Drugs and Cosmetics Act 1940 + New Drugs and Clinical Trials Rules 2019

Applies to

Manufacture, sale, distribution, import or clinical investigation of drugs (including biologicals, vaccines, blood products), medical devices (notified under the Medical Devices Rules 2017), and cosmetics in India.

Key points

• Manufacturing licence (state Drug Controller) — Forms 25/28 for drugs.
• Import registration (CDSCO) — Form 41 + 42.
• Medical Devices Rules 2017: risk-based Class A/B/C/D regime; transition to mandatory licensing complete for most categories by 2024.
• Clinical Trials: NDCT Rules 2019 — DCGI approval, Ethics Committee registration, SUSAR reporting.
• Mandatory QR-code traceability rolled out for top 300 drug brands from Aug 2023 onwards.

Applicability triggers

• Manufacture, sale, import or distribution of drugs / cosmetics / medical devices
• Clinical trial of a new drug or investigational medical device

Practitioner questions

• Which Class (A/B/C/D) does our medical device fall under, and which CDSCO form applies?
• Has the New Drugs Act 2025 Bill been notified, and what transitions does it bring for legacy licences?
• What is the latest QR-code traceability mandate scope — and does our brand fall in?

Sources

• CDSCO
• Drugs and Cosmetics Act 1940 (India Code)