Drug License in West Bengal

The Government has regulated the manufacture, sale, and distribution of drugs in India through the Drugs and Cosmetics Act of 1940. The provisions of Ayurveda and Unani medicines were later drafted into the Act in the year 1964. The administration concerning drugs in the State of West Bengal is vested with the Directorate of Drugs Control, under the Department of Family Welfare of the West Bengal Government. In this article, we look at the procedure for obtaining a drug license in West Bengal in detail.

Functions of the Governing Body

The Department of Health and Family Welfare (DoHFW) of the State of West Bengal entrust with powers to enact the following:

The renewal or grant of manufacturing/ selling licenses about allopathic/ homoeopathic medicines; grant or renewal of cosmetics manufacturing licenses, blood bank, surgical and medical device units.
Organizing inspections on the manufacturing process of the drug/ vaccine units.
Monitoring and issuing G.M.P., G.L.P. certificates, including the issuance of M.S.C., NVC, COPP, Free sales certificate, etc.
Endorsement of Quality control laboratory of medicines and cosmetics.

Designated Authority

The power of licensing and issuing drug licenses is vested with the Assistant Director of Drug Control of the respective jurisdiction.

Regulations

Drug License is governed by the Drugs and Cosmetics Act of 1940, which mandates that all entities pursuing a business which deals with drugs/medicines/cosmetics must obtain a license. This covers all kinds of drugs and cosmetics, including allopathic, homoeopathic, ayurvedic or Unani drugs. India follows certain stringent regulations concerning this domain, the likes of which concern sale of drugs to a minor, import and export regulations and sale of medicines with/without prescriptions. Though primarily regulated under the Drugs and Cosmetics Act of 1940, the following rules are formed under the Act and apply to its various provisions:

Drugs and Cosmetics Act, 1940
Drugs Price Control Order, 2013
Narcotic Drugs and Psychotropic Substances Act, 1985
Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954

Types of Drug License

Drug licenses are issued for manufacturing and selling purpose, and vary according to the nature of the business. Here's a note on them:

Manufacturing License

Manufacturing licenses are issued to endorse the manufacture of allopathic or homoeopathic drugs and cosmetics in a given premise of operation. It is only granted to recognized industrial areas.

Sale License

A sale license will be in the form of a retail drug license or a wholesale drug license. The former is granted to run a chemist shop, and is issued to people holding a degree or diploma in pharmacy from a recognized university; while the latter is issued to people involved in the wholesale business of drugs and medicines.

Loan License

Loan licenses are for the people who are intent on availing the manufacturing facilities owned by another licensee.

A Case of Distinction

A pharmacy business which has extended its portfolio across many states requires to obtain a separate license for each of its state of operation, thanks to the provision that lays out this mandate -the principle of distinction.

Infrastructure

A medical facility in the state of West Bengal, be it a manufacturing or sales one, requires a carpeted space of 108 Square Feet, and a minimum ceiling of 8'2". The premises must be brick-built, plastered floor and cemented with R.C.C. roofing. The entrance must be divided with a separate but identical entrance, without any common residential passage. Coming to the interior specifications, they maintain medicine in a premise which is clean and cool. The vaccines need to be in a freezer; which prompts the need of a refrigerator.

Documents Required

Furnish the following documents along with the application of a trade license:

Power of attorney (if any) in Non-Judicial Stamp Paper as per Proforma.
Trade License/ Trade Enlistment Certificate specifying the nature of trade and system of medicine.
Document depicting possession of the premises (which could be a current house tax receipt/consolidated rate bill/registered deed of conveyance/an owner's consent letter/N.O.C. in the form of an affidavit before 1^st Class Judicial Magistrate/ Rent bill duly signed by the owner or authorized signatory).
Proof of rental agreement with rental receipt (for rental properties).
No Objection Certificate from the owner (for rented properties).
Registered Partnership Deed, along with a firm registration receipt (for a partnership firm).
Copy of Memorandum and Article of Association (for a Private Limited Company).
Same as above (for Limited Liability Partnership).
Copy of resolution of the Board meeting, in addition to a list of Board of Directors (for Private Limited Companies).
Sketch map of the proposed premises comprising of the location and surroundings (CAD model).
Appointment and acceptance letter of the Pharmacist and the name of the competent person (as per Proforma).
P.A.N. Card and cancelled cheque leaf.
Photo ID and proof of address of the director.
Academic qualification particulars of C.P. I (for wholesale businesses).
Pharmacist/C.P.I. record from Registration Certificate and Renewal Certificate of Pharmacist or C.P.I. (if applicable).
Affidavit of Pharmacist/C.P.I. Sworn before the First Class Judicial Magistrate/Executive Magistrate (as per Proforma).
Experience Certificate of the competent individual.
Affidavit of Applicants (Proprietor/Partners/Directors) Sworn before first class Judicial Magistrate/Executive Magistrate (as per Proforma).

Application for a Fresh Retail/Wholesale Drug License

To obtain a drug license in West Bengal, follow the procedure below: Step 1: Registration The applicant may initiate the registration process by visiting the official website of the Department of Health and Family Welfare. Step 2: User ID and Password Upon visiting the website, complete the process of registration, which will provide him/her with a user I.D. and password. Step 3: Log in The registered user can now log in to the portal using the username and password. Step 4: The Apply Button After login in, fill the application form by the applicant by clicking on the "Apply for New License" tab. Step 5: Type of Business Select the type of business following the user's existing or preferred line of business (say retail or wholesale). Step 6: Uploading of Application Upload the application form in PDF format along with other required documents. Step 7: Payment of Fees The applicant has to remit the fee online through any of the payment methodologies. The application procedure concludes with the payment of fees and submission of the form. The applicant will then receive a system-generated acknowledgement, which can be used for future references. The Department will carry on with the internal procedures and render the registration to the applicant. The competent authority may demand further information from the applicant.

Registration Process - Existing Retail/Wholesale Drug License

Since we have covered the application procedure for a fresh application, let us now understand the procedure for the registration of existing retail/wholesale drug license: Step 1: Register first As was the case above, the applicant must visit the official website of the particular portal mentioned above, and register to it if it hasn't been done before. Step 2: login with Credentials Upon registration, the applicant will be provided with a username and password for continuing the process. Step 3: Registration for Existing License The application procedure, which is similar to that of a fresh application procedure takes a different course from here. Step no. 3 prompts the applicant to choose the option "Registration for Existing License." Step 4: Specification of Information Now, the basic details of the company/firm must be provided along with the license number and renewal receipt. Step 5: Choose among the Options Select the kind of license (retail or wholesale). Step 6: Acknowledgment Receipt The applicant will receive the acknowledgement receipt for further reference. Step 7: Addressing to the Authority The system will auto-forward the application to the authorized personnel, who will, in turn, scrutinize the information and intimate the applicant to fill up an online form. Step 8: Filling up the Form Now, the applicant has to fill up the application form by logging into the website. Step 9: Payment of Fees The applicant requires to remit the fee online. Step 10: Final Submission and Acknowledgment The applicant must submit the application form for one last time. Step 11: Competent Authority In a repeated course of events, forward the application to the competent authority, who in turn will forward it to the Senior Inspector/Inspector of Drug Control. Step 12: Verification of Form The Senior Inspector of Drug Control will scrutinize the form and conduct inspection of the unit, and submit a report of the same to the concerned authorities. Step 13: Communication of Information The outcome of the application will then be communicated to the applicant within the prescribed time limit. If eligible, the applicant will receive the application in due course of time. Step 14: The Process Concludes This concludes the application procedure for the existing application, the status of which can be tracked by the applicant online. The applicant will receive an update regarding the application status through email or SMS.

Renewal of License

To renew the license, follow the procedures mentioned below: Step 1: Log in The applicant has to login into the official portal through the "Drug License" tab of the official website. Step 2: Renewal of License Post login, the applicant may choose the option "Apply for Renew License" to further the claim for renewal. Step 3: Application form As is the norm for every application procedure, the applicant requires to fill up the application form with the essential details. Step 4: Uploading it online Upload the application form, along with the required documents in a PDF format. Step 5: Remittance of Fees Before submitting it for retention, the applicant has to meet the fee obligations by paying it online. Step 6: Acknowledgment Upon completion of the application requirements, the applicant will receive the acknowledgement for the reference. Step 7: Auto-forward Now, the application will reach the concerned authority, who will forward the same to the Senior Inspector/Inspector of Drug Control. Step 8: Scrutinization of Form and Inspection After forwarding the application to the concerned authority scrutinizes the form and conducts the necessary inspection of the unit. The competent authority will resubmit the application along with the report of the inspector. This concludes the process of renewal. The Licensee will be notified of the status of the application in each stage of the application process. The competent authority may demand further information from the Licensee.