• Shruti GOCHHWAL

What are Schedule H Drugs?

According to the Drugs and Cosmetic Act and Rules 1945, the Schedule H drugs mean that they should be sold only against the prescription of a registered medical practitioner. These are drugs which cannot be purchased over the counter unless you have a  prescription of a qualified doctor.

Another important thing under this schedule includes prescribing only the required amount of medications mentioned in the prescription can be dispensed. Also, the drugs can be supplied only to the licensed parties.

The drugs under schedule H must exhibit the text “Rx” and a Schedule H drug warning: To be sold by retailers on the prescription of a Registered Medical Practioner only.

Previously there were only 510 drugs mentioned in the Schedule H drugs list. As per the notification issued by the Department of Health under the Ministry of Health and Family welfare on 16th March 2006, the list was updated to 536 Schedule H drugs

Why was Schedule H1 Introduced?

The schedule H1 drugs were introduced to restrict the selling of antibiotics through over the counter (OTC) sales and should not be sold as non-prescription drugs. This is because it was noted that an unlimited  number of these drugs could be bought.

Irrational prescribing of antibiotics has contributed to the increasing antibiotics resistance and tolerance of psychotropics. As a result, the Government of India issued a gazette notification, regarding scheduling H1 Drugs which shows the importance of this schedule.

What Drugs are Included in Schedule H1?

The schedule H1 drug includes drugs for tuberculosis, 3rd & 4th generation antibiotics, and certain psychotropic drugs which are habit-forming.

To dispense these drugs two main criteria have to be followed strictly.

1) The drug supplied under the schedule H1 specification include:

  1. The entry of supplied drugs in a separate register

  2. Mentioning the details of the prescriber like address and name.

  3. Quantity and name of the drug supplied.

This confidentiality of the register is to be maintained up to 3 years and should be open for inspection.

2) Symbol Rx in red, should be clearly displayed on the schedule H1 drugs on the left top corner of the drug label. The label should include

“Schedule H1 Drug-Warning” which states

-It is dangerous to take this preparation except in accordance with the medical advice.

-Not to be sold by retail without the prescription of a Registered Medical Practitioner.”

There are 46 drugs mentioned in the Schedule H1 drugs and the list shows no limitation of using the drugs as a topical preparation.

Other measures to be taken while prescribing Schedule H1 Drugs

Several measures need to be executed in order to limit the tolerance, otc sales and resistance of the drugs. This can be done by:

  1. a) Surveillance of OTC sales

  2. b) Studying the antibiotic sensitivity and resistance patterns of Schedule H1 drugs

  3. c) Launching of appropriate antibiotic and psychotropic policies in a healthcare facility

  4. d) Creating awareness about rational use of antibiotics in all levels of medical setups including teaching medical institutions

  5. e) Conducting frequent pharmacy audits.

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