Drug License Registration




Drug License

Having a Drug license is mandatory to carry out business in drugs & cosmetics in India under the Drugs & Cosmetics act, 1940. This act was to strengthen all the laws relating to drugs & cosmetics, which established the Drugs Control Department. A particular business entity based on their business may require different types of drug license






If a businessman is carrying out his business of drugs in more than two states than he has to obtain drug licenses in every state in which business is being carried out. In other words, if drugs are sold or stocked at more than one place than a license shall be issued for each place.

It is a permission granted by the competent authority under drugs & cosmetic act, 1940 to carry out business in Drugs/ medicines or cosmetics. Under this act, all types of business of drugs & cosmetics are covered including homeopathic, ayurvedic, allopathic or Unani drugs. It is the responsibility of all person engaged in this business to maintain the quality of drugs and cosmetics. If any harm is caused to the person who used or consumed the drug or cosmetic due to the negligence on the part of the manufacturer or the seller then they have to face the consequences set up by the authorities.

Documents required for Drug License

  • Proof of ownership of the premises

  • Rent agreement if premises is on rent

  • ID proof of proprietor, partner, director and the firm under Drugs and cosmetics act, 1940

  • The online fee deposit receipt

  • Appointment letter of a registered pharmacist

  • Proof of constitution of business like incorporation certificate, a competent person employed

  • Affidavit of registered pharmacist regarding full time working with the firm duly attested by Notary.

  • Site plan of premises to set up a pharmacy

Procedure for obtaining a Drug license

You can file the Drug license application directly with the government and the process requires 30-60 days to get completed

Step 1: Documentation

The preparation of documents is the most important step in obtaining a drug license. It includes preparation of the key plan, site plan, various affidavits and declarations as prescribed under the law.

Step 2: Filling the application

Application for drug license is filed online including the payment of government fee. All the documents required are scanned and uploaded at the time of filing the application.

Step3: Inspection

After filing the documents inspection is done. An inspector personally visits the shop in order to verify the documents and to verify whether the information provided is correct or not.

Step 4: Grant of License

After a successful inspection and in case a personal interview is called and is cleared by a competent person then the controller of drugs issues the Drug Licenses.

Types of Drug License

There are mainly two types of Drug license i.e. Retail Drug license and wholesale drug license

Retail Drug License: This license is generally for the pharmacy or chemist shops in your neighborhood primarily involved in the retail sale of medicines and cosmetics in India. In the case of Retail pharmacy/chemist shop a minimum of 10 sq. meters is required

Wholesale Drug License: If a person is involved in the wholesale activity of drugs and medicines, then he has to apply for wholesale drug license registration. For opening a wholesale business, a minimum area of 15 sq. meters is mandatory to get a drug license in India.

Resolve your queries

1. Where the licenses to manufacture drugs can be granted?

The licenses to manufacture drugs can be granted only in the recognized industrial areas of Delhi.

2. What is the minimum area of premises required for wholesale licenses?

The premises should have an area of not less than 15 sqr. mtrs.

3. What should be the location of the premises for obtaining a drug license?

License for the sale of drugs can be granted in the premises independent of residence or commercial premises.

4. What license is required for the sale of household medicines?

Licenses in form 20-A/ 21-Aa are required for the sales of restricted drugs usually old as household remedies. Services of registered pharmacists and prescription of the doctor are not required for the sale of such drugs.

5. What are the documents required for a drug license?

  • ID proof of proprietor, partner, director and the firm under Drugs and cosmetics act, 1940

  • The online fee deposit receipt

  • Appointment letter of a registered pharmacist

  • If the premise is on rent then ret agreement in such cases

  • Proof of constitution of business like incorporation certificate, a competent person employed

  • Affidavit of registered pharmacist regarding full time working with the firm duly attested by Notary.

  • Site plan of premises to set up a pharmacy.

6. Where the complaint is made about the quality of drugs and other violations?

A complaint about the quality of drugs can be made to the drug control department in writing.

7. What are the requirements to obtain a sales drug license for the chemist shop?

The applicant premises should have an area of not less than 10 sqr. Meters and should have proper storage facilities in order to preserve the properties of drugs.

8. What is the jurisdiction of the drug control dept. of Delhi?

Drugs control department deals with the problems relating to Delhi state only also known as National Capital Territory of Delhi.

9. What is a Loan License?

This license is for the applicant who does not have his own manufacturing but intends to avail of the manufacturing facilities owned by another license.

10. How much does a pharmacist earn in India?

Average pay of pharmacist is Rs. 101 per hour and Rs. 230,671 per year.





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