Overview

Owning wholesale drug licenses is not an easy thing for budding entrepreneurs. If you want to make your mark in the world of pharmaceuticals then it is important for you to come up with your own business idea. The pharmaceutical industry is indeed a challenging place where quality plays an important role. You can make a place in this industry by providing quality goods. The drug and cosmetics government of India has made it mandatory to obtain a drug license to ensure quality in business. The Drugs and Cosmetics Act, 1940 is responsible for issuing wholesale drug licenses as well as retail drug licenses. However, the rate of approval of retail licenses is much lower as compared to wholesale drug licenses.

Establishing a wholesale firm that deals solely in the world of pharma is a complex task but not complicated. All you need to do is legally follow all the steps and procedure described by the Drugs and Cosmetics Act, 1940.

Now days the process has become easier as the registration process is available online and with it everything has become more sorted and less time consuming.

However, before applying for a bulk drug license you are wise to analyze all the rules, rules and norms.

Legal formalities

According to the rules for the manufacture, import and spread of medicines in India, the characterization of medicines is done in various schedules.

• Get a license from the CDSCO or Central Drugs Standard Control Organization under Form 19.
• A person applying for a permit must have a degree or certificate in pharmacy.
• In addition, a person should have experience of administering medicines for one year in any event.
• In the light of recent changes in India, it is mandatory to get GST registration number.

Strict regulation

Drugs and cosmetic industries are operating in a managed position only for the bright future and the larger interest of the community. The excellent growth of the healthcare sector in India has made businesses related to medicines and cosmetics a promising area to invest. This type of business requires minimal capital investment and space. These types of organizations are usually set up under a proprietorship or partnership, yet it makes sense to establish a drug-related business as an LLP or private limited company as this will guarantee that the business is transferable and promoters' liability is restricted. The export of medicines outside India is deeply guided. Under any circumstances, H and X drugs cannot be sold without adequate diagnostic measures. For the online seller, it is mandatory to have a copy of such medical remedy and delivery must be local.

You need to provide the following documents along with the application form:

• Constitution of the firm (MOA / AOA)
• Proof of proof of Proprietor / Partner / Director
• If you have any property, copy of the property paper
• If the property is rented, copy of the rent agreement is
• Site plan and main plan of the area
• Refrigerator Invoice
• Affidavit related to MPD 2021 (if the area is located on DDA Residential Flat / Plot / Building)

Required Additional documentation

• Proof of qualification ie final degree certificate / provisional certificate with mark sheet
• Experience Certificate
• Appointment letter and resume

Important points

• For award of permits in Form 20 or Form 21 or both, the premises is of an area of ​​not less than 10 square meters;
• For the award of permits in Form 20-B or Form 21-B or both, the premises is of an area of ​​not less than 10 square meters; And
• For award of permit (i) in Form 20 or Form 21 or both, and (ii) in Form 20-B or Form 21-B or both the premises are of the area of ​​not less than 15 square meters.

• You should have a well-suited place to start a wholesale pharmaceutical business.
• Air-conditioners and fridges are indispensable to avoid biomolecular losses of insulin, injections, vaccines and sera.
• The spot must be sheltered from rodents, and maintain adequate sanitation.
• Legitimate sanitation should be maintained in the premises to avoid any pollution.
• It’s not a tough job to start a wholesale business in pharmaceutical industry all you have to do is be prepared for it. Once you are done with all the formalities then it should not be a big issue for you to register.  

Registration process

If you wish, you can file a drug license application directly with the government. However, the process is long and will take 30–60 days to complete.

• Step 1: The candidate has to obtain the user ID and password by giving a face-to-face request letter in which you should not forget to mention the firm.

   

• Step 2: All documents should be screened at 100 dpi and black and white and later uploaded using the same ID and password. All data is decisively filled out specifically for the application and subsequently e-send the application. Whenever required, the permitting authority may request some other clear documents.

   

• Step 3: You have to catch up with the government department for a report on your application at that point. If there is any objection to your application due to incomplete information, then the fees once paid will be discarded by the government.

   

• Step 4: It will take 45-60 working days for the government department to approve your application. Apart from this, you can contact Retail GST. We will help you in the process of getting the license.