CDSCO & Drug

A CDSCO & Drug License is a mandatory requirement for businesses involved in the manufacturing, distribution, import, or sale of drugs and cosmetics in India. The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health & Family Welfare, regulates and approves licenses to ensure the safety, efficacy, and quality of drugs and medical products.

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Benefits of Obtaining a Business License

Legal Authorization: Mandatory to operate a drug-related business in India.
Market Credibility: Builds trust among customers, suppliers, and regulatory bodies.
Access to New Markets: Enables product distribution and export opportunities.
Product Safety Assurance: Ensures adherence to quality and safety standards.
Regulatory Compliance: Protects against legal penalties, business disruptions, and product bans.

Applicability

CDSCO and Drug License is applicable for:

Drug Manufacturers & Wholesalers
Retail Pharmacy Stores
Importers & Exporters of Drugs & Medical Devices
Cosmetic Product Manufacturers
Online Pharmacies & E-Commerce Sellers
Medical Device Distributors

Process

License Category Identification
Determine whether you need a manufacturing, wholesale, retail, or import license.
Documentation & Application Preparation
Prepare and organize necessary documents, technical data, and safety protocols.
Online Submission to CDSCO Portal
File the application with the appropriate CDSCO/Zonal licensing authority.
Inspection & Query Resolution
Support during site inspection and resolution of any queries raised by the Drug Control Department.
Grant of Drug License / CDSCO Approval
Receive your CDSCO registration certificate or drug license upon successful compliance.

Documents Required

PAN Card and Aadhar Card of the Proprietor/Directors
Business registration certificate (Company/LLP/Firm)
Premises ownership or rental proof
Site plan and key plan of the premises
Proof of qualification of technical staff (e.g., pharmacist)
Affidavit/undertaking regarding compliance with safety norms
Product formula sheet (for manufacturers)
List of equipment and machinery (for manufacturers)

What You’ll Get

CDSCO Registration Certificate / Drug License
Complete application preparation and filing
Regulatory and technical guidance throughout the process
Support in site inspection and compliance management
Assistance with renewal and post-registration modifications

Frequently Asked Questions

Have a look at the answers to the most asked questions

What is CDSCO and why is it important?

CDSCO is India’s national regulatory authority for pharmaceuticals and medical devices. It ensures public safety by enforcing drug quality standards.

Do all drug-related businesses need a license?

Yes, any business involved in manufacturing, importing, distributing, or selling drugs or cosmetics needs an appropriate license under the Drugs and Cosmetics Act, 1940.

How long does the drug license approval take?

It typically takes 30–60 days, depending on the type of license and jurisdiction.

What happens if I operate without a valid license?

Operating without a drug license can result in heavy penalties, business shutdowns, and legal action.

Does SRV Taxcon assist with renewal and amendments?

Yes, we provide full lifecycle support including license renewals, variations, and technical modifications.