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Drug License in India - An Overview
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:
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.
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.
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.
Multi-Drug License
Multi-Drug license is acquired by the entity operating in more than one state having multiple units.
Sale Drug License
Sale drug license is acquired by the entity engaged in whether wholesale or retail business for distribution of drugs in India.
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
Retail Drug License
This Retail Drug License is obtained by retailers engaged in the business of pharmaceuticals, stand-alone pharmacists, etc. by applying to the State Pharmacy Council.
How to Apply for Drug License
Following is the basic procedure to get Drug License in India:
Documents Required to Obtain Drug License Online
Following is the list of Documents required for applying for drug license in India:
Reasons to Trust Fastzeal for Drug License in India
Fastzeal has established itself as one of the leading consulting firms for meeting drug licensing needs for the medical and healthcare industry. Given below are the reasons why we are the first choice for drug license in India-
Frequently Asked Questions:
A drug license is a legal document that facilitates a pharmaceutical company to manufacture, sell, and market a drug in a specific country or region
A drug license specifies-
How much of the medicine can be used
Effective Medicines for Illnesses
How the medicine should be administered
Which patient groups can take the medicine
The following are the features of a drug license:
Drug license is compulsory for drugs, medicine, or cosmetics business
The license shall be granted for a commercial premise
Drugs and cosmetics businesses shall comply with the requirements and conditions imposed by law and authorities
The license shall be displayed at the place of business all the time.
Given below are the qualifications required for getting a drug license in India-
For Wholesale Drug License
Registered with the State Pharmacy Council
Holding a Degree in B Pharma/D Pharma
An Undergraduate with 4 Yrs of Experience or A Graduate with 1 Yr of Experience in Drug Dealing
For Retail Drug License
No Prior Experience is Needed
Registration with the State Pharmacy Council
Holding a Degree in B Pharma/D Pharma
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 occurs in its business.
Yes, a 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.
Yes, pharmaceutical business license is another name of drug license. A drug license is needed for all businesses engaged in the distribution of pharmaceutical and medicine supplements.
Yes, in case a drug business has multiple operating units in two or more states, securing a drug license for a separate state is mandatory. So, despite having a drug license in Bangalore, you can’t sell your drugs in Hyderabad. Acquire a drug license and start selling your drugs in Hyderabad.
The validity of a drug license is 5 years unless it is cancelled or suspended by the Drug Department. The renewal of a drug license can be done before its expiry by visiting drug controlling website.
In case there is any change in the premises, the drug license for the old premise must be surrendered first. After that, the drug business owner can move ahead to apply for a new license.
