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Curb OTC sale of antibiotics, FDA told

The government move, which makes prescription a must, aimed at preventing misuse of drugs used to treat tuberculosis.

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The state health authorities have told the Food and Drugs Administration (FDA) to ban over-the-counter-sale of some antibiotics used for tuberculosis treatment.

These antibiotics are prescribed for cough, cold and diarrhoea. “We have asked the FDA to ensure that the sale of antibiotics prescribed for tuberculosis should be banned from selling without the doctor’s prescription,” said Dr PY Gaikwad, joint director (TB), state health department.

The move, said health officials, will ensure that the indiscriminate use of TB drugs is stopped. The use of drugs without prescription is one of the reasons that has led to multi-drug resistant tuberculosis in the city. “These antibiotics are also prescribed for treatment of cough, diarrhoea and respiratory-tract infection. Their rampant use may develop resistance to them in mycobacterium tuberculosis, especially if a patient has got active tuberculosis infection,” said Dr Gaikwad.

The drugs that cannot be sold over the counter include Rifampicin, Ofloxacin (diarrhoea second line treatment), Ciprofloxacin, Levofloxacin, Kanamycin, Capremomycin and Amikacin. “We will ask the state FDA to send a letter to all chemists to maintain a register to record the names of doctors prescribing these drugs and details of the patient buying the drugs from the outlet,” said Dr Gaikwad.

KB Shende, the joint commissioner (drugs), FDA, said  the over-the-counter (OTC) sale of antibiotics has been banned. “But we want chemist to strictly follow the OTC sale ban for the antibiotics that can be used for TB treatment.”

The state plans to sensitise private practitioners to prescribe antibiotics only when it is the last option. “It will be a wise decision to stop the OTC sale of these antibiotics,” said Dr Subodh Kedia, vice-president of general practitioner of greater Mumbai. “Ofloxacin is often used in the treatment of diarrhoea. This should be avoided. One can treat diarrhoea without this antibiotic. This drug is also used in second-line treatment of TB."

The BMC is yet to contact the general physician association in the city. “We have not got any information from health authorities. We have organised a conference for our doctors to update our doctors on TB treatment and the rising drug-resistant forms of TB.”

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