Drug License

Drug licenses in India have been issued by state food and drug administrations or state drug control departments as per the Drugs and Cosmetics Act of 1940 rules and regulations, which are enforced by the state-level regulatory bodies, which are also responsible for granting drug wholesale and retail licenses. Rules may vary state by state based on a particular procedure and prerequisites for acquiring a drug license, but all licenses are required to follow the guidelines established by the government to guarantee high-quality, safe products.

Different types of drug licenses are issued by food safety and drug administration based on the nature of business activities, such as manufacturing licenses, wholesale licenses, retail licenses, etc. 

In India, a drug wholesale and retail license is a legally recognized document that authorizes a business to distribute pharmaceutical products or medications both wholesale and retail. It is granted by the State Drug Control Department. For a pharmaceutical wholesaler or retailer to ensure that product distribution complies with legal requirements for public safety and government-established quality standards, they must get a drug wholesale or retail license.
 

Form 21 and 20B Drug License
 

Form 20B and Form 21B are the types of drug licenses for the wholesale of drugs. These certifications are issued under the Drugs and Cosmetics Act, 1940, and the rules made under it. Form 20B is the license issued for the wholesale distribution of allopathic drugs that are not specified under Schedules C, C(1), and X of the Drugs and Cosmetics Act. This license allows you to engage in the wholesale distribution of general allopathic medicines, which includes the sale to retailers, hospitals, dispensaries, and other licensed entities.

Form 21B is the license issued for the wholesale distribution of drugs that fall under Schedules C and C(1) of the Drugs and Cosmetics Act. This includes drugs that are biological products, such as vaccines, serums, and other types of injectables, which require specific handling and storage conditions due to their sensitive nature.

•  Form 20-C for the sale of homoeopathic medicines by retail.
   
• Form 20-F for the retail sale of drugs specified in Schedule 'X'.
   
• Form 20-D for the sale of homoeopathic medicines by wholesale.
   
• Form 20-G is issued for the wholesale of drugs specified in Schedule 'X'.
   
• Form 21 for the retail sale of allopathic drugs specified in Schedules C & C(1).
   
• Form 21-A for the retail sale of restricted allopathic drugs specified in Schedule C (I).
   
• Form 21-B is issued for the wholesale of allopathic drugs specified in Schedules C & C(1).
   
• Form 20-B for wholesale of allopathic drugs other than those specified in Schedules C, C(1), and X.
   
• Form 20 for the sale of Allopathic drugs by retail other than those specified in Schedule C, C(1) and X.
   
• Form 20-A for the sale of restricted Allopathic drugs by retail other than those specified in Schedule C, C(1), and X.

• Drug license holders are legally authorized to engage in pharmaceutical-related activities, ensuring that they operate within the bounds of the law and regulatory framework.  
   
• Holding a valid drug license enhances the credibility and trustworthiness of the business or individual, assuring customers, partners, and stakeholders that the pharmaceutical products meet the required quality and safety standards. 
   
• A drug license provides entry and access to the vast Indian pharmaceutical market, allowing license holders to distribute and sell their products to a broad customer base.  
   
• License holders have the opportunity to expand their businesses within the regulated pharmaceutical industry, leading to potential growth and increased market share.  
   
• Licensed businesses often enjoy a competitive advantage, as they demonstrate their commitment to quality and safety, which can attract customers and partners seeking trustworthy suppliers.  
   
• A drug license may facilitate the import and export of pharmaceutical products, enabling international trade and collaboration within the industry.
   
• Regulatory authorities monitor licensed entities to ensure the safety and integrity of the pharmaceutical supply chain, reducing the risk of fake or substandard drugs entering the market.

• A detailed site plan of the premises will be required.
   
• A declaration of any previous drug licenses held by the applicant.
   
• A list of equipment and machinery used in the manufacturing or storage of drugs.
   
• Details about the storage facilities and arrangements for the proper storage of drugs.
   
• Information about the retail premises, including the size, storage facilities, and location.
   
• Educational qualifications and experience details of the authorized signatory or proprietor.
   
• A covering letter stating the purpose of the application and the type of license being sought.
   
• Information about the technical staff employed, including their qualifications and experience.
   
• A duly filled-out and signed application form as prescribed by the respective licensing authority.
   
• Proof of ownership or rental agreement for the premises where drug-related activities will be conducted.
   
• In the case of a partnership firm or an MCA-registered company, a partnership deed or certificate of incorporation.
   
• An affidavit attesting to the accuracy of the product submitted via the application. Fee Receipt: Proof of payment of the prescribed application and license fees.

Step 1: Eligibility Check: Ensure that your product meets the eligibility criteria for obtaining a drug wholesale or retail license. Eligibility requirements may include qualifications, premises standards, and other specific criteria set by the Drug Licensing Authority in your state.  

Step 2: Application Form: Obtain the prescribed application form for drug wholesale or retail from the relevant state authority or online portal.  

Step 3: Document Preparation: Gather and prepare all the necessary documents, as mentioned in the application form and as required by the state licensing authority.  

Step 4: Technical Staff and Qualifications: Hire a registered pharmacist as a competent person in order to handle the drug production and distribution-related activities.  

Step 5: Application Submission: An applicant needs to submit the application form along with the mandatory documents offline to the state licensing authority or online through the portal.  

Step 6: Inspection: After receiving the application, the drug inspector will visit the applicant's premises to inspect and assess compliance with the relevant regulations and quality standards.  

Step 7: Review and Verification: The licensing authority will review the application, documents, and inspection report. The state FDA application reviewing team may ask for additional information or documents if required.  

Step 8: Grant of License: If the authorities are satisfied with the application and find that the applicant meets all of the requirements, you will be rewarded with the issuance of a drug License.  

Note: License Renewal: Ensure that you renew the drug license as per the prescribed schedule to continue your operations legally.
 

Area required for wholesale retail drug license
 

The minimum area required for a wholesale drug license is 10 square meters. In cases where the premises will be used for both retail and wholesale business, the minimum area required is 15 square meters. However, an applicant needs to follow a few more specifications at his premises, like:

• It should be neat and clean
   
• The premises should have proper arrangements for refrigeration
   
• The premises should be well-constructed and have enough storage space for drugs.

Drug License Fee and Validity
 

The fee for obtaining a drug license in India depends on the type of license we are applying for, such as a wholesale license for Rs. 3000 and a retail license for Rs. 3000 for both cases, like a fresh application as well as a renewal. The license is valid for five years. 
 

Drug License Renewal Process

The renewal application for the online drug license must be submitted at least 90 days before the expiration date. An applicant needs to submit the previously issued license copy, a renewal application form, an undertaking, an affidavit, a fee receipt, and sale purchase data. After the application submission, the department will verify the documents online and the drug inspector will visit the premises. After successful verification and inspection, you will get a renewed drug license. 

Agile Regulatory has a deep knowledge of the regulatory process and the specific requirements for obtaining a drug license, whether it is for manufacturing, wholesale, or retail. We always used to stay updated with the latest notifications.  

Application Preparation: Agile Regulatory helps clients prepare all the necessary documents and information required for the application, which includes filling out the application forms correctly, compiling the supporting documents and ensuring the registration process.  

Liaison with Authorities: Agile Regulatory acts as an intermediary between our clients and the relevant authority. We communicate with the state licensing authorities on behalf of the client for application updates, responding to queries, etc. 

Inspection Support: In the event of an inspection by drug inspectors, Agile Regulatory provides guidance and support during the inspection to ensure that the client's premises and operations are in compliance with the regulations.  

License Renewal and Compliance: Agile Regulatory also assists in the timely renewal of licenses, which ensures that the client continues to meet the necessary requirements for the duration of their operations.