Overview
A drug licence is required to manufacture, sell, stock or distribute drugs and medicines in India under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. Retail sale requires a retail drug licence and wholesale supply requires a wholesale drug licence, each issued by the State Drugs Control Department. Applications generally require a qualified or competent person, such as a registered pharmacist for retail, and suitable premises with storage facilities.
Objective
To obtain the licence required to lawfully sell, stock or distribute drugs and medicines in India.
Characteristics
- Governed by the Drugs and Cosmetics Act, 1940 and its Rules
- Retail and wholesale licences are issued separately
- Issued by the State Drugs Control Department in most cases
- Retail licences generally require a registered pharmacist
- Premises must meet area and cold storage requirements as prescribed
Eligibility
- Pharmacies, chemists, wholesalers and distributors of drugs
- Retail applicants with a registered pharmacist on the premises
- Wholesale applicants with a competent person meeting the qualification or experience norms
- Businesses with premises meeting the prescribed area and storage conditions
Governing law
- Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945
- State Drugs Control Department
- Central Drugs Standard Control Organisation (CDSCO) for certain categories
The process
- 1Requirement check
We determine whether you need a retail or wholesale licence and confirm the premises and personnel requirements.
- 2Documentation
We prepare the application, pharmacist or competent person details and premises documents.
- 3Application filing
We file the application with the State Drugs Control Department and pay the fee.
- 4Inspection and grant
We coordinate the drug inspector's visit and follow up until the licence is granted.
Documents required
- Identity and address proof of the applicant
- Proof of ownership or rent agreement for the premises
- Site and layout plan of the premises
- Registration and qualification proof of the pharmacist or competent person
- Refrigerator and storage facility details
- Constitution documents of the entity such as incorporation or partnership deed
Benefits
- Provides lawful authority to sell, stock or distribute medicines
- Builds trust with customers, suppliers and regulators
- Supports participation in supply and institutional tenders
- Helps ensure safe storage and handling of drugs
Frequently asked questions
What is the difference between a retail and wholesale drug licence?
A retail drug licence covers sale of medicines directly to consumers, while a wholesale licence covers supply to other businesses such as chemists, hospitals and distributors.
Is a registered pharmacist required?
For a retail drug licence, a registered pharmacist is generally required. Wholesale licences require a competent person meeting prescribed qualification or experience norms.