Context
- The Ministry of Health & Family Welfare has recently proposed CCTV surveillance in retail pharmacies selling Schedule H, H1 and X drugs, with footage kept for 3 months, to prevent illegal OTC sales and help tackle antimicrobial resistance (AMR). Wholesale pharmacies are excluded.
What are H, H1, X drugs?
| Schedule | What it means |
| H | Prescription medicines that can be sold at retail only on the prescription of a Registered Medical Practitioner. |
| H1 | A category of prescription drugs subject to additional regulatory controls and record-keeping requirements, particularly to monitor their sale and prevent misuse. |
| X | Drugs subject to stricter prescription and record-keeping requirements; their prescriptions must be in duplicate, with one copy retained by the licensee for two years. |
H: Common prescription medicines / H1: Certain antibiotics, anti-TB & habit-forming drugs / X: Certain narcotic & psychotropic drugs.
Key Regulatory Provisions
- Prescription Requirement: Schedule H, H1 and X drugs cannot be sold by retail except in accordance with a prescription issued by a Registered Medical Practitioner.
- Record Keeping: Sale of Schedule H1 drugs is required to be recorded separately, including details such as the prescriber, patient, drug and quantity supplied, with records maintained for three years.
- Schedule X: The prescription is required to be maintained in duplicate, with one copy retained by the licensee for two years.
- Labelling: These drugs carry specific prescription-related warnings and symbols such as Rx/XRx, depending on the applicable schedule.
Conclusion
The proposed amendments strengthen oversight of Schedule H, H1 and X drugs, with CCTV surveillance aimed at improving transparency and preventing their unauthorised sale.
| Important CTC from this article for UPSC Drugs Rules, 1945 |