Under the
Drugs & Cosmetics Rules, drugs specified under Schedule H and Schedule X
are required to be sold by retail on the prescription of a Registered Medical
Practitioner only. At present Schedule H
& Schedule X contains 510 & 15 drugs, respectively. Recently, a new Schedule H1 has been
introduced through Gazette notification GSR 588 (E) dated 30-08-2013, which
contain certain 3rd and 4th generation antibiotics, certain habit
forming drugs and anti-TB drugs. These drugs are required to be sold in the country
with the following conditions:
(1)
The supply of a drug specified in Schedule H1 shall
be recorded in a separate register at the time of the supply giving the name
and address of the prescriber, the name of the
patient, the name of the drug and the quantity supplied and such records shall
be maintained for three years and be open for inspection.
(2) The drug
specified in Schedule H1 shall be labelled with the symbol Rx which shall be in
red and conspicuously displayed on the left top corner of the label, and shall
also be labelled with the following words in a box with a red border:
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“Schedule
H1 Drug-Warning:
-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.”
|
This was
stated by Sh. Ghulam Nabi Azad, Union Minister for
Health and Family Welfare in a written reply to the Lok
Sabha today.
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MV/GM