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Both 1 and 2
Statement 1: These are not to be sold by retail without the prescription of a Registered Medical Practitioner.
The Drugs and Cosmetic Rule, 1945 were amended in 2013 to incorporate a new Schedule H1 under the said rules containing 46 drugs which include IIIrd and IVth generation antibiotics, anti TB drugs and certain habit forming drugs for having strict control over the sale of these drugs.
The Drugs falling under Schedule H1 are required to be sold in the country with the following conditions:
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.
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 (the two question statements) in a box with a red border
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