As per the provisions of the Drugs and Cosmetics Rules, the State Licensing Authority can grant a license for the sale or distribution of drugs in India. The license can be issued under Drugs and Cosmetics Rules to sell, stock, exhibit, or offer for sale or distribute drugs in India. The license can be issued for several products like drugs, biologicals, medical devices, and in-vitro diagnostics. State Licensing Authority (SLA) is the regulatory authority associated with this service. To obtain this license, an individual is required to apply to the State Licensing Authority. The Competent Authority would then carry out an inspection and then grant a license.
The applicant who wishes to store, distribute and sale the drugs in wholesale.
|Creation of login ID on the respective State Licensing Authority website/portal|
|Filing of online data on the portal|
|Uploading of documents as per the checklist|
|Payment of government fee on the portal|
|Submission of application on the portal as well as hard copy in the respective State Licensing Authority|
The license obtained would remain valid lifetime unless the regulatory authority suspends or cancels the license.
The timeline for a wholesale license is 21 Working Days
The applicant looking for permission license for the sale or distribution of drugs must ensure these essentials are followed
The facility should meet the criteria of the State Master Development Plan, if any.
The facility should not be less than 10 square meters.
Proof of identities like aadhar card, pan card, and/or passport of directors and registered pharmacist.
The registered pharmacist should have a graduate degree and one year of experience in dealing drugs.
The owner should provide proof of ownership.
The electric bill of the premises is a mandatory requirement.
If the commercial facility exists on a Delhi Development Authority allotted plot or flat, the Municipal Corporation of Delhi must issue a conversion charge receipt and necessary documents.
No, they can only sell drugs in wholesale.
No, the individual must apply for the respective change and get a new wholesale license.
Yes, but the person should be SSLC passed and have a minimum of four years experience in dealing with drugs.
State Licensing Authorities.
The license is valid perpetually; however, retention fee shall be submitted every 5 years.
No. Each and every state have their own respective portal. e.g.
Yes. Wholesale license is same for medical device, drugs and Biologicals