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Taking a cue from the US, the Health Ministry may introduce warning labels on the third generation antibiotics about the health hazards due to their rampant usage, which is becoming a major contributor to the problem of drug-resistant infections like typhoid and tuberculosis.
The drugs would continue to be available over-the-counter (OTC) but with a warning for the users as presently it is not possible to ban their sale through the chemists as has been proposed in the National Antibiotics Policy, a senior Health Ministry told The Pioneer.
Citing concerns over access of the medicines and basic health facilities in the rural areas, the Ministry has been treading cautiously to go ahead to ban the OTC sale of the antibiotics. Various surveys have suggested that nearly 80 per cent qualified medical practitioners in India practise in cities or towns.
“A broader consensus is needed before we can go ahead with clamping down on OTC sale of third generation antibiotics. The strict curbs would hamper availability of the drugs in the rural areas where not a single doctor is available to treat the patients,” the official said.
Hence we are going stepwise in this direction and introducing a warning label on as many as 90 antibiotics which have been categorised as third-generation drugs is the first-step, he said.
The Food and Drug Administration (FDA) of the US way back in 2003 had introduced warning label on the antibiotics with an aim to reduce inappropriate prescribing of antibiotics for common ailments such as ear infections and chronic coughs, which often are caused by viruses that do not respond to antibiotics.
The Health Ministry plans to try and publicize the warnings through various campaigns to reach out to the people.
After the issue of healthcare facilities in the rural areas is resolved, the Ministry has plans to ban OTC sale of the antibiotics through a notification of a newly introduced Schedule H1 in Drug and Cosmetic Act. The schedule when finalized would have two parts -- Part A having 16 drugs and antibiotics that would be sold directly by drug manufacturers to the tertiary care hospitals.
These drugs will have a label with a red box and would be marked as for use in tertiary care hospitals only. Part B had 74 drugs and formulations that would carry the warning. Part A included drugs like Moxifloxacin, Meropenem, Imipenem, Ertapenem, Doripenem, Colistin, Linezolid and Cefpirome. Part B included drugs like Gentamicin, Amikacin, Pencillin, Oxacilin, Zolpidem, Norfloxacin, Cefaclor and Cefdinir.
The drugs would continue to be available over-the-counter (OTC) but with a warning for the users as presently it is not possible to ban their sale through the chemists as has been proposed in the National Antibiotics Policy, a senior Health Ministry told The Pioneer.
Citing concerns over access of the medicines and basic health facilities in the rural areas, the Ministry has been treading cautiously to go ahead to ban the OTC sale of the antibiotics. Various surveys have suggested that nearly 80 per cent qualified medical practitioners in India practise in cities or towns.
“A broader consensus is needed before we can go ahead with clamping down on OTC sale of third generation antibiotics. The strict curbs would hamper availability of the drugs in the rural areas where not a single doctor is available to treat the patients,” the official said.
Hence we are going stepwise in this direction and introducing a warning label on as many as 90 antibiotics which have been categorised as third-generation drugs is the first-step, he said.
The Food and Drug Administration (FDA) of the US way back in 2003 had introduced warning label on the antibiotics with an aim to reduce inappropriate prescribing of antibiotics for common ailments such as ear infections and chronic coughs, which often are caused by viruses that do not respond to antibiotics.
The Health Ministry plans to try and publicize the warnings through various campaigns to reach out to the people.
After the issue of healthcare facilities in the rural areas is resolved, the Ministry has plans to ban OTC sale of the antibiotics through a notification of a newly introduced Schedule H1 in Drug and Cosmetic Act. The schedule when finalized would have two parts -- Part A having 16 drugs and antibiotics that would be sold directly by drug manufacturers to the tertiary care hospitals.
These drugs will have a label with a red box and would be marked as for use in tertiary care hospitals only. Part B had 74 drugs and formulations that would carry the warning. Part A included drugs like Moxifloxacin, Meropenem, Imipenem, Ertapenem, Doripenem, Colistin, Linezolid and Cefpirome. Part B included drugs like Gentamicin, Amikacin, Pencillin, Oxacilin, Zolpidem, Norfloxacin, Cefaclor and Cefdinir.
