Over–the–counter sale of anti–tuberculosis (TB) drugs, also used as broad spectrum antibiotics for treatment of cough, diarrhoea and respiratorytract infection, will soon be banned in Maharashtra.

The state health department has asked the Food and Drug Administration (FDA) to send instructions to chemists not to sell these antibiotics without a valid prescription from a recognised doctor as indiscriminate use of anti–TB drugs can lead to multi–drug resistant (MDR) TB.

“Rifampicin, ofloxacin, ciprofloxacin, levofloxacin, kanamycin, capremomycin and amikacin must not be sold without a valid prescription from a recognised medical practitioner. The state FDA must send instructions 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,” Pradip Gaikwad, joint director (TB), state health department told TOI on Monday.

“These drugs are being used as antibiotics for treatment of cough, diarrhoea, respiratory tract infection and other ailments. These drugs have got some anti–TB activity. By using them as antibiotics, there is likelihood that this will lead to development of resistance to them in mycobacterium tuberculosis, especially if the patient has got active tuberculosis infection,” he added.

Private medical outlets have an important role to play in improving case detection, ensuring effective treatment and reducing the incidence of drug resistant TB. It is believed that many bypass the clinical setting, preferring to go to the medical outlet as first point of contact, he added.

As it is 80% of Indian population is infected with tubercle bacili. More alarmingly, recently, it has been shown that primary resistance to mycobacterium tuberculosis to ofloxacin is 16 to 23 %, leading to its subsequent withdrawal and replacement by levofloxacin in the DOTS Plus programme for MDR TB, Gaikwad said.

Though great strides were made in addressing TB control many challenges still remain. For the further success of the programme, involvement of private sector is very critical especially to increase case detection and adherence to treatment.

“Hence, greater emphasis is now placed on involving private doctors and pharmacists to expand accessibility to the TB control services,” Gaikwad said.

At present, under the Revised National TB Control Programme (RNTCP), TB diagnosis and treatment services are available for free. This essentially means that all TB patients have access to quality and effective treatment. he RNTCP is implemented in all the 33 districts and 22 corporations in Maharashtra.

“The fluoroquinolone group of antibiotics like ciprofloxacin, ofloxcin, levofloxacin and maxifloxacin have been classified as one group of reserve drugs against tuberculosis by World Health Organisation (WHO) and International Union Against Tuberculosis and Lung Disease,” senior chest physician K C Mohanty, an authority on the treatment of TB in India, said.

Mohanty, who has been practising in the field for more than 40 years, stated this in a letter to the Drug Controller General of India (DCGI).

“No combination of fluoroquinolones with other antibiotics should be manufactured. Otherwise, we will be left with no drug to treat drug resistant (DR), multidrug resistant (MDR), extensively drug resistant and extra–extensively drug resistant tuberculosis,” Mohanty said.

NO OTC SALE:Rifampicin, ofloxacin, ciprofloxacin, levofloxacin, kanamycin, capremomycin & amikacin