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 theprescriber, 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.”
Ministry of Health and Family Welfare, New Delhi on 30 Aug, 2013 vide GSR 588 (E) has notified Schedule H1 after consultation with DTAB. These Rules will come in force after six months of publication in official Gazette.In Rule 65, in condition (3), (9), (11) (11A) wherever Schedule H is their “Schedule H and Schedule H1” shall be substituted.
In Rule 97 in sub rule (1) a provision is made that the formulation containing substance specified in Schedule H1, the drug formulation shall be labelled with symbol Rx which shall be in red and conspicuously displayed in the left top corner of the label and shall also be labelled with following Box warning:
“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,”
In Schedule H, Alprazolam, Cefdinir, Cefepime HCl, Cefetamet Pivoxil, Cefpirome, Cefpodoxime Poxetil, Ceftazidime Pentahydrate, Ceftizoxime Sodium, Chlordiazepoxide, Clofazimine, Codeine, Diazepam, Diphenoxylate and its salts, Ethambutol HCl, Ethionamide, Levofloxacin, Meropenam, Midazolam, Moxifloxacin, Nitrazepam, Pentazocine, Pyrazinamide, Sparfloxacin, Thiacetazone, Tramadol HCl, Zolpidem entries are omitted.
In Schedule H1, following drug substances and their salts excluding those intended for topical or external use (Except ophthalmic and ear or nose preparations) Alprazolam, Balofloxacin, Buprenorphine, Capreomycin, Cefdinir, Cefditoren, Cefepime, Cefetamet, Cefexime, Cefoperazone, Cefotaxime, Cefpirome, Cefpodoxime, Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone, Chlordiazepoxide, Clofazimine, Codeine, Cycloserine, Diazepam, Diphenoxylate, Doripenem, Ertapenem, Etambutol HCl, Ethinamide, Feropenem, Gemifloxacin, Imipenem, Isoniazid, Levofloxacin, Meropenem, Midazolam, Moxifloxacin, Nitrazepam, Pentazocine, Prulifloxacin, Pyrazinamide, Ribabutin, Rafampicin, Sodium Para-aminosalicylate, Sparfloxacin, Thiacetazone, Tramadol and Zolpidem are covered.
Comment: This is indeed a laudable attempt to reduce drug misuse in our country, where routinely 'any' medicine can be purchased without prescription with your local 'helpful' pharmacy.
While there may be some logic in allowing medicines without prescription in a poor country, to reduce health costs, this has lead to a large number of people doing self - diagnosis & self - treatment, or asking the local pharmacist (who is many a times an underpaid school dropout himself!) for medicines.
Putting a lot of these medicines under schdule H1 will hopefully reduce antibiotic misuse and reduce the development of antibiotic resistance in India.