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Drug License

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What is Drug License?

Drug License Registration is a mandatory certificate issued by the Drugs Control Department for the sale and manufacture of drugs and cosmetics. Governed as per the laws of the state government, this license is required for sale and manufacture of drugs and cosmetics all across India as per the Drugs and Cosmetics act, 1940.

Under the Drugs and Cosmetics Act, a relevant authority is authorized to issue Drug license for wholesale, retail and manufacturing of drugs and cosmetics. Per the act, many kings of cosmetics and drugs business are covered such as homeopathic and allopathic (modern medicine).

However, the Ayurvedic and Unani medicines do not fall under the purview of this act. Therefore, you do not require the drug license in order to manufacture or sale these products in India. A manufacture or seller who attempts in the act of sale or manufacture of the products that fall under the Drugs and Cosmetics Act, 1940 without the appropriate authorization will face legal penalties.

What are the different types of drug license?

In simple terms, the drug licenses are divided into the following:

  1. Drug License for Wholesale: Drug License for wholesale is for those who wish to engage in the act of selling the drugs in bulk to organizations. These are B2B businesses that fall under the Drugs and Cosmetics Act, 1940.
  2. Retail Drug License: In India, those wishing to open a retail store – chemists – are required to first obtain the Retail Drug License.
  3. Drug Manufacturing License: Those who desire to start a manufacturing plant for the drugs and cosmetic products that fall under the jurisdiction of the Drugs and Cosmetics act must acquire the Drug Manufacturing license in India.

What are the eligibility Criteria to obtain the Drug License?

Following are the pre-requisites of the Drug License in India:

  1. Size of the facility required for retail or wholesale of the drugs: Those seeking the Drug license registration for the sake of starting a business retailing or wholesaling the products must have a minimum area of 10 square metre and width of 2.75 metre.
  2. Size o the facility required to start a retail and wholesale drug business:Those wishing to do business both wholesaling and retailing drugs need a premise with area of at least 15 square meter and the height of 75 metre. Furthermore, the applicants must have adequate purpose for adding cold storage or deep freezer to store and preserve general drugs.

Documents required for the Drug License

For the Drug license, documents required are as follows:

  1. Duly filled application form based on the relevant drug the applicant wishes to sale (19A/19B/19C)
  2. Site plan of the premises
  3. Key Plan of the premises
  4. Firm Constitution details:
    1. For a Company, Memorandum of Association and Articles of Association are required
    2. For a Society or Trust – a Trust deed is required
  5. Photo IF of the proprietor/director/partner
  6. Affidavit stating the that applicant has not been convicted for any crime in any court of law
  7. Affidavit stating that the premises complies with the MPD 2021 in case it is located in the DDA residential area
  8. Receipt of the online deposit fees
  9. System-generated Affidavit stating the applicant is a competent individual
  10. Appointment letter and bio data
  11. Delhi Pharmacy Council Registration number
  12. Proof of qualification of the applicant
  13. Experience certificate
  14. Sale deed or rent agreement of the premises

Process to obtain the Drug License

For the Drug license, process that has to followed is the following:

  1. Gathering the documents
  2. Duly filling out the application form
  3. Submitting the application to the authorities
  4. Assessment of the application
  5. Inspection of the premises
  6. Grant of the Drug license

Price

Drug License price varies depending upon the nature of the license.

Here is the breakdown of the cost:

  1. Government fee
  2. Professional fee

Our Assistance

Regalguru has experts that are committed to assist you every step of the way. We will:

  1. Furnish your documents
  2. Fill out your application form
  3. Act as a liaison between you and the department
  4. Ensure that you obtain the license as per the stipulated time

Thus, if you are looking for an effortless way to acquire the Drug license in India, reach out to Regalguru.

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