DRUG License
DRUG License
Licensing is mandatory to do business in Drugs & Cosmetics in India. The provisions for this has been made in Drugs & Cosmetics Act, 1940 which is applicable to whole of India. It is an Act to consolidate all the laws relating to drugs & cosmetics, which established the Drugs Control Department. In 1964, the Act was amended to include Ayurvedic & Unani drugs. However a particular business entity may require different types of drug license based on their business, you may contact LegalRaasta for consultancy on it.
Once the licence is granted to the business, all such License must ensure that all the condition in the drug licence are complied at all the time during the course of the business. All the records /registers /Forms must be maintained in the manner specified by the licensing authorities and authorities shall be kept informed for all the changes or modification in the business activities.
Drug License Registration is done through LegalDoor.
Licensing is mandatory to do business in Drugs & Cosmetics in India. The provisions for this has been made in Drugs & Cosmetics Act, 1940 which is applicable to whole of India. It is an Act to consolidate all the laws relating to drugs & cosmetics, which established the Drugs Control Department. In 1964, the Act was amended to include Ayurvedic & Unani drugs. However a particular business entity may require different types of drug license based on their business, you may contact LegalRaasta for consultancy on it.
Once the licence is granted to the business, all such License must ensure that all the condition in the drug licence are complied at all the time during the course of the business. All the records /registers /Forms must be maintained in the manner specified by the licensing authorities and authorities shall be kept informed for all the changes or modification in the business activities.
Drug License Registration is done through LegalDoor.
1. Constitution of the firm (MOA/AOA)
2. Photo ID proof of proprietor/partner/director
3. Copy of Property paper (If owned property)
4. Copy of Rent agreement (If rented property)
5. Site Plan and key plan of the premises
6. Refrigerator invoice and details
7. Affidavit regarding compliance of MPD 2021 (if premises are located on DDA residential flat/ plot/ building)
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 license is obtained by retailers engaged in the business of pharmaceuticals, stand-alone pharmacists, etc. by applying to the State Pharmacy Council.
FAQ
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 mandatory to obtain a license as per the nature of business by applying to the controller of the drugs and cosmetics.
Drugs and Cosmetic Act aims at ensuring safety, effectiveness and conformity of the drugs and cosmetics sold in India to the state quality standards. Drugs or cosmetics of schedule X can be imported into India only after obtaining a License.
Following are the features of drug license:
Drug license is compulsory for drugs, medicine, or cosmetics business
The license shall be granted for a commercial premise
Drugs and cosmetics business shall comply with the requirement and conditions imposed by law and authorities
The license shall be displayed all the time in the place of 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.
