Drugs and Cosmetics Act 1940
Overview
The Drugs and Cosmetics Act 1940 (D&C Act) is the principal legislation governing drugs, cosmetics, and medical devices in India. It provides the statutory authority for CDSCO to regulate medical devices, including the power to:
- Define and classify medical devices;
- License manufacture, import, and sale;
- Prescribe GMP and labelling requirements;
- Take enforcement action (seizure, prosecution);
- Delegate licensing functions to State Governments (for Class A/B devices).
Key provisions for medical devices
| Section | Subject |
|---|---|
| Section 3(b) | Definition of "drug" (includes medical devices) |
| Section 5 | Central Drugs Laboratory |
| Section 7A–7D | Import of drugs/devices |
| Section 18 | Prohibition on manufacture and sale without licence |
| Section 21 | Powers of inspectors |
| Section 22 | Powers of seizure |
| Section 27–27B | Penalties |
| Section 33 | Power to make rules (Medical Devices Rules 2017) |
Amendments
The D&C Act has been amended multiple times. The most significant amendment for medical devices was the Drugs and Cosmetics (Amendment) Act 2008, which formally brought medical devices under the statutory definition and framework.
Official source: D&C Act 1940 — CDSCO