Top Reasons Why Drug Licence Applications Are Rejected?

With the increase in population, the healthcare sector underwent a wide range of transformations. It leads to the production and importation of medical drugs in larger quantities. These factors further improve the economy of India. Meanwhile, in the healthcare sector, obtaining the drug safety certification is a mandatory step. In India, no pharmaceutical industry is allowed to regulate the business without a drug certificate. 

However, the biggest disadvantage for drug operators is the rejection of their pharmacy licenses. Let’s delve into this blog to explore which reasons that affect the application rejection and how it can be cured. 

What are the Causes of Drug Safety License Rejection? 

Here are the top reasons for which the drug license is rejected:

• Documentation faulty

To obtain the drug certificate, the applicant needs to provide various types of documents. The documents involve the identity and address proof of the entity,  the site map of the business, including the personal details of the owner, and many more. 

Well, incorrect or unnecessary evidence proves the primary mistake. The absence of a single proof certificate leads to the rejection of a pharmacy license. The operators can’t receive the certificate until they provide the correct certificates. 

• Malfunctioning premises set-up

Choose a location that is not connected with residential areas. In addition, the hygienic facilities should be available related to medical drug production. While the officials of the governing body inspect to magnify the quality of the premises. They ensure whether the drugs are being produced in a hygienic place, what the nature of the drug stroge and many more. 

Therefore, it is crucial to maintain the manufacturing location with proper hygiene. Focus on the location cleaning, conduct hygiene activities, and provide the training. 

• Unlicensed pharmacist

During the drug safety application procedure, attaching the pharmacist’s license is mandatory. The officials reject the license to those who are trying to operate the medical drug business without a pharmacist’s license.

Therefore, only the business operators who are registered pharmacists are eligible for a drug safety license. The certificate of a pharmacist is provided by the state pharmacy board.

• Choose an incorrect license

Before applying for the drug safety license, it is important to gain knowledge of the various types of drug licenses. In India, there are multiple types of licenses provided by the governing body. As per your business nature, select which license is required. 

The Central Drugs Standard Control Organization regulates the activities of drugs in India. While the authority is responsible for providing multiple types of drug licenses, such as a manufacturing license, a sales license, an import license, a loan license, and a multi-drug license. Understand the business model and select the appropriate license.

• Mistakes in the application form

The errors can develop during the submission of a drug safety application. To avoid errors, review the spelling mistakes in all the provided certificates and match the address details of the company, including the personal details. Ensure whether the required documents are attached or not.

The incorrectness in the application form can lead to the pharmacy license rejection or delay. 

• Fail to pay the fee

CDSCO charges a fee to provide the drug safety certificate. However, during the application submission, the payment failure issue can occur. If the applicant fails to pay the required payment or does not provide proof of payment, the certificate will be rejected. 

To avoid the payment failure mistake, recheck whether the fee was submitted or not, including saving the submitted payment receipt. 

How to fix the issue of drug certificate rejection?

Connecting with the Central Drugs Standards Control Organization for the first time to regulate the drug business without any risks is all about gathering the correct documents. Getting ready is the primary step for a successful certification. 

Understand the legal standards of the regulatory body. Update the documents with the correct guidelines to increase the fast certificate approval. Through the state drug department official checklist, review all documents. Furthermore, ensure that the certificates of pharmacists are not linked to another license. By analyzing the nature of the business, select the appropriate license. 

How many types of drug safety licenses in India?

• Loan license: This license is obtained by those companies that do not have their own proper manufacturing facilities. 
• Manufacturing license: The industries that manufacture the drugs, including homeopathic and allopathic medicine, are required to obtain a manufacturing license. 
• Import license: The dealers who import products for drug manufacturing must register with the CDSCO to obtain an import license.
• Multi-drug license: The pharmaceutical business operating in multiple states in India requires a multi-drug license. This license allows companies to conduct business across various states.
• Wholesale drug license: The business must have a wholesale license to sell the drugs in bulk quantities. 
• Retail drug license: The pharmacies or medical stores have a direct connection to the consumers to sell the medicines and are required to get a retail drug license. 

What are the criteria for drug license qualification?

• To operate the retail business, the individual must qualified pharmacist.
•  If the operators want to regulate the wholesale business, they must have a minimum of 4 years of experience. 
• The location of the drug entity does not exceed more than 15 square meters. 
• Have the premium facilities for drug storage, such as conditioners and refrigerators. 
• Employed only pharmacy-qualified staff to avoid mistakes. The staff must have 1 year of experience with a graduation degree. 
• The location of the firm must meet the guidelines and be accessible for inspection.
• Must have obtained the GST registration certificate for the pharma company.

The procedure to apply for a drug license online 

Follow these simple steps to register with the controlling authority: 

• Application preparation

As per your business type, select whether you need a manufacturing, retail, or wholesale license.

• Collect documentation

The second and major step is to gather important documents like industry proof of address, application form, payment receipts, industry facilities details, and many more. 

• Maintain the premises blueprint.

This procedure includes the proof of ownership and the complete details of the premises.

• Pharmacist paperwork

To regulate the drug business in India, provide educational proof that includes a pharmacist certificate and many other major documents. 

• Online application 

The applicant needs to generate an ID on the state’s drug control authority website. 

• Application submission and payment

Submit the application form with the necessary documents. Complete the payment procedure. 

Note: Stay updated with the Central Drugs Standard Control Authority. According to your state, acknowledge which state authority requires the online procedure and which demands the physical document submission. 

Sum Up

To avoid the drug license certification rejection, maintain the documents and prepare things according to the required guidelines. Take the knowledge that common errors develop during the submission. To understand or ease the drug registration procedure, connect with Legal Raasta, an expert in simplifying the legal and compliance risks.