The Government will include only 48 antibiotics in the proposed Schedule H1, instead of 91 antibiotics as planned in the original proposal. The notification to include this as a separate new Schedule aimed at monitoring and regulating the sale of antibiotics in the country is expected soon.

According to the new proposal, cleared by the Drugs Technical Advisory Board (DTAB), the Schedule H1 will have only third, fourth generation and carbapenum class of antibiotics. Besides, it will also include some anti-TB and habit forming drugs, without affecting the national TB control programme.

Another change in rules will be omission of having two prescriptions to buy these antibiotics. The DTAB has recommended that “in order to keep a check or monitor the sale of such drugs, a condition should be incorporated under Rule 65 that the supply of any drug covered in the Schedule shall be recorded in a separate register at the time of supply giving the name and address of the prescriber, the name of the patient and name of the drug and the quantity supplied. These records shall be maintained for three years and open for inspection.”

As many as 24 antibiotics falling under third and fourth generationn antibiotics and Carbapenum groups of drugs will be among the drugs to be plaed in the Schedule H1. They are Meropenem, Imipenem, Ertapenem, Doripenem, Feropenem, Balofloxacin, Cefdinir, Cefditoren, Cefepime, Cefetamet, Cefixime, Cefoperazone, Cefotaxime, Cefpirome, Cefpodoxime, Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone, Gemifloxacin, Levofloxacin, Moxifloxacin, Prulifloxacin and Sparfloxacin.

The habit forming drugs to be included in the Schedule are Alprazolam, Buprenorphine, Chlordiazepoxide, Codeine, Dextroropoxyphene, Diazepam, Diphenoxylate, Midazolam, Nitrazepam, Pentazocine, Propoxyphene, Tramadol and Zolpidem.

There are going to be 11 anti-TB drugs. They are Ethambutol Hydrochloride, Isoniazid, Pyrazinamide, Rifampicin, Ethionamide, Cycloserine. Sodium Para-aminosalicylate, Rifabutin, Capreomycin, Clofazimine, and Thiacetazone.

The Government had already published draft rule in March 2012 for incorporating the separate Schedule H1. The notification had included 91 antibiotics and the provision for double prescription for the purpose of auditing so as to find out how these drugs are being sold and used. It was based on the recommendation by a Task Force set up by the Government to assess, review and suggest measures to contain anti-microbial resistance.

However, the proposal ran into rough weather with trade bodies and practitioners raising apprehensions and protests over the practical difficulties and possible decline in sales. The Government hence had decided to review the proposal and sent to the DTAB.