Wholesale Drug License Requirements & Registration Process

Wholesale Drug License

Owning a wholesale drug license is not an easy thing for building entrepreneurs. If you want to create your own identity in the world of pharmaceuticals, then you need to come with your unique business idea. The Pharmaceutical industry is indeed a challenging place to be where quality plays a crucial role.

You can make your place in this vying industry by providing the best-quality stuff. To ensure the quality in the business of drugs and cosmetics, the government of India has made it mandatory to obtain Drug License. Drugs and Cosmetics Act, 1940 is responsible for issuing the wholesale drug license and retail drug license. However, the rate of approval of retail licenses is relatively low in comparison to wholesale drug licenses.

Establishing a wholesale firm that thoroughly deals in the pharma world is quite intricate but not complex. All you need to do is legally follow all the steps and procedures described by the Drugs and Cosmetics Act, 1940.

Nowadays, the process has become easier since the registration procedure is available online, and with it, everything has become more sorted and less time-consuming. It is wise of you to analyze all the rules, regulations, and norms before applying for a wholesale drug license.


Requirements for Wholesale Drug License

1. Area = To set up a clinical or drug store, the minimum essential area should be10 square meters if the store business mix with retail and wholesale, then the base region of 15 square meters is required.

2. Storage = On the premises where drugs such as vaccines, insulin injections, etc., are stored, installing a more fantastic air conditioner on that premise becomes essential.

3. Technical Staff = Offline Sale of a Drug-Can is conveyed within the presence of a registered pharmacist approved by the office who is required all through the working hours in the retail shop.


Benefits of Wholesale Drug License



1. Admissibility of Business
A person must file a Wholesale drug license application as it provides admissibility to the business. Also, it is unlawful to engage in the dealing of drugs in India without obtaining a license.

2. The Authority can keep Track of the working
Wholesale drug license helps the authority keep Track of the working and regulating the dealing of medicines in India, which ultimately enhances business reliability and trustworthiness.

3. Proof of Authenticity
A Manufacturing Drug license plays a vital role, as it works as a proof of authenticity and builds an image of the company in the market.

4. Enhances Consumer Base
A drug license certificate proves to your consumers that the business is following strict quality measures while manufacturing drugs. Also, the license demonstrates to the consumers that the medicines and drugs are safe and constitute no deadly chemicals.


Documents Required for Manufacturing Drug License
  • 1. Constitution of the firm (MOA/AOA),
  • 2. Identity proof of proprietor/partner/director,
  • 3. If you own a property, a copy of the property papers,
  • 4. If the property is rented, a copy of the rent agreement,
  • 5. Site plan and critical plan of the area,
  • 6. Refrigerator invoice
  • 7. Affidavit related to MPD 2021(if the area is located on DDA residential flat/plot/building)
Supporting Documents for Wholesale Drug License
      1. Proof of qualification, i.e. final degree certificate/provisional certificate with mark sheets
      2. Experience Certificate
      3. Appointment Letter and Bio-data


Registration Procedure for Obtaining Wholesale Drug License

1st Step: The Candidate needs to acquire a user ID and Password by giving a request letter in which you should not forget to mention details of the firm.

2nd Step: All the documents should be examined in 100 dpi and black and white and afterwards uploaded using the same ID and password at space accommodated with the reason. All the data is filled indecisively for a particular application and later, e-send the application. The permitting authority may request some other explicit documents whenever required.

3rd Step: 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 will be relinquished by the government once paid.

4th Step: The government department will take 45-60 working days to go through your application approve the same.


Penalties Levied in Case of Non-Compliance in Obtaining the Wholesale Drug License

According to the Drugs and Cosmetics Act- As per the license required under clause (c) of Section 18-
If a person whoever himself, or by any other person on his behalf, manufactures for sale or distribution, or sells, or stocks or exhibits for sale any drug without a valid license as required, shall be punishable with imprisonment for a term which shall not be less than one year, but which may extend to 3 years, and with fine which shall not be less than Rs.5000/-


Legal Formalities required for Obtaining the Wholesale Drug License

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

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


Conditions that are Compulsorily required to be Complied with

1. For the permit award in Form 20 or Form 21 or both, the premises are of a region of at the very least 10 square meters.

2. For the award of the 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

3. For the award of the 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.




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Posted by Aashima
Team TaxaJ

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