Drug License

Drug License

A Complete Overview on Drug License Rules in India

calendar29 Dec, 2020
timeReading Time: 4 Minutes
A Complete Overview on Drug License Rules in India

At present, the street of India is flooded with multiple drugstore or pharmacist. Those days are extinct when people get ill in their old age only. Owing to decaying conditions, people have now become less immune to diseases and other health issues. If you are planning to dive into medication business, then you have to abide by the drug license rules and obtain drug license without exception. 

Overview of Pharmacy & Drug Sector in India 

About four decades ago, there were roughly 10000 distributors & 1.25 lakhs retail pharmacies in our country. However, at present, about 550,000 pharmacies are functioning pan India. Henceforth, the Indian retail pharmacy has witnessed tremendous growth in the past few years. As per the government stats, the sector has been growing at an average rate of 18% per annum. 

Read our article:A Detailed Outlook on the Registration Process to Obtain Drug License in India

What is a Drug License?

The right conferred under the Drug and Cosmetic Act, 1940[1] to engage with the business of medication and cosmetics is known as a drug license. Precisely, no one has the authority in our country to conduct drug selling in the absence of a drug license.  

The Objective and Stipulations Related to Drug License Rules  

The drug and cosmetic industry have a fruitful impact on our society since it contributes to the betterment of the individual. The Drug and Cosmetic Act, 1940 was inculcated to curb the discrepancies in manufacturing, import, and sale of drug items. The Act facilitates long lists of standards to ensure that India’s drug is safe and steak to mandatory compliances.

The following list comprises drug license rules that are meant to be followed by the drug license holders. 

  • A person seeking a drug license must have ample experience in the drug distribution business. According to the act, a minimum of 4 years of experience is required to conduct a drug-selling business. 
  • Supervision of registered pharmacist is a must-have requirement if the licensee wants to produce a certain category of drugs. 
  • Further, the drug retailer must keep track of the supply chain of the drug. He/she should maintain a proper register for the same. 
  • The licensee must exercise extra caution while dealing with expired drugs and cosmetics. Under no circumstances, the expired drugs should reach the shelves of the retailer. 
  • The minors are eligible to purchase drugs from the pharmacies. 
  • The veterinary medicines stocked at the pharmacies should exhibit the following messages
    • Not for human use, for treatment of animals only
    • No record of the drugs sold by retail or intended for sale
    • As per the act, no reason would be counted justifiable for stocking the medicine at the personal premises. 
  • Any drugs prescribed by the certified medical practitioner must be under a registered pharmacist’s supervision before retail supply.  
  • Schedule X or Schedule H comes with a validity of two years. Therefore, a writ order will be required for its distribution. 
  • The stocking of expired drugs would not lure any penalties from the IT department, unless they kept isolated from retail selling. 

Drug License Rules that Every Pharmacist Needs To Know

Drug and Cosmetic Act enclose wide arrays of the requirement that an applicant must fulfill to secure the drug license. The section below demonstrates the same: 

  • Drugstore must have 15 square meters of the area to conduct any activities regarding the drug business. 
  • The Drugstore must have ample cooling equipment in place to ensure quality preservation of the drugs. Besides, proper ventilation is equally important from the compliance viewpoint. 
  • As per the act, the presence of the following individuals is following to conduct drug related business. 
    • Any Pharmacist certified by the State Pharmacy Council.
    • A graduate holding experience of one year in drug sales and marketing. 
    • A 10th-grade pass individual with four years of experience in the drug-selling business.
    • Individual certified by the department of drug control.

Documents Required for Drug License as Per the Drug License Rules 

Before indulging in the drug license process, make sure you have the following documents in place:  

  • Certificate of the company’s incorporation.
  • ID proof of the owner as per the case.
  • Address proof such as sale deed/rent agreement
  • A valid affidavit confirming the non-conviction of the owner of the firm under the Drugs and Cosmetics Act, 1940.
  • An affidavit was issued from a registered pharmacist.
  • For retail sale registered pharmacist, proof of qualification for pharmacists is a must-have requirement. 
  • Appointment letter for registration issued by the local pharmacy council.
  • Receipt of the online fee deposit.
  • Site plan as per applicable rules.
  • For wholesale drug license; qualification proof, experience certificate plus the appointment letter.

Procedural Instructions for Obtaining Drug License as per the Drug License Rules 

Procedural Instructions for Obtaining Drug License as per the Drug License Rules

The Food Safety and Drug Administration Department is an apex government body that regulates the drug license rules. Henceforth, the applicant requires attaching the requested document along with the application. The following instructions will help you avail the drug license. 

Fill up the Application

The process for applying for a drug license is completely online, wherein the applicant can access it by paying the requested fees as per drug license rules. Then, upload the soft copy of the requested documents at the time of applying.

Onsite Inspection by the Drug Inspector

As soon as the authority receives the application, they will appoint an official to inspect the applicant’s shop. During the onsite inspection, the official would verify the documents of the applicant. 

Issuance of the Drug License by the Authority

After successful verification, the official will confer his approval for the grant of drug license.  


Opening a pharmacy is certainly a bigger responsibility for an individual since much compliance need to be taken care of. Availing a drug license is equally intimidating as executing the drug business. Feel free to talk to our professionals at the CorpBiz platform for obtaining the drug license without a hassle. 

Read our article:Four Prominent Benefits of Drug license that you must know

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