46 Antibiotics
Kindly note the important points:
- Schedule H1 will be effective for enforcement from 01.03.2014.
- Under Schedule H1 46 molecules are included as per list in attached gazette notification (Serial No.1 to 46).
- The listed 46 molecules and their formulations will attract the new rules for there sale and purchase.
- The old stocks lying in the trade which is not qualifying the specific provisions under the amendment is liable to return back to wholesalers & manufacturers respectively.
- Particularly advise all the wholesales that they will keep the minimal level of the stock of product’s included in list to avoid further complications.
- Particularly advise retailers to sales this drugs under issuance of sale bill only.
- As per new clause “h”the supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of supply giving the name address of the prescriber, 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.
- Also note that preparations containing the above drug substances and their salts excluding those intended for topical or external use (except ophthalmic and ear or nose preparations) containing above substances are also covered by this Schedule.
- Preparations containing listed drug substances specified in Schedule H1.The drug formulations shall be lebelled with the symbol Rx in Red and conspicuously displaced on left top corner of the lable.
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10.The box of preparations containing listed drug substances
specified in Schedule H1 shall also be labelled with the
following words in a box with red border.