TEAM HERALD
PANJIM: The Ministry of Health, in a 30th August, 2013 notification, had amended the Drugs & Cosmetics Rule 1945, and created a new category of medicines – called as Schedule H1, and shifted 46 drugs from the Schedule H category to this new schedule H1.
The new law will be applicable from March 1.
The ministry was forced to take this step when more than a year ago a research study was published in one of the most reputed medical journals in the world – The Lancet, about how India was responsible for creation of the “superbug” – bacteria which are resistant to almost all the antibiotics available.
Along with many antibiotics, the Ministry has included various (11) psychotropic medicines in the Schedule H1 because of their potential for misuse.
The Schedule H1 also includes the first and second line antibiotics for TB, which, with emergence of MDR (Multi Drug Resistant) & XRD (Extremely Drug Resistant) TB, are becoming ineffective on many patients.
The formulation packs of these drugs should have a warning printed on the box with a red border on the label.
These specified list of drugs can only be sold by chemists after retaining a copy of the prescription and maintaining a separate register by them.
The ministry had originally planned to include 91 drugs under the Schedule H1 but in the wake of strong objections from different sections especially from the trading community the list was pruned to 46. With the notification already gazetted, the CDSCO has the responsibility to enforce the order in the days to come.
