The All India Organisation of Chemists and Druggists (AIOCD) has raised objection to Bihar Drug Controller's decision to stop sale and distribution of FDC containing levofloxacin and ofloxacin in the state.
The Bihar state drug controller on September 7, 2017 had issued a circular to stop sale and distribution of formulations containing levofloxacin and ofloxacin indicated for paediatric use in the state. Action will be taken against those involved in selling and stocking of the said FDC, the notification stated.
Levofloxacin and ofloxacin are part of 344 FDCs banned by the central government on 10 March, 2016 citing health risks and lack of therapeutic justification. The ban was quashed by Delhi High Court in December last year. The central government had approached the apex court seeking to enforce ban on 344 FDCs. Currently the matter is pending in the apex court paving the way for manufacture and distribution of any of these FDCs.
The state drug authority has no power to prohibit any such formulations since the matter is pending in the apex court. The drug regulators cannot take suo moto decision to stop sale and stocking of any of the 344 FDCs till the Supreme Court passes the order, said AIOCD general secretary Suresh Gupta.
Levofloxacin and ofloxacin are antibiotics used for a number of bacterial infections. Levofloxacin is recommended by the Paediatric Infectious Disease Society and the Infectious Disease Society of America as a first-line treatment for paediatric pneumonia caused by penicillin-resistant Streptococcus pneumoniae, and as a second-line agent for the treatment of penicillin-sensitive cases. The WHO recommends a paediatric ofloxacin dose for MDR-TB of 15 to 20 mg/kg of body weight daily.