Every establishment dealing with Drugs is required to get a Drug License from the concerned state government authority.
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What is Drug License ?
Drug license is a permission granted by the competent authority under drugs and cosmetic act to carry out a business concerning drugs/medicines or cosmetics. In other words, no person can start or continue a business dealing with drugs or cosmetics in India, unless an appropriate license is obtained for the conduct of such activity. Under the purview of Drugs and Cosmetics Act, 1940 all types of drugs or cosmetics business is covered including allopathic, homoeopathic, ayurvedic or unani drugs. The quality of drugs and cosmetics is the responsibility of all persons dealing with it. If any person consuming or using a drug or cosmetic suffers any harm from the negligence on the part of the manufacturer or seller the same is an offence, which is triable as an offence of grievous hurt under IPC.
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Drug licence is classified into Manufacturing Licence, Sale Licence and Loan licence. Sale licence is further classified as wholesale Licence, Retail Licence and Restricted (Gen.Store) licence depending on the manner in which sales done.
The Drug Control Organization issues two types of licences for operating a pharmacy business. One is the Retail Drug License (RDL) issued to run a general chemist shop. The other is the Wholesale Drug License (WDL) issued to persons or agencies engaged in wholesale of drugs and medicines. In most states, a retail drug license is only issued to persons who possess a degree or diploma in pharmacy from a recognised institute or university after depositing the requisite fee on account of the fact that it is a specialised job and only qualified persons can handle it. But the above conditions are relaxed in case of procuring a Wholesale Drug license (WDL).
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The following are minimum requirements for obtaining drug license or starting a pharmacy in India:
Area: 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.
Storage Facility: The store 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.
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 4y ears 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.
What are the other requirements for an establishment to obtain drug license?
Apart from the above mentioned requirements, entities should ensure that 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 4y ears experience in dealing in drugs, specially approved by the department of drug control for the purpose and 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.
What are the requirements as to the storage facilities which are to be made available in the premises?
The establishment should have Refrigerator and Air Conditioner in the premises, to store few drugs which are to be specifically stored in cool conditions.
What is the minimum area required to obtain drug license?
A minimum area of 10 square meters 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 meters is required.
Who is required to obtain drug license?
Every person or entity dealing with Medicines, Drugs and related products is required to mandatorily obtain Drug License for their organization.