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The Planning Commission of India has set up a working group to look into the drug regulatory mechanism in the country. One of the tasks the panel has been entrusted is to devise a strategy to weed out irrational drugs from the market.
Most of these drugs are fixed dose combination drugs (FDCs), freely prescribed by doctors and often sold over the counter, endangering public health. The working group is likely to submit its report by August 31. An FDC combines two or more active ingredients in a pre-determined ratio, and an irrational FDC is one which has no proven efficacy over single compound drugs administered separately and can be harmful.
FDCs are among the most sold drugs in the country. On a regular day, the Apollo pharmacy in Kalkaji area of south Delhi sells three to four strips of Norflox TZ. The drug is commonly prescribed for diarrhoea. Norflox TZ, manufactured by Cipla Ltd, a Mumbai-based pharmaceutical company, is a combination of two antibiotics— norfloxacin, used in bacterial infections, and tinidazole, used in amoebic dysentery. The combination is called irrational because if a person is suffering from amoebic dysentery and is prescribed the drug, he or she would end up consuming norfloxacin unnecessarily. A 2007 study by A Chakrabarti, professor at the department of pharmacology at the Sikkim Manipal Institute of Medical Sciences, found 59 per cent prescriptions for diarrhoea were FDCs. These FDCs are harmful. For instance, a patient taking Norflox may develop resistance to norfloxacin and not respond to it when he or she needs to be treated with it, says Urmila Thatte, head of the department of clinical pharmacology at KEM Hospital in Mumbai. Cipla refused to comment. Such drugs pose a risk to the whole community because drug resistant germs are transmitted from one person to another.
Whether the Planning Commission panel can check the sale of FDCs is something that remains to be seen. “We are trying to develop an effective mechanism to remove unnecessary drug combinations from the market because earlier attempts of the government have failed,” says Gopal Dabade, member of the Planning Commission panel. He works with the Drug Action Forum, a non-profit based in Karnataka.
| A BAD DOSE | |
| 1. | COMBINATION Ferric ammonium citrate, B12, folic acid and alcohol PRESCRIBED FOR Anaemia WHY HARMFUL Ferric salt is poorly absorbed by the body. Alcohol not needed for treating anaemia |
| 2. | COMBINATION Nimuselide+paracetamol PRESCRIBED FOR Pain and fever WHY HARMFUL There is a worldwide ban on prescribing nimesulide for children because of risk to liver. It combines two similar drugs—both are analgesic and antipyretic |
| 3. | COMBINATION B1, B6, B12, nicotinamide, calcium pantothenate PRESCRIBED FOR Multivitamin deficiency WHY HARMFUL B1, B6, B12 combination is banned because deficiency of the three vitamins rarely occurs together. To avoid ban, Merck has combined them with other compounds |
| 4. | COMBINATION Norfloxacin+tinidazole PRESCRIBED FOR Diarrhoea WHY HARMFUL Norfloxacin treats bacterial diarrhoea and tinidazole treats amoebic dysentery. Combination is unnecessary as both the complications rarely occur together. May lead to antibiotic resistance |
AVOID THESE COMBINATIONS
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