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Wholesale Drug License

Owning a wholesale drug license is not an easy thing for the budding entrepreneurs. If you want to create your own identity in the world of pharmaceuticals then it is important for you to come up with your own business idea.

  • Eligibility Consultation
  • Document Preparation
  • Application Drafting
  • Application Filing
  • Government Fees
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Overview of Wholesale Drug License

Owning a wholesale drug license is not an easy thing for the budding entrepreneurs. If you want to create your own identity in the world of pharmaceuticals then it is important for you to come up with your own business idea. Pharmaceutical industry is indeed a challenging place to be where quality plays a crucial role. You can make your own place in this vying industry by providing best-quality stuff. To ensure the quality in the business of drugs and cosmetics government of India has made it mandatory to obtain Drug License. Drugs and Cosmetics Act, 1940 is responsible to issue the wholesale drug license as well as retail drug license. However, the rate of approval of retail license is quite low in comparison to the wholesale drug license.

Establishing a wholesale firm that completely deals in the pharma world is quite an intricate thing to do but not complex. 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 since the registration procedure is available online and with it everything has become more sorted and less time consuming.

Though, it is wise of you to analyze all the rules, regulations and norms before applying for wholesale drug license.

Legal Formalities

As indicated by the rules for manufacturing, importing and dispersing drugs in India, characterization of medications is done in various schedules.

  • Obtain a license from the CDSCO or Central Drugs Standard Control Organization under Form 19.
  • The individual applying for the permit ought to have a degree or certificate in pharmacy.
  • Additionally, the individual ought to have in any event one year of experience with managing drugs.
  • In the light of the most recent change occurred in India, it is compulsory to get the GST registration number.

Strict regulation in the drugs and cosmetics business in India

Drugs and cosmetic industry have been working in the managed condition only for the brighter future and larger interest of the community. Excellent growth of the healthcare sector in India has made businesses related to drugs and cosmetics a promising sector to invest in. This sort of business requires least capital investment and space. These kinds of organizations are typically set up under a proprietorship or partnership, yet it is prudent to set up a medication related business as LLP or private limited company as it will guarantee that business is transferable and promoter’s liability is restricted. Export of medications outside India is profoundly directed. Under any conditions, schedule H and X drugs can't be sold without a substantial clinical remedy. For the online seller, it is compulsory to have a copy of such medical remedy and delivery must be local.

Basic Requirement for Drug License

  • Area

    To set up a clinical shop or drug store, the basic minimum area should be of 10 square meters. In the event that store business mix with the retail and wholesale than the base region of 15 square meters is required.

  • Storage

    On the premises where drugs such as vaccines, insulin injections etc are stored it becomes essential to install cooler and air conditioner in that premise.

  • Technical Staff

    Offline Sale of a Drug

    Can be conveyed within the presence of registered pharmacist approved by the office who is required all through the working hours in the retail shop

    Wholesale

    Under this, a registered pharmacist has the authority to indulge in the business or someone who is graduate with one year of experience in handling and managing drugs or in the presence of anyone who has passed SSLC and have four years of experience in drugs, make sure it is approved by the drug control department.

Wholesale Drug License

Documents Required to Obtain Wholesale Drug License

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

  • Constitution of the firm (MOA/AOA)
  • Identity proof of proprietor/partner/director
  • If you own a property, copy of property paper
  • If property is rented, copy of rent agreement
  • Site plan and key plan of the area
  • Refrigerator invoice
  • Affidavit related to MPD 2021(if area is located on DDA residential flat/plot/building)

Additional documents for wholesale drug license

  • Proof of qualification i.e. final degree certificate/provisional certificate with mark sheets
  • Experience Certificate
  • Appointment Letter and Bio-data

Other Salient Points

  • You have to have a well-suited space to begin the wholesale drug business.
  • Air-conditioners and fridges are obligatory to avoid bio-molecular damage of insulin, injections, vaccines and sera.
  • The spot must be sheltered from rodents, and sufficient hygiene is must to maintain.
  • Legitimate cleanliness ought to be kept up on 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.  

Conditions for Obtaining Drug License

  • For award of permit in Form 20 or Form 21 or both, the premises are of a region of at the very least 10 square meters;
  • For award of permit in Form 20-B or Form 21-B or both, the premises are of a region of at the very least 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 a region of at the very least 15 square meters

Registration Procedure for Obtaining Drug License

If you want, you can file drug license application directly with the government. Though, the process is long and will take 30-60 days to complete.

  • Step 1

    Candidate needs to acquire user ID and Password by giving request letter face to face in which you should not forget to mention details of the firm.

  • Step 2

    All the documents ought to be examined in 100 dpi and black and white and afterward upload it by using the same ID and password at space accommodated the reason. All the data is filled decisively for particular application and afterward e-send the application. The permitting authority may request some other explicit documents whenever required.

  • Step 3

    You will at that point need to catch up with the government department for a report on your application. If there should arise any objection on your application due to incomplete information, the charges once paid will be relinquished by the government.

  • Step 4

    The government department will take 45-60 working days to go through your application approve the same. Else, you can contact Corpbiz we will help you in the process of obtaining license.

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Frequently Asked Questions

The applicant’s shop/premises should have an adequate area of not less than 10 sqr.mtrs. and person in charge (Competent Person) must be a Registered Pharmacist/who has passed Matriculation or its equivalent with four year’s experience in dealing with Drugs or who holds a degree of a recognized university with one year’s experience in dealing with Drugs.

The applicant’s shop / premises should have an adequate area of not less than 15 sqr. mtrs.

The books of accounts, registers, forms and other documents shall be maintained in such manner as may be specified by the licensing authority at the time of issue of such license. It is the responsibility of the license holder to intimate every change and modification that occurred in its business.

The applicant’s shop / premises should have an adequate area of not less than 10 sqr.mtrs., should be equipped with proper storage facilities for preserving the properties of drugs and applicant (Competent Person) must be a Registered pharmacist with Pharmacy Council.

Following are the features of drug license:

  • Drug license is compulsory for drugs, medicine, or cosmetics business
  • The license shall be granted for a commercial premise
  • Drugs and cosmetics business shall comply with the requirement and conditions imposed by law and authorities
  • The license shall be displayed all the time in the place of business.

Various provisions dealing with Drug licenses are given under Drugs & Cosmetics Act, 1940 & rules there under. Information can also be sought in person from the drug inspectors seated in Drugs Control Department.

Yes, drug license is necessary for every unit operating in any part of India. For instance, in case the drug business has its unit in two separate states, it shall get the license for both such an operational unit.

  • Manufacturing Drug License
  • Sale Drug License
  • Import Drug License
  • Multi-Drug License
  • Proof of qualification i.e. final degree certificate/provisional certificate with mark sheets
  • Experience Certificate
  • Appointment Letter and Bio-data

Any person/company/partnership firm/LLP/OPC can apply for Drug License at Drug Controllong Authority.

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