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DRUG LICENCE;LICENCE

RUNNING A MEDICAL STORE OR A CHEMIST OR A DRUGGIST?

OBTAIN DRUG LICENSE THROUGH

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In India, Drug Licence is mandatory for starting any business related to Drugs and Cosmetics. Though every business entity may require different type of drug license depending upon its requirement. Drugs and Medicines are necessary for ensuring good health of a Public. The necessary provisions have made in this regard under Drugs & Cosmetics Act, 1940 and rules made thereunder which is applicable to whole of India. The provision includes limit of raw material at the time of manufacturing, sale and distribution and every business related to Drugs and Cosmetics needs to comply the same. 

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TYPES OF DRUG LICENCE;DRUG LICENCE

There are various types of Licences which may vary from business to business depending on the business activity stated as follows:

Manufacturing Licence: This Licence is mandatory in case of manufacturing of allopathic and Homeopathic and repacking of drugs. Further, it is granted only to the business set up in the recognized industrial areas.
Sale Licence: This Licence is mandatory in case of Sale of Drugs and Medicines. Sale includes Wholesale Sale, Retail Sale and Restricted Sale.
Loan Licence: This Licence is mandatory for the applicant who intends to avail the manufacturing facilities owned by another licensee.

BASIC REQUIREMENTS FOR DRUG LICENCE

  1. The office/shop area related to medical or pharmacy business(wholesale or retail) shall be a minimum of 10 square meters. Further, If the business of an applicant includes both wholesale as well as retail then minimum area of 15 square meters is required.
  2. The office/shop area must have refrigerator and air conditioner on the premises because certain drugs or medicines are required to be stored in the cool place.
  3. Retail sale can only made in the presence of registered Pharmacist approved by the department who shall be present in the retail shop throughout the working hours.
  4. Wholesale sale can only made either by a registered pharmacist or any competent person who holds a degree of a recognized universitywith one year experience in drugs or any other person who has passed Matriculation or its equivalent with four years’ experience in dealing with Drugs.
  5. Once Licence is obtained, the same must be displayed clearly on the business premises for the purpose of any future inspection.

INCLUSIONS IN PACKAGE

  1. PROFESSIONAL CONSULTATION
  2. DRAFTING OF DOCUMENTS
  3. APPLICATION FILING
  4. GOVERNMENT FEE

REQUIREMENT OF SEPARATE LICENCE IN CASE OF DIFFERENT STATE OR DIFFERENT BUSINESS ACTIVITY

If a business related to Drugs and Medicines is carried out in two or more states, then it has to obtain drug licence for each state in which business is being carried out.

Further, if different business activities are carried out which are covered under different types of licence then separate licence have to applied for the same.

PROCEDURE TO APPLY FOR DRUG LICENCE

An applicant has to register and shall obtain a user ID and Password by making online request including details of Company or firm.
Prepare the necessary documents including affidavits, declaration, key plan and site plan in prescribed format given under law.
File the application online including payment of government fee and upload the necessary documents (scanned) at the time of filing the application.
Once documents are uploaded and application has been submitted, the same shall be verified by Drug inspector. For further verification, he personally visits the shop.
After satisfaction of all documents and information and in case personal interview (if called and held) is cleared by an applicant, the controller of Drugs issues the licence.

PROCEDURE TO APPLY FOR DRUG LICENSE BY USING ePRO EXPRESS SERVICE)

Fill a simple form provided by our experts
Once you filled up the form, our experts will advise you about the eligibility of license.
We will collect all the required documents via Email or Physically as comfortable to you.
We will file the application on your behalf to respective department including all the requisite documents and information.
We will take follow up on your behalf and resolve all the queries raised by department
Once application is approved, we will share the copy of license to you via email or courier.

DOCUMENTS REQUIRED TO APPLY FOR DRUG LICENCE

An application shall be made in Form No. 19/19A/19B/19C as applicable which is available on the portal and the same should also be duly signed by applicant. Following documents shall be required in addition to application which are as follows:

FOR APPLICANT

  1. Certificate of Incorporation in case of Company/LLP or Registration Certificate in case of firm.
  2. MOA/AOA in case of Company or Partnership Deed/ LLP Agreement in case of firm.
  3. List of Existing Directorsand the same should be dulysigned by Authorized Representative of the Company.
  4. List of existing shareholders of the company and the same should be duly signed by Authorized Representative of the Company.
  5. Self-attestedID and Address Proof of directors/partners/ proprietor.
  6. 2 Passport Size photos of directors/partners/ proprietor.
  7. Board Resolution on the letterhead of the Company for authorizing any person to apply for Drug Licence.
  8. Affidavit as per prescribed format from Directors/partner/proprietor.
  9. PAN Card of Company/LLP/Firm.
  10. Cancelled Cheque of Company/LLP/Firm bank account.

FOR PHARMACIST OR COMPETENT PERSON

  1. Bio-data of Competent Person as per Proforma
  2. QualificationProof
  3. Photo, ID and Address proof of competent Person
  4. Affidavit from the competent person
  5. Experience Certificate (in case of Wholesale Licence)
  6. Registration of Delhi Pharmacy Council (in case of Retail Sale)
  7. Appointment Letter of Competent Person

FOR REGISTERED PLACE

  1. If the premises are owned by an applicant or any relative or family of the owner then the applicant must provideSale Deed along with Latest Electricity Bill of the premises (not older than 2 months) and No objection Certificate from the Owner.
  2. If the premises are on rent then the applicant must provideRent Agreement and rent receipt along with Latest Electricity Bill of the premises (not older than 2 months) and No objection Certificate from the Owner.
  3. Key Plan and Site Plan of the premises.

FREQUENTLY ASKED QUESTIONS (FAQS)

What is the eligibility to obtain a Sales drug License (Retail)??

Conditions which have to be fulfilled for obtaining retail drug license are as follows:

  1. An applicant premises should be of area not less than 10 square meters
  2. Proper storage facilities should be there at the premises
  3. Competent person (applicant) should be pharmacist registered with council

What is the eligibility to obtain a Sales drug License (Wholesale)??

Conditions which have to be fulfilled for obtaining wholesale drug license are as follows:

  1. An applicant premises should be of area not less than 10 square meters
  2. Proper storage facilities should be there at the premises
  3. Competent person (applicant) should be pharmacist registered with council/ person who holds a degree of recognized university with one years of experience for dealing in drugs /person who has passed matriculation or equivalent with four years of experience.

Can NGO apply 80G and 12A application together??

Ans Yes, both the applications can be applied together or individually as per NGO requirement. However, if NGO wants to apply for 80G license then it also has to apply for 12A License first.

Do I need to give any other amount apart from the above stated fee??

No, you don’t to pay any other amount apart from the above stated fees.

How much time is required to obtainDrug License??

A Drug License is usually obtained by ePRO EXPRESS in 40-45 working days subject to department processing time and submission of documents and information by client.

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