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Registration Process for Drug License - Form 20, 21

Overview of Drug License Registration

To conduct business in India, you must get a license to sell drugs and cosmetics. The Drugs & Cosmetics Act, of 1940 has provided provisions for this, and it is applicable throughout the territory of India. This Act established the Drugs Control Department by combining all the laws pertaining to drugs and cosmetics. Ayurvedic and Unani medications were included in the Act in 1964 through an amendment.

A business must get a drug license in each state where it conducts business. In case a business exists in two or more states, then a separate drug license will be required. In the unlikely event that pharmaceuticals are provided or offered for purchase at more than one location, a license application must be submitted and granted for each location, with the exception of migrant sellers.

What is a Drug License?

A drug license is the official government authorization given to an entity to deal with drugs. Obtaining a drug license is a requirement before starting a drug company. The Drugs and Cosmetics Act of 1940 defines "drug" under section 3(b).

It consists of the following items:

  • All drugs and materials used to treat, diagnose, prevent, or lessen any illness or disease in humans or animals, including preparations used topically to ward off insects like mosquitoes.
  • Every material that goes into making the medication.
  • Among them are empty gelatin pills.
  • Medical Devices.

Meaning of Drugs

According to the definition of "drug" in Section 3(b) of the Drugs and Cosmetics Act of 1940, a "drug" is defined as any medication or device intended for internal or external use by humans or animals, as well as any substance intended for use in the diagnosis, mitigation, treatment, or prevention of any disorder or disease in humans or animals. This also includes substances applied to the body to ward off insects like mosquitoes. In 1964, the term was revised to include Unani and Ayurvedic drugs.

What is the importance of a Drugs License?

To make sure that people don't abuse or misuse medications and other medical supplies, access to them needs to be controlled. Therefore, under the Drugs and Cosmetics Act of 1940, drug licenses are required for all pharmacists, wholesalers, retailers, producers, distributors, dealers, and importers of medicines, cosmetics, Ayurveda, Siddha, and Unani medications.

The significance of a drug license is to give organizations or individuals authorization to conduct medication and cosmetics-related operations. In India, it is illegal for any company or individual to trade in pharmaceuticals, medications, or cosmetics without first acquiring a drug license. They need to register their shop and establishment and secure a trade license in addition to a drug license.

The government of India is assisted in regulating and overseeing the quality of medications sold in the country by the Medicines and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945. From the time medicines are manufactured, sold, and distributed to the point at which a pharmacist sells them to a patient or consumer in a retail pharmacy, hospital, or dispensary, the government maintains control over the drugs.

The government also has the authority to look over the matters pertaining to the import and export of medications, the sale of pharmaceuticals to minors, the use of drugs listed in Schedule H and X, and other matters that call for careful planning and monitoring. In accordance with the Drugs and Cosmetics Act, of 1940, the drug governing authority grants the drug license.

Types of Drug License in India

The types of Drug licenses are mentioned below:

Retail Drug License

The term "retail sale" describes the distribution of medications to the final customer. Drugs can be sold by retailers to medical, educational, research, and dispensary facilities, among other entities. A drug retailer's or chemist's shop's license is required under the Drugs and Cosmetic Act. Additionally, the State's Drug Controller Authority issues retail licenses.

If someone sells drugs without a license, they can be punished with a minimum one-year sentence, which can go up to three years, or a fine of up to Rs. 5,000.

Wholesale Drug License

If a business, distributor, or independent agent is approved to function as an Indian agent for a domestic or international manufacturer, they will be granted a wholesale license. Therefore, a manufacturer and an authorized Indian representative are granted a wholesale license. The CDSCO grants Whole Sale Drug Licenses to individuals engaged in the wholesale distribution of drugs.

Drug Manufacturing License

This is a license to manufacture drugs. The term "manufacture in drugs" refers to any procedure, or portion of a process, used to create, modify, finish, package, label, fragment, or handle any substance in any way for selling or distributing it.

Loan License

This is permission to manufacture drugs on the premises of any other manufacturer. A valid drug license and manufacturing capacity are requirements for the manufacturer who supplies the drug's production facility.

Import License

In India, importing drugs is mandatory. Licenses for the import of medications are issued by the Central Drug Standard Control Organization or CDSCO.

What are the documents required to obtain a Drug License?

The documents required to obtain a drug license:

  • The company?s constitution, the partnership deed, the articles of association (AOA) for a company, the memorandum of association (MOA) for a partnership, and the LLP agreement for an LLP.
  • Identification of the director, partner, or proprietor.
  • Records pertaining to the premises, such as a copy of the property's ownership papers, the rental agreement, and, if applicable the NOC (No Objection Certificate) from the rented premises' owner.
  • The premises' site plan and key plan.
  • A copy of the board resolution authorizing license acquisition.
  • Evidence of the availability of cold storage, refrigerators, and other storage spaces.
  • Challan copy as evidence of paid deposit.
  • Affidavit of non-conviction of the firm, its proprietor, partner, or director.
  • A cover letter from a qualified individual or certified pharmacist.
  • Cover letter with applicant's name and title Declaration form in the manner required by law.
  • The qualification certificate of the applicant
  • Evidence of eligibility, local Pharmacy Council registration, and letter of appointment of the wholesaler or retailer.

What are the requirements for getting a Drug License?

The following are the main prerequisites for getting a drug license in India:

Area of Premises

A minimum of 10 square meters must be available for anybody wishing to open a retail pharmacy or medical store. It is crucial to note, that a retail or wholesale drug business must have a minimum of 15 square meters.

Storage Space

To keep medications, one must make sure that the space is outfitted with the appropriate storage facilities, such as a refrigerator or cold storage area.

Staff

Technical staff having knowledgeable and skilled staff with extensive expertise in the field is essential for a retail pharmacy store. In addition, the pharmacist must meet the requirements in order to be eligible for a drug license.

It is important to remember that in order to be granted a wholesale drug license, the employee must be either an undergraduate with four years of experience or a graduate with one year of experience.

Property Examination

A Drug Inspector with jurisdictional power may visit the premises for inspection prior to the issue of a drug license. In addition, he will be able to measure the property, confirm the information provided, and speak with the qualified individual.

What is the process of Drug License Registration?

The process of drug license registration is given below:

Step 1: Register on the Drug Licensing Portal

The first step is to register on your state's Drug Licensing Portal. Each state has its own Drug Licensing Authority that oversees an online Drug Licensing Portal for the purpose of registering drug licenses. You can apply for the Drug License Certificate by logging into the portal directly if you already have the necessary credentials.

Step 2: Submission of an Application

You must input the pharmacist's and competent individuals' details after registering on the website. Next, enter the name and parties related to the Pharmacist Council Registration. After that, you may submit the application by using the form that is relevant to the type of application you are submitting.

Forms 19, 19A, 19B, or 19C can be used to apply for a certificate of drug license registration according to your needs. Once the necessary information has been entered, verify the information one last time as it cannot be changed later, and then submit the online Drug License Application Form.

Step 3: Procedure for Inspection

Upon receipt of the completed Drug License Application Form, the Drug Licensing Authority (DLA) arranges for a time to inspect your property. To register for a drug license, a drug inspector comes to the location on the prescribed date.

The conditions for premises for the issuance of a drug license are confirmed by the Drug Inspector (DI). Additionally, the applicant's original documents are verified by the Drug Inspector, and forward the report to the Drug Licensing Authority.

Step 4: Issuance of a drug license

The Drug Licensing Authority reviews the report forwarded by the Drug inspector. The authority verifies if the application is in compliance with the Drug Rules. If the application is found accurate, the applicant is granted a drug license by the relevant authority based on the Drug Inspector's report.

Why Choose PSR Compliance for Obtaining a Drug License?

Obtaining a drug license is necessary before manufacturing or selling drugs or starting a drug store. If you need any kind of drug license, you may get in touch with PSR Compliance directly, regardless of whether you are a manufacturer, distributor, or retailer of medicines and cosmetics in India or elsewhere. PSR Compliance guarantees that your license will be issued on time and this will enhance the credibility of your drugs or medicines. We provide a comprehensive solution to help medicine manufacturers in India secure licenses and testing facilities.

Frequently Asked Questions

Q1- What is the validity of a Drug License in India?

Once obtained, a drug license is valid for five years, until the Drug Department suspends or cancels it.

Q2- What are the essentials for getting a wholesale drug license?

The applicant's store or premises must have a minimum of 10 square meters of space, and the person in charge (the Competent Person) must be a Registered Pharmacist, someone who has completed their high school education or its equivalent and must have four years of experience handling drugs, or hold a degree from an accredited university and have one year of experience handling drugs.

Q3- Where to find information regarding drug licenses and their provisions?

The Drugs & Cosmetics Act of 1940 and the rules enacted thereunder contain several sections pertaining to drug licensing. You can also contact the drug inspector of your area to obtain information about drug licenses. Moreover, in order to get any information, you can contact the expert of PSR Compliance and ask your questions.

Q4- Do I need to get a separate license for selling drugs via vehicle?

Yes, selling drugs using motor vehicles does require a special license. Applicants must choose to take it at the time of making an application.

Q5- What to do if the premise of my existing drug license had been changed?

If the applicant's address changes, they must surrender the drug license that was issued for the previous location and apply for a new one.