Schedule H1 in Drug And Cosmetics Act of India

The Government Of India on a wide notification No. dated Aug. 30 2013 vide GSR (588) 3 has amended the Drug And Cosmetics Act  to include new Schedule, namely Schedule H1.
Please fine below here certain salient feature of the same :

• the schedule H1 will be in effect from March 1, 2014.
• Schedule H1 consists of a list of 46 drugs, which is given in annexure 1
• Those retailers who are doing manual billing ( not computerized ) are advised to keep separate bill books  or separate series of bill numbers, so that they can produce the records immediately when asked by the drug control officials.
• Those retailers using computerized billing are advised to fill the column of schedule in the product master  against those drugs included in the Schedule H1 , as Schedule H1.
• Retailers have to maintain a separate register to record the sale of Schedule H1 drugs.TheSchedule H1 register should have the following columns :
• Name of the product and potency
• Quantity sold
• Name and Address of the prescriber
• Name and Address of the patient
• These records are to be maintained for a period of minimum three (3) years.
• It is mandatory from March 1, 2014 that all the products included in schedule H1 are labelled with Schedule H1 warning " To be sold by retail only on the prescription of a Registered Medical Practitioner only" in a box with red border.
• Preparation of the Schedule H1 drugs containing products for topical and external use are not included in the schedule.
• Facts in the Law which automatically apply to the Schedule H1 :
• These drugs are to be sold only against the prescription of a Registered Medical Practitioner .
• The prescription has to be complete in all aspects with all details.
• When the prescription mis dispensed, the pharmacy/ medical store has to put the dispensed/ supplied stamp, date and sign on it .
• A prescription can be dispensed only once unless the doctor specifies in writing that it can be dispensed more than once, and how many times.
• verbals, telephonic, E- mail, Fax, SMS etc. requests / orders for dispensing Schedule H1 Cannot Be entertained.

ANNEXURE 1 :
Alprazolam, Balofloxacin, buprenorphine, capreomycin, cefdinir, cefditoren, cefepime,cefetamet, cefixime, cefoperazone, cefotaxime, cefpirome, cefpodoxime, ceftazidime, cefibuten, ceftriaxone, ceftizoxime, chlordiazepoxide, clofazimine, codeine, cycloserin, diazepam, diphenoxylate, doripenem, ertapenem, ethambutol hydrochloride, ethionamide, feropenem, gemifloxacin, imipenem, isoniazid, lecofloxacin, meropenem, midazolam, moxifloxacin, nitrazepam, pentazocine, prulifloxacin, pyrizinamide, rifabutin, rifampicin, sodium para aminosalicylate, sparfloxacin, thiacetazone, tramadol, zolpidem.

NOTE : In case of any query about schedule H1, please consult the drug inspector of your area in FDA Office.

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