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Drug License is mandatory for Pharmacy story and wholesale trading of medicines. Get it with ComplyKart Experts Hassle Free.

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  1. Consultancy with Expert

  2. Documents preparation

  3. Follow up with Department

  4. Registration Certificate

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DRUG LICENSE

The Drug License is mandatory under the Drugs & Cosmetics Act, 1940 and it is applicable to all over India. Drug license is the permission grant by the government to deal with pharmaceutical industries like drugs and cosmetics in India, doing this without the permission of the government is a cognizable offence. There are stringent regulations over manufacturing and distribution of drugs and medicines in India, in order to prevent their abuse and misuse, which are listed under the Drugs and Cosmetics Act, 1940. In 1964, Ayurvedic and Unani drugs were also included in this Act.

The time frame for obtaining and granting drug license by the authority is 30 days after becoming eligible under this act. Once the Entity has obtained Drug License, it is required to ensure the condition mentioned in license are duly complied during the course of business. All the records and registered required to be maintained in prescribed manner as mentioned by authorities and they must be informed of any changes in the business activities of license holder. Since the Drug Control Authorities are state governed, separate application should be made for each state. The retailer or wholesaler are required to have a self-occupied premise of atleast 15 sq. meters for being eligible for Drug License.

ComplyKart is among the best drug License consultant committed to provide 100 percent success to business.

Types of Sale Drug License

There are mainly two types of License that are issued for the Pharmaceutical business:

1.Retail Drug License (RDL)

  It is granted for a Chemist or Standalone Pharmacy Shop awarded to people registered with state pharmacy council.

2. Wholesale Drug License (WDL)

  It is granted to the people who are into wholesale distribution of drugs.

The other types of License are:

  1. Manufacturing License

  2. Loan license

  3. Restricted license for general stores on the basis of type of sale

Multi-State Operation

If the business is operating in more than 2 state then obtain drug license for each state and they have to maintain all the registers records and forms in the manner specified by the authority.

Import Drug License

To obtain drug import license the person has to file the various forms such as Form 8, Form 9, and Form 10 at the CDSCO portal along with the prescribed fees.

Conditions for Drug License

Pharmacist with competency

Medicines should be handled by a competent person, therefore a qualified pharmacist will be given Retail license and wholesale license will be given to a graduate with 1 year experience and an undergraduate with 4 (Four) years.

Area of Premises

To apply for a retail license, the carpet area of premises must be of 10 square meters and for retail and wholesale both license, the minimum area should be 15 square meters with proper open areas.

Clean Storage for Drugs

Refrigerator facility is must for Drug license as few of the medicines specially vaccines need to be kept at freezing temperature. The drugs must be kept at a cool storage facility with clean ad properly ventilated premises.

Prior Inspection

When you apply for Drug License, the Drug Inspector of your jurisdiction will visit to verify the documents submitted and also check the premises where Drug is to be kept.

Benefits of drug license

Legal Requirement

Having a Drug License is mandatory to acquire by someone willing to run a retail or wholesale Drug selling business or even the manufacturer of Medicines.

Safety

After obtaining the drug license the entity feels safe in producing any types of medicine or drugs because Government take necessary measures to control over the entity.

Reduce Risk

The customer feels safe and secure in buying drugs from the registered entity or from the entity who have drug license.

Improves Communication

The retailer will not hesitate in dealing with the person like whole-seller who obtained the license with the authority and it will improve the communication between the different chain of marketing.

Transparent

With the help of drug license the intention to make the process of drug license transparent and user friendly will be achieved.

Registration Procedure

  • 1

    Consultation by Experts

    Our Drug Registration Experts will explain you the documents and procedure to obtain the drug license within stipulated time.

  • 2

    File Application

    The application for Drug License is submitted with the prescribed fees as mentioned in the application.

  • 3

    Furnish the Documents

    The necessary documents are prepared and furnished for verification and inspection. It must be scanned and uploaded along with application.

  • 4

    Inspection

    The Drug inspector can personally visit to the shop to inspect and verify the documents furnished in the information provided by the applicant.

  • 5

    Grant the License

    After submission, the application is inspected and verified after which drug license is granted to the applicant.

Documents Required

  • Copy of Memorandum & Article
  • Copy of Certificate of Incorporation
  • Copy of Rented Agreement or property papers
  • Site plan, factory map and key plan of premises
  • Affidavit from directors
  • Invoices of Refrigerator & its details
  • Proof of qualification of pharmacist
  • Bio-Data & Appointment Letter
  • List of directors and shareholders
  • How ComplyKart helps in this entire process

    Consulting & Strategy

    We have a selective team of Professionals who are expert in their respective fields. Our Drug License experts will give you the best consulting and prepare the strategy for your company

    Client’s Growth

    Our services are aimed at achieving growth for clients. We provide necessary guidance for understanding the Drug License process.

    Competence is our strength

    We make every effort to stay updated with the rules and regulations by Drug License Department. This enables us to deal with client’s needs effectively.

    Always there for you

    The assurance of a dedicated workforce including support staff and managers can be a promising factor in the drug License process.

    Post Registration Compliance

    Once the Drug License is approved by the authority we help you to comply with certain rules to keep your business running.

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