Which License is required for the Storage of Medicine?

The storage of medicine is the only way to maintain its effectiveness. The storage of pharmaceutical products is crucial to maintain their effectiveness, prevent harm, and ensure their safety. If the manufacturers or the other operators fail to maintain the quality of medicines, it reduces potency, causes degradation, or can even cause ineffective degradation. Therefore, to ensure the effectiveness and the safety of pharmaceutical products, a drug license is mandated. It determines who is operating the medicine storage and needs to secure a drug certificate. In this comprehensive guide, we will explore which certificate is required for medicine storage, the authority, the process, and much more.

Why is the Storage of Medicine Important?

Inappropriate storage of medicines can lead to serious risks. Maintaining the quality is crucial to providing an effective product. In addition, maintaining the storage of temperature-sensitive medications, like insulin or specific antibiotics, is essential. The following outlines the importance of proper storage for pharmaceutical products:

• Preserves Potency: The heat, light, or humidity causes the loss of their effectiveness. These factors increase the risk of harm to consumers.
• Prevents Degradation: A majority of medical drugs are susceptible to light and air exposure. Therefore, it is always recommended that you keep the medicine away from light and air. This is because, due to these factors, the medicine lost its therapeutic properties and converted into a harmful product. 
• Avoid Contamination: Improper storage of medications can lead to contamination. Therefore, to prevent the consumers from contamination, proper and hygienic storage is crucial.
• Maintain Stability: Insulin is temperature-sensitive; therefore, it requires refrigeration. The refrigerator maintains its safety and keeps it stable for a long time. 
• Minimize Waste: Appropriate storage is helpful to prevent spoilage and degradation. It avoids the waste of medicines and also minimizes the cost of investing in making them. 

The Required Certificate for Medicine Storage

Imagine storage facilities where the medicine is stored improperly. What will happen then? How will you determine the medical drug’s effectiveness and quality? That’s the place where the drug certificate is required. This signifies that the drug safety certification is mandatory for the storage of medicine. Specifically, obtaining the license for a wholesaler is important. Often, the wholesaler is involved in the drug storage; therefore, they need to obtain the wholesale drug license registration. The retail pharmacy or medical store needs to maintain the medicine storage facilities. If they fail to maintain them, they can face serious penalties, and it can be worse. Here is more detail:

• Wholesale Drug License

In India, the national authority responsible for issuing drug certificates is the Central Drugs Standard Control Organization (CDSCO). Apart from CDSCO, the Central Licensing Authority is also involved in providing the drug license. On the other hand, the wholesale drug license is issued to those organizations that distribute the medicines in bulk. It further covers the medicine storage, which comes during the distribution process. 

• Retail Drug License

The individuals who are part of pharmacies, medical stores, and other businesses are required to register with the CDSCO to obtain the retail drug license registration. Such stores are connected to consumers directly; therefore, they are also required to maintain medicine storage. 

• Drug Certificate Importance

The drug license registration is essential to ensure the safety and quality standards of pharmaceutical products. Before the sale of medicines, compliance with the Drugs and Cosmetics Act of 1940 is mandatory.

• Specific Requirements

The storage facilities depend on the type of drug. For the temperature-sensitive medicines, a proper storage facility is required. In addition, other facilities, like refrigerators or air conditioning, might be needed. 

The Process to Obtain a License for Medicine Storage

Whoever is involved in the healthcare industry, whether for drug manufacturing or distribution, or storage, needs to secure a drug safety certification. Even for the medicine storage, you also need to obtain a license. To obtain the license, you need to apply to the State Drug Control Authority. Here are the steps for the license:

Step 1: Determine License Type

According to your business nature, select the specific drug certificate type, for example, retail drug license registration or wholesale drug license registration. 

Step 2: Necessary Documentation

Initiate the drug license registration process by collecting the necessary documents. Prepare documents like identity proof, premises address proof, or other specified paperwork by the national authority.

Step 3: Online Application

If you are a new user, make an account with your state’s Drug Control Department. Complete the application form and ensure that all filled details are accurate or not. 

Step 4: Document Submission

After completing the application form, attach all the prepared documents with it. Recheck the details of the documents and submit them on the official CDSCO online portal.

Step 5: Fee Payment

For the license registration, make the license payment as prescribed. During registration, also attach the payment receipt.

Step 6: Review and Inspection

Your submitted documents, including the application form, will be reviewed by the officials. If required, an inspection of your premises will also be conducted. The officials of the authority will visit your premises to ensure the facilities. 

Step 7: License Issuance

If the inspection and application meet the authority requirements, the State Drug Control Authority will allocate a drug license to you. 

What are the Key Requirements for Drug Safety Certification?

To obtain the license, there are a few specific requirements that you need to meet before applying for the certificate. Here is the elaboration

1. Before registering your business as a pharmacist, you need to provide appropriate details of your qualifications and experience. Without the required qualifications, one cannot apply for a drug license.
2. For the space, sanitization, and temperature, your storage premises must meet to specified authority requirements.
3. If you own a unit, you need to showcase the proof of ownership. Otherwise, you can provide a lease agreement.
4. The wrong application can cause the license rejection; therefore, choose a correct application form according to your business type. 

Final Words | Wholesale Drug License Registration for Medicine Storage

Medicine storage is required to maintain its effectiveness and quality. Furthermore, CDSCO (Central Drugs Standard Control Organization) is the one that maintains the whole operation of pharmaceutical products from manufacturing to distribution. Under the Drugs and Cosmetics Rules, obtaining a license is mandatory for all businesses that are involved in drug activities. But they are required to meet the specific requirements, and it can vary between states. Before applying for drug license registration, you must appoint a consultant. The consultant will guide you and provide end-to-end service. Register now with the CDSCO to maintain storage facilities accurately. Get in touch with LegalRaasta experts who specialize in helping businesses to obtain a valid license for their organizations. 

FAQ | Pharmacy License Apply Online

1. Which license is required to open a medical store?

Ans. For the medical store, you need to register with the CDSCO to obtain the pharmacy license.

2. To regulate the medical store, FSSAI license is required?

Ans. Whoever is involved in the medical store operations is required to obtain the FSSAI license from the relevant authority.

3. How can I get the CDSCO certificate for drug storage?

Ans. You need to register your business on the CDSCO SUGAM portal. After the application submission and premises inspection, the license will be allocated to you.

4. For which SUGAM stands?

Ans. SUGAM is a digital platform provided by CDSCO, which represents “System for Unmanned Gateways Approval of Manufacturers.”

5. How much do I need to pay to obtain a drug license in India?

Ans. The fee for drug safety certification depends on the type of license and the state. However, the general registration cost starts from Rs 3,000 to Rs 25,000.