Step-by-Step Blueprint for Getting Authorized to Sell Medicines

The healthcare industry is the core part of human life. The pharmaceutical industry’s role is to improve the health of humans and provide them with a new life. Well, there are various entrepreneurs who are committed to serving their community in healthcare. In the present time, there are various business opportunities in the pharmaceutical sector. But here is a catch. Before starting the business in healthcare, the applicant is required to meet specific requirements.

Whether your dream is to establish a pharmacy shop or manage wholesale drug distribution in India, you will need to navigate the drug license certificate apply online. Yes, this is a legal authorization that is provided by the Indian government. This comprehensive guide will shed light on the blueprint to get the legal authorization, including initial drug registration requirements and inspection by the regulatory authority, with compliance management.

The Foundation Preparation—A Right Business Type

Before navigating the drug certificate application, it is crucial to understand which type of business you are going to handle. The starting base should be strong to start any business in India. Determine these steps:

1. Decide on Business Model and License Type

The initial step is to determine which type of work is managed by you in the healthcare sector. The type of license is dictated by the nature of the business. Prefer these details:

Retail Drug License (Form 20/21): The retail drug license in India is obtained by chemists or pharmacy shops. If you have a medical shop, then apply for a retail drug license registration.

Wholesale Drug License (Form 20B/21B): To sell the pharmaceutical products to retailers or hospitals in bulk quantities, one needs to apply for a wholesale drug license registration. However, with this license, you cannot sell medicines directly to patients. 

Manufacturing Drug License: Drug manufacturing industries come under the strict regulations of CDSCO. To obtain the manufacturing drug certificate license in India, one needs to solve a complex registration process and strictly follow various laws by the Indian government. 

2.  Eligibility Criteria for License Approval

As the medicine’s connection is directly to consumers, the businesses are required to comply with several requirements. You must fulfill several non-negotiable criteria. 

Applicant Eligibility: Whoever is operating the pharmaceutical business in India can be an individual or a part of a corporate body, such as a private limited company or a public limited company. 

For a Retail License: Appoint a certified pharmacist who will oversee the premises. However, the hired pharmacist must be qualified (B.Pharma or D.Pharma). 

For a Wholesale License: To operate the wholesale business in India, you must have a “skilled, qualified person.” If the person is a graduate, they must have at least one year of experience in the relevant field. 

3. Business Premises Eligibility

The business premises will be inspected by the official of CDSCO to ensure compliance with the specific standards. The requirements for premises establishment are:

Size: To establish a pharmaceutical premise, there is a certain size requirement. If you have a retail store, the size should not exceed 15 square meters. Meanwhile, the size of the wholesale store should be 10 square meters. However, the premise size requirements change state by state. Therefore, go through state and local rules and laws. 

Storage and Conditions: To manage a pharmaceutical industry, the premises must implement a strong facility. To maintain the quality of medicine, there should be a storage facility. It also includes adequate lighting, proper ventilation, and, most critically, a refrigerator. For the air- and heat-sensitive drugs, a refrigerator and/or air conditioner has been required. Through this, the business can maintain the temperatures of medicines. 

User Query: Essential Compliance Tips for First-Time Medicine Sellers

The Required Documents  for Drug Certificate Application Online

The entire drug license registration process is covered with intensive paperwork. To obtain the license required to prepare the multiple documents in advance. Here is the list you are required to attach to the application form:

• Application Form: For retail drug license registration, fill out the Application Form-19.
• Identity Proof: Identity proof of the applicant/partners/director, such as Aadhaar card, voter ID, etc.
• Address Proof: For the address proof, provide a utility bill or a rent agreement. 
• Proof of Ownership: If the premises are on rent, provide the rent agreement, or for the owned, the required sale deed as ownership proof. 
• Partnership Deed/MOA & AOA: In the case of a corporate industry, a necessary memorandum along with the Articles of Association illustrates the company’s rules and regulations, as well as the responsibilities of the director and partners.
• Site Plan: Premises—a complete layout that visualizes important things such as storage and other facilities. 

The Required Documents of a Pharmacist are:

• Pharmacist’s registration certificate from the State Pharmacy Council.
•  B.Pharm/D.Pharm degree certificate as proof
• If required, experience evidence
• Appointment letter and affidavit from the pharmacist 
• For the drug wholesale, documents of the competent person
• The certificate of business registration 

Inspection & Authorization—Drug Certificate Apply Online

This is the last stage where all your details, including the unit, are examined by the CDSC officials.

Visit by Drug Inspector: Upon the successful document verification, the drug inspector will visit your pharmaceutical products’ premises. Upon visit, they will verify whether the information you provide is correct or not. The common things that will be checked by them during inspection are:

• Verify the area requirements. They will ensure that the size of the premises meets minimum requirements. To succeed in this part, keep the area clean and have proper ventilation and lighting facilities.
• For the storage of medicines, the refrigerator and air conditioner will be examined during inspection. 
• To verify the qualification of the pharmacist, the drug inspector might ask questions related to drug laws, regulations, and storage requirements.

Final Result and Drug License Approval 

After the successful inspection, a report will be submitted by the inspector to the State Drug Controller. If the report satisfies the authority by meeting the specific rules and regulations and the facility requirements, a drug certificate is issued. The approved license will contain a few unique numbers with details of the premises. 

Obtaining the drug license is not a one-time requirement. Every license is valid for a specific timeline. A drug license is usually valid for 3 to 5 years. Failure to renew the license before its expiry can lead to a possible legal penalty. On the other hand, to maintain the ongoing compliance, manage records accurately, align with storage facility norms, and do much more.

Summing Up | Getting Authorized with the pharmacy license Apply Online

Securing the drug certificate license in India is a legal requirement, but also showcases the commitment to patients’ health and safety. Registration is a strategic move to establish a trustworthy and legitimate business in India. The above-mentioned authorization blueprint can help navigate the registration process or can leverage a consultation. LegalRaasta helps aspiring entrepreneurs to build a firm with all legal documents and license approval. Choose us as your consultant!

Frequently Asked Questions related to Pharmaceutical Licenses

1. Can I sell medicines without a drug certificate?

Ans. The Indian government, including CDSCO (Central Drugs Standard Control Organization), bans those businesses that sell medicines without a license. 

2. How to obtain a wholesale drug license in Delhi?

Ans. To obtain the wholesale license, apply through the Department of Drugs Control portal or hire a consultant to streamline the registration process.

3. What is Form 20 in the pharmaceutical industry?

Ans. Form-20 is a retail license that is required to sell medicines in markets. 

4. What is the cost of drug registration in India?

Ans. The cost of a medical license depends on the type of certificate you require. For example, the cost for wholesale licensing varies up to Rs 3,000, while for the manufacturing license, it can be Rs 7,500 or more.

5. Who approves the new drugs in India?

Ans. For the new drug approval, the Central Drugs Standard Control Organization (CDSCO) is responsible.