Schedule H1 in Drug And Cosmetics Act of India
Import drug rules of
The Government Of India on a wide notification No. dated Aug. 30, 2013, vise GSR (588) 3 has amended the Drug And Cosmetics Act to include new Schedule, namely Schedule H1.
Please, find 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 annex 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. The Schedule 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 labeled with Schedule H1 warning " To be sold by retail only on the prescription of a Registered Medical Practitioner only" in a box with a 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 is 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, Email, 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, Zolpiderm.
