What is Schedule H1 Drug Under Drugs and Cosmetics Rules & Why Should it Matter to You?

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Updated July 31, 2022

You cannot buy Schedule H1 drugs without a valid prescription and there is buzz about it for sometime now. To understand this precisely, you need to understand the relevant ACT which is Drugs and Cosmetics Act and the rules thereunder.

The Drugs and Cosmetics Rules, 1945, are the set of rules under The Drugs and Cosmetics Act, 1940, which has provisions for classification of drugs into different schedules and also guidelines for storage, sale, display. Schedule H1 has been introduced through Gazette notification GSR 588 (E) dated 30-08-2013 to check the indiscriminate use of antibiotics, anti-TB and some other drugs in the country.

Scientifically, Schedule H1 Drug includes 3rd and 4th generation antibiotics, anti-tuberculosis drugs and certain habit-forming drugs like psychotropic drugs. The list of drugs that comes under the Schedule H1 drugs can be sold only after the prescription of a registered medical practitioner.

To Deal with Schedule H1 Drug Norms has to be Followed

(a) The Schedule H1 drugs that are being sold must be recorded in a separate register, mentioning the name and address of the prescriber, patient and the amount that has been supplied. Even, this register has to be maintained confidentially up to three years and should be open for inspection.

(b) The Schedule H1 drugs should be labelled with the symbol Rx in red. This must be displayed clearly.

Why Hydroxychloroquine is in News?

Hydroxychloroquine: Hydroxychloroquine is a prescription drug. It comes as an oral tablet.

Hydroxychloroquine is available as the brand-name drug Plaquenil. It’s also available in a generic version. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug.

Hydroxychloroquine may be used as part of combination therapy. That means you may need to take it with other drugs.

The government has put the anti-malarial drugs Hydroxychloroquine under Schedule H1 drug. It has been done by exercising its powers granted by Section 26B of the Drugs and Cosmetics Act, 1940.

This move was taken to stop the misuse of the drugs which has now been allowed by the government for prophylactic use in high-risk contacts of COVID-19 patients and healthcare workers treating such patients

Beyond Schedule H1 Drug Under G.A. Reads

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