When you’re sick, you’ll need to take medications or prescriptions to stay well. But how can you be certain that the medication you’re buying from a pharmacy is genuine? The first and most important thing to look for when purchasing medicines from a pharmacy or drugstore is whether or not they are Drug Licensed. The Indian government has implemented tight laws and regulations for the manufacture and distribution of medications and medications in our country’s drugstores and pharmacies to offer this a market edge. In this blog, we’ll look at how you may get a drug license in India.

What is Drug License?

Drug License is a government-issued permit provided to the owner of a pharmacy or drugstore. The Drugs and Cosmetics Act, 1940 controls drug licencing in India, including provisions for carrying on the business of drugs, medicines, and cosmetics.

The Drug license is issued by the authorities at the following two levels:

  • State Drugs Standard Control Organization (SDSCO): Sales and distribution, as well as manufacturing control, are controlled by state agencies under the Drugs and Cosmetics Act.
  • Central Drugs Standard Control Organization (CDSCO): The CDSCO is in charge of approving new drugs, performing clinical trials in the nation, monitoring the quality of imported medications, and working with the SDSCO, according to the Drugs and Cosmetics Act.

However, many people are unaware that there is a difference between a pharmacy and a drugstore. We’ll describe the drug licencing in India briefly in this post.

Prerequisites for Obtaining a License

  • Pharmacist/ Competent Individual: In the situation of retail business, the pharmacist must be eligible. In the wholesale industry, however, the individual must be a graduate with one year of experience or an undergraduate with at least 4 years of experience.
  • Space Requirement: Another important need is space, which is specified as the area of the pharmacy or unit for both retail and wholesale licenses – 15 square meters.
  •  10 square meters – In all other situations.
  • The apparent height of the premises of the sale must be calculated according to the guidelines set out in the National Building Code of India, 2005.
  • Storage Facility: The storage facility is also a must since some drugs must be kept in refrigerators, at low temperatures, and in air conditioners.

A brief about Drug License and Drug License Registration

Drugs are used in the creation of medicine in a medically defined ratio in order to cure an individual’s health. As a result, the State and Central Drug Standard Organizations have established particular guidelines for taking the proper dosage of drugs that do not harm the body. 

As a result, any violation of the medically prescribed limits might have a serious effect on the patient’s health.

What is the difference between a pharmacy and a Drugstore?

Pharmacy or Dispensary Drugstore
A place where prescription drugs are dispensed A retail store where both prescription and non-prescription drugs are sold along with other first aid and similar products.
The only source of income is the prescribed medicines of individuals. These drugstores earn a majority of their revenue from these products, which includes health and beauty products.

What are the types of Drug License issued in India?

Retail Drug License

Retail Drug license is issued to the people involved in chemist stores.

Wholesale Drug License

A wholesale drug license is issued to the people or businesses who are connected to the wholesale distribution of drugs.

Drug License

Forms for Drug Licenses for sale and wholesale of Drugs

Different licenses are required for getting various kinds of licenses which can be obtained by filing various forms:

FORM Types of Drugs
FORM 20        Allopathic Drugs
FORM 20-A Restricted Allopathic Drugs
FORM 20-B Wholesale of Allopathic Drugs
FORM 20-C Homoeopathic medicines by retail 
FORM 21 Allopathic drugs specified in Sch C & C (1). 
FORM 21-B Wholesale of Allopathic drugs specified in Sch C & C(1). 
FORM 21-A    Retail sale of restricted Allopathic drugs specified in Schedule C (I). 
FORM 20-F    Retail sale of drugs specified in Sch. ‘X’.
FORM 20-G Wholesale of drugs Specified in Sch. ‘X’.

Read about: How to get a Manufacturing License of Drugs in India?

What are the Documents needed for Drug License Registration?

The documents needed for the Drug License Registration in India are as follow:

  • The application form must be completed in the required format and signed by the proper authority.
  • A copy of the Challan will serve as proof that you have paid the required fee.
  • Id proofs such as PAN, Voter Id, Driver’s license, Passport, etc. Id proofs such as PAN, Voter Id, Driver’s license, Passport, etc. 
  • In the case of a proprietorship Id proof of each partner, as well as a copy of the partnership deed – for the partnership company.
  • In the case of a private/public/OPC CTC of Board Resolution allowing the firm to get the license, a copy of the MOA, AOA, and COI is required.
  • Appointment letter of the company’s authorized representative
  • Proof of storage space, such as cold storage, a refrigerator, and so on.

Additional documents if the applicant is registered, pharmacist:

  • Registration certificate issued by pharmacy council
  • Diploma pharmacy
  • Appointment letter
  • Affidavit of pharmacist
  • Education qualification certifications: high school & intermediary mark sheets, graduation certificate, post-graduation degree, etc.
  • Any pharmaceutical business must have at least one year of expertise in drug sales and marketing.
  • Plan the layout of the area where the license will be used.
  • If the license is requested for the wholesale or retail sale of pharmaceuticals, the area must be at least 10 square meters.
  • If the license is used for both wholesale and retail drug sales, a minimum of 15 square meters of space is required.
  • Electricity availability and similar installation on the premise.

What is the Procedure for applying for Drug License?

The laws and regulations controlling the Drug License are administered by the Food Safety and Drug Administration of the concerned state government:

Following steps need to be followed for receiving the Drug License –

Visit the site: The authority to issue each drug license has been given to the individual state authorities.

Visit the website for your state; for example, a person who wants to open a pharmacy in Uttar Pradesh should go to the state’s government portal at http://fsdaup.gov.in/online-licensing.htm.

Filing of Application: Fill the online application form and upload the properly scanned copy of all the documents.

A visit by Drug Inspector: Next to receiving the application form, the Drug Inspector will personally visit the shop or the drugstore for the confirmation of documents.

Grant of the license: After a successful inquiry by the Drug Inspector, the Controller of the Drugs will issue the drug license.

What if you violate the law?:  Anyone who breaks the law and sells drugs without a valid license is subject to penalties under Section 18(C) of the Drugs and Cosmetics Act, 1940. A punishment of not less than one year and up to three years in prison or a fine of not less than 5,000 rupees can be issued.

Conclusion

To sum up, everyone who desires to run a pharmacy in India must first get a drug license before starting their business. The Indian government has developed some basic norms and Norms that must be followed by every pharmacy in the country, both at the state and national levels. After all, everyone’s major motto is that “health is wealth.”

Need Drug License In Maharashtra?

We at MeraLegal guarantee that you are completely aware about all governmental rules for running a pharmaceutical business, from documentation to area standards, as the top supplier in Pune. As a result, your inspection by the regulatory authorities will go easily, allowing you to get your firm up and running quickly. Please click on the following link to connect with our experts.

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