Drugs which can lead to resistance and are habit-forming will now have to be labelled “dangerous” along with a box warning, stating: “To be sold on the prescription of a registered medical practitioner only”.
To make sure that such drugs are not prescribed unabated, the government has proposed the insertion of a new “Schedule H1”, labelling of such formulations with symbol Rx which shall be in red conspicuously displayed on the left top corner of the label.
A notification to this effect is likely to come this week and is aimed at preventing the widespread misuse and overuse of antibiotics which was earlier blamed for the spread of “superbug” NDM-1, resistant to even the most powerful group of antibiotics. The government has segregated about 80 drugs from the existing Schedule H of the Drugs and Cosmetics Act that contains a list of 536 drugs which are required to be dispensed on the prescription of a registered medical practitioner. The segregated drugs, mostly habit-forming, third-line treatment drugs, anti TB, anti malaria drugs etc will be placed under a new Schedule-H1. “We are expecting that this will act as a deterrent for the doctors and chemists who prescribe third line drugs unabated. TB resistance and resistance to malaria has become quite common, that’s why it was decided to put them in the new schedule so that extra vigil can be kept,” said a senior official in the health ministry.
The government had in 2010 decided to come out with a comprehensive policy on antibiotic use after British medical journal Lancet blamed India for spreading the superbug. The new rules, according to the ministry officials, are baby steps in the same direction. “Instead of shelving the whole antibiotic policy, we have decided to make a move forward and create H1 so as to create better awareness not only among the doctors but also among people. The earlier decision to have two prescriptions from the doctors however has been shelved for the time being,” added the official.
The steps have been taken following the report of a task force under former director-general of health services R.K. Srivastava and included experts from India’s top medical institutes. The experts had proposed that hospitals should mandatorily set up a drug control committee to approve high-end antibiotics and an infection control committee to track infections.