The Indian Drug Manufacturers' Association (IDMA) has urged Maharashtra Food & Drug Administration (FDA) to allow manufacturing and marketing of fixed dose combination (FDC) of cefixime (200/200/100) + azithromycin (250/500/125). The manufacturers and marketers of FDC of cefixime + azithromycin are facing problems as they are not allowed to sell their product in certain parts of Maharashtra.
Recently, the special committee operation was undertaken by a drug inspector in Maharashtra where 6000 FDCs dossiers were scrutinized and a report was submitted to the concerned ministry.
Various companies had submitted dossiers to DCGI with the necessary data of the SLA-approved FDCs prior to September 2012 and post 1988. DCGI is yet to make a policy decision pertaining to SLA-approved FDCs status. The manufacturers and the marketers are requesting the Maharashtra FDA to allow them to manufacture and sell their product till the final decision is made by the DCGI.
O S Sadhwani, joint commissioner, FDA Maharashtra says, “6000 FDCs were evaluated and they were categories as rational and irrational. One of the drug inspectors in Nagpur has stopped the sales and marketing of the FDC of cefixime + azithromycin in all the chemist shops, after receiving the letter.”
He further adds, “The drug inspector could not understand the role of FDC of cefixime + azithromycin which is used for treating typhoid and contributes 1 per cent of pharma market share in India. We are looking into the matter and I have explained the entire matter to the Maharashtra FDA Commissioner and DCGI. We are now waiting for final decision from DCGI.”
Zifi AZ manufactured by Akums; Hifen AZ manufactured by Hetero; Ziminic AZ manufactured by Akums; Zithrox Cefolac-AZ manufactured by Macleods; Brutacef-AZ manufactured by Relax and Taxim AZ manufactured by Alkem are the brands which have suffered affected due to this issue.
“The FDC of cefixime + azithromycin needs to be persisted because the said combination is useful for certain population of patients with multi-resistant typhoid fever or moderate-to-severe lower respiratory tract infections. We therefore request the Maharashtra FDA to allow the existing manufacturers to continue the manufacturing and marketing of the said product until DCGI's final decision is made,” the IDMA urged the Maharashtra FDA.