Drug Licence Registration
Drug Licence Registration is a mandatory approval issued by the Central Drugs Standard Control Organization (CDSCO) or State Drug Control Department for businesses engaged in the manufacture, distribution, and sale of drugs, cosmetics, or pharmaceuticals in India. This ensures safety, quality, and compliance with the Drugs and Cosmetics Act, 1940.
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Benefits of Drug Licence Registration
Legal authorization to sell or manufacture drugs and medicines
Builds credibility and trust with consumers and suppliers
Enables participation in government tenders and B2B contracts
Avoids penalties, business shutdowns, or confiscation of goods
Ensures compliance with health and safety standards
Applicability
Drug Licence Registration is required for:
Pharmacy shops and medical stores (Retail)
Drug distributors or wholesalers
Online pharmacies and stockists
Drug or cosmetic manufacturers
Health supplement and Ayurvedic medicine producers
Third-party pharmaceutical marketing firms
Process
Document Collection & Eligibility Check
Determine the appropriate licence type: Retail, Wholesale, or Manufacturing.Application Filing with Drug Department
Submit the online application via CDSCO or State Drug Authority portal with relevant documentation.Premises Inspection by Drug Inspector
Verification of space, storage conditions (like refrigerator for certain medicines), and pharmacist details.Approval & Licence Issuance
Receive your Drug Licence Certificate, usually valid for 5 years.
Documents Required
Identity and Address Proof of applicant
Rent Agreement/Ownership proof of premises
Site plan/layout of the premises
Qualification certificate of the Registered Pharmacist (Retail)
Experience certificate (for Wholesale)
Refrigerator purchase bill (if required)
Affidavit and declaration forms as per State norms
Partnership deed / Company Incorporation Certificate
What You’ll Get
Retail Drug Licence / Wholesale Drug Licence / Manufacturing Licence
Compliance guidance for record maintenance and renewals
Assistance with stock register formats and pharmacist employment requirements
Ongoing support for additions, modifications, or renewal
Frequently Asked Questions
No, selling medicines without a valid drug licence is illegal and punishable by law.
Generally, 10 square meters for Retail/Wholesale, and 15 square meters for both combined (as per state guidelines).
No, but the applicant must have pharmaceutical experience and appoint a competent person.
Typically, 15–30 working days, depending on the state authority and inspection schedule.
Drug licences are non-transferable, but amendments can be made in certain cases.
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