application, the drug inspector will plan a visit to verify the documents and the premises.
  3. If verification is successful and all the documents are found to be correct then the drug license is issued. 
  4. Download drug license online with valid e-signatures and official seal from the website. 

E- Payment of Drug License

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