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Drug License

Drug License is a permission granted by the authority under the Drugs and Cosmetic Act in order to carry out a business of drugs/medicines or cosmetics. The Drug License is issued by the State Drugs Standard Control Organization or the Central Drug Standard Control Organization.

The drugs are used in the medicines, in a medically defined ratio to cure our health. Drugs come in use on a need basis, to ensure our well being. However such medicines are manufactured with very restricted and correct amount of the drugs and it does not harm the body.

However, any violation of the medically defined limits may have a very serious effect on the health of the person using it. Therefore it requires to be regulated by the government via imposing stringent law and regulations in the process of manufacturing and distribution of drugs and medicines in India. Once you have Drug License from the government, you can deal with drugs otherwise not.

The rules and regulations pertaining to Drug License are governed by the Food Safety and Drug Administration Department of the concerned State Government.

Well, the procedure to obtain Drug License is quite simple and with proper documentation, it is assured to get the Drug License.

Step1: Application Filling

Application for the Drug License is completely online, along with the payment of government fee. The scanned copy of all documents is uploaded at the time of filing the application.

Step2: Visit by the Inspector

On receipt of the application, the Drug Inspector shall personally visit the shop to verify the documents and correctness of provided information.

Step3: Grant of License

On successful completion of the inspection, Personal Interview is conducted by the Inspector or such competent person and upon verification of all information and documents furnished is correct, the Controller of drugs issues the Drug License.

Drugs have various categories and for different categories, the different License is required to be obtained by filing different forms as given below:

  1. FORM 20: For the sale of Allopathic drugs

In case a retailer is willing to obtain Drugs License to sell Allopathic drugs, he/she has to apply by filling FORM 20 for drugs license. Note that Form 20 is to be filed for drugs to be sold by retail other than those specified in Schedule C, C(1) and X (Form-19A).

  1. FORM 20-A: For the sale of Restricted Allopathic drugs

In case a retailer is willing to obtain Drugs License to sell restricted Allopathic drugs, he/she has to apply by filling FORM 20-A for drugs license. Note that Form 20-A is to be filed for drugs to be sold by retail other than those specified in Schedule C, C(1) and X (Form-19A).

  1. FORM-20-B For wholesale of Allopathic drugs

Drug License for wholesale of Allopathic drugs is to be applied in Form 20-B, however not for the categories specified in Sch C, C(1) and X. (Form-19).

  1. Form 20-C – For the sale of Homoeopathic medicines by retail

Fill in Form 20-C in case you are a retailer of Homoeopathic medicines.

  1. Form 21-For Sale of Allopathic drugs specified in Sch C & C (1).

To sell the Allopathic drugs, first apply for Drug License by filing Form 21.

  1. Form 21-B-For wholesale of Allopathic drugs specified in Sch C & C(1).

In order to deal in the wholesale business of Allopathic drugs, obtain a License by filing Form 21-B.

  1. Form 21-A- For the retail sale of restricted Allopathic drugs specified in Schedule C (I).

Obtain Drug License for retail of sale of the restricted Allopathic drugs, which are specified in Schedule C (I).

  1. Form 20-F-For retail sale of drugs specified in Sch. ‘X’.

For certain drugs specified in Sch. X of the Act, apply for Drug License in form 20-F.

  1. Form 20-G For wholesale of drugs Specified in Sch. ‘X’.

To establish a wholesale business for drugs specified in Sch. X, apply for Drug License in form 20-G.

  1. Form No. 19
  2. Challan Rs. 3000/-
  3. Affidavit of the proprietor on stamp paper of 20 Rs.
  4. Educational certificate copies of the proprietor (Self-attested)
  5. Self-attested copies of Identity proof of proprietor ( Domicile/ Driving license/ Voter ID card)
  6. Affidavit of Regd. Pharmacist.
  7. Educational certificate copies of Regd. Pharmacist (Self-attested)
  8. Self-attested copies of Identity proof of Regd. Pharmacist ( Domicile/Driving license/ Voter ID card)
  9. Blueprint of Plan layout of proposed area/ premises.
  10. Electricity bill of proposed area/ premises.
  11. Copy of Refrigerator bill.
  12. Rent agreement ( 50 Rs. Stamp paper)
  13. Ownership document of the premises including the copy of tax receipt of proposed area/ premises.
  14. Covering letter.
  15. Photo 5-5 each of Regd. Pharmacist and proprietor.
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