Drug License in India

In India, the business entity who works in the health care sector such as medicines, drugs or cosmetics shall obtain the Drug License from the appropriate authority. As per the Drugs and Cosmetics Act, License is issued by State/Central Drug Standard Control Organization.

Drugs are used in the formation of medicines in a medically defined ratio. Drugs are used in medicines that cure disease and are used as per the needs to ensure the well-being of human beings. Therefore the preparation and use of such drugs in medicines is restrictive, and the standards are set for using the correct amount of drugs that don't harm the body by its overdose.

Therefore any violation in the medically defined terms and limits will have a serious effect on health of the person consuming it and in order to protect the consumers having medication, government is regulating medicines manufacturing by imposing strict and stringent laws and regulations which are to be followed by distributor and manufacturer of drugs and medicines in India.

Types of Drug Licenses Issued in India

Following are the different types of licenses issued depending upon the type of business for which the license is obtained:

1.      Manufacturing Drug License

All the manufacturers of allopathic, cosmetics, ayurvedic products or any other medications or drugs as specified under the Drugs and Cosmetics Act 1940. This is the state license that is issued by the particular state government where the unit is situated.

2.      Loan Drug License

The manufacturer of drugs who don't possess land on his own rather willing to manufacture using his brand name on the land to which license is already issued.

3.      Import Drug License

Any dealer importing the products for the manufacturing of drugs or is engaged in the business of importing drugs in India shall obtain this license.

4.      Multi-Drug License

Multi-Drug license is acquired by the entity operating in more than one state having multiple units.

5.      Sale Drug License

Sale drug license is acquired by the entity engaged in whether wholesale or retail business for distribution of drugs in India.

6.      Wholesale Drug License

Wholesalers doing the business of pharmaceuticals shall obtain wholesale drug license from the central drugs standard control organization. Wholesale drug license specifies certain minimum requirement on the person applying for this license such as:

1. Degree and diploma in pharmacy

2. Minimum 1-year experience in drug dealing

7.      Retail Drug License

This license is obtained by retailers engaged in the business of pharmaceuticals, stand-alone pharmacists, etc. by applying to the State Pharmacy Council.

Key-Requirement to Obtain Drug License in India

Following are the essential key-factors to be kept in mind before applying for Drug License:

Premise Area

Minimum area of 10 sq. meters is required for setting up a medical shop or retail pharmacy. However, if they are operating with the wholesale business along with retail, the minimum area required shall be 15 sq. meters.

Storage

Proper storage facility should be in-housed by the implementation of cold storage, refrigerators or similar places for the storage of medicines and vaccines as they shall be restored in cool places.

Technical and Expert Staff

Retail pharmacy shall have a qualified and technical staff with thorough knowledge of the same.

Business entities dealing in medicines or drugs would need different types of drug licenses based on their business. Drug License being region-specific needs to be obtained by a single drug dealer having its multiple units in more than one state. Other than a migrant vendor, drug license shall be applied for every place where drugs are stocked and sold.

Drug license holders have to make sure it complies with the terms and conditions. The license issued overlooking these terms and conditions can get cancelled or suspended. Authorities shall be notified about any change or modification if occurred in business.

How to Get Drug License?

Following is the basic procedure to get Drug License in India:

1.  Based on business entity and type of license, the applicant shall apply online for registration
   
2. Once the application form is done and registration is completed, the system will auto-generate unique registration number which can be used for future reference.
   
3. Within 15 days of registration, necessary documents shall be submitted to the officer of the Drug Licensing Authority of a concerned district in hard copy.
   

Documentation

Following is the list of documents required for applying for drug license in India:

1.  Application form duly signed which has already been filed
   
2. Copy of Challan as proof of depositing the requisite fee
   
3. Identity proof such as PAN, Voter Id, Driving license, Passport, etc. in case an applicant is a proprietor
   
4. In case the applicant is a partnership firm, Id proof of every partner along with the copy of partnership deed
   
5. Copy of MOA, AOA, and COI in case of private/public/OPC
   
6. CTC of Board Resolution for authorizing the company for obtaining the license.
   
7.  Appointment letter of the person who is being authorized by the company
   
8.  Proof of availability of storage space such as cold storage, refrigerator, etc.
   

Additional documents if the applicant is registered pharmacist:

1. Diploma pharmacy
   
2. Registration certificate issued by pharmacy council
   
3. Appointment letter
   
4. Affidavit of pharmacist
   
5. Education qualification certificates such as high school & intermediary mark sheets, graduation certificate, post-graduation degree, etc.
   
6. Minimum, one year of experience, is mandatory in drug sales and marketing of any pharmaceutical company.
   
7. Plan the layout of the premise for which the license is applied
   
8. There shall be an area of minimum of 10 square meters in case the license is applied for the wholesale or retail sale of drugs.
   
9. There shall be an area of a minimum of 15 square meters in case the license is applied for both wholesale and retail sales of drugs.
   
10. ​ Necessary Electricity availability and related installation in the premise
    

 

FAQs

 

Q.  Is it necessary to obtain Drug License before the commencement of the drug business?

Yes, before you start any business dealing in drugs, whether it is Allopathic Drugs, Ayurvedic Medicine, Homeopathy or Unani, to manufacture, distribute or sell the drugs, it is compulsory to obtain a license as per the nature of business by applying towards the controller of the drugs and cosmetics

 

Q. What are the provisions for maintaining accounts by a registered drug company?

The books of accounts, registers, forms and other documents shall be maintained in such manner as may be specified by the licensing authority at the time of issue of such license. It is the responsibility of the license holder to intimate every change and modification that occurred in its business.

 

Q. Are different licenses necessary for every operation of the drug business?

Yes, drug license is necessary for every unit operating in any part of India. For instance, in case the drug business has its unit in two separate states, it shall get the license for both such an operational unit.

 

Q. How do I renew my drug license?

In order to renew the license fill the application form and provide the necessary documents to be submitted with form. If the application is complete, it will be filed with the drug control department with fees. After verifying the documents fresh certificate shall be issued.

 

Q. What is a Licensed Drug?

A licensed drug means a drug that goes through a strictly monitored process. It involves researching in the lab and testing it through trials. After it goes through all these tests and trials then it shall be granted a license.

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