Introduction

For a company/distributor/independent agent to be an Authorized Indian Agent for a local / foreign manufacture at the Central Drugs Standard Control Organization (CDSCO), they should hold a valid Wholesale Drug License in Form 20B and 21B. The wholesale drug license is submitted to and granted by individual State Licensing Authorities. this is related to our PM Modi’s “Come Make in India”, to initiate several projects to show that India is open to business. The Manufacturing License in India is essentially about the State Drug Licensing Authority, CDSCO Zonal/Sub-Zonal Office and Drugs Controller General of India CDSCO (HQ).

Some of the basic requirement for obtaining a wholesale drug license are,

• The office / shop area should be a minimum of 15 square meter.
• The office / shop must have refrigerator & air-conditioner on the premises.
• A Wholesale Drug License can be made under personal supervision of the registered pharmacist / competent person. In some states, a Wholesale Drug License is issued only to a company/entity who has a person(s) with a degree or diploma in pharmacy from a recognized institute/university.
• The pharmacist or a competent person should be a graduate with 1 year experience in dealing in drugs or be S.S.L.C passed with 4 years’ experience in dealing in drugs.
• Once the Drug License is obtained, the same should be displayed clearly on the premises for purpose of any future inspection.