Drug License in West Bengal
The Drugs and Cosmetics Act of 1940 regulates the manufacture, sale, and distribution of drugs in India. Ayurveda and Unani medicines were later incorporated into the Act in 1964. The administration of drugs in the State of West Bengal is vested in the Directorate of Drugs Control, which reports to the West Bengal Government‘s Department of Family Welfare. We will examine the process of obtaining a drug license in West Bengal in detail in this article. Drug License Online Application in West Bengal, How to get & renew retail drug license.
Table of Contents
The Governing Body’s Functions
The State of West Bengal‘s Department of Health and Family Welfare (DoHFW) is vested with the authority to enact the following:
Renewal or grant of allopathic/homoeopathic medicine manufacturing/sales license; grant or renewal of cosmetics manufacturing license, blood bank, surgical and medical device units.
Organizing inspections of the drug/vaccine manufacturing process.
Monitoring and issuance of G.M.P. and G.L.P. certificates, including M.S.C., NVC, COPP, and free sales certificates, among others.
Endorsement of a pharmaceutical and cosmetics quality control laboratory.
Authority Appointed
The authority to license and issue drug license is delegated to the respective jurisdiction’s Assistant Director of Drug Control.
Regulations
The Drug License is governed by the 1940 Drugs and Cosmetics Act, which requires all entities engaged in the business of selling drugs/medicines/cosmetics to obtain a license. This includes allopathic, homoeopathic, ayurvedic, and unani drugs.
India adheres to stringent regulations in this area, including those governing the sale of drugs to minors, import and export regulations, and the sale of medicines with and without prescriptions.
Though primarily regulated by the 1940 Drugs and Cosmetics Act, the Act establishes the following rules that apply to its various provisions:
1940 Act on Drugs and Cosmetics Drugs Price Control Order, 2013
1985 Act on Narcotic Drugs and Psychotropic Substances 1954 Act on Drugs and Magic Remedies (Prohibited Advertisement)
Different Types of Drug Licenses
Licenses for manufacturing and selling drugs are issued on a case-by-case basis, depending on the nature of the business. Here’s some information about them:
Manufacturing Permit
Manufacturing license authorise the manufacture of allopathic or homoeopathic drugs and cosmetics in a particular location. It is only granted to industrial areas that have been recognised.
License for Sale
A sale license will either be a retail or a wholesale license. The former is required to operate a chemist shop and is awarded to individuals who have earned a degree or diploma in pharmacy from a recognised university; the latter is awarded to individuals engaged in the wholesale distribution of drugs and medicines.
Loan Permit
Loan license are available to individuals who wish to utilise the manufacturing facilities of another licensee.
Distinction
Due to the provision that outlines this mandate – the principle of distinction – a pharmacy business that has expanded its portfolio across multiple states is required to obtain a separate license for each state in which it operates.
Infrastructure
In the state of West Bengal, a medical facility, whether manufacturing or sales, requires a carpeted space of 108 square feet and a minimum ceiling height of 8’2″. The premises must be constructed of brick, have a plastered floor, and be roofed with R.C.C. The entrance must be divided into two distinct but identical entrances, without the use of a shared residential passage.
In terms of interior specifications, they maintain medication in a clean and cool environment. Vaccines must be stored in a freezer, necessitating the purchase of a refrigerator.
Required Documents
Along with your application for a trade license, you must submit the following documents:
- Power of attorney (if applicable) on Non-Judicial Stamp Paper in accordance with the Proforma.
- Certificate of Trade License/Trade Enlistment specifying the nature of the trade and medical system.
- Possession document (which may be a current house tax receipt/consolidated rate bill/registered deed of conveyance/consent owner’s letter/notice of cancellation in the form of an affidavit before a First Class Judicial Magistrate/rent bill duly signed by the owner or authorised signatory).
- Rental agreement documentation in the form of a rental receipt (for rental properties).
- Certificate of No Objection from the owner (for rented properties).
- Together with a firm registration receipt, a registered partnership deed (for a partnership firm).
- Copies of the Association’s Memorandum and Articles of Association (for a Private Limited Company).
- Identical to preceding (for Limited Liability Partnership).
- A copy of the Board meeting resolution, as well as a list of the Board of Directors (for Private Limited Companies).
- A rough sketch map of the proposed premises, including the location and immediate surroundings (CAD model).
- Pharmacist’s appointment and acceptance letter, as well as the name of the competent person (as per Proforma).
- A.N. Card and cheque leaf that has been cancelled.
- The director’s photo identification and proof of address are required.
- Particulars of C.P. I’s academic credentials (for wholesale businesses).
- Pharmacist/C.P.I. record from the Pharmacist’s or C.P.I.’s Registration Certificate and Renewal Certificate (if applicable).
- Pharmacist/C.P.I. Affidavit Sworn before a Judicial Magistrate/Executive Magistrate of the First Class (as per Proforma).
- Certification of the competent individual’s experience.
- Affidavit of Applicants (Proprietor/Partners/Directors) Sworn Before a Judicial Magistrate/Executive Magistrate of First Class (as per Proforma).
Fresh Retail/Wholesale Drug License Application
To obtain a license to sell drugs in West Bengal, follow the steps outlined below:
Registration is the first step.
The applicant may begin the registration process by visiting the Department of Health and Family Welfare’s official website.
Step 2: Creating a User ID and a Password
Complete the registration process upon visiting the website, which will provide him/her with a user ID and password.
Step 3: Create an account
The registered user can now access the portal via the username and password they created.
The Apply Button in Step 4
After logging in, the applicant should complete the application form by clicking the “Apply for New License” tab.
Step 5: Business Type
Select the business type that corresponds to the user’s current or preferred line of business (say retail or wholesale).
Step 6: Application Upload
Along with the other required documents, upload the application form in PDF format.
Step 7: Fees Payment
The applicant must submit the fee online using one of the available payment methods.
The application process is completed upon payment of the application fee and submission of the completed form. Following that, the applicant will receive a system-generated acknowledgement that can be used for future reference purposes. Internal procedures will be followed and the applicant will be registered. The competent authority may require the applicant to provide additional information. Drug License Online Application in West Bengal, How to get & renew retail drug license.
Process for Registration – Existing Retail/Wholesale Drug License
Given that we have discussed the procedure for submitting a new application, let us now examine the procedure for registering an existing retail/wholesale drug license:
Step 1: Create an account.
As was the case previously, the applicant must visit the official website of the relevant portal and register if they have not already done so.
Step 2: Login with your Username and Password
After registering, the applicant will receive a username and password for the remainder of the process.
Step 3: Renew Existing License
From here, the application procedure, which is similar to that of a new application, takes a different path. The applicant is prompted in Step 3 to select the option “Registration for Existing License.”
Step 4: Information Specification
Now, the company/basic firm’s information must be provided, as well as the license number and renewal receipt.
Step 5: Select from the Available Options
Choose the appropriate type of license (retail or wholesale).
Step 6: Receipt of Acknowledgement
The applicant will receive a copy of the acknowledgment receipt for his or her records.
Step 7: Addressing the Authority
The system will automatically route the application to authorised personnel, who will scrutinise the data and notify the applicant to complete an online form.
Step 8: Completing the Form
Now that the applicant has logged into the website, he or she must complete the application form.
Step 9: Fees Payment
The applicant must pay the application fee online.
STEP 10: FINAL SUBMISSION AND ACCEPTANCE
The applicant must resubmit the application form.
Step 11: Appropriate Authority
Submit the application to the competent authority, who will forward it to the Senior Inspector/Inspector of Drug Control in a repeated manner.
Step 12: Form Verification
The Senior Inspector of Drug Control will examine the unit’s form and conduct an inspection, and will submit a report to the appropriate authorities.
Step 13: Information Communication
The applicant will then be notified of the outcome of the application within the specified time frame. If the applicant is eligible, he or she will receive the application in a timely manner.
Step 14: The Procedure Is Complete
This concludes the application procedure for the previously submitted application, the status of which the applicant can track online. The applicant will be notified via email or SMS of the application’s status. Drug License Online Application in West Bengal, How to get & renew retail drug license.
Drug License Renewal
To renew your license, simply follow the steps outlined below:
Step 1: Create an account.
The applicant must access the official portal via the official website’s “Drug License” tab.
Step 2: License Renewal
After logging in, the applicant may select the option “Apply for Renew License” to proceed with the renewal claim.
Step 3: Complete the application form
As is customary for all application procedures, the applicant must complete the application form with all required information.
Step 4: Uploading it to the Internet
Upload the application form in PDF format, along with any required documents.
Step 5: Fee Remittance
Prior to submitting it for retention, the applicant must satisfy all fee obligations through online payment.
Step 6: Acknowledgement
The applicant will receive an acknowledgement for the reference once all application requirements have been met.
Step 7: Automated forwarding
The application has now been forwarded to the appropriate authority, who will forward it to the Senior Inspector/Inspector of Drug Control.
Step 8: Form and Inspection Examination
After forwarding the application to the appropriate authority, the form is scrutinised and the unit is inspected as necessary. The competent authority will resubmit the application with the inspector’s report attached.
This concludes the renewal process. The Licensee will be notified of the application’s status at each stage of the process. The competent authority may require the Licensee to provide additional information. Drug License Online Application in West Bengal, How to get & renew retail drug license.
