DRUG LICENSE – APPLICATION, DOCUMENTS, REGISTRATION, & FORMS |  PROCEDURE FOR OBTAINING DRUG LICENSE IN INDIA

INTRODUCTION

Any government’s primary concern is to ensure that everybody has equal and equitable access to medicines and medication. The right to produce and distribute drugs and medicines, on the other hand, must be granted with caution. As a result, the government has strict regulations in place for issuing licenses to manufacture and distribute medicines and medication. The Drugs and Cosmetics Act, 1940, controls the entire mechanism of drug manufacturing and distribution in India.

DRUGS

Section 3(b) of the Drugs and Cosmetics Act,1940 provides that the drugs as all medicines and devices for the internal or external use of humans or animals, as well as all substances intended to be used for or in the diagnosis, mitigation, treatment, or prevention of any condition or disease in animals or humans, including preparations applied to the human body for the purpose of repelling insects like mosquitoes, are described as “drugs.”It also contains all substances that can be used to kill insects, as well as all medication elements, such as empty gelatin capsules. Ayurvedic and Unani drugs were added to the description in 1964.

For more information, please contact us on info@trijuris.com or call us Mb. No. 85100 58386 or 9310 717274.

REQUIREMENTS FOR FEES FOR OBTAINING DRUG LICENSE

  • A fee of Rs. 3250 is required to obtain a Retail Chemist Shop License for the selling of Allopathic and Homeopathic medicines.
  • A fee of Rs 3000 is required to obtain a wholesale shop license (whether it is a new one or a renewal of an existing one).
  • To be authorized, wholesale shops that specialize in homeopathic medicines must pay a remittance fee of Rs. 250.
  • A fee of Rs. 600 can be paid to pursue retail selling of Schedule X medications. To take advantage of the same benefit, wholesale outlets must pay a fee of Rs. 1200.

DRUG LICENSING TYPES

In India, the pharmaceutical industry needs the following types of licenses, based on the concept of “drug”:

Manufacturing License– A license given to a company that produces medications, including allopathic and homeopathic medicines.

Sale License-A license for the selling of drugs is known as a sale license. The bifurcations are as follows: – Restricted Drugs – Wholesale Drug License – Retail Drug License.

Loan License – A license given to a company that does not own a manufacturing unit but uses another licensee’s manufacturing facilities.

Import License – A permit to bring drugs into the country.

Multi-Drug License – A license given to a company that owns pharmacies of the same name in different states.

PREREQUISITES FOR OBTAINING A LICENSE

  • Pharmacist/ Competent Individual: In the case of a retail company, the pharmacist must be eligible. In the case of a wholesale company, the person must be a graduate with one year of experience or a four-year undergraduate.
  • Space Requirement: Another essential requirement is room, which refers to the size of the pharmacy or device. – 15 square meters for both wholesale and retail licenses -In all other cases, a minimum of 10 square meters is required. The clear height of the sales premises must comply with the National Building Code of India, 2005 guidelines.
  • Storage Facility: Another critical requirement is a storage facility, as certain medications must be stored at low temperatures, which necessitates the use of refrigerators and air conditioners.
  • It is granted in a commercial setting or anywhere else that isn’t your home.
  • On the property, there is a refrigerator or an air conditioner.
  • It is essential to adhere to the issuing Authority’s license requirements.
  • It is displayed at the business’s place.
  • A technical staff consists of a licensed pharmacist or a qualified individual with similar experience who has been certified by the Department of Drug Control.

IN INDIA, THERE ARE SOME REQUIREMENTS FOR OBTAINING A DRUG LICENSE

Premises Minimum Area & Height.

To open a medical store, pharmacy, or wholesale outlet, you’ll need a minimum of 10 square meters. A minimum of 15 square meters is expected if the pharmacy company combines retail and wholesale. The simple height of the building should comply with the National Building Code of India, 2005, as amended from time to time.

Facility for Storage

A refrigerator and an air conditioner are needed on the premises. Certain medications, such as vaccinations, serum, and insulin injections, must be kept in the refrigerator according to labelling requirements.

Pharmacist / Competent / Technical Staffs

Manufacturing: – For a drug manufacturing facility, there must be Technical Staff at manufacturing as well as Technical Staff for research.

Wholesale: – The selling of drugs by wholesale must be done in the presence of a licensed pharmacist or a qualified individual who is a graduate with one year of experience in dealing with drugs or a person who has passed S.S.L.C with four years of experience in dealing with drugs, who has been specially approved by the department of drug control for the purpose.

Retail: – Drugs must be sold in the presence of a licensed pharmacist who has been approved by the government. A registered pharmacist must be present at all times during working hours.

Commercial Real Estate.

Licenses for the selling of drugs can only be issued at industrial or non-residential locations. The state drug office provides guidelines for this reason, which can be consulted.

The license is based on the location.

If drugs are sold or stocked for sale in more than one location, each location requires its own license. A separate license is required in the case of a manufacturer to produce the same or different drugs at different locations.

Each state requires its own license.

If a company operates in more than two states, it must obtain a drug license in each of the states where it does business. Since a drug license is exclusive to a specific area, all sites must be listed on the state application.

Importer of pharmaceuticals and cosmetics

The Drugs and Cosmetics Act aims to ensure that drugs and cosmetics sold in India are safe, affordable, and meet state quality requirements. Only after obtaining a license will schedule X drugs or cosmetics be imported into India.

For more information, please contact us on info@trijuris.com or call us Mb. No. 85100 58386 or 9310 717274.

AN APPLICATION FOR A DRUG LICENSE IS REQUIRED

The following are the steps that must be followed in order to receive a drug license:

  • The applicant must apply for the license electronically according to the line of business, and he or she must have a valid email address and phone number.
  • The following move is to keep all of the documents updated.
  • After that, you must upload the documents and the form, as well as any relevant fees.
  • An auditor can visit the site after the online procedure is completed to check the authenticity of the documents.
  • The Authority will grant the drug license if all of the above measures have been completed correctly.
  • The Authority will take 45 to 60 days to complete the approval process.

LIST OF DOCUMENTS required FOR OBTAINING A LICENSE

The following documents are required to obtain a selling license:

  • Memorandum of Association (MOA), Articles of Association (AOA) for a corporation, partnership deed, and LLP agreement in the case of a partnership and LLP.
  • Proof of identity for the partner/director/proprietor.
  • Documents pertaining to the premises – Copy of the property’s ownership papers or, if applicable, the rental agreement.
  • The premises’ site plan and main plan.
  • A copy of the Board resolution or BR authorizing the application for a license.
  • Proof of storage space, such as cold storage, refrigerators, and so on.
  • As proof of depositing fee, a copy of the challan is needed.
  • Affidavit about the proprietor/partner/and director’s the firm’s non-conviction.
  • The licensed pharmacist’s/competent person’s affidavit.
  • At a drug sale, for a pharmacist: – A letter of appointment – Proof of competence – Registration with the local pharmacy council
  • Proof of qualification for a pharmacist at a wholesale sale – Certificate of experience – Letter of appointment.

In the event of Change in the Constitution

  • Application form that has been fully filled out.
  • A letter announcing the constitutional amendment.
  • The documents that make up the company’s constitution.
  • Proprietor/Partner/Director/Trustee details, etc.
  • Revisions to the leasing agreement (if applicable).
  • Documents pertaining to the ownership of additional property.

Change in Premises.

  • Application type that has been fully filled out.
  • Ownership of the property must be proven.
  • An agreement to rent or lease a property.
  • NOC (No Objection Certificate) (if applicable).
  • The bill for the premises’ electricity.
  • The plan’s structure.

For Additional License.

  • Completed application type.
  • Registered Pharmacist’s Documents (if a wholesaler is applying for a retail license).

For the purpose of retaining the license.

  • Application must be submitted online.
  • A copy of the paid retention fee receipt license.

For the purpose of changing a pharmacist’s 

  • Certificate of registration.
  • Form for self-declaration (duly signed by the pharmacist and employer).

For Change in Competent Person.

  • The qualified person’s appointment letter and acceptance letter.
  • Proof of residence of the competent individual.
  • The competent person’s educational certification certificate.
  • The competent person’s certificate of experience.

For a Premises Addition or Reduction

  • Rent/Lease Arrangement has been updated.
  • Ownership of the property must be proven.
  • The development plan has been modified.

For Change in Specific Condition.

  • Proof that cold storage facilities have been built.
  • Just three pharmacists and safety measures are available 24 hours a day, seven days a week.

Surrender of License.

  • Letter of license surrender (signed by the proprietor, spouse, legal heir, director, or approved signatory).

Change in Director.

  • The incoming director’s Form 32.

No Conviction Certificate.

  • Self-declaration in the format needed.
  • a copy of the tender

HOW TO MAKE AN APPLICATION

Now that we’ve covered the basics, let’s look at how to apply for this important document:

Step 1Go to the official website.

The applicant can begin the process by going to the official website dedicated to this purpose.

Step 2Make a set of login credentials.

The choice “New login ID and PWD” (located on the right side of the page) must be selected. From the drop-down menu, select the MH option.

Step 3:Fresh License or Renewal

The user will be provided with two choices on the next tab, the first of which is for current license holders and the second for new applicants. Choosing any of the choices will take the applicant to a page where they must fill out and save information specifications. Within 24 hours, the user’s User ID and Password will be sent to the user’s registered mobile phone.

Step 4:Login.

By entering his or her username and password, the user can access the portal.

Step 5:Create or revise your online application

Select the ‘prepare/edit online application’ choice from the menu in the left-hand corner of the screen.

Step 6:New Inward Option

Select the desired ‘Inward style’ by clicking the ‘Inward button’ on the tab.

Step 7:What are you applying for?

Choose the option for which the application is made for.

Step 8:Information Input

Fill in the needed information and save it.

Step 9:Print the document

The applicant must take a printout of the document and sign it appropriately.

Step 10Uploading of Documents

After uploading the necessary documents, the user will be directed to the payment gateway.

Step 11Fee Remittance

The applicant will be required to make payments after completing the inward application process. This can be achieved through the ‘make payment’ tab that appears after the inward application process is completed.

Step 12: Time to Make Choices.

The applicant will now be asked to make his or her selections, which could include the following:

  • The division (the option Food and Drugs Administration is apt for this purpose).
  • Payment forms (select the category under which the payment will be made); for example, a drug-selling license.
  • Name of the scheme
  • Enrollment district.
  • The title of the role.
  • The time span during which payment is made.
  • Identification of the type.
  • Payment options are available.

Step 13:Make a financial deposit.

Using the GRAS website, the payment may be made based on the module selected by the applicant.

Step 14:The Final Act.

Following payment via the GRAS System, a payment receipt can be printed and uploaded into the system, and the application can then be forwarded to the department. When the application is received, it will be reviewed by the appropriate authorities. The inspector, the Licensing Authority, or the Assistant Commissioner can raise concerns about incomplete or insufficient submissions. If the applicant’s response is unsatisfactory, the certificate will be returned to him or her so that he or she can resubmit it with the requisite adjustments.

CONCLUSION

The rules that detail the working protocols of the drug’s manufacturer and seller are cited in the drug license. The violation of bylaws governing drug licenses could jeopardize the existence of pharmaceutical companies. Having a drug license will provide you with a number of advantages as well as protect your company from serious penalties.

For more information, please contact us on info@trijuris.com or call us Mb. No. 85100 58386 or 9310 717274.