Drug License Application
Drug License Application is the permission granted under the Drugs and Cosmetic Act to carry out a drug/medicine or cosmetic business. As per the Drugs and Cosmetics Act, 1940, the Central or State Drug Standard Control Organization grants such License.
Documents For Obtaining a License
The following documents are essential for obtaining a sale license:
- Constitution of the entity – Memorandum of Association (MOA), Articles of Association (AOA) for a company, partnership deed, LLP agreement in case of partnership and LLP.
- ID proof of partner/director/proprietor such as Aadhar Card, PAN Card, Driving License
- Documents related to premises – Copy of ownership documents of property or rental agreement as the case may be.
- Site plan and also key plan of the premises.
- Copy of Board resolution permitting obtaining of a license.
- Proof of availability of storage space such as cold storage, refrigerator, etc.
- Copy of challan as a proof of depositing fee.
- Affidavit regarding non-conviction of proprietor/partner/director and the firm.
- The affidavit from the registered pharmacist/competent person.
- For a pharmacist at a retail sale, the following additional documents are a requirement:
- Proof of qualification
- Registration of local pharmacy council
- Appointment letter
- For a pharmacist at a wholesale sale, the following additional documents are a requirement:
- Proof of qualification
- Experience certificate
- Appointment letter
Forms to Obtain a Drug License
The following are different forms an applicant is required to fill according to the type of License required:
- Allopathic Drugs – FORM 20
- Restricted Allopathic Drugs – FORM 20-A
- Wholesale of Allopathic Medicines – FORM 20-B
- Retail of Homoeopathic Medicines – FORM 20-C
- Allopathic drugs mentioned in the Schedule C & C (1) – FORM 21
- Wholesale of Allopathic Medicines specified in the Schedule C & C (1) – FORM 21-B
- Retail sale of the Restricted Allopathic Medicines specified in the Schedule C (I) – FORM 21-A
- Retail Sale of Drugs specified in the Schedule ‘X’ – FORM 20-F
- Wholesale of Drugs Specified in the Schedule ‘X’ – FORM 20-G
Drug License Application Procedure
Refer to the following steps in order to complete you Drug Licence Application Procedure:
- Sign Up
Firstly, the applicant is to obtain User ID and Password by giving a request letter in person along with the firm’s details.
- Fresh License or Renewal
There exists two options, one is for existing license holders and the latter for new applicants. Choosing any of the options will direct the applicant to a page for specification of information, which must be duly filled and saved. The User ID and Password will appear on the registered mobile number of the user within 24 hours.
- Login using ID & Password
Subsequently, The user may log in to the portal by entering his/her username and password.
- Prepare Online Application
Choose the option ‘prepare/edit online application’, which can be found in the left-hand corner of the page. The drug License applications are filed online, these days including the payment of government fee. All documents are also scanned and uploaded at the time of filing the application. However, filed documents are verified by the inspector.
- Documentation
The most important step in obtaining the drug License is the preparation of documents which includes, preparation of key plan and site plan and various affidavits and declaration as prescribed under law.
- Inspection
After the application for grant of drug license is filed, the same is marked for inspection. Subsequently, The drug inspector personally visits the shop to verify the documents and correctness of information.
- Grant Of License
Once the Inspection is complete, the inspector may call for a personal interview. Upon verification if all the information and documents is correct the controller of drugs issues the Drug License.
FAQs
The Drug Regulatory Authority has made it compulsory for all its officials to attend as well as issue all the licenses, whether wholesale or retail, in a time frame of 30 days, if all the required eligibility criteria are fulfilled. However, the main intention is to make the whole process of obtaining drug license transparent and user-friendly.
For the Renewal of Drug License, the applicant needs to fill out an application form and submit all the required documents along with the form. Further, after filing the application form, the applicant requires to submit the same to the Drug Control Department, along with the prescribed fees. After that, the authorities will review the application form submitted, and if satisfied, will issue a new certificate of Drug License to the applicant.
To obtain a Drug Distribution Licence, the applicant needs to file an application 19 and the prescribed documents such as the Identity Proof, Ownership Documents of the Premises, Affidavit of Registered Pharmacist, etc. with the authorities.
You require license in Form 20-A and 21-A for the sale of Restricted Drugs, commonly known as Household Remedies or Medicines. Further, for the sale of such drugs, services of a registered pharmacist and prescription of a Doctor (RMP) are not needed.
Trade License is a license or permission issued by a municipal corporation granting permission to carry on a particular business at a particular address. It ensures that the citizens are not adversely affected by health hazard and nuisance by the improper carrying of trade.