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Shambhavi Suyesha
| Updated: 23 Jun, 2022 | Category: Drug License

Who Needs to Obtain a Drug Shop License in India?

Who Needs to Obtain a Drug Shop License in India?

Without a drug shop license, an entity or individual cannot run the business of or open a shop that deals in drugs or cosmetics. In India, it is mandatory for every person who intends to open a drug shop needs to obtain Drug License

Meaning of Drugs 

Section 3 of the Drugs and Cosmetics Act defines drugs. The drug includes all medicines as well as devices used for human beings or animals internally or externally. All substances used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparation applied on the human body for the purpose of repelling insects. It also includes all substances that can be used for the destruction of insects and all components of drugs. 

In 1964, an amendment took place where Ayurvedic and Unani drugs were also included in the meaning of drugs. 

Drug Shop License 

A drug License is made mandatory under the Drugs and Cosmetics Act, 1940[1] for business in India. This Act consolidates all laws related to drugs and cosmetics in India. The purpose of a Drug License is to permit or allow individuals or entities to engage in businesses related to drugs and cosmetics. 

There is a variety of drugs, and so are multiple numbers of drug shops. All the drug shops established in India require a drug license. The drug shop cannot be opened without an appropriate license. If an individual or entity operates its drug business in more than two states, it must obtain it in each state where it operates. 

A drug License is location-specific. A drug license ensures quality compliance in drug shops at all times during its business is carried on. All records/forms/registers are maintained as specified by licensing authorities. And if the change is made in the drug shop, then it should be informed to the licensing authorities. 

A drug license is valid for five years; however, it can be suspended or cancelled in between those five years by the Drug Department. It should be renewed before the expiry of the original one.  

Prerequisite for Drug Shop License

The prerequisites for obtaining a drug license are as follows:

  • Competent drug shop owner/pharmacist 

A pharmacist or individual who owns a drug shop must be qualified in case he is in a retail business. And in the case of wholesale business, he must be a graduate with one year of experience or an undergraduate with experience of four years.

  • Space in shop

The requirement of space means the area of the shop, and it is a very important prerequisite. The area of a shop having a drug business should be 10 square meters. The area and height of the shop should be as per the guidelines stated by the National Building Code of India, 2005.

  • Storage facility

The storage facility is another important prerequisite because some drugs are required to be stored in low temperatures. So, the air conditioners and refrigerators are a must at the shop, and they must be in proper working condition.  

  • Technical staff

The technical staff means the pharmacy staff at the drugs shop should have depth knowledge. The staff of the wholesale pharmacy shop must be a graduate with one year of experience or an undergraduate with four years of experience. 

Types of Drug Shop License 

There are two types of licenses for the sale of drugs in a Drug Shop. These types are as follows:

  • Wholesale License:

Wholesale means the sale of drugs to a person or retailer for further sale of such drugs. A drug wholesaler needs to obtain a wholesale license.

  • Retail License:

A retail sale means the sale of drugs to end consumers. Retailers can sell drugs to dispensaries, hospitals, and educational or research institutes. A retail license is required for such retail sale of drugs and by retailers who are engaged in pharmaceuticals, cosmetics, ayurvedic shops, pharmacists, etc.  

So, anyone who is engaged in the wholesale or retail sale of drugs needs to obtain a Drug License.  

Drug Shop License: Eligibility 

The eligibility criteria to obtain a Drug License for the sale of drugs are as follows:

  • Pharmacists registered under State Pharmacy Council
  • A graduate with at least one year of experience in pharma marketing and has passed SSLC
  • An individual with four years of experience in pharma marketing and has passed SSLC
  • A person approved by Drug Control Department.

Drug Shop License: Required Documents

  • Appropriate Application Form
  • A copy of the Challan 
  • ID such as PAN Card, Passport, Driving License, Voter ID, etc.
  • A copy of Property Papers
  • Proof of storage Availability
  • Proof of Qualification of Registered Pharmacist and competent person
  • Registration from State Pharmacy Council
  • Experience Certificate
  • Any other required document

Drug Shop License: Procedure 

The steps involved in procedure for obtaining Drug License are as follows:

  • First step: Applicant submits request letter along with firm details
  • Second Step: Applicant prepares documents and affidavits as prescribed by law.
  • Third Step: Applicant files application with the prescribed government fee. 
  • Fourth Step: The application is marked for Inspection. The Drug Inspector personally visits the concerned shop to verify the documents and to check the correctness of details provided by the applicant. 
  • Fifth Step: After completion of the Inspection and verification process, the Controller of Drugs issues the License. 

Conclusion

The Drug License is obtained by manufacturers, retailers, wholesalers, importers, or anyone involved in the drug-related business. One running a drug shop needs to obtain a Drug Shop License by fulfilling the eligibility criteria and all the conditions prescribed by law. The State Drug Standard Control Organisation (SDSCO) is the authority to grant a Drug License for the sale of drugs. The sale of drugs is divided into two categories, wholesale and retail sales. The person involved in both these categories needs to have Drug License to move forward with the sale of drugs.

Read Our Article:How One Can Apply For Wholesale Drug License In India?

Shambhavi Suyesha

Shambhavi holds a strong legal background, having completed her BA LLB and LLM. She is particularly interested in legal research and writing, and wishes to utilise her knowledge to create informative legal content. She is an analytical researcher and keeps herself updated about the current legal affairs. She also holds prior experience in publishing articles on assorted legal areas.

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