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Health ministry notifies amendment in D&C Rules to insert Schedule H1 with 46 drugs 
September 15th, 2013 I Author: Manu UK
After dilly-dallying on the issue of antibiotics policy for long, the government has amended the Drugs and Cosmetics Rules to insert Schedule H1 category to regulate the use of antibiotics in the country, but placing 46 antibiotics under category instead of original proposal to include 91 drugs. While doing away with many of the original recommendations which ran into tough resistance from the traders community, the government made it compulsory for these listed antibiotics to carry warning. "If it contains a drug substance specified in Schedule H1, the drug formulation shall be labeled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label," according to the official notification by the health ministry.
It also said the warning should be labeled in a box with red border. The words of the warning will be: "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."
"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," according to the extraordinary gazette notification.
Antibiotics falling under third and fourth generation and several habit forming drugs are in the list. Alprazolam, Balofloxacin, Buprenorphine, Capreomycin, Cefdinir, Cefditoren, Cefepime, Cefetamet, Cefixime, Cefoperozone, Cefotaxirne, Cefpirome, Cefpodoxime, Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone, Chlordiazepoxide, Clofazimine, Codein, Cycloserine, Diazepam, Diphenoxyl ate, Doripenem, Ertapenem, Ethambutol Hydrochloride, Ethionamide, Feropenem, Gemifloxacin, Imipenem, Isoniazid, Levofloxacin, Meropenem, Midazolam, Moxifloxacin, Nitrazepam, Pentazocine, Prulifloxacin, Pyrazinamide, Rifabutin, Rifampicin, Sodium Para-aminosalicylate, Sparfloxacin, Thiacetazone, Tramadol and Zolpidem are the drugs included in the list.
"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," the notification said.
The draft rules were published on March 20,2012, without consulting the Drugs Technical Advisory Board, inviting suggestions and objections. Later, the DTAB was consulted and the suggestions and objections were also considered by the government, according to the notification. The rules will come into effect after six months of the publication of the official gazette, dated August 30, it added.
The final notification has diluted many of the original provisions. First the proposal was to include 91 antibiotics, but the chemists' bodies objected to it. Another provision of having two prescriptions to buy antibiotics was also deleted. The DTAB instead suggested the amendment in Rule 65 to incorporate the conditions of keeping registers by the seller.
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