Drug License is obtained by those business entities who are involved in the manufacture, import, and distribution of drugs or medicine in India as per the provisions of the Drugs and Cosmetics Act, 1940. There are different kinds of licenses issued based on the business. Drug License is region-specific and must be obtained by a single drug dealer who has multiple units in more than one state.
Overview of Drug License
In India, business entities working in the health care sector, such as drugs, cosmetics, or medicines, must obtain drug license from the concerned authority. As per the provisions of the Drugs and Cosmetics Act, 1940, the license is issued by the Central or State Drug Standards Control Organization. Drugs are used for making medicines in a medically prescribed ratio. The medicines formed by using drugs are used to cure disease and ensure that a person stays healthy. The preparation of medicines by using different drugs is very delicate that is why the standards are very strict for using the correct amount of drugs so that the medicines do not have any harm or side effect on the human body.
Therefore, any violation or breach in a medically defined limit will have a harmful effect on an individual's health. In order to save the consumer from the harmful effects of medication, the government of India regulates the process of manufacturing medicines by imposing stringent and strict regulations and laws that must be followed by every manufacturer and distributor of medicines and drugs in India.
Types of Drug Licenses
The license is issued based on the type of business. Following are the different types of licenses:
Manufacturing Drug License
All the manufacturers of cosmetics, ayurvedic, allopathic, or any other form of government-approved drugs or medications, as stated under the Drugs and Cosmetics Act of 1940. This license is a state license issued by a particular state government where the business unit is situated.
Loan Drug License
The manufacturers of medicines or drugs do not possess land on their own rather keen on manufacturing using the brand name on the land, which already has a license.
Import Drug License
Any dealer importing the commodities for the manufacturing of medicines or is involved in the business of importing drugs in India must acquire this license.
Multi-Drug License
This license is obtained by the business entity, which has multiple operating units in more than one state.
Sale Drug License
This license is obtained by the business entity engaged in the retail or wholesale business for selling drugs in India.
Wholesale Drug License
Wholesalers involved in the business of pharmaceuticals must acquire this license from the Central Drugs Control Organization. This license specifies a minimum requirement on an individual applying for this license, such as:
Diploma and Degree in pharmacy.
A minimum of one year of experience in dealing with drugs.
Retail Drug License
This license is acquired by retailers involved in the business of stand-alone pharmacists, pharmaceuticals, etc. by applying to the State Pharmacy Council.
Documents Required for Manufacturing Drug License
One copy of the payment of application along with a Covering letter.
One copy of Self Assessed checklist of documents.
A maximum of ten products must be applied under each Form 24 and Form 27.
Two copies of the Product list.
One copy of the List of Excipients.
One copy of a similar product.
One copy of Draft Label.
One copy of the Method of Analysis.
One copy of the Additional Information Form.
In the case of a company, Memorandum of Association (MoA), Articles of Association (AoA), and Certificate of Incorporation.
In the case of a Partnership firm: Partnership Deed.
In the case of Limited Liability Partnership: LLP agreement.
One copy of the List of Directors along with their address.
One copy of the Power of Attorney to sign the documents.
One copy of Plan approval.
Consent from SSI or No Objection Certificate (NOC).
Documents Required for Obtaining Wholesale Drug Licenses
Form- 19 (http://fsdaup.gov.in/sales-licence.htm).
Copy of Layout of location or Plan of Premises.
A self Assessed checklist of documents.
Challan of the amount of the stated fees must be deposited in Government Treasury, or an original copy of the treasury challan must be submitted along with the application and Government Branch of SBI (State Bank of India) of the city where the license is needed.
Proof of Possession.
Covering letter mentioning the purpose of the application.
In the case of a company, Memorandum of Association (MoA), Articles of Association (AoA), and Certificate of Incorporation.
In the case of a Partnership firm: Partnership Deed.
In the case of Limited Liability Partnership: LLP agreement.
In case of a public or private limited company: Board Resolution signed by all the Directors.
List of partners/directors.
Certificates of super wiser in charge or competent person:
A copy of the offer of Appointment.
A copy of the Acceptance or Consent Letter.
A copy of the Experience Certificate.
A copy of the Degree Certificate.
A copy of Marks Statement.
Affidavit of Pharmacist.
As per the provisions of the Stamp Act, a stamp.
For signing the documents, the Power of Attorney is required.
A government-issued Photo Identity Proof.
Documents Required for Obtaining Loan Drug License
One copy of the payment of application along with a Covering letter.
One copy of Self Assessed checklist of documents.
A maximum of ten products must be applied under each Form 24- A and Form 27- A.
Original Manufacturing Loan numbers 1, 2, and 3.
A copy of the Selling License.
Two copies of the Product List.
A copy of the List of Excipients.
A copy of Similar Products.
A copy of Draft Label.
One copy of the Method of Analysis.
One copy of the Additional Information Form.
A copy of the Memorandum of Articles.
One copy of the List of Directors along with their address.
For signing the documents, the Power of Attorney is required.
Conclusion
In India, business entities working in the health care sector, such as drugs, cosmetics, or medicines, must obtain drug license from the concerned authority. As per the provisions of the Drugs and Cosmetics Act, 1940, the license is issued by the Central or State Drug Standards Control Organization. For obtaining a license, a person has to submit some mandatory documents to the concerned authority, so they can check whether a person is eligible to obtain a License.
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