Drug License registration process

by varun · Published December 11, 2020 · Updated December 24, 2021

Drug license registration

The Drugs and Cosmetics Act, 1940 is an Act which regulates the import, manufacture and distribution of drugs in India. Main objectives of this ac is to make sure that drugs sold or manufactured in India are safe and conform to standards. This act was passed in 1940. Since then, act has gone several amendments. It is also known as Drugs and cosmetics act, 1940.

Drug license or Pharmacy license is issued foe both wholesale are retail sale purposes. Drug license or Pharmacy license is a mandatory requirement to distribute drugs anywhere in India. In this article, we are going to discuss various documents required for drug license in India.

In this article, we are going to discuss registration process for Drug License in Delhi. Registration for the drug license can be done online on respective drug authority within state. Having a drug license is a mandatory requirement under drugs and cosmetics act. For sale purposes, there are three types of dug licenses granted to seller in India. These licenses are – 1) Retail drug license 2) Wholesale drug license 3) Restricted drug license.

Retail drug license is granted for sale of drugs and medicinal items to end users. While Wholesale drug license is granted for wholesale of drugs and Restricted drug license is granted for sale of restricted drugs to be sold at general stores without a presence of a competent person.

Drug License registration

Drug license registration can be divided into following sequence of steps-

Obtain Login credentials

Prepare Documents

Filling of application

Visit by the drug inspector

Issuance of License

Obtain Login credentials

Applicant has to create a login Id and password on drug authority portal of the given state. Basic details would be required for obtaining login credentials

Prepare Documents

All the documents should be scanned in required format, and then should be uploaded using the said ID and Password at space provided for the purpose.
These documents should be shown in original to the drug inspector at the time of verification.
Complete list of documents would include –
- Application for the relevant drug license (Form 19/19A/19B/19c). These forms can be downloaded from respective state drug authority. For Delhi drug license you can visit this link.
- Site plan and key plan of the premise
- Documents related to constitution of the firm – Memorandum of association(MOA), Article of association (AOA) for limited company, Partnership deed or LLP agreement in case of a partnership or LLP firm.
- Photo ID of partner/director/managing director
- Affidavit regarding non-conviction of Property/Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940
- Affidavit regarding compliance with MPD 2021
- Fee deposits receipts
- System generated affidavit from the registered pharmacist/competent person.
- Documents related to registered pharmacist for retail drug license – 1) Proof of qualification for pharmacy degree such as final or provisional degree certificate along with mark sheets of all years. 2) Registration of state level pharmacy council 3) Appointment letter and bio data
- Documents related to wholesale drug license competent person – 1) Proof of qualification for pharmacy such as final degree certificate or provisional degree certificate along with marksheets 2) Experience certificate 3) Appointment letter along with Bio data.
- Documentation related to ownership of premise –
1. Owned – Registered sale deed or Registered GPA (General power of attorney) or Conveyance Deed in the name of owner or unregistered Sale Deed or Unregistered GPA supported with utility bills like like electricity bill/water bill and property tax receipt.
2. Rented – Rent Receipt along with registered rent agreement or rent receipt with unregistered rent agreement along with ownership documents of landlord.
For Delhi drug license and Haryana drug license applications in old village area. Khasra and Khatauni documents can also be considered for ownership of premise.

Filling of application

Applicant need to fill all details required in application form for respective drug license. There are different form for registration under different licenses. Applicant should make sure that he is filling correct form and details mentioned in the form are correct. Application form once submitted cannot be edited and fess submitted for it would also be forfeited. Application form need to be submitted online along with required documents. For complete list of various type of application forms for drug licenses, kindly visit this link. Applicant also need to submit a drug license fee at the time of submission of drug license application on portal.

Visit by drug inspector

Once the application form is submitted in portal. A drug inspector assigned to the geographical area would visit business premise for the inspection. He would verify details presented in the form and correctness of various documents. Applicant’s premise would be varified for details like area of premise, storage and cooling facility present etc. It is one of the most important steps in getting a drug license number. Verification would take under the umbrella of drugs and cosmetics act.

Issuance of Drug License

Post completion of Inspection and verification of all the documents and information filed, and also the competent person clears the personal interview in a case called for, the Controller of Drugs, then issues the Drug License. It usually takes around 45 to 50 working days for the issuance of a Drug License. Issuance of a drug license number is a function of many inputs and most important among them is fulfilling various drug license rules as stated in drugs and cosmetics act.

Upon, vetting of drug license application, application can either be rejected or accepted. In both cases, applicant would receive SMS and mail on his registered mobile and email id given at the time of filling Drug license form. Thus, it is very important to fill correct details at the time of registration on Drug portal. Upon, successful approval, applicant download Drug license from Drug authority portal. Drug license certificate would contain details like name of license holder, address of premise, date of issue, validity period of license, drug license number etc.

Usually, A drug license is issued within 30 to 60 days of successful vetting of application by a drug inspector. It is mandatory for drug license holder to display drug license at the prominent place within his premise. Not showing drug license can attract penalty under drugs and cosmetics rules.

In this article, we have discussed various steps required for the registration of retail drug license and wholesale drug license. We would continue to publish more informative articles related to Pharmacy license, Meanwhile, you can read on different types of trade licenses required in India in different subsections of our website.