How to apply and renewal for Drug license (Wholesale/Retail)?

Once the license is granted to you then it is your responsibility to renew it after the particular period. In this blog, we will discuss in very easy steps, How to apply and renewal for Drug license (Wholesale/Retail)?. There is not much difference in Wholesale and Retail Drug License as they both perform the same function. The main thing which distinguish the both is technical staff. Otherwise the documents, area and procedure is similar for both the terms.

Who Will Provide Drug License?

In India, all the laws and rules related to the Drugs, Cosmetics and medicines are established by the Drugs Control Department. There are mainly two bodies who have the power to provide you Drug license. Here are the two main regulatory bodies for drug license registration in India.

  • Central Drug Standard Control Organization ( the head official of the drugs Controller General India)
  • State Drug Standard Control Organization

Certain Requirements To Attain a Drug License in India

Before applying for the drug license, make sure that you have to meet some basic necessities which are important to get a Drug License. There are some conditions  which should be followed to get the access to Drug License. Here are the list of requirements which is mandatory to be fulfilled for Drug License in India.

Space Requirement – 

  • The pharmacist premises should have minimum 10 square meter for chemist shop or pharmacy and 15 square meter for retail and whole sale business.

Storage Facility – 

  • The associates should must own a refrigerator and air conditioner for the storage and quality maintenance of the products like vaccines, insulin, injections etc.

Qualification – 

  • The associate must be a registered pharmacist under the State Pharmacy Council.
  • If you are a wholesaler and not registered under the State Pharmacy Council then the individual should be a graduation holder.
  • He should also have minimum 1-2 year experience in sales and marketing of the drugs under a reputed company.
  • If the individual is S.S.L.C passed then he should have 4 years of experience in the pharma sales and marketing.

List of Documents Which are Required to Own a Drug License

Unlike other business industries, the pharmaceutical industry also requires certain list of documents to cross check the authenticity of the individual. The documents list can be vary from state to state. As every state has its own protocols to operate the business ventures. Here is the set of documents which need to be fulfilled and submitted along with the application form while obtaining Drug License in India.

  • Constitution of the entity – Memorandum of Association (MOA), Articles of Association (AOA) for a company, partnership deed, LLP agreement in case of partnership and LLP.
  • ID proof of partner/director/proprietor.
  • Documents related to premises – Copy of ownership documents of property or rental agreement as the case may be.
  • Site plan and key plan of the premises.
  • Copy of Board resolution permitting obtaining of a license.
  • Proof of availability of storage space as cold storage, refrigerator, etc.
  • Copy of challan as a proof of depositing fee.
  • Affidavit regarding non-conviction of proprietor/partner/director and the firm.
  • The affidavit from the registered pharmacist/competent person.
  • For a pharmacist at a retail sale:
    – Proof of qualification
    – Registration of local pharmacy council
    – Appointment letter
  • For a pharmacist at a wholesale sale::
    – Proof of qualification
    – Experience certificate
    – Appointment letter

Registration Process for the Drug License

Here is the registration process to apply for a fresh Drug License. Follow the instructions carefully and get your Drug license without any problem.

Step 1 – Apply online to the Senior Drug Control Officer and Licensing Authority of the Zone. The required amount of fee will be paid through e- banking services. Make sure that you upload all the required documents by scanning them.

Step 2 – The application form will be processed and the inspection Officer will come to your place to cross check the facts and documents. After that your report will be forwarded to the higher authorities.

Step 3 – After checking all the aspects, the license will be granted to you by Licensing Authority and you will be informed through SMS/ email.

Procedure for Renewal of Drug License

The license Renewal fee is equal to the fee required or obtaining the drug license excluding the inspection fee. Pay the Renewal fee before the due date for the Renewal of  the drug license. If you fail to do so then the expiry period of succeeding five years from the date of its issue will deemed to have been cancelled.