Concerns have been expressed with respect to the development of antimicrobial resistance in pathogens, even to the newer, more potent anti-microbial drugs, on account of increased availability and use of antibiotics across the country. A Task Force was constituted by the government to recommend measures to address the problem of multi-drug resistance arising out of the widespread and indiscriminate use of antimicrobial drugs in the country, and to assess, review and suggest measures on anti-microbial resistance. The Task Force recommended various steps to rationalize the use of antibiotics in the country.

The recommendations include inter alia, a separate Schedule under the Drugs and Cosmetics Rules to regulate the sale of antibiotics. The Drug and Cosmetics Rules, 1945 have since been amended vide Gazette Notification No GSR 588 (E) dated August 30, 2013 incorporating a new, namely, Schedule H1 under the Drugs and Cosmetics Rule containing 46 drugs which include antibiotic drugs, anti TB drugs and certain habit forming drugs.

The drugs falling under Schedule H1 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 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.

(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.

As a part of its global program, the WHO Secretariat is in the process of the development of a draft global action plan on antimicrobial resistance and is now inviting contributions from all relevant organizations, institutions, networks, civil society groups, national authorities and ministries through an online consultation.