Schedule H

Schedule H is a class of prescription drugs in India falling under the Drugs and Cosmetics Rules, 1945. These drugs cannot be purchased over the counter without the prescription of a qualified doctor. The label of Schedule H drugs carries a symbol 'Rx' which needs to be prominently displayed on the label.

Overview

The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, have clear guidelines on the sale of Schedule H and Schedule H1 drugs. These can only be sold by a registered pharmacist in a licensed pharmacy on a doctor's prescription. The pharmacist is required to maintain a separate register for the sale of these drugs and the register is to be retained for two years.

Schedule H1

In 2013, the Ministry of Health and Family Welfare introduced a new category, Schedule H1, to prevent the misuse of certain drugs. This category includes antibiotics, anti-TB drugs, and certain habit-forming drugs. The packaging of these drugs is marked with a symbol 'Rx' in red, along with a box with red border.

Regulations

The sale of Schedule H drugs is regulated under the Drugs and Cosmetics Act. The Act prohibits the sale of these drugs without a valid prescription and mandates the maintenance of a sales record for these drugs. Violation of these regulations can result in imprisonment and a fine.

List of Schedule H Drugs

The list of Schedule H drugs is extensive and includes a wide range of drugs from different therapeutic categories. Some of these include antibiotics, antidiabetics, antihypertensives, and drugs used for the treatment of psychiatric disorders.

See Also

• Drugs and Cosmetics Act
• Pharmacy Act
• Pharmaceutical policy in India