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Get the Drug License of your choice with Registrationwala's aid

To register your business in the Pharma Industry or launch a Healthcare Facility, you must obtain a drug license from the State or Central Drug Standard Control Organization. To seek aid in the drug license registration procedure, connect with the Legal Experts at Registrationwala.

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Process of Drug License in India

Step 1
Documentation
Step 2
Application Filling
Step 3
Application Assessment
Step 4
Grant Of Drug License

Drug License Application in India

Whether you been planning to get into Pharma industry or launching a healthcare entity, obtaining a drug license from the respective authority is something you can’t afford to miss. According to the Drugs and Cosmetics Act, a drug license is usually allotted by State/Central Drug Standard Control Organization.

The Central Drugs Standard Control Organization (CDSCO) administers the Drugs and Cosmetics Act in order to control substandard drugs and regulate the import, manufacturing, distribution, and sale of drugs and cosmetics through licencing. The D&C Act's Section 26B, which gives the CDSCO the authority to control, regulate, or prohibit the manufacturing of a medicine in the public interest, has recently been the subject of several notices.

The term “drug” may include:

  • All medications intended for internal or exterior usage in humans or animals, as well as all compounds used in the treatment, mitigation, or prevention of any disease or ailment in either humans or animals, including preparations used to ward off insects like mosquitoes
  • As may occasionally be specified by the Central Government by notification in the Official Gazette, such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of 10[vermin] or insects which cause disease in human beings or animals
  • All chemicals, including empty gelatin capsules that are intended to be used as medication ingredients.
  • The Central Government may from time to time, following consultation with the Board, specify such devices intended for internal or external use in the diagnosis, treatment, mitigation, or prevention of sickness or disorder in humans or animals.

Types of Drug Licenses in India

Below are different types of drug licenses being issues by the concerning authority. 

1. Retail Drug License

Retailers selling medications, independent pharmacists, etc. can apply for this licence with the State Pharmacy Council. This usually refers to a drug license for medical shop or medical shop license.

2. Wholesale Drug License

This drug licenses is given by the central drugs standard control authority to wholesalers involved into pharmaceutical business. The person applying for wholesale drug license online should meet the following eligibility criteria:

  • Professional diploma or degree in pharmacy
  •  At least one year of experience in drug sales

3. Import Drug License

As its name indicates, this license is sought by dealers that want to import the raw materials for the manufacturing of drugs or import ready-to-sell drugs in India

4. Loan Drug License

The drug manufacturer who is willing to use his brand name to manufacture on property for which a licence has already been granted but does not own his own land.

5. Drug Manufacturing License

Every manufacturer of allopathic, cosmetic, Ayurveda, or any other pharmaceuticals or remedies as defined by the Drugs and Cosmetics Act of 1940. This is the state permit that was granted by the particular state administration in which the property is located.

6. Multi-drug License

This drug license is meant for those businesses that have operations in multiple states and different units.

7. Sale Drug License

The company involved in the distribution of medications in India, whether on a wholesale or retail basis, acquires a sale drug licence.

 

Eligibility Criteria for Obtaining Drug License in India

  • The applicant's premises must be at least 15 square metres in size.
  • To keep the vaccinations, insulin injections, sera, and other supplies, the applicant's premises must have an air conditioner and a refrigerator.
  • A licence is given to someone who possesses a pharmacy degree or diploma from an accredited university.
  • A pharmacist must be a graduate with one year of drug selling experience.
  • The licence must be visible on the property.

 

Required Documents

Below are the documents required to apply for a drug license in India:

  • Dully filled application for
  • Identity proof like a PAN card, passport, driving license etc., if the applicant is a proprietor
  • Challan copy as a proof of payment
  • In the case of a partnership firm, Identity proof of every partner along with the partnership dee
  • Copy of AOA, MOA, and COI if the applicant is a private, public, or a one-person company
  • CTC of Board Resolution approving the company's licensing application.
  • Appointment letter from the subject of a corporation authorization 
  • Proof that storage capacity is available, such as a refrigerator or cold storage facility.

 

Essential Requirements To Obtain Drug License in India

Below are some of the essential conditions that need to be met by the applicant of drug license.

Property Area

Setting up a pharmacy or medical store requires a minimum space of 10 square metres. However, if they are running both a wholesale and a retail operation, a minimum of 15 square metres is needed.

Storage

The implementation of cold storage, freezers, or similar facilities should be done to provide proper storage for medications and vaccines as they need to be kept in cool areas.

  • Personnel with technical and expert knowledge
  •  Retail pharmacies must have a competent staff with these skills.

Depending on their line of work, companies that deal in medications or medicines may need a variety of drug licences. Drug licences must be obtained by a single drug dealer who has several units in more than one state since they are region-specific. Every location where drugs are kept and sold must apply for a drug licence, except migrant vendors.

Holders of drug licences must ensure that the product conforms to all rules and regulations. The licence that was granted in defiance of these terms and conditions may be revoked or suspended. Authorities must be notified of any business-related changes or modifications.

How to apply for drug license in India

Here is the basic procedure to follow to obtain drug license in India:

  • After determining the type of drug license required, an online application needs to be submitted.
  • After the successful filing and submission of drug license registration form is done, the applicant will get a unique registration number which will be used for future reference.
  • All the necessary documents need to be submitted to the officer of the Drug Licensing Authority within the 15 days of registration
  • Then the visit of a drug inspector is done who verifies the authenticity of the submitted documents and facts stated in the drug license application
  • The drug license is eventually issued once the verification of documents is done satisfactorily by the drug inspector

 

How Registrationwala can help you in getting a drug license in India?

At Registrationwala, we have a team of skilled and experienced professionals who first understand your specific drug license requirements, nature of the business, and other specifications and then provide full-fledged support in regard to drug license procurement. We ensure that your drug license registration is done proficiently so that it gets approved quickly without any hassle.

So, apply for a drug license online today with Registrationwala.

When you apply for online drug license you get:

  • Professional drug license registration support
  • Peace of mind
  • Quick license approval
  • A team of industry experts

 

FAQs

Q. Are drug license and Pharma business license same?

Yes, they both refer to the same thing. Obtaining a drug license is mandatory for all businesses indulged in the sale of pharmaceutical and medicines.

Q. For how long, a drug license remains valid?

A drug license remains valid for five years unless the drug department suspends and cancels it. By going onto the relevant drug regulating website, feeding the drug license number, filling out the renewal application, and submitting the document together with the fee for the issuance of the renewal of the drug license, it can be renewed before its expiry. A new drug license will be issued by the drugs controller.

Q. What the major features of having a drug license?

The characteristics of a drug license are as follows:

  • For businesses selling pharmaceuticals, medicines, or cosmetics, a drug license is required
  • The license must be issued for a business location.
  • The pharmaceutical and cosmetics industries must adhere to all legal and regulatory requirements and restrictions.
  • The license must always be visible in the business location.

Q. What do forms 20B & 21B mean?

The State Licensing Authority in India issues a wholesale license in Forms 20B and 21B or its renewal in Form 21C to the manufacturer (subsidiary office/representative of the parent firm) or to anybody else who wants to sell, stock, show, or offer for sale or distribute medications.

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