The Purpose of Drug License Registration

Securing the drug certificate in India signifies a legal requirement. Under the Drugs and Cosmetics Act, 1940, the manufacturers, retailers, wholesalers, and importers are required to register with the CDSCO for a drug license. The major purpose was to introduce the rules and regulations to provide market access to drug business operators. The wholesale drug license registration is the process to align with regulatory compliance to ensure product safety and quality.

Although no single drug business operator is allowed to regulate the pharmaceutical sector without a license. Overall, with a pharmacy license apply online, businesses and individuals get the permission to engage in the drug market legally. The certificate signifies that the entities are aligning with regulatory compliance. It is important to protect the patients from expired or hazardous products.

Types of Drug Licenses in India

The governing authority, CDSCO, introduced the multiple drug license online apply based on the business nature. The types of drug certificates are:

Wholesale Drug License (WDL)

The wholesale drug license in Delhi is required when the business distributes in bulk quantities to other retailers or hospitals.

Retail Drug License (RDL)

Pharmacies or medical stores in connection with drug consumers are required to apply for a retail drug license registration.

Manufacturing Drug License (MDL)

The business that manufactures the drug or cosmetics needs to obtain the manufacturing drug certificate.

Import License

The businesses that import medicines and their raw substances in India, required to register for an import license with the CDSCO.

Export License

This license is needed when a business exports drugs or pharmaceutical products.

Loan License

It is obtained by the drug manufacturers who utilize the facility of a registered licensed manufacturer (contract manufacturing).

Multi-Drug License

Businesses engaged in the drug trade across multiple states in India under the same organizational name are required to secure a multi-drug license.

Required Documentation for Drug License Registration

Gather the documents related to the premises, applicant, and any relevant personnel. The essential required documents are:

Applicant Information

Affidavit of Proprietor/Partner/Director

Certificates of Educational Qualification

Photo ID proof

Proof of applicant's residence

Premise Information

Proof of evidence of ownership

The ownership documents

Detailed layout of premises

Premise connectivity proof (Electricity or water bill)

Steps for Getting the Drug Certificate or Drug License

To obtain the drug license, apply online to the relevant state drug control authority.

Step 1: Select License Type

As per your drug business nature, choose the right license type ( e.g, retail, manufacturing, wholesale, or import)

Step 2: Collect Necessary Documents

Gather the documents like proof of ownership, application forms, certificate copies, and many others. The drug control authority must specify the other documents.

Step 3: Online Application

Choose the online application mode for drug license registration. Every state of India has an online application portal where applicants register.

Step 4: Mandatory Fee

Pay the mandatory government fee online and keep a copy of the Challan/Payment receipt.

Step 5: Application Submission

Submit the drug license application form with the necessary documents.

Step 6: Inspection by CDSCO

The officials of CDSCO may conduct a premises inspection to ensure compliance with regulations.

Step 7: Drug License Approval

The State Drug Control Authority will issue the drug license after the application review and inspection.

Eligibility Criteria to Obtain a Drug Certificate

Technical Staff

The staff of a retail pharmacy must be knowledgeable in the relevant field. They must have 1 year of pharmacy field experience and have a graduation degree. If you are an undergraduate, you must have four years of experience.

Storage Facility

Most of the medicines are required to be stored at a certain temperature or a low temperature. The drug businesses must have the facility of pharmaceutical product storage, like refrigerators and air conditioners.

Premise Requirements

The pharmacy or the unit area must not exceed 15 square meters. This category is fixed for both retail and wholesaler license recipients. The height of the unit must align with the guidelines of the National Building Code of India, 2005.

Qualified Personnel

The applicant for the drug register is required to possess a degree in B. Pharm or D. Pharm. To obtain a wholesale drug license, the applicant must hold a graduation degree along with at least one year of experience, or if they are an undergraduate, they must have four years of experience.

Drug License

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Fill the simple application form provided on our website.

Send your documents that are required according to your category of business.

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