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A Drug Licence is a government permission to sell, store, distribute or make medicines in India. It is required under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. Without this licence, nobody can legally run a medical store, a pharmacy or a medicine distribution business.
The licence is mostly given by the State Drugs Control Department of your state. For some kinds of drugs and activities, such as import, certain special drugs and some types of manufacturing, the Central Drugs Standard Control Organisation (CDSCO) is also involved.
CA Arpit Gupta helps pharmacists, shop owners and businesses understand the rules, prepare the documents and apply for the Drug Licence.
You need a Drug Licence if you want to do any of the following:
| Type of Licence | Who It Is For | What It Allows |
|
Retail Drug Licence |
Medical stores and pharmacies |
Sale of medicines directly to patients and customers |
|
Wholesale Drug Licence |
Distributors, stockists and wholesalers |
Sale of medicines to retailers, hospitals and other dealers |
|
Retail and Wholesale Licence |
Businesses doing both |
Both activities from the same premises, as per the area rules |
|
Restricted Drug Licence |
General stores and some small dealers without a pharmacist |
Sale of limited, ordinary medicines only |
|
Manufacturing Licence |
Drug makers |
Making of medicines in a licensed factory |
|
Loan Licence |
Companies that get their medicines made by another licensed maker |
Marketing of the medicines made by another unit |
|
Import Registration and Licence |
Importers |
Bringing medicines into India, through CDSCO |
| Document | Purpose |
|
Application in the prescribed form |
Request for the licence |
|
PAN and Aadhaar of the owner, partner or director |
Identity |
|
Certificate of Incorporation, Partnership Deed or LLP Agreement |
For companies, firms and LLPs |
|
Board resolution or authority letter |
To show who can apply for the company |
|
Proof of premises (ownership paper or rent agreement) |
Right to use the place |
|
NOC from the property owner |
Permission to run a medical store |
|
Site plan and key plan of the premises with measurements |
For inspection |
|
Registered Pharmacist's certificate and State Pharmacy Council registration |
For a retail licence |
|
Appointment letter and affidavit of the pharmacist or competent person |
Confirms the person will be present |
|
Qualification and experience proof of the competent person |
For wholesale |
|
Passport size photographs |
Application |
|
GST registration, where applicable |
Business registration |
|
Fee payment challan |
Government fee |
|
Declaration and undertaking |
As required by the state |
|
Cold storage details |
For refrigerated medicines |
Note: The exact list differs in each state. We share the full list after we know your state and your business type.
A Drug Licence needs the right pharmacist, the right place and the right papers. Share your plan with CA Arpit Gupta, and we will guide you from the first step to the licence in hand.
Call or WhatsApp CA Arpit Gupta at: +91-7081220600.
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