The Drugs and Cosmetics Rules, 1945 contain the detailed regulatory framework for implementing the Drugs and Cosmetics Act, 1940.
These Rules are extremely important for retail pharmacies, wholesale drug dealers, manufacturers, hospitals, pharmacists, regulatory professionals and lawyers dealing with drug law compliance.
Why These Rules Matter
- Retail and wholesale drug licences
- Conditions of sale licence
- Schedule H, Schedule H1 and Schedule X drugs
- Prescription and record requirements
- Labelling and packaging requirements
- Manufacturing and distribution compliance
Important Rules and Schedules
- Rule 61 – Forms of sale licences
- Rule 64 – Conditions before grant of licence
- Rule 65 – Conditions of licences
- Rule 65A – Additional conditions for Schedule X drugs
- Schedule H – Prescription drugs
- Schedule H1 – Special prescription and record requirements
- Schedule X – Special control drugs
Last verified: June 2026