Drug License Registration
Drug License Registration in India
Compulsory Drug License for Pharmaceutical Business in India
- Retail Drug License
- Wholesale Drug License
- Pharmaceutical Manufacturing Drug License
- Cosmetic Manufacturing Drug License
Our Price Starts @ Rs 12,890/-
Drug License in India at a glance
For any Individual/Corporate/Partnership Firms etc , it is mandatory to obtain a valid Drug Licence from concerned State Authorities (Drugs Control Department). The provisions for this has been made in Drugs and Cosmetic Act 1940 and Rules 1945 applicable in India.
basic pre-requisites for a Drug License
- Minimum area of the Office/Shop.
- Granted in the commercial premises or other premises independent of residence.
- Refrigerator or Air Conditioner on the premises.
- Needs to comply with the conditions of licence of the issuing Authority.
- Displayed at premises of business.
- A technical staff :- A registered pharmacist or competent person with same line experienced as approved by the Department if Drug Control.
Based on business type, an entity may require different types of drug license. For exact requirement and applicability, consult with our Consultant.
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Conditions for obtaining Drug License in India
Minimum Area & Height of Premises
The minimum area of 10 square meter is required to start a medical shop or pharmacy or wholesale outlet. In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meter is required. The clear height of the premises should be in accordance with the National Building Code of India, 2005 as amended from Time to Time.
Storage Facility
Must have refrigerator & air conditioner in the premises. According to the labeling specifications certain drugs like vaccines, Sera, Insulin Injections etc., are required to be stored in the refrigerator.
Phamacist / Competent / Technical Staffs
Manufacturing :- for an Drug manufacturing unit there must be Technical Staff at manufacturing and Technical Staff for testing as well. Wholesale :– The sale of drug by wholesale shall be made either in the presence of registered pharmacist or in the presence of a competent person who shall be a graduate with 1 yr experience in dealing in drugs or a person who has passed S.S.L.C with 4 years experience in dealing in drugs, specially approved by the department of drug control for the purpose. Retail :– The sale of drug by retail must be made in the presence of registered pharmacist approved by the department, Registered pharmacist is required throughout the working hours.
Commercial Premises
Licences for the sale of drugs can be granted only at premises that is commercial premises or premises independent of residence. For this purpose state drug office issues guidance which may be referred to.
Location Based License
If drugs are sold or stocked for sale at more than one place, a separate license is needed in respect of each such place. Similarly, in case of manufacturer, a separate license is required to manufacture same or different drugs but at different location
License for Each State
In case a business is operating in more than two states, it has to obtain drug licence in every state in which business is being carried on. Drug licence is location specific, and hence within state application, all site must be included.
Importer of Drugs or 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
