Drug License

What is a Drug License?

The word “Drug License” refers to the government’s permission to deal with drugs and cosmetics. It is a must-have for everyone who wants to work in the pharmaceutical industry, whether in wholesale, manufacturing, retail, or distribution.

Types of drug license

Retail Drug License

An application for a Retail Selling drug license is required for the retail sale of drugs. It isn’t designed for the customer to resell. As a result, the buyer doesn’t have to have a current drug license. Anyone, including a hospital, dispensary, medical, educational, or research centre, might purchase the drug.

Wholesale Drug License 

The term “wholesale” implies the sale of a product to someone who intends to resell it, therefore the purchaser of these drugs will need to obtain either a wholesale or retail drug license. Wholesalers can opt for third-party manufacture. Third-party manufacturing refers to the production of drugs by a licensed manufacturer to satisfy the demands of a client, such as a wholesaler. A brand affidavit is required before a producer can produce any medicine using the Wholesaler brand name. On the product package, the manufacturer and wholesaler will be printed. If a client requests pharmaceuticals that require approval from the Drug Control Authority, the manufacturer must obtain that approval before producing those drugs.

Drug Manufacturing License

This is a license to manufacture drugs. Manufacture in pharmaceuticals refers to any method or portion of a process for making, modifying, completing, packing, labeling, breaking up, or otherwise treating or adopting any medicine with the goal of its sale or distribution.

Loan License

This is a license that allows you to produce a medication using the facilities and premises of another company. A valid drug license and surplus production capacity are required of the manufacturer who offers the facility for drug production.

Import License

Importing pharmaceuticals into India required the acquisition of an import license. Drug import licenses are granted by the Central Drug Standard Control Organization (CDSCO).

Documents required to get drug license

The following documents must be included with the application form:

• Firm formation (MOA/AOA).
• Identification with a photograph Copy of Property Paper Proof of Proprietorship/Partnership/Directorship (If owned property).
• Copy of the Lease Agreement (If rented property).
• The property’s site plan and core plan.
• Invoice and information about the refrigerator.
• Affidavit of compliance with MPD 2021 (where the premises are in a DDA residential flat, plot, or building).

Additional document for Retail Sale Registered Pharmacist

• Final degree certificate/provisional certificate with mark sheets as proof of qualification.
• Appointment Letter and Bio-data Registration with the Delhi Pharmacy Council.

Additional document for Wholesale License

• Final degree certificate/provisional certificate with mark sheets as proof of qualification.
• Experience Certificate, Letter of Appointment, and Bio-data.

Procedure to get drug license

• Every application must be sent electronically (ESEND is a service that makes it simple to move files from one account to another account), as no applications will be accepted in person at the office.
• The applicant must get the user ID and password for this reason by submitting a request online with the firm’s information.
• All papers must be scanned in black and white at a resolution of 100 dpi, and then submitted using the user id and password generated.
• At the time of inspection, all original documentation must be presented to the inspector.
• You will receive an SMS confirming the approval or rejection of your application.
• For new licenses and renewals, print the approval/rejection from the ‘Print License’ option, and for other approvals, click ‘MISC approvals’ within 3 days.
• Licenses/approvals with a valid e-signature and official seal will be sent to you.

How long does it take to get a drug license?

According to a recent storey in “The Times of India, the Drug Regulatory Authority has made it mandatory for all of its staff to attend and issue all licenses, whether wholesale or retail, within a 30-day time frame if all of the required qualifying criteria are met. The major goal is to make the entire drug licencing process clear and user-friendly.

Validity of a Drug License 

Once obtained, a drug license is valid for five years unless the Drug Department suspends and cancels it. The licensee is bound by specific terms and restrictions. A drug wholesaler/retailer who holds a drug license must.

• Maintain a clear record of drug sales in cash or credit memos.
• Comply with the license conditions and other provisions set forth in The Drugs and Cosmetics Act, 1940, and the Rules enacted thereunder, as amended from time to time.
• Not to use its establishment’s sale premises for any other purpose than the sale of medications authorised by the licenses.
• Ensure that the nominated registered pharmacist or competent person is not employed by any other company than the current one.
• If CP/RP has to quit the company/firm for whatever reason, notify the Assistant Drugs Controller and the licencing authority.
• Changes in name or constitution, premises, directors/partners/proprietors must be reported to the state’s drug control authority.

Renewal of Drug License

Application Form: Obtain and complete the necessary application form from the appropriate authority.

Documentation: Attach all of the relevant documents to the application form.

Submit your application: – Once the application is complete, it will be submitted to the Drug Control Department along with the required payments, which may vary depending on the type of license being renewed.

Drug License: After the Department has thoroughly reviewed the application, a new certificate is issued in the Applicant’s name.

License Cancellation and Suspension

In the event that the licensee violates the terms of the license, the Licensing Authority may cancel or suspend the license for the wholesale or retail of pharmaceuticals, in whole or in part, after giving the licensee the chance to clarify his or her position. However, if it is later proven that the violation of license conditions was not caused by or instigated by the licensee, or that the licensee was not guilty of any serious act within 12 months, and that he/she was sincere and the violation was not intentional, he/she may apply for reconsideration to the State Government’s Licensing Authority within 3 months.