Everything you Need to Know About “Drug licenses in India”

Everything you Need to Know About “Drug licenses in India”

 

Medicinal drugs have an essential part of our daily lives. The role of drugs in everybody's life is undeniable. It is profitable for an individual to open a drug store and sell life-saving drugs as it is an essential part of everyone's life. The drug store is an evergreen business One can open a drug store by getting a drug license. It is mandatory to obtain a drug license before establishing a drug store. Let's take a look at essential details about drug licenses and drug store business.

  • Why is it important to have a Drug License?
  • Types of Drug License
  • Procedure for Obtaining drug license
  • Various application forms for drug license
  • Required Document for getting drug license

Why is it important to have a Drug License?

Millions of lives depend on medicinal drugs. Inappropriate use of drugs can lead to serious health issues it must be used only for the betterment of society. To conquer these subjects all pharmacists, retailers and wholesalers must possess a drug license. The drug license allows you to sell and deal with medicinal drugs appropriately. 

Types of Drug License

  • Manufacturing license 
  • Sale license
  • Loan license

Manufacturing License

A manufacturing license is given to the manufacturer who builds ayurvedic, homoeopathic, and allopathic drugs and cosmetic products.

Sale license

A sale license is given to individuals who want to sell medicinal drugs. Two types of sale licenses are

  •  Retail license 
  • Wholesale license

Loan License  

A loan license is a process in which one individual or company hire another manufacturing unit to build their products.

Procedure for Obtaining drug license

Only those individuals with a pharmacy degree can apply for this licence. For obtaining a drug license one has to submit the application form with all necessary documents to the state drugs standard control organisation or central drugs standard control organisation. After visiting the related organisation, fill out the application form with the required documents and expect a visit from the authority. 

Eligibility criteria for obtaining the drug license are -

  • One should possess a degree in pharmacy
  • Area
  • Proper storage facility for medicines
  • Well qualified staff

Various application forms for drug license

Various types of drug licenses needed different types of forms to be filled which are given below.

Form 19 - for renewal of a license to sell, stock and distribute or exhibit items apart from those mentioned in Schedule X.

Form 19A - for renewal or granting a restricted license to sell, stock or distribute drugs by retail through the dealer.

Form 19B - This form is used to sell, stock or exhibit homoeopathic medicines

Form 19C - This form is filled for renewal of a license to sell, stock, distribute or exhibit drugs mentioned in Schedule X.

Form 20 - This form is used to sell, stock, distribute or exhibit drugs by retailers other than those described under schedules C and C(1), X.

Form 24 - This form is used to get a renewal of a license or to grant a license to manufacture the drugs for sale/distribution other than those described under schedules C and C(1), X.

Form 24A -  This form is used to grant/renew a loan license to manufacture the drugs for sale/distribution other than those mentioned in schedules C and C(1), X. 

Form 24B - This form is used to grant/renew a license to repack the drugs for sale/distribution other than those mentioned in schedules C and C(1).

Form 24C -  This form is used to get the license to sell homoeopathic medicines.

Form 24D -  this application is used to grant/renew of license to sell ayurvedic or Unani drugs.

Form 24F -this form is used to renew/grant the license to manufacture drugs to distribute or sell mentioned in Schedule X.

Form 27 -  This form is used to get the license to manufacture for sale and distribution drugs mentioned in Schedule C and C(1).

Required Document for getting drug license

If you fulfil the eligibility criteria for obtaining the drug license then you will need the following documents for getting a drug license.

  • Application form
  •  Copy of Challan
  • Valid identity proof: Adhar card/pan card /Driving license/passport etc.
  • Qualification of applicant
  • If the business holder has a partnership then a copy of the partnership deed
  • Copy of key plan
  • Copy of site plan
  • Copy of property paper
  • Copy of rental agreement
  • Proof of storage facility
  • Affidavit from an experienced pharmacist
  • In the case of retailers
  1. Proof of qualification
  2. Registration from the  state drugs standard organisation
  3. Bio-data
  4. Appointment letter
  • In the case of wholesalers
  1. Proof of qualification
  2. Experienced certificate
  3. Bio-data
  4. Appointment letter
 

Wrapping up

Obtaining a drug license in India is a straightforward process if you have all the necessary things. One can fill out the application form with the required documents. After issuing the license one can start a drug store business.


 
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