(a) the number of medicines notified by the Government which cannot be sold
without doctors` permission in the country;
(b) whether the Government proposes to impose restriction on over-the-counter
sale of certain new medicines in the country;
(c) if so, the details thereof; and
(d) the other measures being taken by the Government to check the indiscriminate use of
antibiotics and other drugs, including anti-tuberculosis drugs in the country?
THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI GHULAM NABI AZAD)
(a) to (d) : 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:
“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.â€