Overview
This article provides a detailed explanation of Central Drug Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940 and applicable Rules/Regulations. All amendments, notifications, and official circulars up to March 2026 are incorporated.
Relevant provisions: Section 3B + Rules.
Legal Framework
Section 3B + Rules of the Drugs and Cosmetics Act, 1940 establishes the regulatory framework for CDSCO. The provisions cover: (a) scope and applicability, (b) licensing/registration requirements, (c) compliance conditions, (d) inspection and enforcement, and (e) penalties for violation.
Who Must Comply?
| Entity Type | Applicable? | Key Requirement |
|---|---|---|
| Manufacturer | Yes | License/Registration mandatory before operations |
| Importer | Yes | Import license + compliance with Indian standards |
| Dealer/Distributor | Yes | Trade license + labelling compliance |
| E-Commerce Seller | Yes | Same compliance as physical sellers + digital display rules |
| Retailer | Yes | Verification of goods, display of mandatory information |
| Exporter | Partially | Export goods may have different standards; check destination country |
Detailed Explanation with Examples
Example 1: A manufacturer in Faridabad must obtain the required license before commencing production. The application is filed with the prescribed authority along with all required documents. Non-compliance can result in seizure of goods and penalties.
Example 2: An importer bringing goods into India must ensure compliance with Indian standards and obtain necessary registrations/approvals before customs clearance. Goods not meeting standards may be rejected at the port or destroyed.
Example 3: An e-commerce seller listing products online must ensure all mandatory declarations (MRP, net quantity, manufacturer details, country of origin) are displayed on the product listing, just as they would appear on physical packaging.