Drug license is a prerequisite requirement for any person, that gives him the Authority to carry on the business relating to drugs, medicines, or cosmetics.
Drug license is a permission granted under the Drug and Cosmetics Act to carry out a drug or Cosmetic business.
Obtaining a drug license is mandatory for dealing in any kind of business relating to medicines, drugs, or cosmetics whether it is Allopathy, Ayurvedic, Homeopathic, or any other kind of medicine.
Types of Drug License
There are two types of Drug License :
- Retail Drug License
- Wholesale Drug License
Apart from this, several other licenses are issued to the persons carrying on the pharmaceutical business. The details of these licenses are as follows:
- Drug Manufacturing License
- Import of Drugs or Cosmetics
- Export of Medicines
- Import of Medical Equipment
Applicability of Drug License
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There are various kinds of licenses based on the kind of business, that needs to be obtained by a person carrying on the specified business activity in the pharmaceutical field.
The businessmen need to take the applicable license relating to the proposed activity in the pharmaceutical field before commencing his business.
Requirement of Obtaining Drug License
The following are the requirements of obtaining Drug license :
Minimum Area Requirement
There is a minimum area requirement that needs to be fulfilled before applying for Drug license which is as follows:
In case of wholesale outlet or Medical Shop: Minimum Carpet area of 10 sq. meter is required
In case a person carrying on both wholesale and Retail business: Minimum area of 15 sq. meter is required.
Refrigerator and air-conditioner in the premises is a must.
It is mandatory for the person carrying on the wholesale business, to employ a person being a graduate having an experience of not less than 1 year in dealing in Drugs or any person who has passed the intermediate level of schooling and having the experience of at least 4 years in dealing in drugs, the sale of Drug shall be made before the registered pharmacist only.
The sale of Drugs in case of Retail business shall be made before registered pharmacist and he shall be present for overseeing his dealings till the closure of working hours.
Process for Applying for Drug License
The Process for applying Drug License is as follows :
- Documentation for Applying License : The first step in applying a Drug license is to collect the required documents for applying a drug License. The applicant should be kept in mind while collecting the Documents that the documents shall be true and correct and nothing misleading shall be contained in the documents. The documents submitted shall be legible to the Authority.
- Submission of Online Application: The second step for applying is to submit Online application for the drug License. The application shall be submitted along with the prescribed government fees. While applying the scanned copy of each and every required document shall be uploaded.
- Verification and inspection by drug Inspector: The drug inspector may on receipt of the application for drug license visit personally at the premises of the applicant for verifying the accuracy of the information and documents as provided by way of online application.
- Personal Interview by the inspector: The inspector or any other competent individual as may be Authorised may after successful completion of the Inspection of the details, information, and documents provided by the applicant, conduct personal interview for getting any other details or information as he may consider necessary.
- Issue of Drug License: After successful verification of every information and documents as provided, if the controller of drugs considers that everything is fit and proper, then he shall issue the Drug License.
Documents Required for Drug License
The Documents required for applying Drug License are mentioned as follows :
- Company Memorandum of Association (MOA) and Article of Association (AOA)
- Photographs of Proprietor / Partner / Director
- Identity Proofs of Proprietor / Partner / Director
- Address proof of Premises (Conveyance Deed / Rent Agreement)
- Blueprint or site plan of premises
- PAN Card and Cancelled Cheque
- NOC Certificate from the owner of the Premises
- Particulars and invoice of the refrigerator, if any, required in case of drugs requiring cold environment
- Affidavit for compliance relating to MPD 2021
- Qualification Proofs of Pharmacist
- Experience Certificate of Pharmacist
- Any other documents as may be required by the authority
The list of documents mentioned above is not exhaustive. There may be several other documents based on the type of license that is required to be submitted while applying for a Drug License.
What is Drug License?
Drug license is an Authorisation given by the Government or concerned Authority of Government to carry on the business of dealings in drugs, medicines.
What are the types of Drug License?
There are two types of Drug License :
- Retail License for distribution and sale of drugs in India
- Wholesale License for distribution and sale of drugs in India
What are the prerequisites of drug license?
The following are the prerequisites of Drug license :
- It is mandatory to obtain a drug license, for the person carrying on the business of drugs, medicines, or cosmetics.
- The license shall be displayed by the Applicant at the premises of the business and also in case of any kind of verification by the inspector or any other Authorised person of the Concerned Authority.
- The Drug License shall be granted for commercial purpose only
- The business carried on by the Applicant shall comply with the requirement of law, rules, and regulations as may be prescribed.
Is there any requirement of renewal of Drug license?
Yes, the drug license shall be renewed before or after the expiry of license to keep carry on the business further by the applicant.
At what time the drug license shall be obtained?
The drug license shall be obtained only before the commencement of business by the applicant. The applicant cannot carry on the business of drug license before obtaining the applicable drug license.