How to get Drug License in India?

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

Therefore any violation in the medically defined terms and limits will have a severe effect on the health of the person consuming it and 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 permit is obtained:

  • Manufacturing 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.

  • Loan License
The manufacturer of drugs who doesn't possess land on his own somewhat willing to manufacture using his brand name on the area to which license is already issued.

  • Import 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.

  • Multi License
Multi-license for drugs is acquired by the entity operating in more than one state having multiple units.

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

  • Wholesale License
Wholesalers doing the business of pharmaceuticals shall obtain a wholesale license from the central drugs standard control organization. The wholesale license specifies the particular 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

  • Retail 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
The minimum area of 10 sq. Meters are 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
The 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 cold areas.

  • Technical and expert staff
The retail pharmacy shall have a qualified and professional staff with thorough knowledge of the same.
Business entities dealing in medicines or drugs would need different types of licenses based on their business. The permit 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.
The 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 necessary procedure to get License in India:

Ø  Based on business entity and type of license, the applicant shall apply online for registration
Ø  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.
Ø  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.

What are the necessary documents?

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

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


Additional documents if the applicant is registered, pharmacist:

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

Conclusion

Drugs are used in the formation of medicines in a mainly defined ratio. Medications are used in drugs 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 medications in medicines are restrictive, and the standards are set for using the correct amount of drugs that don't harm the body by its overdose.
In case of any query related to drug license, contact Corpbiz. 

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