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.
Document Requirement for Wholesale Drug License
The required documents can differ based on each state. However, below is the list of generic document requirement for obtaining wholesale drug license in India.
- Covering Letter stating the purpose of the application
- Two applications in Form 19 with
- Declaration Form
- Covering Letter stating the purpose of the application
- Challan of fee
- Blue print for the premises
- Rental Agreement / Proof of Ownership of the premises
- Property Tax Receipt
- Incorporation Certificate / MOA / AOA / Partnership Deed
- Board Resolution, in case of a private limited company
- List of directors, in case of a private limited company
- Affidavit of registered pharmacist / competent person
- Biodata of the registered pharmacist / competent person
- Degree Certificates of the registered pharmacist / competent person
- Appointment letter of registered pharmacist / competent person, if applicable.
- Invoice receipt of the purchased Air-condition
- Invoice receipt of the purchased Refrigerator
- Four Rs. 2 Stamps
The Step by Step Process to Register your Medical Device in India determines whether the product requires registration and it should be an Notified Medical Device, if yes then go ahead with appointing an authorized Indian agent, Submitting the Regulatory Dossier, Obtain Registration Certificate, Obtain Import License and then start Marketing in India
