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All You Need to Know About Drug License in India

Every individual has the right to access medicines and drugs for their physical and mental well-being. The store that manages the distribution and sale of these drugs is called a drug store. If you plan to open a drug store in India, you will need to obtain a drug license for practicing your profession. 

Why Do You Need a Drug License?

Though drugs are primarily used for the betterment of health, they can often be misused. Irregular dosage, improper knowledge about proper application or intake, or addiction can lead to serious consequences. To prevent such occurrences, it is necessary for pharmacists and other medicinal retailers and wholesalers to possess a drug license. A drug license gives the person the right to sell and appropriately deal with medicines. Any individual or business that deals in drugs without a drug license is liable for imprisonment and/or fine payment.

According to the Drugs and Cosmetics Act of 1940, the government can check the quality of drugs sold in India. It also helps the government monitor the manufacture, sale, and distribution of drugs right from the beginning, where the raw material is sourced. The government also performs regular checks on medical stores and pharmacists who stock these medicines.

Different Types of Drug License

Just like there are different types of drugs, there are different types of drug licenses. Every pharmaceutical business in India must have the following drug licenses.

  1. Manufacturing license

This license is given to a business that manufactures drugs of any kind, including homoeopathic and ayurvedic. 

  1. Sale license

This drug license is issued to the individual or store selling the drugs. There are two types of sale licenses:

  • Wholesale license

This license is issued to a drug wholesaler. They sell drugs to a drug retailer and usually sell drugs on a large scale.

  • Retail license

This license is issued to a drug retailer. They buy drugs directly from the manufacturer or a wholesaler and sell directly to the customer. Retailers can sell to different types of customers like standalone customers, dispensaries, hospitals, medical colleges, research institutes, etc.

  1. Loan license

This drug license is issued to a company that uses the manufacturing unit of another licensed drug manufacturer.

  1. Import license

This drug license is issued to a dealer who imports drugs or the raw materials required for manufacturing the drugs.

  1. Multi-drug license

This drug license is issued to a business that owns pharmaceutical units with the same name in multiple states.

Requirements for Obtaining a Drug License in India

You have to fulfil the following requirements to get a drug license for a medical store in India:

  1. Pharmacist

A medical license is issued only to a registered pharmacist. The pharmacist should know the details of the retail business as well. For a wholesale business, a graduate with one year of experience or an undergraduate with four years of relevant experience can apply.

  1. Premises

A retail medical store needs to have a minimum area of 10 square metres. In the case of a wholesale medical store, the minimum area requirement is 15 square metres.

  1. Storage

The medical store or manufacturing unit must have proper storage facilities including cold storage and refrigerators. Medicines that do not need to be stored in a refrigerator also need to be stored safely without exposure to the sun.

  1. Staff

As the staff of a medical store will be dealing with patients and sick people, it is important to hire people who have experience in such matters. A graduate with at least a year of experience or an undergraduate with at least four years of experience is preferred.

A business dealing in medicines needs to consider the different licenses they will need for operating their business. A medical license is region-specific, that is, a medical store license in state A is valid only for that state. The business cannot operate in state B. 

Before obtaining a drug license, you need to be aware of all the terms and conditions you need to follow while running your establishment. Failure to follow these rules can get your medical store license revoked or suspended.

Regulatory Authority for Issuing a Drug License

The Drugs and Cosmetics Act, 1940 has mentioned the various drug controlling authority that is responsible for the safe manufacturing, distribution, and sale of drugs in India. They are as follows:

  1. State Drugs Standard Control Organisation (SDSCO)

This organisation issues licenses for the manufacture, distribution, and sales of drugs as regulated by the State.

  1. Central Drugs Standard Control Organisation (CDSCO)

This organisation issues licenses for newly manufactured medicines and cosmetics and also for clinical trials. It also monitors the quality of imported drugs and coordinates with the SDSCO for seamless drug distribution and sales.

  1. State Drug Controlling Authority and Central License Approving Authority

These two organisations work with each other to issue licenses for blood banks and other related products like vaccines, serums, etc.

  1. AYUSH department

AYUSH issues licenses for dealers in ayurvedic, Unani, Siddha, and homoeopathic medicines and cosmetics.

How to Apply for a Drug License?

If you wish to apply for a drug license, you must approach the regulatory authority that is responsible for it. You must apply to the respective drug controlling authority depending on the type of drug license you want. Each authority is responsible for different licenses. 

You must follow these steps to obtain a drug license:

  1. Visit the concerned authority

Once you have decided the type of pharmaceutical unit you are going to establish, visit the respective drug controlling authority for the drug license. This is an online process.

  1. Fill out the application form

Fill out the details asked in the application form correctly. 

  1. Upload relevant documents

Upload the documents and submit the application form with the fees. 

  1. Expect a visit from the drug inspector

Within 15 days of submitting your application online, the Drug Licensing Authority will receive your application. A drug inspector will come and inspect your premises, storage facilities, and staff. They will also check your documents.

  1. Grant

Once the drug inspector visits and verifies your setup, you will receive your medical store license from the concerned authority.

Documents Required for Obtaining Drug License

You will require the following documents while applying for a drug license:

  1. Identity proof of proprietor/partner/co-founder/director, etc.
  2. Address proof of applicant and other members
  3. Educational qualification of the applicant
  4. Declaration form
  5. Constitution of the establishment, Memorandum of Association (MOA), Articles of Association (AOA), partnership deed, LLP agreement, etc.
  6. Premises ownership or rental agreement. If rental property, NOC (No Objection Certificate) from the landowner.
  7. Site plan of premises
  8. Proof of storage space availability
  9. Copy of Board resolution allowing you to obtain a drug license
  10. Copy of fee challan
  11. Affidavit from a registered pharmacist
  12. Cover letter in which the name and designation of the applicant are mentioned
  13. Affidavit of non-conviction of proprietor/partner/director under the Drugs and Cosmetics Act, 1940
  14. For a retail medical outlet pharmacist
    • Qualification certificate
    • Registration certificate
    • Appointment letter
  15. For a wholesale medical outlet pharmacist
    • Qualification certificate
    • Experience certificate
    • Appointment letter

List of Application Forms for Drug License Application

The Food Safety and Drug Administration (FSDA) Department of a state government issues and handles the rules and regulations related to drugs license. It receives and processes your application. The different application forms you need to fill out are:

Application NameDescription
Form 14AApplication from a buyer to test or analyse a drug under Section 26 of the Drugs and Cosmetics Act, 1940
Form 19Application for grant or renewal or drug license to sell, stock, or distribute drugs other than those mentioned in Schedule X
Form 19AApplication for grant or renewal of a restricted drug license to see, stock or distribute drugs by retail by dealers who do not hire or engage a qualified person
Form 19BApplication for drug license to sell, stock, or distribute homoeopathic medicines
Form 19CApplication for grant or renewal or drug license to sell, stock, or distribute drugs mentioned in Schedule X
Form 20Application for license to sell, stock, or distribute drugs by retail other than those mentioned in Schedule X
Form 20AApplication for restricted license to sell, stock, or distribute drugs by retail other than those mentioned in Schedules C, C (1), and X for dealers who do not hire or engage a registered pharmacist
Form 20BApplication for license to sell, stock, or distribute drugs by wholesale other than those mentioned in Schedules C, C (1), and X
Form 20CApplication for license to sell, stock, or distribute homoeopathic medicines by retail
Form 20DApplication for license to sell, stock, or distribute homoeopathic medicines by wholesale
Form 20EApplication for certificate of renewal of a license to sell, stock, or distribute homoeopathic medicines
Form 20FApplication for license to sell, stock, or distribute by retail drugs mentioned in Schedule X
Form 20GApplication for license to sell, stock, or distribute by wholesale drugs mentioned in Schedule X
Form 21CApplication for certificate of renewal of a license to sell, stock, or distribute drugs
Form 24Application for grant or renewal of a drug license to manufacture for sale or distribution of drugs other than those mentioned in Schedules C, C (1), and X
Form 24AApplication for grant or renewal of a loan license to manufacture for sale or distribution of drugs other than those mentioned in Schedules C, C (1), and X
Form 24BApplication for grant or renewal of a drugs license to repack for sale or distribution of drugs other than those mentioned in Schedules C and C (1), and excluding those mentioned in Schedule X
Form 24CApplication for grant or renewal of a drug license to manufacture for sale or for distribution of homoeopathic medicines or a license to manufacture potentised preparations from back potencies by licensees holding license Form 20C
Form 24DApplication for grant or renewal of a drug license to manufacture for sale or distribution of ayurvedic, Siddha, or Unani drugs
Form 24EApplication for grant or renewal of a loan license to manufacture for sale of ayurvedic, Siddha, or Unani drugs
Form 24FApplication for grant or renewal of a drug license to manufacture for sale or distribution of drugs mentioned in Schedule X but not mentioned in Schedules C and C (1)
Form 27Application for grant or renewal of a drug license to manufacture for sale or distribution of drugs specified in Schedules C and C (1) excluding those in part XB and Schedule X
Form 27AApplication for grant or renewal of a loan license to manufacture for sale or distribution of drugs mentioned in Schedules C and C (1) excluding those in part XB and Schedule X
Form 27BApplication for grant or renewal of a drug license to manufacture for sale or distribution of drugs mentioned in Schedules C, C (1), and X
Form 27CApplication for grant or renewal of license for operating a blood bank for processing whole blood and/or preparing other blood components
Form 27DApplication for grant or renewal of a drug license to manufacture for sale or distribution of large volume parenterals/sera and vaccines other than those mentioned in Schedule X
Form 27DAApplication for grant or renewal of loan license to manufacture for sale or distribution of large volume parenterals/sera and vaccine/recombinant DNA (R-DNA) derived drugs other than those mentioned in Schedule X
Form 27EApplication for grant or renewal of a license to manufacture blood products for sale or distribution
Form 27FApplication for grant or renewal of drugs license
Form 30Application for license to manufacture drugs to examine, test, or analyse
Form 31Application for grant or renewal of a loan license to manufacture cosmetics for sale or distribution
Form 31AApplication for grant or renewal of a loan license to manufacture cosmetics for sale or distribution
Form 36Application for grant or renewal of approval for testing drugs or cosmetics or raw materials used in manufacture thereof on behalf of the licensees for manufacture for sale of drugs or cosmetics
Form 44Application for grant or permission to import or manufacture new drugs or to undertake clinical trials
Form 3FApplication for grant of recognition to medical institutions
Form 3JApplication for blood storage centre

Conclusion

Obtaining a drug license in India is a pretty straightforward process. You need to be clear about what kind of pharma unit you want to run. Once you have decided, all you have to do is fill out the application form and get your unit verified by the drug inspector. With all the relevant documents in place, you can get a drug license easily to proceed with your business.

Frequently Asked Questions

Can I sell cosmetic products with a drug license?

Yes, you can obtain the appropriate drug license and sell cosmetics as well.

Do I require a drug license for a franchise medical store?

Yes, every medical enterprise requires a drug license. In addition to the drug license of the owner, you will need state-regulated drug licenses.

I run a medical store in Mumbai. Can I open one in Chennai too?

Before opening a store in Chennai, you will need to obtain a multi-drug license as well as the state-regulated license from Tamil Nadu.

How long is a drug license valid?

A drug license is valid for five years unless revoked or suspended by the drug controlling authority. You can renew it online by filling out the appropriate application form.

Can a doctor obtain a drug license?

Only a registered pharmacist can obtain a drug license. For retail and wholesale stores, the pharmacist should have a D. Pharm. or B. Pharm. Degree and registration certificate with the state pharmacy council. While for retail stores, the pharmacist needs no experience, for a wholesale store, the owner can be a graduate with one year of drug dealing experience or an undergraduate with four years of relevant experience.

What are the fees for a drug license in India?

The fees can range from INR 500 to INR 1,500 depending on the type of application, store, and location. There may be additional charges for obtaining lab tests, etc.