WHAT ARE THE LEGAL DOCUMENTS REQUIRED TO OPEN A RETAIL MEDICINE SHOP?

• By Jainey Sheth, Communications, RetailerShakti.
• April 7, 2023

The process of getting a license for drugs can be long and extremely tiring at the same time. The regulations around licensing for selling medicines at retail medicine shops have become extremely strict. The Drugs and Cosmetics Act (1940) is the main regulatory framework that looks after the entire lifecycle of drug licensing. Drug licensing is also dependent on the location.

CATEGORIES FOR ISSUING DRUG LICENSE

• Drug Manufacturing License

Manufacturing rights are granted to allow the production of homeopathic or allopathic drugs and cosmetics in a specific location. It is solely granted to approve industrial zones.

• Loan License

Loan licenses are intended for people who want to use another licensee's manufacturing facilities.

• Drug Sales License

A retail drug license or a wholesale drug license will be required to sell drugs. The former is given to people who hold a degree or diploma in pharmacy from a recognised university and is experienced in running a chemist shop, whereas the latter is used to running a drug and medicine wholesale business.

REQUIREMENTS TO GET A MEDICINE LICENSE

Those businessmen who wish to get a drug-selling license have to meet a number of requirements that are mandatory. It is often difficult to obtain a grant. For being able to get a grant for selling medicine and with a low level of success rate it can be concluded that meeting all the requirements is necessary, especially for those who are seeking a license for a retail medicine store.

The main requirements for getting a license are listed down below:

1. Availability of necessary space: This requirement is with respect to the area of the pharmacy or the place allotted for use as a wholesale unit. 

• For a retail operator or a wholesaler, the space used for storage should be no less than 10 square meters in total. 
• As for units that conduct both retail and wholesale, the premises should be at least 15 square meters. 
• The premise should have adequate ventilation systems or channels. 

The height of the premise in question used for selling drugs should align with those dictated by the National Building Code of India (2005).

2. Adequate facilities for storage of drugs: There are a number of medicines that have to be stored at a much lower temperature to ensure they are effective. Some examples of the same are vaccines, insulin doses, and different sera. Refrigerators and air conditioners are thus important in order to create a cool space for storing these medicines and they must be installed before applying for a license.

3. Skilled and qualified staff: It is extremely important to have skilled and competent human resources before applying for a drug license. 

 An overview of the requirement is listed down below:

• In the case of a wholesale operator, sales could be made under the supervision of a pharmacist who is legally registered. However, personnel with a graduate degree and a year of experience could also substitute a pharmacist in this case. For those cases where both of them are unavailable, a person with an SSLC and at least four years of experience in dealing with drugs could be substituted. This however needs to be approved by the Department of Drug Control. 
• Retail operations must only be conducted in the presence of a registered pharmacist. This competent person must be present during the store's operating hours as well.

After having met the above requirements, one could apply for a license. 

DOCUMENTS REQUIRED FOR PROCURING A DRUG LICENSE

The availability of suitable premises, competent personnel, and cooling facilities are basic requirements for applying for a drug license. The main document required is a completed Form 19. This form requests permission to sell, display, stock, or offer for distribution or sale of drugs. These drugs, however, must not be those on Schedule X. Form 19A is required for dealers who look forward to selling drugs in a retail setting without any help from a qualified individual. If one has to stock, sell, or distribute homeopathic medicines, one must fill out Form 19B. Those who want to sell Schedule X drugs must fill out Form 19C in the meantime.

DOCUMENTS TO BE SUBMITTED

• A 3,000 rupees challan is issued.
• Affidavit of the proprietor on 20 rupees stamp paper
• Self-attested copies of the proprietor's education certificate and identity proof
• A registered pharmacist's or competent person's affidavit.
• Copies of registered pharmacist's or competent person's education certificate and identity proof
• A competent person's experience certificate
• A blueprint of a proposed premises' plan layout
• The electricity bill for the proposed location
• Copy of the refrigerator bill 
• Rent agreement or property ownership document
• Cover letter 
• 5 photos, one of the proprietor and one of the registered pharmacists or competent person.

APPLYING FOR A NEW RETAIL/WHOLESALE DRUG LICENSE

Follow the steps below to obtain a drug license in West Bengal:

Step 1: Registration

The applicant can begin the registration process by going to the Department of Health and Family Welfare's official website.

Step 2: User ID and Password   

Complete the registration process after visiting the website, which will equip him/her with a user ID and password.

Step 3: Log in

The registered user could now access the portal by entering their username and password.

Step 4: The Apply Button  

After logging in, the applicant should fill out the application form by clicking on the "Apply for New License" tab.

Step 5: Type of Business

Choose the type of business that corresponds to the user's current or preferred line of business (say retail or wholesale).

Step 6: Uploading of Application

Upload the request form in PDF format, along with any other documents required.

Step 7: Payment of Fees

The applicant must pay the fee online using one of the available payment methods.

The application process is completed when the fees are paid and the form is submitted. Following that, the applicant will get a system-generated acknowledgment that can be used for easy reference. The Department will proceed with the standard processes and register the applicant. The applicant may be required to provide additional information by the competent authority