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Yatin ShahPratik VoraYatin Shah is a Post-graduate student of Pharmacy at Department of Pharmaceutics and Pharmaceutical Technology, Ramanbhai Patel College of Pharmacy, Charotar
University of Science and Technology (CHARUSAT), Changa, India.
Pratik Vora received his bachelor’s degree in pharmacy from the Gujarat Technological University with fourth rank, and since mid-2012, has been a postgraduate student in pharmaceutics at Parul Institute of Pharmacy, India. Vora is doing his research work in Torrent Research Center, Gandhinagar.

In an effort to encourage rational prescribing of antibiotics and minimize the development of resistance to antimicrobials in India, the Central Drugs Standard Control Organisation (CDSCO) has introduced Schedule H1 to take major vicissitudes on antibiotics. The new provision calls for monitoring the sale and supply of covered schedule drugs by recording the name and address of prescriber, the name of the patient, the name of the drug, and the quantity supplied in a separate register. These records shall be maintained for three years and open for inspection.

The Schedule H1 covers 46 drugs including 24 antibiotics (Balofloxacin, Cefdinir, Cefditoren, Cefepime, Cefetamet, Cefximime, Cefoperazone, Cefotaxime, Cefpirome, Cefpodoxime, Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone, Doripenem, Ertapenem, Feropenem, Gemifloxacin, Imipenem, Levofloxacin, Meropenem, Moxifloxacin, Prulifloxacin, and Sparfloxacin), 11 habit-forming drugs (Alprazolam, Buprenorphine, Chlordiazepoxide, Codeine, Diazepam, Diphenoxylate, Midazolam, Nitrazepam, Pentazocine, Tramadol, and Zolpidem), and 11 commonly prescribed anti-tuberculosis drugs (Ethambutol HCl, Ethionamide, Isoniazid, Pyrazinamide, Rifabutin, Rifampicin, Sodium p-aminosalicylate, Thiacetazone, Capreomycin, Clofazimne, and Cycloserine). This provision was released on August 30, 2013 by the Ministry of Health and Family Welfare and will likely be effective starting on March 01, 2014. Preparation of aforementioned drug substances and their salts will be covered as well, except those intended for topical or external use, i.e., ophthalmic and ear or nose preparations.

In this provision, all scheduled drug formulations must be conspicuously labelled with the symbol Rx in red and a box with a red border displayed on the left top corner of the label.

schedule h1

This new provision of the revised Drugs and Cosmetic Act was created with following objectives:

  1. To check the continuing practice of indiscriminate use of antibiotics in India
  2. To decrease the irrational use of antibiotics
  3. To reduce multiple drug resistance
  4. To decrease the cost of the total therapy, rationality in the prescription

What are your thoughts about the impact of Schedule H1 on prevention of drug resistance?